A Study of Selpercatinib (LOXO-292) in Participants With... | NCT03157128 | Trialant
NCT03157128
Sponsor
Eli Lilly and Company
Status
Active, not recruiting
Last Update Posted
Apr 16, 2026Actual
Enrollment
857Actual
Phase
Phase 1Phase 2
Conditions
Non-Small Cell Lung Cancer
Medullary Thyroid Cancer
Colon Cancer
Any Solid Tumor
Interventions
LOXO-292
Countries
United States
Australia
Canada
Denmark
France
Germany
Hong Kong
Israel
Italy
Japan
Singapore
South Korea
Spain
Switzerland
Taiwan
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03157128
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
17477
Secondary IDs
ID
Type
Description
Link
J2G-OX-JZJA
Other Identifier
Eli Lilly and Company
LOXO-RET-17001
Other Identifier
Loxo Oncology, Inc.
2017-000800-59
EudraCT Number
2023-507702-13-00
EU Trial (CTIS) Number
Brief Title
A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)
Official Title
A Phase 1/2 Study of Oral Selpercatinib (LOXO-292) in Patients With Advanced Solid Tumors, Including RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors With RET Activation (LIBRETTO-001)
Acronym
LIBRETTO-001
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Mar 2026
Overall Recruitment Status or Expanded Access Status
Active, not recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
YesNCT03906331Approved for marketing
Start Date
May 2, 2017Actual
Primary Completion Date
Feb 14, 2025Actual
Completion Date
Feb 2027Estimated
First Submitted Date
May 9, 2017
First Submission Date that Met QC Criteria
May 15, 2017
First Posted Date
May 17, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Feb 13, 2026
Results First Submitted that Met QC Criteria
Mar 27, 2026
Results First Posted Date
Apr 16, 2026Actual
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
Mar 27, 2026
Last Update Posted Date
Apr 16, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Name
Class
Loxo Oncology, Inc.
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
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 is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of selpercatinib (also known as LOXO-292) administered orally to participants with advanced solid tumors, including rearranged during transfection (RET)-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.
Detailed Description
This is an open-label, multi-center Phase 1/2 study in participants with advanced solid tumors, including RET fusion-positive solid tumors, MTC, and other tumors with RET activation. The trial will be conducted in 2 parts: Phase 1 (dose escalation - completed) and phase 2 (dose expansion). Participants with advanced cancer are eligible if they have progressed on or are intolerant to available standard therapies, or no standard or available curative therapy exists, or in the opinion of the Investigator, they would be unlikely to tolerate or derive significant clinical benefit from appropriate standard of care therapy, or they declined standard therapy. A dose of 160 milligrams (mg) twice a day (BID) has been selected as the recommended phase 2 dose (RP2D). Approximately 875 participants with advanced solid tumors harboring a RET gene alteration in tumor and/or blood will be enrolled to one of six phase 2 cohorts:
Cohort 1: Advanced RET fusion positive solid tumor other than NSCLC or thyroid cancer for participants who progressed on or intolerant to first line therapy (open)
Cohort 2: Advanced RET fusion positive solid tumor other than NSCLC or thyroid cancer for treatment naïve participants (open)
Cohort 3: Advanced RET-mutant MTC participants who progressed on or intolerant to first line therapy (closed)
Cohort 4: Advanced RET-mutant MTC participants who are treatment naïve (closed)
Cohort 5: Advanced RET-altered solid tumor for participants other than NSCLC or thyroid cancer and RET-mutant MEN2 spectrum tumors (e.g. pheochromocytoma) otherwise ineligible for cohorts 1-4. See details in inclusion/exclusion criteria (open)
Cohort 6: Participants otherwise eligible for Cohorts 1-5 who discontinued another RET inhibitor due to intolerance may be eligible with prior Sponsor approval (closed)
Conditions Module
Conditions
Non-Small Cell Lung Cancer
Medullary Thyroid Cancer
Colon Cancer
Any Solid Tumor
Keywords
LOXO-292
KIF5B-RET
M918T
CCDC6-RET
RET-PTC1
NCOA4-RET
RET-PTC
RET-PTC3
RET-PTC4
PRKAR1A-RET
RET-PTC2
GOLGA5-RET
RET-PTC5
ERC1-RET
KTN1-RET
RET-PTC8
HOOK3-RET
PCM1-RET
TRIM24-RET
RET-PTC6
TRIM27-RET
TRIM33-RET
RET-PTC7
AKAP13-RET
FKBP15-RET
SPECC1L-RET
TBL1XR1-RET
BCR-RET
FGRF1OP-RET
RFG8-RET
RET-PTC9
ACBD5-RET
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
857Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase 1: 20 mg Selpercatinib QD
Experimental
Participants received Selpercatinib 20 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Drug: LOXO-292
Phase 1: 20 mg Selpercatinib BID
Experimental
Participants received Selpercatinib 20 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Drug: LOXO-292
Phase 1: 40 mg Selpercatinib BID
Experimental
Participants received Selpercatinib 40 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Drug: LOXO-292
Phase 1: 60 mg Selpercatinib BID
Experimental
Participants received Selpercatinib 60 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Drug: LOXO-292
Phase 1: 160 mg Selpercatinib QD
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LOXO-292
Drug
Oral LOXO-292
Phase 1: 120 mg Selpercatinib BID
Phase 1: 160 mg Selpercatinib BID
Phase 1: 160 mg Selpercatinib QD
Phase 1: 20 mg Selpercatinib BID
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 1: Maximum Tolerated Dose (MTD)
The MTD is defined as the highest dose level at which none of the first 3 treated patients, or not more than 1 of the first 6 treated patients, experiences a DLT. A DLT is any adverse events that starts on or after first administration of study drug, as defined by National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Any Grade(G) ≥3 nonhematologic toxicity, excluding
G3 AST, ALT, and/or total bilirubin elevation for <7 days.
G3 neutropenia <7 days
G3 thrombocytopenia without clinically significant bleeding
G3 or G4 lymphopenia.
