A Study of TAK-981 in People With Advanced Solid Tumors o... | NCT03648372 | Trialant
NCT03648372
Sponsor
Takeda
Status
Terminated
Last Update Posted
Nov 19, 2024Actual
Enrollment
109Actual
Phase
Phase 1Phase 2
Conditions
Neoplasms
Lymphoma
Hematologic Neoplasms
Interventions
TAK-981
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT03648372
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
TAK-981-1002
Secondary IDs
ID
Type
Description
Link
U1111-1214-4537
Registry Identifier
WHO
2020-003947-27
EudraCT Number
Brief Title
A Study of TAK-981 in People With Advanced Solid Tumors or Cancers in the Immune System
Official Title
An Open Label, Dose-Escalation, Phase 1/2 Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of TAK-981 in Adult Patients With Advanced or Metastatic Solid Tumors or Relapsed/Refractory Hematologic Malignancies
Acronym
Not provided
Organization
TakedaINDUSTRY
Status Module
Record Verification Date
Oct 2024
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Enrolment Challenges
Expanded Access Info
No
Start Date
Oct 1, 2018Actual
Primary Completion Date
Nov 22, 2023Actual
Completion Date
Dec 14, 2023Actual
First Submitted Date
Aug 24, 2018
First Submission Date that Met QC Criteria
Aug 24, 2018
First Posted Date
Aug 27, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Oct 24, 2024
Results First Submitted that Met QC Criteria
Oct 24, 2024
Results First Posted Date
Nov 19, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 24, 2024
Last Update Posted Date
Nov 19, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
TakedaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is in 2 parts.
The main aims of the 1st part of the study are to check if people with advanced solid tumors or cancers in the immune system (lymphomas) have side effects from TAK-981, and to check how much TAK-981 they can receive without getting side effects from it.
The main aims of the 2nd part of the study are to learn if the condition of people with specific cancers improves after treatment with TAK-981. Another aim is to check for side effects from TAK-981.
In the 1st part of the study, participants will receive TAK-981. In the 2nd part of the study, participants with specific tumor types will receive TAK-981 at the recommended phase 2 dose determined during the 1st part of the study.
In both parts of the study, participants can receive TAK-981 for up to 1 year or longer if their condition stays improved. Participants will receive TAK-981 through vein.
Detailed Description
The drug being tested in this study is called TAK-981. TAK-981 is being tested to evaluate safety, tolerability, preliminary efficacy and PK in participants with advanced or metastatic solid tumors or relapsed/refractory hematologic malignancies. The study will include 2 phases: Phase 1 dose escalation and Phase 2 dose expansion cohorts (cancer treatment expansions).
The study will enrol approximately 202 participants, approximately 70 participants in the dose escalation phase, approximately 132 participants in cancer treatment expansion phase.
In the dose escalation, dose levels will be escalated based on safety, and available PK and pharmacodynamic data and will also determine the single agent RP2D. Participants in dose expansion phase will be enrolled, once RP2D is determined. There will be 6 cohorts in cancer treatment expansions.
Cohort A: Nonsquamous NSCLC
Cohort B: Cervical cancer
Cohort C: MSS-CRC
Cohort D: Relapsed/refractory DLBCL progressed or relapsed after CAR T-cells therapy
Cohort E: Relapsed/refractory DLBCL that have not received prior cellular therapy
Cohort F: Relapsed/refractory FL
This multi-center trial will be conducted in European Union, China and United States. The overall time to participate in this study is approximately 2 years. The overall time to receive treatment in the dose escalation and cancer treatment is approximately 1 year. Based on decision of sponsor, participants with demonstrated clinical benefit can continue treatment beyond 1 year. Participants will make multiple visits to the clinic and will make a final visit 30 days after receiving their last dose of drug or before the start of subsequent anticancer therapy, whichever occurs first for a follow-up assessment.uroped
Conditions Module
Conditions
Neoplasms
Lymphoma
Hematologic Neoplasms
Keywords
Drug therapy
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
109Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase 1, Dose Escalation Cohort: TAK-981
Experimental
TAK-981, intravenously, administered as 60 minute-infusion, once on Days 1, 4, 8, and 11 in a 21-day treatment cycle for up to approximately 12 months or until discontinuation from the study. If clinical safety, pharmacokinetics, and pharmacodynamics are supportive, the dosing schedule may be modified to evaluate a less intensive administration of TAK-981 on Day 1, or Days 1 and 8, or Day 1, Day 8, and Day 15 in 21-day cycles in participants with advanced or metastatic solid tumors or lymphomas. Dose levels will be escalated based on the Bayesian logistic regression modeling (BLRM). The dose escalation phase will determine the RP2D of TAK-981.
Drug: TAK-981
Phase 2, Cohort A: Nonsquamous NSCLC
Experimental
TAK-981 intravenously administered as 60 minute-infusion in a 21-day treatment cycle for up to approximately 12 months or until discontinuation from the study in participants with nonsquamous non-small cell lung cancer (NSCLC).
Drug: TAK-981
Phase 2, Cohort B: Cervical Cancer
Experimental
TAK-981 intravenously administered as 60 minute-infusion in a 21-day treatment cycle for up to approximately 12 months or until discontinuation from the study in participants with cervical cancer.
Drug: TAK-981
Phase 2, Cohort C: MSS-CRC
Experimental
TAK-981 intravenously administered as 60 minute-infusion in a 21-day treatment cycle for up to approximately 12 months or until discontinuation from the study in participants with microsatellite-stable colorectal cancer (MSS-CRC).
Interventions
Name
Type
Description
Arm Group Labels
Other Names
TAK-981
Drug
Intravenous infusion.
Phase 1, Dose Escalation Cohort: TAK-981
Phase 2, Cohort A: Nonsquamous NSCLC
Phase 2, Cohort B: Cervical Cancer
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 1: Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs)
TEAEs were adverse events (AEs) that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug. AE means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product. Any abnormal laboratory results were considered as TEAEs.
From the first dose of study drug through 30 days after the last dose of study drug (up to 35.3 months)
Phase 1: Number of Participants With Grade 3 or Higher TEAEs
The severity grade was evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0, except for Cytokine Release Syndrome (CRS), which was assessed by American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading. Where Grade 3 was severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living (ADL), Grade 4 was life-threatening consequences; urgent intervention indicated, and Grade 5 was death related to AE. TEAEs were AEs that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug.
From the first dose of study drug through 30 days after the last dose of study drug (up to 35.3 months)
Phase 1: Duration of TEAEs
TEAEs were AEs that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug. AE means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product.
From the first dose of study drug through 30 days after the last dose of study drug (up to 35.3 months)
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
Secondary Outcomes
Measure
Description
Time Frame
Phase 1, Cmax: Maximum Observed Plasma Concentration for TAK-981
Cmax for TAK-981 was reported.
Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose; Cycle 1 Day 8: pre-dose and at multiple timepoints (up to 24 hours) post-dose (Cycle length = 21 days)
Phase 1, Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for TAK-981
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Adult male or female participants ≥18 years old.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Population for Phase 1 dose escalation:
Has histologically or cytologically confirmed advanced (local regionally recurrent not amenable to curative therapy) or metastatic solid tumors who have no standard therapeutic option with a proven clinical benefit, are intolerant, or have refused them. OR
Has relapsed/refractory lymphoma not amenable to therapies with proven clinical benefit or who are intolerant or who refuse them. Participants with low-grade lymphomas such as FL, small lymphocytic lymphoma, lymphoplasmacytoid lymphoma, and marginal zone lymphomas, may not need to exhaust all available therapy. These participants can be enrolled after failure of at least 2 prior systemic therapies, provided that there is not an immediate need for cytoreduction. In these cases, participants who need immediate therapy for tumor bulk are not eligible for this trial.
Population for Phase 2 dose expansion cohorts:
o Has histologically or cytologically documented, advanced (metastatic and/or unresectable) cancer as listed below, that is incurable and for which prior standard first-line treatment has failed: Note: Prior neoadjuvant or adjuvant therapy included in initial treatment may not be considered first- or later-line SOC treatment unless such treatments were completed less than 12 months before the current tumor recurrence.
o Nonsquamous NSCLC that has progressed to 1 prior systemic immune checkpoint inhibitors (CPI)/anti-PD-(1/L1)-containing therapy and no more than 2 lines of therapy. Participants must have not shown evidence of tumor progression during the first 5 months of treatment with first-line CPI/anti-PD-(1/L1)-containing therapy (cohort A).
Note: Participants with known driver mutations/genomic aberrations (example- epidermal growth factor receptor [EGFR], B-Raf proto-oncogene mutation V600E [BRAF V600E], and ROS proto-oncogene 1 [ROS1] sensitizing mutations, neurotrophic receptor tyrosine kinase [NRTK] gene fusions, and anaplastic lymphoma kinase [ALK] rearrangements) must have also shown progressive disease after treatment with a commercially available targeted therapy.
o CPI-naïve cervical cancer (squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix) participants who have received no more than 1 prior systemic line of therapy for recurrent or Stage IVB cervical cancer (cohort B).
Note: The following cervical tumors are not eligible: minimal deviation/adenoma malignum, gastric-type adenocarcinoma, clear-cell carcinoma, and mesonephric carcinoma. Histologic confirmation of the original primary tumor is required via pathology report.
Note: First-line treatment must have consisted of platinum-containing doublet. Chemotherapy administered concurrently with primary radiation (example- weekly cisplatin) is not counted as a systemic chemotherapy regimen.
o CPI-naïve MSS-CRC participants who have progressed on no more than 3 chemotherapy regimens (cohort C).
Note: Participants must have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing regimens if indicated.
Relapsed/refractory DLBCL progressed or relapsed after prior CAR T cell therapy that has received approval by a health authority for the treatment of DLBCL (cohort D).
Relapsed/refractory DLBCL that has progressed or relapsed after at least 2 but no more than 3 prior lines of systemic therapy and has not received prior cellular therapy. At least one prior line of therapy must have included a CD20-targeted therapy (cohort E).
Relapsed/refractory FL that has progressed or relapsed after at least 2 but no more than 3 prior lines of systemic therapy. At least 1 prior line of therapy must have included a CD20-targeted therapy (cohort F).
In Phase 2 only, have at least 1 radiologically measurable lesion based on RECIST v1.1 for participants with solid tumors or Lugano criteria for lymphoma. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Note: In Phase 2 stage 1, have an additional lesion for pretreatment and on-treatment biopsy.
In Phase 2 stage 1, willing to consent to mandatory pretreatment and on-treatment tumor biopsy.
Note: For fresh tumor biopsies, the lesion must be accessible for a biopsy procedure as assessed by the investigator.
Is willing to provide archival tumor tissue sample, if available.
Adequate bone marrow reserve and renal and hepatic function.
Recovered to Grade 1 or baseline or established as sequelae from all toxic effects of previous therapy (except alopecia, neuropathy, or autoimmune endocrinopathies with stable endocrine replacement therapy, bone marrow parameters [any of Grade 1 or 2 permitted if directly related to bone marrow involvement).
Consented to undergo serial skin punch biopsies (dose escalation only).
Suitable venous access for safe drug administration and the study-required PK and pharmacodynamics sampling.
Women of childbearing potential participating in this study should avoid becoming pregnant, and male participants should avoid impregnating a female partner. Nonsterilized female participants of reproductive age and male participants should use effective methods of contraception through defined periods during and after study treatment as specified below. Female participants must meet 1 of the following:
Postmenopausal for at least 1 year before the screening visit, or
Surgically sterile, or
If they are of childbearing potential, agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception at the same time, from the time of signing of the informed consent form (ICF) through 6 months after the last dose of study drug, or
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)
Male participants, even if surgically sterilized (that is, status post vasectomy) must agree to 1 of the following:
Agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, or
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)
Exclusion Criteria:
Phase 1 dose escalation and Phase 2 cancer treatment expansion cohorts:
o Has received treatment with systemic anticancer treatments or investigational products within 14 days before the first dose of study drug or 5 half-lives, whichever is shorter.
Note: Low-dose steroids (oral prednisone or equivalent ≤20 mg per day), hormonal therapy for prostate cancer or breast cancer (as adjuvant treatment), and treatment with bisphosphonates and receptor activator of nuclear factor kappa-Β ligand (RANKL) inhibitors are allowed.
o Has received extended field radiotherapy ≤4 weeks before the start of treatment (≤2 weeks for limited field radiation for palliation), and who has not recovered to grade 1 or baseline from related side effects of such therapy (except for alopecia).
History of any of the following ≤6 months before first dose: congestive heart failure New York Heart Association Grade III or IV, unstable angina, myocardial infarction, unstable symptomatic ischemic heart disease, severe noncompensated hypertension despite appropriate medical therapy, ongoing symptomatic cardiac arrhythmias of >Grade 2, pulmonary embolism, or symptomatic cerebrovascular events, or any other serious cardiac condition (example, pericardial effusion or restrictive cardiomyopathy). Chronic atrial fibrillation on stable anticoagulant therapy is allowed.
Baseline prolongation of the QT interval with Fridericia correction method (QTcF) (example, repeated demonstration of QTcF interval >480 milliseconds (ms), history of congenital long QT syndrome, or torsades de pointes).
Psychiatric illness/social circumstances that would limit compliance with study requirements and substantially increase the risk of adverse events (AEs) or has compromised ability to provide written informed consent.
Admission or evidence of illicit drug use, drug abuse, or alcohol abuse.
History of autoimmune disease requiring systemic immunosuppressive therapy.
History of immune-related AEs related to treatment with immune checkpoint inhibitors that required treatment discontinuation.
History of noninfectious pneumonitis that required steroids or a history of interstitial lung disease.
Has evidence of active, noninfectious pneumonitis.
Have a significant active infection.
Known history of human immunodeficiency virus (HIV) infection or any other relevant congenital or acquired immunodeficiency.
Known hepatitis B virus (HBV) surface antigen seropositive or detectable hepatitis C infection viral load. Note: Participants who have positive hepatitis B core antibody or hepatitis B surface antigen antibody can be enrolled but must have an undetectable hepatitis B viral load.
Receiving or requiring the continued use of medications that are known to be strong or moderate inhibitors and inducers of cytochrome P-450 3A4/5 (CYP3A4/5) or are strong permeability glycoprotein (P-gp) inhibitors. To participate in this study, participants should discontinue use of such agents for at least 2 weeks (1 week for CYP3A4/5 and P-gp inhibitors) before receiving a dose of TAK-981.
Participant requires the use of drugs known to prolong QTc interval (during Phase 1 only).
History of allogeneic tissue or solid organ transplant.
Second malignancy within the previous 3 years, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, cervical carcinoma in situ, resected colorectal adenomatous polyps, breast cancer in situ, or other malignancy for which the participant is not on active anticancer therapy.
Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before first dose of study drug.](streamdown:incomplete-link)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Study Director
Takeda
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of California San Diego Moores Cancer Center
Liu H, Seo S, Joung H. TAK-981 enhances antitumor activity in ELT3 uterine leiomyoma cells through the modulation of apoptosis, cell cycle arrest, and autophagy. Biochem Biophys Res Commun. 2025 Jul 12;770:152000. doi: 10.1016/j.bbrc.2025.152000. Epub 2025 May 12.
Nakamura A, Grossman S, Song K, Xega K, Zhang Y, Cvet D, Berger A, Shapiro G, Huszar D. The SUMOylation inhibitor subasumstat potentiates rituximab activity by IFN1-dependent macrophage and NK cell stimulation. Blood. 2022 May 5;139(18):2770-2781. doi: 10.1182/blood.2021014267.
See Also Links
Label
URL
To obtain more information on the study, click here/on this link
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
Not provided
Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants were enrolled in Phase 1 (Dose Escalation) and in Phase 2 (Dose Expansion) to receive TAK-981 doses.
Recruitment Details
Participants took part in the study at 17 investigative sites in Poland, Belgium, Spain, the United States and China from 01 October 2018 to 14 December 2023.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 milligram (mg), infusion, intravenously, twice weekly (BIW) on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
FG001
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
FG002
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
FG003
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
FG004
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
FG005
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
FG006
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
FG007
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, once weekly (QW) on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
FG008
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
FG009
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
FG010
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
FG011
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
FG012
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
FG013
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
FG014
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
FG018
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
FG019
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0005 subjects
FG0013 subjects
FG0024 subjects
FG0033 subjects
FG0044 subjects
FG0054 subjects
FG0067 subjects
FG0076 subjects
FG0086 subjects
FG0096 subjects
FG0108 subjects
FG0117 subjects
FG0127 subjects
FG0138 subjects
FG0146 subjects
FG0157 subjects
FG0163 subjects
FG0177 subjects
FG0184 subjects
FG0193 subjects
FG0201 subjects
COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0004 subjects
FG0013 subjects
FG0024 subjects
FG0033 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Safety analysis set consisted of participants who received at least 1 dose, even if incomplete, of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Phase 1: Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs)
TEAEs were adverse events (AEs) that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug. AE means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product. Any abnormal laboratory results were considered as TEAEs.
Safety analysis set consisted of participants who received at least 1 dose, even if incomplete, of study drug.
Posted
Count of Participants
Participants
From the first dose of study drug through 30 days after the last dose of study drug (up to 35.3 months)
ID
Title
Description
OG000
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Adverse Events Module
Frequency Threshold
5
Time Frame
Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 milligram (mg), infusion, intravenously, twice weekly (BIW) on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal discomfort
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
More Info Module
Limitations and Caveats
The study was terminated early due to enrollment challenges.
Phase 2, Cohort D: r/r DLBCL after CAR T-cells therapy
Experimental
TAK-981 intravenously administered as 60 minute-infusion in a 21-day treatment cycle for up to approximately 12 months or until discontinuation from the study in participants with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after prior chimeric antigen receptor (CAR) T-cells therapy.
Drug: TAK-981
Phase 2, Cohort E: r/r DLBCL without prior cellular therapy
Experimental
TAK-981 intravenously administered as 60 minute-infusion in a 21-day treatment cycle for up to approximately 12 months or until discontinuation from the study in participants with relapsed/refractory DLBCL that have not received prior cellular therapy.
Drug: TAK-981
Phase 2, Cohort F: r/r Follicular Lymphoma
Experimental
TAK-981 intravenously administered as 60 minute-infusion in a 21-day treatment cycle for up to approximately 12 months or until discontinuation from the study in participants with relapsed/refractory follicular lymphoma (FL).
Drug: TAK-981
Phase 2, Cohort C: MSS-CRC
Phase 2, Cohort D: r/r DLBCL after CAR T-cells therapy
Phase 2, Cohort E: r/r DLBCL without prior cellular therapy
Phase 2, Cohort F: r/r Follicular Lymphoma
DLTs were evaluated according to NCI CTCAE version 5.0. Grade 5 AE. Hematologic toxicity: Nonfebrile Grade 4 neutropenia/Grade greater than or equal to (>=) 3 febrile neutropenia; Significant Grade 3 thrombocytopenia; Grade 4 thrombocytopenia. Nonhematologic Grade 3 or higher toxicities; Grade 2 nonhematologic toxicities that were considered by the investigator to be related to study drug and dose-limiting.
Cycle 1 (Cycle length is equal to [=] 21 days)
Phase 2: Overall Response Rate (ORR)
ORR was defined as percentage of participants who achieved complete response (CR) or partial response (PR) during the study as determined by the investigator according to response assessments based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1) for solid tumors or Lugano classification for lymphoma.
From the first dose of study drug until first disease progression (PD) or death, whichever occurred first (up to 11.2 months)
Tmax for TAK-981 was reported.
Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose; Cycle 1 Day 8: pre-dose and at multiple timepoints (up to 24 hours) post-dose (Cycle length = 21 days)
Phase 1, AUC0-last: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-981
AUC0-last for TAK-981 was reported.
Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose; Cycle 1 Day 8: pre-dose and at multiple timepoints (up to 24 hours) post-dose (Cycle length = 21 days)
Phase 1, AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-981
AUC0-inf for TAK-981 was reported.
Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose; Cycle 1 Day 8: pre-dose and at multiple timepoints (up to 24 hours) post-dose (Cycle length = 21 days)
Phase 1, t1/2z: Terminal Disposition Phase Half-life for TAK-981
t1/2z for TAK-981 was reported.
Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose; Cycle 1 Day 8: pre-dose and at multiple timepoints (up to 24 hours) post-dose (Cycle length = 21 days)
Phase 1, CL: Total Clearance for TAK-981
CL for TAK-981 was reported.
Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose; Cycle 1 Day 8: pre-dose and at multiple timepoints (up to 24 hours) post-dose (Cycle length = 21 days)
Phase 1, Vss: Volume of Distribution at Steady State for TAK-981
Vss for TAK-981 was reported.
Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose; Cycle 1 Day 8: pre-dose and at multiple timepoints (up to 24 hours) post-dose (Cycle length = 21 days)
Phase 1: ORR
ORR was defined as percentage of participants who achieved CR or PR during the study as determined by the investigator according to response assessments based on RECIST v1.1 for solid tumors or Lugano classification for lymphoma.