First occurrence of G3 or G4 electrolyte abnormalities
G3 fatigue, weakness, nausea; other manageable constitutional symptom
G3 or G4 vomiting or diarrhea that lasts for <48hours with antiemetic/antidiarrheal medication in case of G3 and <24 hours in case of G4
G4 manageable constitutional symptom.
Cycle 1 (cycle length = 28 days)
Phase 1: Recommended Phase 2 Dose (RP2D)
Phase 1: RP2D
Cycle 1 (cycle length = 28 days)
Phase 2: Objective Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment
Objective Response Rate was defined as the percentage of participants with best overall response of confirmed response (CR), or Partial response (PR). Response was confirmed by a repeat assessment no less than 28 days.
CR is defined as disappearance of all target lesions.
PR is defined as at least a 30% decrease in the sum of diameter (LD for non-nodal lesions and short axis diameter [SAD] for nodal lesions) of target lesions, taking as reference the baseline sum LD.
ORR was assessed by independent review committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 95% confidence interval was calculated using Clopper-Pearson method.
Approximately for up to 7 years 8 months
Secondary Outcomes
Measure
Description
Time Frame
Phase 1: Number of Participants With a Treatment-Related Adverse Event(s) (TRAE[s])
Phase 1: Number of Participants with a TRAE(s) is reported.
Up to 28 days
Phase 1: Number of Participants With an Abnormal Laboratory Values
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
For Phase 1:
Participants with a locally advanced or metastatic solid tumor that:
Has progressed on or is intolerant to standard therapy, or
For which no standard therapy exists, or in the opinion of the Investigator, are not candidates for or would be unlikely to tolerate or derive significant clinical benefit from standard therapy, or
Decline standard therapy
Prior multikinase inhibitors (MKIs) with anti-RET activity are allowed
A RET gene alteration is not required initially. Once adequate PK exposure is achieved, evidence of RET gene alteration in tumor and/or blood is required as identified through molecular assays, as performed for clinical evaluation
Measurable or non-measurable disease as determined by RECIST 1.1 or RANO as appropriate to tumor type
Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2 or Lansky Performance Score (LPS) greater than or equal to (≥) 40 percent (%) (age less than [<] 16 years) with no sudden deterioration 2 weeks prior to the first dose of study treatment
Adequate hematologic, hepatic and renal function
Life expectancy of at least 3 months
For Phase 2: As for phase 1 with the following modifications:
For Cohort 1: Participants must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinical benefit from appropriate standard of care therapy
Cohorts 1 and 2:
Enrollment will be restricted to participants with evidence of a RET gene alteration in tumor
At least one measurable lesion as defined by RECIST 1.1 or RANO, as appropriate to tumor type and not previously irradiated
Cohorts 3 and 4: Enrollment closed
Cohort 5:
Cohorts 1-4 without measurable disease
MCT not meeting the requirements for Cohorts 3 or 4
MTC syndrome spectrum cancers (e.g., MTC, pheochromocytoma), cancers with neuroendocrine features/differentiation, or poorly differentiated thyroid cancers with other RET alteration/activation may be allowed with prior Sponsor approval
cfDNA positive for a RET gene alteration not known to be present in a tumor sample
Cohort 6: Participants who otherwise are eligible for Cohorts 1, 2 or 5 who discontinued another RET inhibitor may be eligible with prior Sponsor approval
Cohort 7: Participants with a histologically confirmed stage IB-IIIA NSCLC and a RET fusion; determined to be medically operable and tumor deemed resectable by a thoracic surgical oncologist, without prior systemic treatment for NSCLC
Key Exclusion Criteria (Phase 1 and Phase 2):
Phase 2 Cohorts 1 and 2: an additional known oncogenic driver
Cohorts 3 and 4: Enrollment closed
Cohorts 1, 2 and 5: prior treatment with a selective RET inhibitor Notes: Participants otherwise eligible for Cohorts 1, 2, and 5 who discontinued another selective RET inhibitor may be eligible for Phase 2 Cohort 6 with prior Sponsor approval
Investigational agent or anticancer therapy (including chemotherapy, biologic therapy, immunotherapy, anticancer Chinese medicine or other anticancer herbal remedy) within 5 half-lives or 2 weeks (whichever is shorter) prior to planned start of LOXO-292 (selpercatinib). In addition, no concurrent investigational anti-cancer therapy is permitted Note: Potential exception for this exclusion criterion will require a valid scientific justification and approval from the Sponsor
Major surgery (excluding placement of vascular access) within 2 weeks prior to planned start of LOXO-292 (selpercatinib)
Radiotherapy with a limited field of radiation for palliation within 1 week of planned start of LOXO-292 (selpercatinib), with the exception of participants receiving radiation to more than 30% of the bone marrow or with a wide field of radiation, which must be completed at least 4 weeks prior to the first dose of study treatment
Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy
Symptomatic primary CNS tumor, metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression. Participants are eligible if neurological symptoms and CNS imaging are stable and steroid dose is stable for 14 days prior to the first dose of LOXO-292 (selpercatinib) and no CNS surgery or radiation has been performed for 28 days, 14 days if stereotactic radiosurgery (SRS)
Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of LOXO-292 (selpercatinib) or prolongation of the QT interval corrected (QTcF) greater than (>) 470 milliseconds (msec)
Participants with implanted pacemakers may enter the study without meeting QTc criteria due to nonevaluable measurement if it is possible to monitor for QT changes.
Participants with bundle branch block may be considered for study entry if QTc is appropriate by a formula other than Fridericia's and if it is possible to monitor for QT changes.
Required treatment with certain strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers and certain prohibited concomitant medications
Phase 2 Cohort 7 (neoadjuvant treatment): Participant must not have received prior systemic therapy for NSCLC.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
12 Years
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Gautschi O, Park K, Solomon BJ, Tomasini P, Loong HH, De Braud F, Goto K, Peterson P, Barker S, Liming K, Oxnard GR, Frimodt-Moller B, Drilon A. Selpercatinib in RET Fusion-Positive Non-Small Cell Lung Cancer: Final Safety and Efficacy, Including Overall Survival, From the LIBRETTO-001 Phase I/II Trial. J Clin Oncol. 2025 May 20;43(15):1758-1764. doi: 10.1200/JCO-24-02076. Epub 2025 Feb 21.