From the first dose of study drug until first PD or death, whichever occurred first (up to 34.3 months)
Phase 1 and 2: Disease Control Rate (DCR)
DCR was defined as the percentage of participants who achieved stable disease (SD) (greater than [>] 6 weeks) or better as determined by the investigator according to RECIST v1.1 for solid tumors or Lugano classification for lymphoma.
From first dose of study drug up to 34.3 months (for Phase 1) and up to 11.2 months (for Phase 2)
Phase 1 and 2: Duration of Response (DOR)
DOR was defined as the time from the date of first documentation of a PR or better to the date of first documentation of PD for responders (PR or better) and determined by the investigator according to RECIST v1.1 with solid tumors or Lugano classification for lymphoma.
From first documented confirmed CR or PR until first documentation of PD up to 34.3 months (for Phase 1) and up to 11.2 months (for Phase 2)
Phase 1 and 2: Time to Progression (TTP)
TTP was defined as the time from the date of the first dose administration to the date of first documented PD as determined by the investigator according to RECIST v1.1 for solid tumors or Lugano classification for lymphoma.
From first dose of study drug to the date of the first documentation of PD up to 34.3 months (for Phase 1) and up to 11.2 months (for Phase 2)
Phase 1 and 2: Time to Response (TTR)
TTR was defined as the time from the date of first study drug administration to the date of first documented PR or better by the investigator for responders according to RECIST v1.1 for solid tumors or Lugano classification for lymphoma. Here, "overall number of participants analyzed" signifies participants who had CR or PR.
From first dose of study drug to the date of the first documentation of PR or better, whichever occurred first up to 34.3 months (for Phase 1) and up to 11.2 months (for Phase 2)
Phase 1 and 2: Progression-free Survival (PFS)
PFS was defined as the time from the date of the first dose administration to the date of first documentation of PD or death due to any cause, whichever occurs first as determined by the investigator according to RECIST v1.1 for solid tumors or Lugano classification for lymphoma.
From the first dose of study drug to date of PD or death, whichever occurred first up to 34.3 months (for Phase 1) and up to 11.2 months (for Phase 2)
Phase 1 and 2: Overall Survival (OS)
OS was defined as the time from the date of the first dose administration to the date of death.
From date of first dose of study drug up to death up to 34.3 months (for Phase 1) and up to 11.2 months (for Phase 2)
Phase 1: Fold Change From Baseline in Levels of TAK-981 Small Ubiquitin-like Modifier (SUMO) Adduct Formation in Blood Lymphocytes
TAK-981-SUMO adduct formation in peripheral blood lymphocytes was tested by flow cytometry with an antibody recognizing the TAK-981-SUMO adduct formation during the inhibition of the SUMO-activating enzyme by TAK-981.
Cycle 1 Day 1: 1, 4 and 8 hours post-dose; Cycle 1 Day 8: Pre-dose, 1, 4 and 8 hours post-dose (Cycle length = 21 days)
Phase 1: Fold Change From Baseline in Levels of TAK-981 SUMO Adduct Formation in Skin
TAK-981-SUMO adduct formation in skin was tested by flow cytometry with an antibody recognizing the TAK-981-SUMO adduct formation during the inhibition of the SUMO-activating enzyme by TAK-981.
Cycle 1 Day 8 (Cycle length = 21 days)
Phase 1: Fold Change From Baseline in SUMO Pathway Inhibition in Blood Lymphocytes
SUMO pathway inhibition in peripheral blood lymphocytes was tested by flow cytometry with an antibody recognizing SUMO-2/3 chains.
Cycle 1 Day 1: 1, 4 and 8 hours post-dose; Cycle 1 Day 8: Pre-dose, 1, 4 and 8 hours post-dose (Cycle length = 21 days)
Phase 1: Fold Change From Baseline in SUMO Pathway Inhibition in Skin
SUMO pathway inhibition in skin was tested by flow cytometry with an antibody recognizing SUMO-2/3 chains.
Cycle 1 Day 8 (Cycle length = 21 days)
Phase 2: Number of Participants Reporting One or More TEAEs
TEAEs were AEs that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug. AE means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product. Any abnormal laboratory results were reported as TEAEs.
From the first dose of study drug through 30 days after the last dose of study drug (up to 12.2 months)
Phase 2: Number of Participants With Grade 3 or Higher TEAEs
The severity grade was evaluated as per the CTCAE Version 5.0, except for CRS, which was assessed by ASTCT consensus grading. Where Grade 3 was severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4 was 4 Life-threatening consequences; urgent intervention indicated. and Grade 5 was death related to AE. TEAEs were AEs that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug.
From the first dose of study drug through 30 days after the last dose of study drug (up to 12.2 months)
Phase 2: Duration of TEAEs
TEAEs were AEs that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug. AE means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product.
From the first dose of study drug through 30 days after the last dose of study drug (up to 12.2 months)
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Barbara Ann Karmanos Cancer Institute
Detroit
Michigan
48201
United States
HealthPartners Cancer Care Center - Regions Hospital
Saint Paul
Minnesota
55101
United States
University Hospitals Seidman Cancer Center
Cleveland
Ohio
44106
United States
Fox Chase Cancer Center
Philadelphia
Pennsylvania
19111
United States
The University of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
Froedtert and the Medical College of Wisconsin
Milwaukee
Wisconsin
53226
United States
1 subjects
FG0051 subjects
FG0062 subjects
FG0071 subjects
FG0081 subjects
FG0091 subjects
FG0102 subjects
FG0112 subjects
FG0121 subjects
FG0131 subjects
FG0140 subjects
FG0151 subjects
FG0161 subjects
FG0171 subjects
FG0184 subjects
FG0192 subjects
FG0201 subjects
3 subjects
FG0053 subjects
FG0065 subjects
FG0075 subjects
FG0085 subjects
FG0095 subjects
FG0106 subjects
FG0115 subjects
FG0126 subjects
FG0137 subjects
FG0146 subjects
FG0156 subjects
FG0162 subjects
FG0176 subjects
FG0180 subjects
FG0191 subjects
FG0200 subjects
0 subjects
FG0040 subjects
FG0051 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0102 subjects
FG0110 subjects
FG0122 subjects
FG0130 subjects
FG0140 subjects
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FG0180 subjects
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FG0200 subjects
Progressive Disease
FG0002 subjects
FG0013 subjects
FG0024 subjects
FG0033 subjects
FG0042 subjects
FG0052 subjects
FG0063 subjects
FG0073 subjects
FG0085 subjects
FG0095 subjects
FG0102 subjects
FG0113 subjects
FG0123 subjects
FG0133 subjects
FG0146 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0112 subjects
FG0121 subjects
FG0133 subjects
FG0140 subjects
FG0155 subjects
FG0161 subjects
FG0175 subjects
FG0180 subjects
FG0191 subjects
FG0200 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0131 subjects
FG0140 subjects
FG0151 subjects
FG0160 subjects
FG0171 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
Start of a New Systemic Treatment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
BG001
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
BG002
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
BG003
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
BG004
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
BG005
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
BG006
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
BG007
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
BG008
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
BG009
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
BG010
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
BG011
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
BG012
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
BG013
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
BG014
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
BG018
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
BG019
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
BG021
Total
Total of all reporting groups
5
BG0013
BG0024
BG0033
BG0044
BG0054
BG0067
BG0076
BG0086
BG0096
BG0108
BG0117
BG0127
BG0138
BG0146
BG0157
BG0163
BG0177
BG0184
BG0193
BG0201
BG021109
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00059.8± 9.78
BG00161.0± 14.73
BG00252.0± 11.05
BG00366.7± 10.69
BG00459.5± 5.80
BG00565.0± 4.69
BG00659.3± 10.21
BG00762.5± 9.07
BG00860.8± 10.87
BG00962.3± 10.97
BG01060.5± 9.56
BG01162.4± 14.21
BG01264.4± 7.93
BG01359.4± 11.02
BG01457.8± 8.33
BG01564.0± 6.98
BG01653.3± 2.08
BG01751.6± 13.02
BG01856.3± 18.06
BG01971.7± 5.51
BG02053.0± NAStandard Deviation could not be estimated due to insufficient number of participants available for analysis.
BG02160.3± 10.3
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0012
BG0022
BG0032
BG0042
BG0052
BG0063
BG0072
BG0084
BG0094
BG0103
BG0115
BG0124
BG0133
BG0145
BG0151
BG0163
BG0173
BG0180
BG0193
BG0201
BG02158
Male
BG0001
BG0011
BG0022
BG0031
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0020
BG0030
BG0041
BG0050
BG0060
BG0070
BG0080
BG0090
BG0101
BG0110
BG0120
BG0131
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0213
Not Hispanic or Latino
BG0005
BG0013
BG0024
BG0032
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0031
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
Asian
BG0000
BG0010
BG0020
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0010
BG0020
BG0030
BG004
White
BG0005
BG0013
BG0024
BG0033
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
OG001
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG002
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG003
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG004
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG005
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG006
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG007
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG008
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG009
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG010
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG011
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG012
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG013
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG014
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Units
Counts
Participants
OG0005
OG0013
OG0024
OG0033
OG0044
OG0054
OG0067
OG0076
OG0086
OG0096
OG0108
OG0117
OG0127
OG0138
OG0146
Title
Denominators
Categories
Title
Measurements
OG0004
OG0013
OG0024
OG0033
OG0044
OG0054
OG0066
OG0076
OG0085
OG0096
OG0108
OG0117
OG0127
OG0138
OG0146
Primary
Phase 1: Number of Participants With Grade 3 or Higher TEAEs
The severity grade was evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0, except for Cytokine Release Syndrome (CRS), which was assessed by American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading. Where Grade 3 was severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living (ADL), Grade 4 was life-threatening consequences; urgent intervention indicated, and Grade 5 was death related to AE. TEAEs were AEs that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug.
Safety analysis set consisted of participants who received at least 1 dose, even if incomplete, of study drug.
Posted
Count of Participants
Participants
From the first dose of study drug through 30 days after the last dose of study drug (up to 35.3 months)
ID
Title
Description
OG000
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG001
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG002
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG003
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG004
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG005
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG006
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG007
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG008
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG009
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG010
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG011
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG012
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG013
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG014
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Units
Counts
Participants
OG0005
OG0013
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0002
OG0012
OG0023
OG003
Primary
Phase 1: Duration of TEAEs
TEAEs were AEs that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug. AE means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product.
Safety analysis set consisted of participants who received at least 1 dose, even if incomplete, of study drug.
Posted
Median
Full Range
days
From the first dose of study drug through 30 days after the last dose of study drug (up to 35.3 months)
ID
Title
Description
OG000
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG001
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG002
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG003
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG004
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG005
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG006
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG007
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG008
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG009
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG010
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG011
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG012
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG013
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG014
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Units
Counts
Participants
OG0005
OG0013
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0003.0(1 to 37)
OG0014.0(1 to 21)
OG0021.0(1 to 33)
OG003
Primary
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
DLTs were evaluated according to NCI CTCAE version 5.0. Grade 5 AE. Hematologic toxicity: Nonfebrile Grade 4 neutropenia/Grade greater than or equal to (>=) 3 febrile neutropenia; Significant Grade 3 thrombocytopenia; Grade 4 thrombocytopenia. Nonhematologic Grade 3 or higher toxicities; Grade 2 nonhematologic toxicities that were considered by the investigator to be related to study drug and dose-limiting.
DLT-evaluable analysis set consisted of participants in dose escalation who received all Cycle 1 doses of TAK-981 without experiencing a DLT or who had a DLT during Cycle 1 of the study.
Posted
Count of Participants
Participants
Cycle 1 (Cycle length is equal to [=] 21 days)
ID
Title
Description
OG000
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG001
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG002
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG003
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG004
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG005
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG006
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG007
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG008
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG009
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG010
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG011
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG012
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG013
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG014
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Units
Counts
Participants
OG0003
OG0013
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Phase 2: Overall Response Rate (ORR)
ORR was defined as percentage of participants who achieved complete response (CR) or partial response (PR) during the study as determined by the investigator according to response assessments based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1) for solid tumors or Lugano classification for lymphoma.
Tumor response-evaluable analysis set consisted of participants who received at least 1 dose of study drug, had sites of measurable disease at baseline, and 1 postbaseline disease assessment, or was discontinued due to symptomatic deterioration or death before a postbaseline evaluation happened.
Posted
Number
95% Confidence Interval
percentage of participants
From the first dose of study drug until first disease progression (PD) or death, whichever occurred first (up to 11.2 months)
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG003
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG004
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Units
Counts
Participants
OG0007
OG0013
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 40.96)
OG0010.0(0.0 to 70.76)
OG0020.0(0.0 to 45.93)
OG003
Secondary
Phase 1, Cmax: Maximum Observed Plasma Concentration for TAK-981
Cmax for TAK-981 was reported.
Pharmacokinetic (PK) analysis set consisted of participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specified time-points. As planned, this outcome measure was analyzed in Phase 1 only.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms per milliliter (ng/mL)
Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose; Cycle 1 Day 8: pre-dose and at multiple timepoints (up to 24 hours) post-dose (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG001
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG002
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG003
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG004
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG005
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG006
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG007
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG008
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG009
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG010
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG011
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG012
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG013
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG014
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Units
Counts
Participants
OG0005
OG0013
OG0024
OG003
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG003
Secondary
Phase 1, Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for TAK-981
Tmax for TAK-981 was reported.
PK analysis set consisted of participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specified time-points. As planned, this outcome measure was analyzed in Phase 1 only.
Posted
Median
Full Range
hours
Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose; Cycle 1 Day 8: pre-dose and at multiple timepoints (up to 24 hours) post-dose (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG001
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG002
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG003
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG004
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG005
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG006
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG007
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG008
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG009
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG010
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG011
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG012
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG013
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG014
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Units
Counts
Participants
OG0005
OG0013
OG0024
OG003
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG003
Secondary
Phase 1, AUC0-last: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-981
AUC0-last for TAK-981 was reported.
PK analysis set consisted of participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specified time-points. As planned, this outcome measure was analyzed in Phase 1 only.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours*nanograms per milliliter (h*ng/mL)
Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose; Cycle 1 Day 8: pre-dose and at multiple timepoints (up to 24 hours) post-dose (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG001
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG002
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG003
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG004
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG005
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG006
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG007
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG008
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG009
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG010
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG011
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG012
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG013
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG014
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Units
Counts
Participants
OG0005
OG0013
OG0024
OG003
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG003
Secondary
Phase 1, AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-981
AUC0-inf for TAK-981 was reported.
PK analysis set consisted of participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specified time-points. As planned, this outcome measure was analyzed in Phase 1 only.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose; Cycle 1 Day 8: pre-dose and at multiple timepoints (up to 24 hours) post-dose (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG001
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG002
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG003
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG004
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG005
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG006
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG007
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG008
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG009
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG010
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG011
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG012
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG013
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG014
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Units
Counts
Participants
OG0005
OG0013
OG0024
OG003
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG003
Secondary
Phase 1, t1/2z: Terminal Disposition Phase Half-life for TAK-981
t1/2z for TAK-981 was reported.
PK analysis set consisted of participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specified time-points. As planned, this outcome measure was analyzed in Phase 1 only.
Posted
Median
Full Range
hours
Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose; Cycle 1 Day 8: pre-dose and at multiple timepoints (up to 24 hours) post-dose (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG001
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG002
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG003
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG004
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG005
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG006
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG007
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG008
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG009
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG010
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG011
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG012
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG013
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG014
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Units
Counts
Participants
OG0005
OG0013
OG0024
OG003
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG003
Secondary
Phase 1, CL: Total Clearance for TAK-981
CL for TAK-981 was reported.
PK analysis set consisted of participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specified time-points. As planned, this outcome measure was analyzed in Phase 1 only.
Posted
Geometric Mean
Geometric Coefficient of Variation
liter per hour (L/h)
Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose; Cycle 1 Day 8: pre-dose and at multiple timepoints (up to 24 hours) post-dose (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG001
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG002
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG003
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG004
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG005
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG006
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG007
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG008
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG009
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG010
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG011
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG012
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG013
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG014
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Units
Counts
Participants
OG0005
OG0013
OG0024
OG003
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG003
Secondary
Phase 1, Vss: Volume of Distribution at Steady State for TAK-981
Vss for TAK-981 was reported.
PK analysis set consisted of participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specified time-points. As planned, this outcome measure was analyzed in Phase 1 only.
Posted
Geometric Mean
Geometric Coefficient of Variation
liters
Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose; Cycle 1 Day 8: pre-dose and at multiple timepoints (up to 24 hours) post-dose (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG001
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG002
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG003
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG004
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG005
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG006
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG007
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG008
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG009
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG010
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG011
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG012
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG013
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG014
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Units
Counts
Participants
OG0005
OG0013
OG0024
OG003
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG003
Secondary
Phase 1: ORR
ORR was defined as percentage of participants who achieved CR or PR during the study as determined by the investigator according to response assessments based on RECIST v1.1 for solid tumors or Lugano classification for lymphoma.
Tumor response-evaluable analysis set consisted of participants who received at least 1 dose of study drug, had sites of measurable disease at baseline, and 1 postbaseline disease assessment, or was discontinued due to symptomatic deterioration or death before a postbaseline evaluation happened.
Posted
Number
95% Confidence Interval
percentage of participants
From the first dose of study drug until first PD or death, whichever occurred first (up to 34.3 months)
ID
Title
Description
OG000
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG001
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG002
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG003
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG004
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG005
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG006
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG007
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG008
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG009
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG010
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG011
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG012
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG013
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG014
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Units
Counts
Participants
OG0004
OG0013
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.00 to 60.24)
OG0010.0(0.00 to 70.76)
OG0020.0(0.00 to 60.24)
OG003
Secondary
Phase 1 and 2: Disease Control Rate (DCR)
DCR was defined as the percentage of participants who achieved stable disease (SD) (greater than [>] 6 weeks) or better as determined by the investigator according to RECIST v1.1 for solid tumors or Lugano classification for lymphoma.
Tumor response-evaluable analysis set consisted of participants who received at least 1 dose of study drug, had sites of measurable disease at baseline, and 1 postbaseline disease assessment, or was discontinued due to symptomatic deterioration or death before a postbaseline evaluation happened.
Posted
Number
95% Confidence Interval
percentage of participants
From first dose of study drug up to 34.3 months (for Phase 1) and up to 11.2 months (for Phase 2)
ID
Title
Description
OG000
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG001
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG002
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG003
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG004
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG005
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG006
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG007
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG008
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG009
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG010
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG011
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG012
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG013
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG014
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG018
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG019
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Units
Counts
Participants
OG0004
OG0013
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 60.24)
OG0010.0(0.0 to 70.76)
OG00225.0(0.63 to 80.59)
OG003
Secondary
Phase 1 and 2: Duration of Response (DOR)
DOR was defined as the time from the date of first documentation of a PR or better to the date of first documentation of PD for responders (PR or better) and determined by the investigator according to RECIST v1.1 with solid tumors or Lugano classification for lymphoma.
Tumor response-evaluable analysis set consisted of participants who received at least 1 dose of study drug, had sites of measurable disease at baseline, and 1 postbaseline disease assessment, or was discontinued due to symptomatic deterioration or death before a postbaseline evaluation happened. Here, "overall number of participants analyzed" signifies participants who had CR or PR.
Posted
Median
95% Confidence Interval
months
From first documented confirmed CR or PR until first documentation of PD up to 34.3 months (for Phase 1) and up to 11.2 months (for Phase 2)
ID
Title
Description
OG000
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG001
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG002
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG003
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG004
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG005
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG006
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG007
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG008
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG009
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG010
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG011
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG012
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG013
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG014
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG018
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG019
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Title
Measurements
OG0056.93(NA to NA)Upper and lower limit of 95% confidence internal (CI) could not be estimated due to insufficient number of participants with events.
OG0111.41(NA to NA)Upper and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG013
Secondary
Phase 1 and 2: Time to Progression (TTP)
TTP was defined as the time from the date of the first dose administration to the date of first documented PD as determined by the investigator according to RECIST v1.1 for solid tumors or Lugano classification for lymphoma.
Tumor response-evaluable analysis set consisted of participants who received at least 1 dose of study drug, had sites of measurable disease at baseline, and 1 postbaseline disease assessment, or was discontinued due to symptomatic deterioration or death before a postbaseline evaluation happened.
Posted
Median
95% Confidence Interval
months
From first dose of study drug to the date of the first documentation of PD up to 34.3 months (for Phase 1) and up to 11.2 months (for Phase 2)
ID
Title
Description
OG000
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG001
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG002
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG003
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG004
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG005
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG006
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG007
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG008
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG009
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG010
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG011
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG012
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG013
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG014
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG018
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG019
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Units
Counts
Participants
OG0005
OG0013
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.18(0.72 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0010.79(0.76 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG002
Secondary
Phase 1 and 2: Time to Response (TTR)
TTR was defined as the time from the date of first study drug administration to the date of first documented PR or better by the investigator for responders according to RECIST v1.1 for solid tumors or Lugano classification for lymphoma. Here, "overall number of participants analyzed" signifies participants who had CR or PR.