In Phase 2, participants were assigned to one of six tumor-based groups: RET Fusion Solid Tumor, RET Fusion Solid Tumor Without Standard Therapy, RET Mutant MTC, RET Mutant MTC Without Standard Therapy, Advanced RET Altered Solid Tumor, RET Inhibitor-Discontinued Participants and received selpercatinib at the RP2D.
The current results reported are for the primary completion date (i.e., up to 7 years 9 months). Additional results will be reported at the time of final results reporting.
Recruitment Details
This study includes two parts:
Phase 1 (dose escalation) and;
Phase 2 (dose expansion)
In Phase 1, participants received selpercatinib, with dosing based on body surface area. The Phase 2 portion of the study was opened after confirmation of the RP2D of 160 mg BID.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase 1: 20 mg Selpercatinib QD
Participants received Selpercatinib 20 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
FG001
Phase 1: 20 mg Selpercatinib BID
Periods
Title
Milestones
Reasons Not Completed
Phase 1 (Dose Escalation)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Aug 15, 2023
Feb 10, 2026
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
MYH13-RET
CUX1-RET
KIAA1468-RET
FRMD4A-RET
SQSTM1-RET
AFAP1L2-RET
PPFIBP2-RET
EML4-RET
PARD3-RET
G533C
C609F
C609G
C609R
C609S
C609Y
C611F
C611G
C611S
C611Y
C611W
C618F
C618R
C618S
C620F
C620R
C620S
C630R
C630Y
D631Y
C634F
C634G
C634R
C634S
C634W
C634Y
K666E
E768D
L790F
V804L
V804M
A883F
S891A
R912P
CLIP1-RET
Y806C
RET fusion
RET alteration
RET mutation
RET rearrangement
RET translocation
Neoplasms by Site
Neoplasms
Non-Small Cell Lung Cancer
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Cancer of Lung
Cancer of the Lung
Lung Cancer
Neoplasms, Lung
Neoplasms, Pulmonary
Pulmonary Cancer
Pulmonary Neoplasms
Respiratory Tract Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Medullary Thyroid Cancer
Papillary Thyroid Cancer
Thyroid Diseases
Thyroid Neoplasms
Cancer of the Thyroid
Cancer of Thyroid
Neoplasms, Thyroid
Thyroid Ademona
Thyroid Cancer
Thyroid Carcinoma
Endocrine System Diseases
Endocrine Gland Neoplasms
Head and Neck Neoplasms
Thoracic Neoplasms
CNS tumor
Primary CNS tumor
Cancer of Colon
Cancer of the Colon
Colon Cancer
Colon Neoplasms
Colonic Cancer
Neoplasms, Colonic
Malignant tumor of Breast
Mammary Cancer
Mammary Carcinoma, Human
Mammary Neoplasm, Human
Neoplasms, Breast
Tumors, Breast
Human Mammary Carcinoma
Malignant Neoplasm of Breast
Breast Carcinoma
Breast Tumors
Cancer of the Breast
Breast Neoplasms
Breast Cancer
RET Inhibitor
MTC
NSCLC
selpercatinib
neo-adjuvant treatment in early stage NSCLC
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Experimental
Participants received Selpercatinib 160 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Drug: LOXO-292
Phase 1: 80 mg Selpercatinib BID
Experimental
Participants received Selpercatinib 80 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Drug: LOXO-292
Phase 1: 120 mg Selpercatinib BID
Experimental
Participants received Selpercatinib 120 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Drug: LOXO-292
Phase 1: 160 mg Selpercatinib BID
Experimental
Participants received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Drug: LOXO-292
Phase 1: 200 mg Selpercatinib BID
Experimental
Participants received Selpercatinib 200 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Drug: LOXO-292
Phase 1: 240 mg Selpercatinib BID
Experimental
Participants received Selpercatinib 240 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Drug: LOXO-292
Phase 2, Cohort 1: RET Fusion Solid Tumor
Experimental
Participants with Rearranged during transfection (RET) Fusion solid tumor progressed on/intolerant to standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Drug: LOXO-292
Phase 2, Cohort 2: RET Fusion Solid Tumor Without Standard Therapy
Experimental
Participants with RET Fusion solid tumor without standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Drug: LOXO-292
Phase 2, Cohort 3: RET Mutant MTC
Experimental
Participants with RET mutant medullary thyroid cancer (MTC) progressed on/intolerant to standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Drug: LOXO-292
Phase 2, Cohort 4: RET Mutant MTC Without Standard Therapy
Experimental
Participants with RET mutant MTC without prior standard first line therapy or other kinase inhibitor(s) with anti-RET activity received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Drug: LOXO-292
Phase 2, Cohort 5: Advanced RET Altered Solid Tumor
Experimental
Participants with RET altered solid tumor (cohorts 1-4, disease not measurable; MTC not eligible for Cohort 3 or 4; MTC syndrome spectrum cancer; circulating free tumor DNA [cfDNA+] for RET alteration not known to be present in tumor) received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Drug: LOXO-292
Phase 2, Cohort 6: RET Inhibitor-Discontinued Participants
Experimental
Participants otherwise eligible for Cohorts 1-5 who discontinued other RET inhibitors received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Drug: LOXO-292
Phase 1: 20 mg Selpercatinib QD
Phase 1: 200 mg Selpercatinib BID
Phase 1: 240 mg Selpercatinib BID
Phase 1: 40 mg Selpercatinib BID
Phase 1: 60 mg Selpercatinib BID
Phase 1: 80 mg Selpercatinib BID
Phase 2, Cohort 1: RET Fusion Solid Tumor
Phase 2, Cohort 2: RET Fusion Solid Tumor Without Standard Therapy
Phase 2, Cohort 3: RET Mutant MTC
Phase 2, Cohort 4: RET Mutant MTC Without Standard Therapy
Phase 2, Cohort 5: Advanced RET Altered Solid Tumor
Phase 2, Cohort 6: RET Inhibitor-Discontinued Participants