Tumor response-evaluable analysis set consisted of participants who received at least 1 dose of study drug, had sites of measurable disease at baseline, and 1 postbaseline disease assessment, or was discontinued due to symptomatic deterioration or death before a postbaseline evaluation happened.
Posted
Median
95% Confidence Interval
months
From first dose of study drug to the date of the first documentation of PR or better, whichever occurred first up to 34.3 months (for Phase 1) and up to 11.2 months (for Phase 2)
ID
Title
Description
OG000
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG001
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG002
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG003
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG004
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG005
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG006
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG007
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG008
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG009
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG010
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG011
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG012
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG013
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG014
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG018
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG019
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Title
Measurements
OG005NA(1.38 to NA)Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG011NA(3.91 to NA)Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG013
Secondary
Phase 1 and 2: Progression-free Survival (PFS)
PFS was defined as the time from the date of the first dose administration to the date of first documentation of PD or death due to any cause, whichever occurs first as determined by the investigator according to RECIST v1.1 for solid tumors or Lugano classification for lymphoma.
Safety analysis set consisted of participants who received at least 1 dose, even if incomplete, of study drug.
Posted
Median
95% Confidence Interval
months
From the first dose of study drug to date of PD or death, whichever occurred first up to 34.3 months (for Phase 1) and up to 11.2 months (for Phase 2)
ID
Title
Description
OG000
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG001
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG002
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG003
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG004
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG005
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG006
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG007
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG008
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG009
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG010
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG011
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG012
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG013
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG014
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG018
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG019
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Units
Counts
Participants
OG0005
OG0013
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.95(0.46 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0010.79(0.76 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG002
Secondary
Phase 1 and 2: Overall Survival (OS)
OS was defined as the time from the date of the first dose administration to the date of death.
Safety analysis set consisted of participants who received at least 1 dose, even if incomplete, of study drug.
Posted
Median
95% Confidence Interval
months
From date of first dose of study drug up to death up to 34.3 months (for Phase 1) and up to 11.2 months (for Phase 2)
ID
Title
Description
OG000
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG001
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG002
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG003
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG004
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG005
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG006
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG007
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG008
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG009
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG010
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG011
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG012
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG013
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG014
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG018
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG019
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Units
Counts
Participants
OG0005
OG0013
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA(0.46 to NA)Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG001NA(NA to NA)Median, upper limit and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG002
Secondary
Phase 1: Fold Change From Baseline in Levels of TAK-981 Small Ubiquitin-like Modifier (SUMO) Adduct Formation in Blood Lymphocytes
TAK-981-SUMO adduct formation in peripheral blood lymphocytes was tested by flow cytometry with an antibody recognizing the TAK-981-SUMO adduct formation during the inhibition of the SUMO-activating enzyme by TAK-981.
Pharmacodynamic analysis set consisted of participants who provided evaluable blood samples (Cycle 1 Day 1 pre-dose sample and at least 1 post-dose sample). Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and here, "number analyzed" signifies participants evaluable at specified time-points.
Posted
Mean
Standard Deviation
fold change
Cycle 1 Day 1: 1, 4 and 8 hours post-dose; Cycle 1 Day 8: Pre-dose, 1, 4 and 8 hours post-dose (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG001
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG002
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG003
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG004
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG005
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG006
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG007
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG008
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG009
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG010
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG011
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG012
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG013
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG014
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Units
Counts
Participants
OG0004
OG0013
OG0024
OG003
Title
Denominators
Categories
Cycle 1 Day 1: 1 hour post-dose
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG003
Secondary
Phase 1: Fold Change From Baseline in Levels of TAK-981 SUMO Adduct Formation in Skin
TAK-981-SUMO adduct formation in skin was tested by flow cytometry with an antibody recognizing the TAK-981-SUMO adduct formation during the inhibition of the SUMO-activating enzyme by TAK-981.
Pharmacodynamic analysis set consisted of participants who provided evaluable skin biopsies (screening sample and at least 1 on-treatment sample). Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
fold change
Cycle 1 Day 8 (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG001
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG002
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG003
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG004
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG005
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG006
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG007
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG008
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG009
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG010
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG011
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG012
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG013
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG014
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Units
Counts
Participants
OG0000
OG0010
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG002115.57± NAStandard Deviation could not be estimated due to insufficient number of participants available for analysis.
OG0111343.23± NAStandard Deviation could not be estimated due to insufficient number of participants available for analysis.
Secondary
Phase 1: Fold Change From Baseline in SUMO Pathway Inhibition in Blood Lymphocytes
SUMO pathway inhibition in peripheral blood lymphocytes was tested by flow cytometry with an antibody recognizing SUMO-2/3 chains.
Pharmacodynamic analysis set consisted of participants who provided evaluable blood samples (Cycle 1 Day 1 pre-dose sample and at least 1 post-dose sample). Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and here, "number analyzed" signifies participants evaluable at specified time-points.
Posted
Mean
Standard Deviation
fold change
Cycle 1 Day 1: 1, 4 and 8 hours post-dose; Cycle 1 Day 8: Pre-dose, 1, 4 and 8 hours post-dose (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG001
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG002
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG003
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG004
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG005
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG006
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG007
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG008
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG009
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG010
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG011
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG012
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG013
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG014
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Units
Counts
Participants
OG0004
OG0013
OG0024
OG003
Title
Denominators
Categories
Cycle 1 Day 1: 1 hour post-dose
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG003
Secondary
Phase 1: Fold Change From Baseline in SUMO Pathway Inhibition in Skin
SUMO pathway inhibition in skin was tested by flow cytometry with an antibody recognizing SUMO-2/3 chains.
Pharmacodynamic analysis set consisted of participants who provided evaluable skin biopsies (screening sample and at least 1 on-treatment sample). Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
fold change
Cycle 1 Day 8 (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG001
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG002
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG003
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG004
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG005
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG006
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG007
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG008
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG009
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG010
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG011
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG012
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG013
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG014
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Units
Counts
Participants
OG0003
OG0013
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.01± 0.067
OG0010.71± 0.398
OG0020.82± 0.088
OG003
Secondary
Phase 2: Number of Participants Reporting One or More TEAEs
TEAEs were AEs that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug. AE means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product. Any abnormal laboratory results were reported as TEAEs.
Safety analysis set consisted of participants who received at least 1 dose, even if incomplete, of study drug.
Posted
Count of Participants
Participants
From the first dose of study drug through 30 days after the last dose of study drug (up to 12.2 months)
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG003
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG004
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Units
Counts
Participants
OG0007
OG0013
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG0006
OG0013
OG0027
OG003
Secondary
Phase 2: Number of Participants With Grade 3 or Higher TEAEs
The severity grade was evaluated as per the CTCAE Version 5.0, except for CRS, which was assessed by ASTCT consensus grading. Where Grade 3 was severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4 was 4 Life-threatening consequences; urgent intervention indicated. and Grade 5 was death related to AE. TEAEs were AEs that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug.
Safety analysis set consisted of participants who received at least 1 dose, even if incomplete, of study drug.
Posted
Count of Participants
Participants
From the first dose of study drug through 30 days after the last dose of study drug (up to 12.2 months)
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG003
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG004
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Units
Counts
Participants
OG0007
OG0013
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG0004
OG0011
OG0026
OG003
Secondary
Phase 2: Duration of TEAEs
TEAEs were AEs that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug. AE means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product.
Safety analysis set consisted of participants who received at least 1 dose, even if incomplete, of study drug.
Posted
Median
Full Range
days
From the first dose of study drug through 30 days after the last dose of study drug (up to 12.2 months)
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG003
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
OG004
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Units
Counts
Participants
OG0007
OG0013
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG0008.5(1 to 336)
OG0014.0(1 to 45)
OG0025.0(1 to 72)
OG003
1
5
3
5
4
5
EG001
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
0
3
2
3
3
3
EG002
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
0
4
3
4
4
4
EG003
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
0
3
1
3
2
3
EG004
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
1
4
2
4
4
4
EG005
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
1
4
2
4
4
4
EG006
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
2
7
3
7
6
7
EG007
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, once weekly (QW) on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
1
6
1
6
6
6
EG008
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
1
6
3
6
5
6
EG009
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
0
6
1
6
6
6
EG010
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
2
8
5
8
7
8
EG011
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
2
7
2
7
7
7
EG012
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
1
7
2
7
7
7
EG013
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
1
8
5
8
8
8
EG014
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
1
7
4
7
7
7
EG018
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
4
4
2
4
4
4
EG019
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
0
1
0
1
1
1
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0191 affected3 at risk
EG0200 affected1 at risk
Acute kidney injury
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0041 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0161 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Appendicitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Biliary obstruction
Hepatobiliary disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Blood bilirubin increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
COVID-19
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0181 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Cognitive disorder
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Colorectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Cystitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0111 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Cytokine release syndrome
Immune system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0152 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0041 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Dizziness postural
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0141 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Fall
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Fatigue
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Glossodynia
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0121 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Haematuria
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Hepatic failure
Hepatobiliary disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0191 affected3 at risk
EG0200 affected1 at risk
Incarcerated umbilical hernia
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0181 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Intestinal mass
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Nausea
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0121 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Oedema peripheral
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Pain
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Platelet count decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Pneumonia
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0181 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0141 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Presyncope
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0121 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Rectal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Rectal obstruction
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0041 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Sinus bradycardia
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0031 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0111 affected7 at risk
EG0121 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Squamous cell carcinoma of the tongue
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0121 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Vomiting
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0121 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0113 affected7 at risk
EG0121 affected7 at risk
EG0132 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Abdominal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0121 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0081 affected6 at risk
EG0091 affected6 at risk
EG0104 affected8 at risk
EG0112 affected7 at risk
EG0121 affected7 at risk
EG0131 affected8 at risk
EG0141 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0172 affected7 at risk
EG0180 affected4 at risk
EG0191 affected3 at risk
EG0200 affected1 at risk
Abdominal pain lower
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Acute kidney injury
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0111 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Alanine aminotransferase increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Ammonia increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Anaemia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0082 affected6 at risk
EG0091 affected6 at risk
EG0102 affected8 at risk
EG0112 affected7 at risk
EG0122 affected7 at risk
EG0132 affected8 at risk
EG0141 affected6 at risk
EG0151 affected7 at risk
EG0160 affected3 at risk
EG0174 affected7 at risk
EG0180 affected4 at risk
EG0192 affected3 at risk
EG0200 affected1 at risk
Anisocoria
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Anxiety
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0102 affected8 at risk
EG0110 affected7 at risk
EG0121 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0181 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
EG0061 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0092 affected6 at risk
EG0101 affected8 at risk
EG0112 affected7 at risk
EG0121 affected7 at risk
EG0132 affected8 at risk
EG0141 affected6 at risk
EG0151 affected7 at risk
EG0161 affected3 at risk
EG0171 affected7 at risk
EG0181 affected4 at risk
EG0191 affected3 at risk
EG0200 affected1 at risk
Ascites
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0121 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0172 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0071 affected6 at risk
EG0082 affected6 at risk
EG0091 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Asthenia
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0161 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Ataxia
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Atrial tachycardia
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0191 affected3 at risk
EG0200 affected1 at risk
Axillary pain
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0141 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG0031 affected3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
EG0062 affected7 at risk
EG0070 affected6 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0112 affected7 at risk
EG0122 affected7 at risk
EG0130 affected8 at risk
EG0141 affected6 at risk
EG0152 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Biliary obstruction
Hepatobiliary disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Bladder pain
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Bladder spasm
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Blepharitis
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0151 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Blood alkaline phosphatase increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Blood antidiuretic hormone increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0191 affected3 at risk
EG0200 affected1 at risk
Blood bilirubin increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0062 affected7 at risk
EG0070 affected6 at risk
EG0082 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Blood creatine increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Blood creatinine increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0151 affected7 at risk
EG0161 affected3 at risk
EG0172 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Body temperature increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Bronchitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
COVID-19
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0152 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0182 affected4 at risk
EG0190 affected3 at risk
EG0201 affected1 at risk
COVID-19 pneumonia
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0201 affected1 at risk
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0161 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Cardiac ventricular thrombosis
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0181 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Catheter site inflammation
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Cerebrovascular accident
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0151 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Chest pain
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0161 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Chills
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0031 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0081 affected6 at risk
EG0094 affected6 at risk
EG0104 affected8 at risk
EG0111 affected7 at risk
EG0123 affected7 at risk
EG0133 affected8 at risk
EG0142 affected6 at risk
EG0151 affected7 at risk
EG0161 affected3 at risk
EG0176 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Cholestasis
Hepatobiliary disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0161 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Chromaturia
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Clostridium difficile colitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Coccydynia
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Colorectal cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0141 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Complication associated with device
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0111 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Confusional state
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0121 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Constipation
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0022 affected4 at risk
EG0031 affected3 at risk
EG0041 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0092 affected6 at risk
EG0101 affected8 at risk
EG0111 affected7 at risk
EG0121 affected7 at risk
EG0132 affected8 at risk
EG0141 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0172 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0141 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0111 affected7 at risk
EG0121 affected7 at risk
EG0131 affected8 at risk
EG0142 affected6 at risk
EG0151 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0191 affected3 at risk
EG0200 affected1 at risk
Cytokine release syndrome
Immune system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0102 affected8 at risk
EG0112 affected7 at risk
EG0120 affected7 at risk
EG0132 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0161 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG0031 affected3 at risk
EG0041 affected4 at risk
EG0050 affected4 at risk
EG0062 affected7 at risk
EG0072 affected6 at risk
EG0082 affected6 at risk
EG0092 affected6 at risk
EG0105 affected8 at risk
EG0111 affected7 at risk
EG0122 affected7 at risk
EG0134 affected8 at risk
EG0143 affected6 at risk
EG0152 affected7 at risk
EG0160 affected3 at risk
EG0173 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Deep vein thrombosis
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0191 affected3 at risk
EG0200 affected1 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0071 affected6 at risk
EG0081 affected6 at risk
EG0091 affected6 at risk
EG0103 affected8 at risk
EG0110 affected7 at risk
EG0121 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0151 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Delirium
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0141 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0121 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Device dislocation
Product Issues
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0111 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected5 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0052 affected4 at risk
EG0063 affected7 at risk
EG0071 affected6 at risk
EG0082 affected6 at risk
EG0094 affected6 at risk
EG0104 affected8 at risk
EG0113 affected7 at risk
EG0123 affected7 at risk
EG0132 affected8 at risk
EG0142 affected6 at risk
EG0153 affected7 at risk
EG0160 affected3 at risk
EG0174 affected7 at risk
EG0181 affected4 at risk
EG0192 affected3 at risk
EG0200 affected1 at risk
Diplopia
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0181 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Discomfort
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0181 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Dizziness
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0062 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0092 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0132 affected8 at risk
EG0141 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Dry eye
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Dry mouth
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0121 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Dysgeusia
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0111 affected7 at risk
EG0121 affected7 at risk
EG0132 affected8 at risk
EG0141 affected6 at risk
EG0151 affected7 at risk
EG0160 affected3 at risk
EG0173 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0041 affected4 at risk
EG0051 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0122 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0151 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Dysphagia
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
EG0063 affected7 at risk
EG0071 affected6 at risk
EG0081 affected6 at risk
EG0092 affected6 at risk
EG0104 affected8 at risk
EG0111 affected7 at risk
EG0122 affected7 at risk
EG0132 affected8 at risk
EG0142 affected6 at risk
EG0151 affected7 at risk
EG0160 affected3 at risk
EG0172 affected7 at risk
EG0181 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Dysuria
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0161 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Ear discomfort
Ear and labyrinth disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Ear pain
Ear and labyrinth disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0121 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Eczema
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0151 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Electrocardiogram QT prolonged
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Encephalopathy
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0172 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Eye pruritus
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0151 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Eyelid ptosis
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Face oedema
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Faeces pale
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Fall