Selpercatinib
LY3527723
Up to 28 days
Phase 2: Overall Response Rate (ORR) Based on RECIST 1.1 or RANO, as Appropriate to Tumor Type
Phase 2: ORR based on RECIST 1.1 or RANO, as Appropriate to Tumor Type
Approximately for up to 9 years 8 months
Phase 2: ORR (by Investigator)
Phase 2: ORR (by Investigator)
Approximately for up to 9 years 8 months
Phase 2: Best Change in Tumor Size From Baseline (by IRC and Investigator)
Phase 2: Best Change in Tumor Size from Baseline (by IRC and Investigator)
Approximately for up to 9 years 8 months
Phase 2: Duration of Response (DOR; by IRC and Investigator)
Phase 2: DOR (by IRC and Investigator)
Approximately for up to 9 years 8 months
Phase 2: Central Nervous System (CNS) ORR (by IRC)
Phase 2: CNS ORR (by IRC)
Approximately for up to 9 years 8 months
Phase 2: CNS DOR (by IRC)
Phase 2: CNS DOR (by IRC)
Approximately for up to 9 years 8 months
Phase 2: Time to Any and Best Response (by IRC and Investigator)
Phase 2: Time to Any and Best Response (by IRC and Investigator)
Approximately for up to 9 years 8 months
Phase 2: CBR (by IRC and Investigator)
Phase 2: CBR (by IRC and Investigator)
Approximately for up to 9 years 8 months
Phase 2: PFS (by IRC and Investigator)
Phase 2: PFS (by IRC and Investigator)
Approximately for up to 9 years 8 months
Phase 2: Overall Survival (OS)
Phase 2: OS
Approximately for up to 9 years 8 months
Phase 2: Percentage of Participants With Any Serious Adverse Event (SAE[s])
Phase 2: Percentage of Participants with any SAE(s)
Approximately for up to 9 years 8 months
Phase 2: Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve of LOXO-292 (Selpercatinib)
Phase 2: PK: AUC of LOXO-292 (Selpercatinib)
Cycle 5 Day 1 (Cycle = 28 days)
Phase 2: PK: Maximum Concentration (Cmax) of LOXO-292 (Selpercatinib)
Phase 2: PK: Cmax of LOXO-292 (Selpercatinib)
Cycle 5 Day 1 (Cycle = 28 days)
Phase 1: Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours
Cycle 1 Day 8: Predose, 1, 2, 4, 8, 24 hours post dose (cycle length = 28 days)
Phase 1: Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax)
Cycle 1 Day 8: Predose, 1, 2, 4, 8, 24 hours post dose (cycle length = 28 days)
Duarte
California
91010-0269
United States
UCLA Medical Center
Los Angeles
California
90095
United States
Hoag Memorial Hospital Presbyterian
Newport Beach
California
92663
United States
Kaiser Permanente
Oakland
California
94611-5400
United States
Irvine Medical Center
Orange
California
92868
United States
University of California - San Diego
San Diego
California
92103
United States
UCSF Medical Center at Mission Bay
San Francisco
California
94158
United States
Kaiser Permanente Medical Center
Walnut Creek
California
94596
United States
Sarah Cannon Research Institute at HealthOne
Denver
Colorado
80218
United States
Yale Cancer Center
New Haven
Connecticut
06520
United States
Mayo Clinic in Florida
Jacksonville
Florida
32224
United States
Memorial Hospital Pembroke
Pembroke
Florida
33028
United States
Emory University
Atlanta
Georgia
30329-5102
United States
University of Chicago Medicine-Comprehensive Cancer Center
Chicago
Illinois
60637
United States
Ochsner Clinic Foundation
New Orleans
Louisiana
70121
United States
University of Maryland Medical Center
Baltimore
Maryland
21201
United States
Johns Hopkins University
Baltimore
Maryland
21287
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Dana-Farber Cancer Institute
Boston
Massachusetts
02215
United States
University of Michigan
Ann Arbor
Michigan
48109
United States
START Midwest
Grand Rapids
Michigan
49546
United States
Mayo Clinic
Rochester
Minnesota
55905-0002
United States
Washington University Medical School
St Louis
Missouri
63110
United States
Comprehensive Cancer Centers of Nevada
Las Vegas
Nevada
89169
United States
Roswell Park Cancer Institute
Buffalo
New York
14263
United States
NYU Langone
New York
New York
10016
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
University of North Carolina
Chapel Hill
North Carolina
27514
United States
Cleveland Clinic Foundation
Cleveland
Ohio
44195
United States
Ohio State University Hospital
Columbus
Ohio
43210-1257
United States
Oregon Health and Science University
Portland
Oregon
97201
United States
University of Pennsylvania Hospital
Philadelphia
Pennsylvania
19104
United States
Thomas Jefferson University
Philadelphia
Pennsylvania
19107
United States
Sarah Cannon Research Institute SCRI
Nashville
Tennessee
37203
United States
Vanderbilt University Medical Center
Nashville
Tennessee
37232-6303
United States
University of Texas Southwestern Medical Center at Dallas
Dallas
Texas
75390-9063
United States
University of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
Huntsman Cancer Institute
Salt Lake City
Utah
84112
United States
USO-Virginia Cancer Specialists, PC
Fairfax
Virginia
22031
United States
University of Wisconsin-Madison Hospital and Health Clinic
Madison
Wisconsin
53792
United States
Royal North Shore Hospital
St Leonards
New South Wales
2065
Australia
Peter MacCallum Cancer Centre
Melbourne
Victoria
3000
Australia
BC Cancer Vancouver
Vancouver
British Columbia
V5Z 4E6
Canada
Rigshospitalet
Copenhagen
2200
Denmark
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux
Aquitaine
33076
France
Centre Leon Berard
Lyon
Auvergne-Rhône-Alpes
69008
France
APHM Hôpital de la Timone
Marseille
13385
France
Institut du Cancer de Montpellier - Val d'aurelle
Montpellier
34298
France
Gustave Roussy
Villejuif
94805
France
Hôpital Européen Georges Pompidou
Paris
Île-de-France Region
75015
France
Universitätsklinikum Würzburg A. ö. R.