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0141 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Fatigue
General disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected3 at risk
EG0022 affected4 at risk
EG0030 affected3 at risk
EG0042 affected4 at risk
EG0052 affected4 at risk
EG0064 affected7 at risk
EG0075 affected6 at risk
EG0084 affected6 at risk
EG0094 affected6 at risk
EG0105 affected8 at risk
EG0112 affected7 at risk
EG0125 affected7 at risk
EG0133 affected8 at risk
EG0142 affected6 at risk
EG0153 affected7 at risk
EG0160 affected3 at risk
EG0174 affected7 at risk
EG0181 affected4 at risk
EG0191 affected3 at risk
EG0200 affected1 at risk
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Fluid retention
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Flushing
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Foot fracture
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0111 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Gait disturbance
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Gastritis
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Gastrointestinal pain
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Gouty arthritis
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Haematuria
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0041 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0151 affected7 at risk
EG0160 affected3 at risk
EG0172 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0151 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Haemorrhoids
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Hair texture abnormal
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Hallucination
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0121 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Hallucination, visual
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Headache
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected5 at risk
EG0012 affected3 at risk
EG0022 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0072 affected6 at risk
EG0081 affected6 at risk
EG0095 affected6 at risk
EG0104 affected8 at risk
EG0114 affected7 at risk
EG0124 affected7 at risk
EG0131 affected8 at risk
EG0143 affected6 at risk
EG0152 affected7 at risk
EG0161 affected3 at risk
EG0174 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0191 affected3 at risk
EG0200 affected1 at risk
Hepatic pain
Hepatobiliary disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Herpes simplex reactivation
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0172 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Hot flush
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0111 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0172 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0141 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0161 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0121 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0201 affected1 at risk
Hypertension
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0151 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0181 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0111 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG0030 affected3 at risk
EG0041 affected4 at risk
EG0050 affected4 at risk
EG0062 affected7 at risk
EG0070 affected6 at risk
EG0083 affected6 at risk
EG0091 affected6 at risk
EG0103 affected8 at risk
EG0112 affected7 at risk
EG0122 affected7 at risk
EG0133 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0191 affected3 at risk
EG0201 affected1 at risk
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0102 affected8 at risk
EG0112 affected7 at risk
EG0121 affected7 at risk
EG0132 affected8 at risk
EG0141 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0062 affected7 at risk
EG0070 affected6 at risk
EG0082 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0062 affected7 at risk
EG0071 affected6 at risk
EG0081 affected6 at risk
EG0091 affected6 at risk
EG0102 affected8 at risk
EG0111 affected7 at risk
EG0120 affected7 at risk
EG0132 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Hypotension
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0121 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Hypothyroidism
Endocrine disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0142 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0191 affected3 at risk
EG0200 affected1 at risk
Influenza like illness
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0121 affected7 at risk
EG0130 affected8 at risk
EG0142 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Infusion site bruising
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0121 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Infusion site pain
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Injection site bruising
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0141 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Injection site pain
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Insomnia
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0041 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0083 affected6 at risk
EG0092 affected6 at risk
EG0102 affected8 at risk
EG0110 affected7 at risk
EG0121 affected7 at risk
EG0131 affected8 at risk
EG0141 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0172 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Interferon alpha level increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0201 affected1 at risk
Interferon gamma level increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0201 affected1 at risk
Interleukin level increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0191 affected3 at risk
EG0201 affected1 at risk
Lethargy
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Leukocyturia
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0161 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Lip blister
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Lip scab
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Lymphocyte count decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0111 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Lymphopenia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0181 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Malaise
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0081 affected6 at risk
EG0091 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0121 affected7 at risk
EG0130 affected8 at risk
EG0141 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Malignant peritoneal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0141 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Memory impairment
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Metastases to lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Micturition urgency
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Middle insomnia
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Mitral valve incompetence
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Mouth ulceration
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0161 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Mucosal inflammation
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0121 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0151 affected7 at risk
EG0161 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0081 affected6 at risk
EG0091 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0122 affected7 at risk
EG0130 affected8 at risk
EG0141 affected6 at risk
EG0152 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0181 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0081 affected6 at risk
EG0092 affected6 at risk
EG0101 affected8 at risk
EG0111 affected7 at risk
EG0121 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0151 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Nausea
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected5 at risk
EG0011 affected3 at risk
EG0021 affected4 at risk
EG0031 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0062 affected7 at risk
EG0072 affected6 at risk
EG0082 affected6 at risk
EG0096 affected6 at risk
EG0106 affected8 at risk
EG0115 affected7 at risk
EG0125 affected7 at risk
EG0135 affected8 at risk
EG0143 affected6 at risk
EG0151 affected7 at risk
EG0162 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Neuropathy peripheral
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0152 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0182 affected4 at risk
EG0192 affected3 at risk
EG0200 affected1 at risk
Neutrophil count decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0111 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0191 affected3 at risk
EG0201 affected1 at risk
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0122 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0172 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Non-cardiac chest pain
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0102 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0141 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Oedema peripheral
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
EG0061 affected7 at risk
EG0072 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0102 affected8 at risk
EG0113 affected7 at risk
EG0120 affected7 at risk
EG0132 affected8 at risk
EG0141 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0172 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Oesophagitis
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0111 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Onycholysis
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Ophthalmic migraine
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0111 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Oral candidiasis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0102 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Oral herpes
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0161 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0092 affected6 at risk
EG0100 affected8 at risk
EG0111 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Orthopnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Osteolysis
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Otitis media
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Pain
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG0031 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Palpitations
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0141 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Pancreatic failure
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Pancytopenia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Paraesthesia
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Paronychia
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Parotitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Performance status decreased
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0121 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Peripheral swelling
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Phlebitis
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Platelet count decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0082 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0181 affected4 at risk
EG0191 affected3 at risk
EG0201 affected1 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0062 affected7 at risk
EG0071 affected6 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0111 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0172 affected7 at risk
EG0180 affected4 at risk
EG0191 affected3 at risk
EG0200 affected1 at risk
Pleural fluid analysis abnormal
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0191 affected3 at risk
EG0200 affected1 at risk
Pneumonia
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Pollakiuria
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0151 affected7 at risk
EG0161 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Postmenopausal haemorrhage
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Presyncope
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Proctalgia
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0161 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0141 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Prostatitis
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Prothrombin level increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0201 affected1 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0081 affected6 at risk
EG0091 affected6 at risk
EG0102 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0151 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Pyrexia
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0031 affected3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
EG0062 affected7 at risk
EG0071 affected6 at risk
EG0083 affected6 at risk
EG0093 affected6 at risk
EG0104 affected8 at risk
EG0112 affected7 at risk
EG0122 affected7 at risk
EG0136 affected8 at risk
EG0143 affected6 at risk
EG0152 affected7 at risk
EG0161 affected3 at risk
EG0175 affected7 at risk
EG0181 affected4 at risk
EG0191 affected3 at risk
EG0201 affected1 at risk
Radiculopathy
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0111 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0041 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0121 affected7 at risk
EG0131 affected8 at risk
EG0141 affected6 at risk
EG0151 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0151 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0151 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Retching
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected8 at risk
EG0111 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0151 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Scab
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Sinus tachycardia
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0041 affected4 at risk
EG0050 affected4 at risk
EG0062 affected7 at risk
EG0072 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0191 affected3 at risk
EG0200 affected1 at risk
Sinusitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Skin laceration
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Somnolence
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0161 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Spondylitis
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Stoma prolapse
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Stomatitis
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0052 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0111 affected7 at risk
EG0121 affected7 at risk
EG0133 affected8 at risk
EG0140 affected6 at risk
EG0151 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0191 affected3 at risk
EG0200 affected1 at risk
Stridor
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Supraventricular extrasystoles
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0191 affected3 at risk
EG0200 affected1 at risk
Supraventricular tachycardia
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Tachycardia
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0141 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Thirst
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0191 affected3 at risk
EG0200 affected1 at risk
Tooth abscess
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Toothache
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Tremor
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Umbilical hernia
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0061 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Urinary incontinence
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0022 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0141 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Urinary occult blood
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0201 affected1 at risk
Urinary retention
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Urinary tract infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