Würzburg
Bavaria
97080
Germany
Universitätsklinikum Köln
Cologne
North Rhine-Westphalia
50931
Germany
Prince of Wales Hospital
Hong Kong
Shatin, New Territories
999077
Hong Kong
Sheba Medical Center
Ramat Gan
Central District
5262100
Israel
Shaare Zedek Medical Center
Jerusalem
Jerusalem
9103102
Israel
Soroka Medical Center - Pediatric Outpatient Clinic
Beersheba
8410101
Israel
Hadassah Medical Center
Jerusalem
9112001
Israel
Istituto Nazionale dei Tumori
Milan
Lombardy
20133
Italy
Nagoya University Hospital
Nagoya
Aichi-ken
466-8560
Japan
National Cancer Center Hospital East
Kashiwa
Chiba
277-8577
Japan
Hokkaido University Hospital
Sapporo
Hokkaido
060-8648
Japan
Hyogo Cancer Center
Akashi
Hyōgo
673-8558
Japan
Kanazawa University Hospital
Kanazawa
Ishikawa-ken
920-8641
Japan
Kindai University Hospital
Osaka Sayama-shi
Osaka
589 8511
Japan
Tominaga Hospital
Nagaizumi-cho,Sunto-gun
Shizuoka
411-8777
Japan
National Cancer Center Hospital
Chuo-ku
Tokyo
104-0045
Japan
Japanese Foundation for Cancer Research
Koto
Tokyo
135-8550
Japan
Tottori University Hospital
Yonago
Tottori
683-8504
Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka
811-1395
Japan
Okayama University Hospital
Okayama
700-8558
Japan
Osaka City General Hospital
Osaka
534-0021
Japan
National Cancer Centre Singapore
Singapore
Central Singapore
169610
Singapore
National Cancer Center
Goyang-si
Kyǒnggi-do
10408
South Korea
Seoul National University Bundang Hospital
Seongnam
Kyǒnggi-do
13620
South Korea
Severance Hospital, Yonsei University Health System
Seoul
Seoul-teukbyeolsi [Seoul]
03722
South Korea
Asan Medical Center
Seoul
Seoul-teukbyeolsi [Seoul]
05505
South Korea
Samsung Medical Center
Seoul
06351
South Korea
Hospital Universitari Vall d'Hebron
Barcelona
Barcelona [Barcelona]
8035
Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid
28040
Spain
Hospital Madrid Norte Sanchinarro
Madrid
28050
Spain
Kantonsspital Luzern
Lucerne
Canton of Lucerne
6000
Switzerland
Taichung Veterans General Hospital
Taichung
40705
Taiwan
National Taiwan University Hospital
Taipei
10002
Taiwan
Royal Marsden Hospital
London
SW3 6JJ
United Kingdom
Derived
Raez LE, Massey AC, Barker SS, Peterson PM, Liming K, Pennell NA. Long-term safety of selpercatinib for Rearranged during transfection (RET)-activated advanced solid tumors in LIBRETTO-001: differing patterns of adverse events over time. Oncologist. 2024 Dec 6;29(12):1068-1078. doi: 10.1093/oncolo/oyae282.
Deschler-Baier B, Krebs M, Kroiss M, Chatterjee M, Gundel D, Kestler C, Kerscher A, Kunzmann V, Appenzeller S, Maurus K, Rosenwald A, Bargou R, Gerhard-Hartmann E, Venkataramani V. Rapid response to selpercatinib in RET fusion positive pancreatic neuroendocrine carcinoma confirmed by smartwatch. NPJ Precis Oncol. 2024 Jul 31;8(1):167. doi: 10.1038/s41698-024-00659-x.
Subbiah V, Burris HA 3rd, Kurzrock R. Revolutionizing cancer drug development: Harnessing the potential of basket trials. Cancer. 2024 Jan;130(2):186-200. doi: 10.1002/cncr.35085. Epub 2023 Nov 7.
Duke ES, Bradford D, Marcovitz M, Amatya AK, Mishra-Kalyani PS, Nguyen E, Price LSL, Fourie Zirkelbach J, Li Y, Bi Y, Kraft J, Dorff SE, Scepura B, Stephenson M, Ojofeitimi I, Nair A, Han Y, Tezak Z, Lemery SJ, Pazdur R, Larkins E, Singh H. FDA Approval Summary: Selpercatinib for the Treatment of Advanced RET Fusion-Positive Solid Tumors. Clin Cancer Res. 2023 Sep 15;29(18):3573-3578. doi: 10.1158/1078-0432.CCR-23-0459.
Murciano-Goroff YR, Falcon CJ, Lin ST, Chacko C, Grimaldi G, Liu D, Wilhelm C, Iasonos A, Drilon A. Central Nervous System Disease in Patients With RET Fusion-Positive NSCLC Treated With Selpercatinib. J Thorac Oncol. 2023 May;18(5):620-627. doi: 10.1016/j.jtho.2023.01.008. Epub 2023 Jan 16.
Drilon A, Subbiah V, Gautschi O, Tomasini P, de Braud F, Solomon BJ, Shao-Weng Tan D, Alonso G, Wolf J, Park K, Goto K, Soldatenkova V, Szymczak S, Barker SS, Puri T, Bence Lin A, Loong H, Besse B. Selpercatinib in Patients With RET Fusion-Positive Non-Small-Cell Lung Cancer: Updated Safety and Efficacy From the Registrational LIBRETTO-001 Phase I/II Trial. J Clin Oncol. 2023 Jan 10;41(2):385-394. doi: 10.1200/JCO.22.00393. Epub 2022 Sep 19.
Subbiah V, Wolf J, Konda B, Kang H, Spira A, Weiss J, Takeda M, Ohe Y, Khan S, Ohashi K, Soldatenkova V, Szymczak S, Sullivan L, Wright J, Drilon A. Tumour-agnostic efficacy and safety of selpercatinib in patients with RET fusion-positive solid tumours other than lung or thyroid tumours (LIBRETTO-001): a phase 1/2, open-label, basket trial. Lancet Oncol. 2022 Oct;23(10):1261-1273. doi: 10.1016/S1470-2045(22)00541-1. Epub 2022 Sep 12.
Rolfo C, Hess LM, Jen MH, Peterson P, Li X, Liu H, Lai Y, Sugihara T, Kiiskinen U, Vickers A, Summers Y. External control cohorts for the single-arm LIBRETTO-001 trial of selpercatinib in RET+ non-small-cell lung cancer. ESMO Open. 2022 Aug;7(4):100551. doi: 10.1016/j.esmoop.2022.100551. Epub 2022 Aug 2.
Subbiah V, Gainor JF, Oxnard GR, Tan DSW, Owen DH, Cho BC, Loong HH, McCoach CE, Weiss J, Kim YJ, Bazhenova L, Park K, Daga H, Besse B, Gautschi O, Rolfo C, Zhu EY, Kherani JF, Huang X, Kang S, Drilon A. Intracranial Efficacy of Selpercatinib in RET Fusion-Positive Non-Small Cell Lung Cancers on the LIBRETTO-001 Trial. Clin Cancer Res. 2021 Aug 1;27(15):4160-4167. doi: 10.1158/1078-0432.CCR-21-0800. Epub 2021 Jun 4.
Wirth LJ, Sherman E, Robinson B, Solomon B, Kang H, Lorch J, Worden F, Brose M, Patel J, Leboulleux S, Godbert Y, Barlesi F, Morris JC, Owonikoko TK, Tan DSW, Gautschi O, Weiss J, de la Fouchardiere C, Burkard ME, Laskin J, Taylor MH, Kroiss M, Medioni J, Goldman JW, Bauer TM, Levy B, Zhu VW, Lakhani N, Moreno V, Ebata K, Nguyen M, Heirich D, Zhu EY, Huang X, Yang L, Kherani J, Rothenberg SM, Drilon A, Subbiah V, Shah MH, Cabanillas ME. Efficacy of Selpercatinib in RET-Altered Thyroid Cancers. N Engl J Med. 2020 Aug 27;383(9):825-835. doi: 10.1056/NEJMoa2005651.
Drilon A, Oxnard GR, Tan DSW, Loong HHF, Johnson M, Gainor J, McCoach CE, Gautschi O, Besse B, Cho BC, Peled N, Weiss J, Kim YJ, Ohe Y, Nishio M, Park K, Patel J, Seto T, Sakamoto T, Rosen E, Shah MH, Barlesi F, Cassier PA, Bazhenova L, De Braud F, Garralda E, Velcheti V, Satouchi M, Ohashi K, Pennell NA, Reckamp KL, Dy GK, Wolf J, Solomon B, Falchook G, Ebata K, Nguyen M, Nair B, Zhu EY, Yang L, Huang X, Olek E, Rothenberg SM, Goto K, Subbiah V. Efficacy of Selpercatinib in RET Fusion-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Aug 27;383(9):813-824. doi: 10.1056/NEJMoa2005653.
Participants received Selpercatinib 20 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
FG002
Phase 1: 40 mg Selpercatinib BID
Participants received Selpercatinib 40 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
FG003
Phase 1: 60 mg Selpercatinib BID
Participants received Selpercatinib 60 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
FG004
Phase 1: 160 mg Selpercatinib QD
Participants received Selpercatinib 160 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
FG005
Phase 1: 80 mg Selpercatinib BID
Participants received Selpercatinib 80 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
FG006
Phase 1: 120 mg Selpercatinib BID
Participants received Selpercatinib 120 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
FG007
Phase 1: 160 mg Selpercatinib BID
Participants received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
FG008
Phase 1: 200 mg Selpercatinib BID
Participants received Selpercatinib 200 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
FG009
Phase 1: 240 mg Selpercatinib BID
Participants received Selpercatinib 240 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
FG010
Phase 2, Cohort 1: RET Fusion Solid Tumor
Participants with Rearranged during transfection (RET) Fusion solid tumor progressed on/intolerant to standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
FG011
Phase 2, Cohort 2: RET Fusion Solid Tumor Without Standard Therapy
Participants with RET Fusion solid tumor without standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
FG012
Phase 2, Cohort 3: RET Mutant MTC
Participants with RET mutant medullary thyroid cancer (MTC) progressed on/intolerant to standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
FG013
Phase 2, Cohort 4: RET Mutant MTC Without Standard Therapy
Participants with RET mutant MTC without prior standard first line therapy or other kinase inhibitor(s) with anti-RET activity received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
FG014
Phase 2, Cohort 5: Advanced RET Altered Solid Tumor
Participants with RET altered solid tumor (cohorts 1-4, disease not measurable; MTC not eligible for Cohort 3 or 4; MTC syndrome spectrum cancer; circulating free tumor DNA [cfDNA+] for RET alteration not known to be present in tumor) received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
FG015
Phase 2, Cohort 6: RET Inhibitor-Discontinued Participants
Participants otherwise eligible for Cohorts 1-5 who discontinued other RET inhibitors received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
FG0006 subjects
FG00110 subjects
FG00216 subjects
FG00312 subjects
FG0041 subjects
FG00520 subjects
FG00619 subjects
FG007764 subjects
FG0083 subjects
FG0096 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
COMPLETED
FG0006 subjects
FG00110 subjects
FG00216 subjects
FG00312 subjects
FG0041 subjects
FG00520 subjects
FG00619 subjects
FG007764 subjects
FG0083 subjects
FG0096 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
NOT COMPLETED
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
FG0130 subjects
FG0140 subjects
FG0150 subjects
Phase 2 (Dose Expansion)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG010307 subjectsParticipants who completed Phase 1 portion of the study, entered the Phase 2 to receive 160 mg Selpercatinib BID as per their tumor types.