EG0061 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0091 affected6 at risk
EG0101 affected8 at risk
EG0111 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0141 affected6 at risk
EG0151 affected7 at risk
EG0161 affected3 at risk
EG0171 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Urinary tract obstruction
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0111 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Vaginal discharge
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0161 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0161 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Vaginal infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Vertigo
Ear and labyrinth disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0161 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Vessel puncture site bruise
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Vision blurred
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Vomiting
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG0031 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0071 affected6 at risk
EG0080 affected6 at risk
EG0093 affected6 at risk
EG0104 affected8 at risk
EG0113 affected7 at risk
EG0124 affected7 at risk
EG0134 affected8 at risk
EG0143 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0171 affected7 at risk
EG0181 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Vulvovaginal inflammation
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0111 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Weight decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0101 affected8 at risk
EG0110 affected7 at risk
EG0121 affected7 at risk
EG0131 affected8 at risk
EG0142 affected6 at risk
EG0150 affected7 at risk
EG0161 affected3 at risk
EG0172 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0201 affected1 at risk
White blood cell count decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0191 affected3 at risk
EG0201 affected1 at risk
White blood cell count increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0131 affected8 at risk
EG0140 affected6 at risk
EG0150 affected7 at risk
EG0160 affected3 at risk
EG0170 affected7 at risk
EG0180 affected4 at risk
EG0190 affected3 at risk
EG0200 affected1 at risk
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
D007160
Immunoproliferative Disorders
D007154
Immune System Diseases
D009371
Neoplasms by Site
D006402
Hematologic Diseases
2
BG0052
BG0064
BG0074
BG0082
BG0092
BG0105
BG0112
BG0123
BG0135
BG0141
BG0156
BG0160
BG0174
BG0184
BG0190
BG0200
BG02151
3
BG0054
BG0067
BG0076
BG0086
BG0096
BG0106
BG0116
BG0126
BG0136
BG0145
BG0157
BG0163
BG0177
BG0184
BG0193
BG0201
BG021100
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0101
BG0111
BG0121
BG0131
BG0141
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0216
0
BG0050
BG0061
BG0070
BG0080
BG0090
BG0100
BG0111
BG0120
BG0130
BG0140
BG0150
BG0160
BG0172
BG0180
BG0191
BG0201
BG0216
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
0
BG0050
BG0062
BG0072
BG0082
BG0090
BG0101
BG0110
BG0120
BG0131
BG0140
BG0150
BG0160
BG0171
BG0180
BG0190
BG0200
BG0219
3
BG0054
BG0064
BG0074
BG0084
BG0096
BG0107
BG0116
BG0127
BG0135
BG0145
BG0157
BG0163
BG0172
BG0184
BG0192
BG0200
BG02188
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0171
BG0180
BG0190
BG0200
BG0211
1
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0132
BG0141
BG0150
BG0160
BG0171
BG0180
BG0190
BG0200
BG0215
3
OG0044
OG0054
OG0067
OG0076
OG0086
OG0096
OG0108
OG0117
OG0127
OG0138
OG0146
1
OG0042
OG0052
OG0064
OG0073
OG0084
OG0090
OG0106
OG0115
OG0124
OG0137
OG0143
3
OG0044
OG0054
OG0067
OG0076
OG0086
OG0096
OG0108
OG0117
OG0127
OG0138
OG0146
3.0
(1 to 5)
OG0044.0(1 to 39)
OG0059.5(1 to 36)
OG0064.0(1 to 42)
OG0073.0(1 to 47)
OG0088.0(1 to 82)
OG0092.0(1 to 58)
OG0104.5(1 to 188)
OG0115.0(1 to 37)
OG0122.0(1 to 80)
OG0133.0(1 to 131)
OG0144.0(1 to 64)
3
OG0044
OG0054
OG0066
OG0075
OG0085
OG0096
OG0106
OG0116
OG0127
OG0136
OG0146
0
OG0040
OG0050
OG0061
OG0070
OG0080
OG0090
OG0101
OG0110
OG0120
OG0132
OG0140
4
OG0043
OG0051
0.0
(0.0 to 60.24)
OG0040.0(0.0 to 70.76)
OG005100.0(2.50 to 100.0)
3
OG0044
OG0054
OG0067
OG0076
OG0086
OG0096
OG0107
OG0117
OG0127
OG0138
OG0145
3
ParticipantsOG0044
ParticipantsOG0054
ParticipantsOG0067
ParticipantsOG0076
ParticipantsOG0086
ParticipantsOG0096
ParticipantsOG0107
ParticipantsOG0117
ParticipantsOG0127
ParticipantsOG0138
ParticipantsOG0145
Title
Measurements
OG00014.0± 74.6
OG00122.5± 19.7
OG00246.1± 45.3
OG00361.0± 69.0
OG004124± 80.9
OG005314± 37.8
OG006417± 33.4
OG007446± 27.4
OG008738± 37.1
OG009685± 30.4
OG010773± 49.3
OG011887± 54.5
OG012668± 32.9
OG0131410± 46.8
OG0141100± 36.4
Cycle 1 Day 8
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0054
ParticipantsOG0066
ParticipantsOG0075
ParticipantsOG0085
ParticipantsOG0096
ParticipantsOG0106
ParticipantsOG0116
ParticipantsOG0126
ParticipantsOG0136
ParticipantsOG0145
Title
Measurements
OG00122.5± 22.8
OG00233.8± 35.7
OG003114± 103.6
OG004
3
OG0044
OG0054
OG0067
OG0076
OG0086
OG0096
OG0107
OG0117
OG0127
OG0138
OG0145
3
ParticipantsOG0044
ParticipantsOG0054
ParticipantsOG0067
ParticipantsOG0076
ParticipantsOG0086
ParticipantsOG0096
ParticipantsOG0107
ParticipantsOG0117
ParticipantsOG0127
ParticipantsOG0138
ParticipantsOG0145
Title
Measurements
OG0001.17(1.08 to 1.62)
OG0011.22(1.03 to 1.33)
OG0021.03(0.93 to 1.08)
OG0031.08(1.07 to 1.65)
OG0041.08(1.07 to 1.57)
OG0051.18(1.05 to 2.13)
OG0061.12(1.00 to 1.68)
OG0071.08(1.00 to 1.40)
OG0081.02(0.97 to 1.20)
OG0091.17(1.08 to 1.22)
OG0101.03(1.00 to 1.13)
OG0111.12(1.05 to 1.25)
OG0121.17(1.03 to 1.25)
OG0131.11(1.07 to 1.27)
OG0141.05(1.02 to 1.17)
Cycle 1 Day 8
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0054
ParticipantsOG0066
ParticipantsOG0075
ParticipantsOG0085
ParticipantsOG0096
ParticipantsOG0106
ParticipantsOG0116
ParticipantsOG0126
ParticipantsOG0136
ParticipantsOG0145
Title
Measurements
OG0011.19(1.13 to 1.25)
OG0021.17(1.07 to 2.08)
OG0031.03(1.00 to 1.05)
OG004
3
OG0044
OG0054
OG0067
OG0076
OG0086
OG0096
OG0107
OG0117
OG0127
OG0138
OG0145
3
ParticipantsOG0044
ParticipantsOG0054
ParticipantsOG0067
ParticipantsOG0076
ParticipantsOG0086
ParticipantsOG0096
ParticipantsOG0107
ParticipantsOG0117
ParticipantsOG0127
ParticipantsOG0138
ParticipantsOG0145
Title
Measurements
OG00050.1± 35.0
OG00198.4± 15.5
OG002178± 19.6
OG003289± 40.6
OG004438± 34.5
OG005939± 20.7
OG0061070± 28.2
OG0071020± 25.8
OG0081310± 16.9
OG0091330± 15.7
OG0101460± 31.0
OG0111670± 31.9
OG0121410± 31.8
OG0132510± 30.1
OG0141890± 39.7
Cycle 1 Day 8
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0054
ParticipantsOG0066
ParticipantsOG0075
ParticipantsOG0085
ParticipantsOG0096
ParticipantsOG0106
ParticipantsOG0116
ParticipantsOG0126
ParticipantsOG0136
ParticipantsOG0145
Title
Measurements
OG00198.6± 13.5
OG002174± 23.0
OG003364± 58.0
OG004
3
OG0044
OG0054
OG0067
OG0076
OG0086
OG0096
OG0107
OG0117
OG0126
OG0137
OG0145
3
ParticipantsOG0044
ParticipantsOG0054
ParticipantsOG0067
ParticipantsOG0076
ParticipantsOG0086
ParticipantsOG0096
ParticipantsOG0107
ParticipantsOG0117
ParticipantsOG0126
ParticipantsOG0137
ParticipantsOG0143
Title
Measurements
OG00053.5± 31.1
OG001100± 14.7
OG002181± 19.5
OG003294± 39.2
OG004443± 34.7
OG005949± 20.2
OG0061090± 28.0
OG0071040± 26.1
OG0081330± 17.0
OG0091350± 15.5
OG0101480± 31.6
OG0111700± 31.7
OG0121360± 32.3
OG0132540± 33.3
OG0142280± 5.6
Cycle 1 Day 8
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0054
ParticipantsOG0065
ParticipantsOG0075
ParticipantsOG0084
ParticipantsOG0096
ParticipantsOG0106
ParticipantsOG0116
ParticipantsOG0125
ParticipantsOG0135
ParticipantsOG0145
Title
Measurements
OG001103± 12.8
OG002183± 21.9
OG003382± 53.5
OG004
3
OG0044
OG0054
OG0067
OG0076
OG0086
OG0096
OG0107
OG0117
OG0126
OG0137
OG0145
3
ParticipantsOG0044
ParticipantsOG0054
ParticipantsOG0067
ParticipantsOG0076
ParticipantsOG0086
ParticipantsOG0096
ParticipantsOG0107
ParticipantsOG0117
ParticipantsOG0126
ParticipantsOG0137
ParticipantsOG0143
Title
Measurements
OG0005.41(2.92 to 6.40)
OG0017.37(4.90 to 9.90)
OG0027.60(6.92 to 8.49)
OG0037.88(5.81 to 10.32)
OG0047.87(7.30 to 9.78)
OG0058.12(6.77 to 9.19)
OG0069.18(8.05 to 10.95)
OG0078.89(6.56 to 11.81)
OG0089.44(7.58 to 10.23)
OG0099.62(7.30 to 10.48)
OG0108.01(5.39 to 9.90)
OG0118.32(7.06 to 13.77)
OG0128.38(7.01 to 10.74)
OG0138.99(7.38 to 11.67)
OG0148.61(7.01 to 9.74)
Cycle 1 Day 8
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0054
ParticipantsOG0065
ParticipantsOG0075
ParticipantsOG0084
ParticipantsOG0096
ParticipantsOG0106
ParticipantsOG0116
ParticipantsOG0125
ParticipantsOG0135
ParticipantsOG0145
Title
Measurements
OG0015.74(5.65 to 5.83)
OG0026.02(4.53 to 6.74)
OG0036.08(4.51 to 7.45)
OG004
3
OG0044
OG0054
OG0067
OG0076
OG0086
OG0096
OG0107
OG0117
OG0126
OG0137
OG0145
3
ParticipantsOG0044
ParticipantsOG0054
ParticipantsOG0067
ParticipantsOG0076
ParticipantsOG0086
ParticipantsOG0096
ParticipantsOG0107
ParticipantsOG0117
ParticipantsOG0126
ParticipantsOG0137
ParticipantsOG0143
Title
Measurements
OG00056.1± 31.1
OG00159.8± 14.7
OG00255.3± 19.5
OG00351.0± 39.2
OG00456.4± 34.7
OG00542.2± 20.2
OG00655.3± 28.0
OG00757.8± 26.1
OG00856.3± 17.0
OG00955.7± 15.5
OG01060.7± 31.6
OG01152.9± 31.7
OG01266.0± 32.3
OG01347.3± 33.3
OG01452.6± 5.6
Cycle 1 Day 8
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0054
ParticipantsOG0065
ParticipantsOG0075
ParticipantsOG0084
ParticipantsOG0096
ParticipantsOG0106
ParticipantsOG0116
ParticipantsOG0125
ParticipantsOG0135
ParticipantsOG0145
Title
Measurements
OG00158.3± 12.8
OG00254.7± 21.9
OG00339.3± 53.5
OG004
3
OG0044
OG0054
OG0067
OG0076
OG0086
OG0096
OG0107
OG0117
OG0126
OG0137
OG0145
3
ParticipantsOG0044
ParticipantsOG0054
ParticipantsOG0067
ParticipantsOG0076
ParticipantsOG0086
ParticipantsOG0096
ParticipantsOG0107
ParticipantsOG0117
ParticipantsOG0126
ParticipantsOG0137
ParticipantsOG0143
Title
Measurements
OG000332± 37.9
OG001437± 18.2
OG002443± 28.9
OG003411± 72.8
OG004392± 39.9
OG005234± 36.0
OG006359± 33.5
OG007367± 19.2
OG008311± 24.0
OG009345± 29.1
OG010314± 46.3
OG011290± 59.4
OG012396± 25.8
OG013271± 31.3
OG014288± 27.6
Cycle 1 Day 8
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0054
ParticipantsOG0065
ParticipantsOG0075
ParticipantsOG0084
ParticipantsOG0096
ParticipantsOG0106
ParticipantsOG0116
ParticipantsOG0125
ParticipantsOG0135
ParticipantsOG0145
Title
Measurements
OG001385± 12.9
OG002390± 32.0
OG003233± 119.7
OG004
3
OG0044
OG0053
OG0066
OG0076
OG0086
OG0096
OG0107
OG0116
OG0125
OG0137
OG0145
0.0
(0.00 to 70.76)
OG0040.0(0.00 to 60.24)
OG00533.3(0.84 to 90.57)
OG0060.0(0.00 to 45.93)
OG0070.0(0.00 to 45.93)
OG0080.0(0.0 to 45.93)
OG0090.0(0.0 to 45.93)
OG0100.0(0.0 to 40.96)
OG01116.7(0.42 to 64.12)
OG0120.0(0.0 to 52.18)
OG01314.3(0.36 to 57.87)
OG0140.0(0.00 to 52.18)
3
OG0044
OG0053
OG0066
OG0076
OG0086
OG0096
OG0107
OG0116
OG0125
OG0137
OG0145
OG0157
OG0163
OG0176
OG0184
OG0193
OG0201
33.3
(0.84 to 90.57)
OG00475.0(19.41 to 99.37)
OG00566.7(9.43 to 99.16)
OG0060.0(0.0 to 45.93)
OG00766.7(22.28 to 95.67)
OG00816.7(0.42 to 64.12)
OG00966.7(22.28 to 95.67)
OG01042.9(9.90 to 81.59)
OG01150.0(11.81 to 88.19)
OG01260.0(14.66 to 94.73)
OG01342.9(9.90 to 81.59)
OG01420.0(0.51 to 71.64)
OG01571.4(29.04 to 96.33)
OG01666.7(9.43 to 99.16)
OG01733.3(4.33 to 77.72)
OG0180.0(0.0 to 60.24)
OG0190.0(0.00 to 70.76)
OG020100.0(2.50 to 100.0)
0
OG0040
OG0051
OG0060
OG0070
OG0080
OG0090
OG0100
OG0111
OG0120
OG0131
OG0140
OG0150
OG0160
OG0170
OG0180
OG0190
OG0201
NA
(NA to NA)
Median, upper and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0205.55(NA to NA)Upper and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
3
OG0044
OG0054
OG0067
OG0076
OG0086
OG0096
OG0108
OG0117
OG0127
OG0138
OG0146
OG0157
OG0163
OG0177
OG0184
OG0193
OG0201
1.38
(0.59 to NA)
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0031.25(1.18 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0042.10(1.38 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0055.49(1.25 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0061.21(0.46 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0073.75(0.72 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0081.28(1.22 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0092.71(1.35 to 8.08)
OG0106.97(2.66 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0113.94(1.18 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0122.79(1.25 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG013NA(1.38 to NA)Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0141.97(1.74 to 2.04)
OG0156.06(2.07 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0163.78(0.99 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0171.18(0.92 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0181.04(0.59 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0191.09(0.43 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG02011.17(NA to NA)Upper and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
0
OG0040
OG0051
OG0060
OG0070
OG0080
OG0090
OG0100
OG0111
OG0120
OG0131
OG0140
OG0150
OG0160
OG0170
OG0180
OG0190
OG0201
NA
(1.74 to NA)
Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0205.65(NA to NA)Upper limit and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
3
OG0044
OG0054
OG0067
OG0076
OG0086
OG0096
OG0108
OG0117
OG0127
OG0138
OG0146
OG0157
OG0163
OG0177
OG0184
OG0193
OG0201
1.38
(0.59 to NA)
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0031.25(1.18 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0042.10(1.38 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0055.49(1.25 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0061.18(0.46 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0072.53(1.02 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0081.27(1.22 to 1.54)
OG0092.71(1.35 to 8.08)
OG0102.66(0.82 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0113.94(1.18 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0122.79(1.25 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0133.32(1.38 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0141.97(1.74 to 2.04)
OG0156.06(2.07 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0163.78(0.99 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0171.18(0.92 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0181.38(0.59 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0191.09(0.43 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG02011.17(NA to NA)Upper limit and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
3
OG0044
OG0054
OG0067
OG0076
OG0086
OG0096
OG0108
OG0117
OG0127
OG0138
OG0146
OG0157
OG0163
OG0177
OG0184
OG0193
OG0201
NA
(NA to NA)
Median, upper limit and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG003NA(NA to NA)Median, upper limit and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG004NA(3.02 to NA)Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG005NA(1.48 to NA)Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG006NA(1.25 to NA)Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG007NA(NA to NA)Median, upper limit and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG008NA(NA to NA)Median, upper limit and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG009NA(NA to NA)Median, upper limit and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG010NA(0.82 to NA)Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0115.49(5.49 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG012NA(1.77 to NA)Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG013NA(5.22 to NA)Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG014NA(NA to NA)Median, upper limit and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG015NA(1.87 to NA)Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG016NA(3.29 to NA)Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG017NA(1.87 to NA)Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0182.43(1.28 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG0196.14(1.58 to NA)Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
OG020NA(NA to NA)Median, upper limit and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.