FG01174 subjectsParticipants who completed Phase 1 portion of the study, entered the Phase 2 to receive 160 mg Selpercatinib BID as per their tumor types.
FG012143 subjectsParticipants who completed Phase 1 portion of the study, entered the Phase 2 to receive 160 mg Selpercatinib BID as per their tumor types.
FG013116 subjectsParticipants who completed Phase 1 portion of the study, entered the Phase 2 to receive 160 mg Selpercatinib BID as per their tumor types.
FG014201 subjectsParticipants who completed Phase 1 portion of the study, entered the Phase 2 to receive 160 mg Selpercatinib BID as per their tumor types.
FG01516 subjectsParticipants who completed Phase 1 portion of the study, entered the Phase 2 to receive 160 mg Selpercatinib BID as per their tumor types.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Ongoing
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
All enrolled Participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 1: 20 mg Selpercatinib QD
Participants received Selpercatinib 20 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
BG001
Phase 1: 20 mg Selpercatinib BID
Participants received Selpercatinib 20 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
BG002
Phase 1: 40 mg Selpercatinib BID
Participants received Selpercatinib 40 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
BG003
Phase 1: 60 mg Selpercatinib BID
Participants received Selpercatinib 60 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
BG004
Phase 1: 160 mg Selpercatinib QD
Participants received Selpercatinib 160 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
BG005
Phase 1: 80 mg Selpercatinib BID
Participants received Selpercatinib 80 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
BG006
Phase 1: 120 mg Selpercatinib BID
Participants received Selpercatinib 120 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
BG007
Phase 1: 160 mg Selpercatinib BID
Participants received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
BG008
Phase 1: 200 mg Selpercatinib BID
Participants received Selpercatinib 200 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
BG009
Phase 1: 240 mg Selpercatinib BID
Participants received Selpercatinib 240 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG00110
BG00216
BG00312
BG0041
BG00520
BG00619
BG007764
BG0083
BG0096
BG010857
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0015
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
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: Maximum Tolerated Dose (MTD)
The MTD is defined as the highest dose level at which none of the first 3 treated patients, or not more than 1 of the first 6 treated patients, experiences a DLT. A DLT is any adverse events that starts on or after first administration of study drug, as defined by National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Any Grade(G) ≥3 nonhematologic toxicity, excluding
G3 AST, ALT, and/or total bilirubin elevation for <7 days.
G3 neutropenia <7 days
G3 thrombocytopenia without clinically significant bleeding
G3 or G4 lymphopenia.
First occurrence of G3 or G4 electrolyte abnormalities
G3 fatigue, weakness, nausea; other manageable constitutional symptom
G3 or G4 vomiting or diarrhea that lasts for <48hours with antiemetic/antidiarrheal medication in case of G3 and <24 hours in case of G4
G4 manageable constitutional symptom.
All Participants who received at least 1 or more doses of selpercatinib and had evaluable data for this outcome.
Posted
Number
milligrams
Cycle 1 (cycle length = 28 days)
ID
Title
Description
OG000
Phase 1 - Selpercatinib (All Participants)
All Phase 1 Participants who received Selpercatinib (20 mg - 240 mg) orally once daily (QD) or twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Units
Counts
Participants
OG000827
Title
Denominators
Categories
Title
Measurements
OG000160
Primary
Phase 1: Recommended Phase 2 Dose (RP2D)
Phase 1: RP2D
All Participants who received at least 1 or more doses of selpercatinib and had evaluable data for this outcome.
Posted
Number
milligrams
Cycle 1 (cycle length = 28 days)
ID
Title
Description
OG000
Phase 1 - Selpercatinib (All Participants)
All Phase 1 Participants who received Selpercatinib (20 mg - 240 mg) orally once daily (QD) or twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Units
Counts
Participants
OG000
Primary
Phase 2: Objective Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment
Objective Response Rate was defined as the percentage of participants with best overall response of confirmed response (CR), or Partial response (PR). Response was confirmed by a repeat assessment no less than 28 days.
CR is defined as disappearance of all target lesions.
PR is defined as at least a 30% decrease in the sum of diameter (LD for non-nodal lesions and short axis diameter [SAD] for nodal lesions) of target lesions, taking as reference the baseline sum LD.
ORR was assessed by independent review committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 95% confidence interval was calculated using Clopper-Pearson method.
All phase 2 participants who received at least 1 or more doses of selpercatinib and had evaluable data for this outcome.
Posted
Number
95% Confidence Interval
percentage of participants
Approximately for up to 7 years 8 months
ID
Title
Description
OG000
Phase 2, Cohort 1: RET Fusion Solid Tumor
Participants with Rearranged during transfection (RET) Fusion solid tumor progressed on/intolerant to standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG001
Phase 2, Cohort 2: RET Fusion Solid Tumor Without Standard Therapy
Secondary
Phase 1: Number of Participants With a Treatment-Related Adverse Event(s) (TRAE[s])
Phase 1: Number of Participants with a TRAE(s) is reported.
All Participants who received at least 1 or more doses of selpercatinib and had evaluable data for this outcome.
Posted
Count of Participants
Participants
No
Up to 28 days
ID
Title
Description
OG000
Phase 1: 20 mg Selpercatinib QD
Participants received Selpercatinib 20 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG001
Phase 1: 20 mg Selpercatinib BID
Participants received Selpercatinib 20 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG002
Phase 1: 40 mg Selpercatinib BID
Participants received Selpercatinib 40 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Secondary
Phase 1: Number of Participants With an Abnormal Laboratory Values
All Participants who received at least 1 or more doses of selpercatinib and had evaluable data for this outcome.
Posted
Count of Participants
Participants
No
Up to 28 days
ID
Title
Description
OG000
Phase 1: 20 mg Selpercatinib QD
Participants received Selpercatinib 20 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG001
Phase 1: 20 mg Selpercatinib BID
Participants received Selpercatinib 20 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG002
Phase 1: 40 mg Selpercatinib BID
Participants received Selpercatinib 40 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG003
Secondary
Phase 2: Overall Response Rate (ORR) Based on RECIST 1.1 or RANO, as Appropriate to Tumor Type
Phase 2: ORR based on RECIST 1.1 or RANO, as Appropriate to Tumor Type
Not Posted
Feb 2028
Approximately for up to 9 years 8 months
Participants
Secondary
Phase 2: ORR (by Investigator)
Phase 2: ORR (by Investigator)
Not Posted
Feb 2028
Approximately for up to 9 years 8 months
Participants
Secondary
Phase 2: Best Change in Tumor Size From Baseline (by IRC and Investigator)
Phase 2: Best Change in Tumor Size from Baseline (by IRC and Investigator)
Not Posted
Feb 2028
Approximately for up to 9 years 8 months
Participants
Secondary
Phase 2: Duration of Response (DOR; by IRC and Investigator)
Phase 2: DOR (by IRC and Investigator)
Not Posted
Feb 2028
Approximately for up to 9 years 8 months
Participants
Secondary
Phase 2: Central Nervous System (CNS) ORR (by IRC)
Phase 2: CNS ORR (by IRC)
Not Posted
Feb 2028
Approximately for up to 9 years 8 months
Participants
Secondary
Phase 2: CNS DOR (by IRC)
Phase 2: CNS DOR (by IRC)
Not Posted
Feb 2028
Approximately for up to 9 years 8 months
Participants
Secondary
Phase 2: Time to Any and Best Response (by IRC and Investigator)
Phase 2: Time to Any and Best Response (by IRC and Investigator)
Not Posted
Feb 2028
Approximately for up to 9 years 8 months
Participants
Secondary
Phase 2: CBR (by IRC and Investigator)
Phase 2: CBR (by IRC and Investigator)
Not Posted
Feb 2028
Approximately for up to 9 years 8 months
Participants
Secondary
Phase 2: PFS (by IRC and Investigator)
Phase 2: PFS (by IRC and Investigator)
Not Posted
Feb 2028
Approximately for up to 9 years 8 months
Participants
Secondary
Phase 2: Overall Survival (OS)
Phase 2: OS
Not Posted
Feb 2028
Approximately for up to 9 years 8 months
Participants
Secondary
Phase 2: Percentage of Participants With Any Serious Adverse Event (SAE[s])
Phase 2: Percentage of Participants with any SAE(s)
Not Posted
Feb 2028
Approximately for up to 9 years 8 months
Participants
Secondary
Phase 2: Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve of LOXO-292 (Selpercatinib)
Phase 2: PK: AUC of LOXO-292 (Selpercatinib)
Not Posted
Feb 2028
Cycle 5 Day 1 (Cycle = 28 days)
Participants
Secondary
Phase 2: PK: Maximum Concentration (Cmax) of LOXO-292 (Selpercatinib)
Phase 2: PK: Cmax of LOXO-292 (Selpercatinib)
Not Posted
Feb 2028
Cycle 5 Day 1 (Cycle = 28 days)
Participants
Secondary
Phase 1: Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours
All Participants who received at least 1 or more doses of selpercatinib and had PK evaluable data for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram*hour per milliliter (ng*h/mL)
Cycle 1 Day 8: Predose, 1, 2, 4, 8, 24 hours post dose (cycle length = 28 days)
ID
Title
Description
OG000
Phase 1: 20 mg Selpercatinib QD
Participants received Selpercatinib 20 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG001
Phase 1: 20 mg Selpercatinib BID
Participants received Selpercatinib 20 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG002
Phase 1: 40 mg Selpercatinib BID
Participants received Selpercatinib 40 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Secondary
Phase 1: Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax)
All Participants who received at least 1 or more doses of selpercatinib and had PK evaluable data for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram per milliliter (ng/mL)
Cycle 1 Day 8: Predose, 1, 2, 4, 8, 24 hours post dose (cycle length = 28 days)
ID
Title
Description
OG000
Phase 1: 20 mg Selpercatinib QD
Participants received Selpercatinib 20 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG001
Phase 1: 20 mg Selpercatinib BID
Participants received Selpercatinib 20 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG002
Phase 1: 40 mg Selpercatinib BID
Participants received Selpercatinib 40 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Time Frame
Phase 1: Up to 28 days; Phase 2: Up to 7 years 8 months
Description
All Participants who received at least 1 or more doses of Selpercatinib.
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: 20 mg Selpercatinib QD
Participants received Selpercatinib 20 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
0
6
4
6
6
6
EG001
Phase 1: 20 mg Selpercatinib BID
Participants received Selpercatinib 20 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
0
10
8
10
10
10
EG002
Phase 1: 40 mg Selpercatinib BID
Participants received Selpercatinib 40 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
0
16
9
16
16
16
EG003
Phase 1: 60 mg Selpercatinib BID
Participants received Selpercatinib 60 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
0
12
7
12
12
12
EG004
Phase 1: 160 mg Selpercatinib QD
Participants received Selpercatinib 160 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
0
1
1
1
1
1
EG005
Phase 1: 80 mg Selpercatinib BID
Participants received Selpercatinib 80 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
0
20
13
20
20
20
EG006
Phase 1: 120 mg Selpercatinib BID
Participants received Selpercatinib 120 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
0
19
11
19
19
19
EG007
Phase 1: 160 mg Selpercatinib BID
Participants received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
0
764
380
764
764
764
EG008
Phase 1: 200 mg Selpercatinib BID
Participants received Selpercatinib 200 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
0
3
3
3
3
3
EG009
Phase 1: 240 mg Selpercatinib BID
Participants received Selpercatinib 240 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
0
6
3
6
6
6
EG010
Phase 2, Cohort 1: RET Fusion Solid Tumor
Participants with Rearranged during transfection (RET) Fusion solid tumor progressed on/intolerant to standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
147
307
187
307
307
307
EG011
Phase 2, Cohort 2: RET Fusion Solid Tumor Without Standard Therapy
Participants with RET Fusion solid tumor without standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
27
74
39
74
74
74
EG012
Phase 2, Cohort 3: RET Mutant MTC
Participants with RET mutant medullary thyroid cancer (MTC) progressed on/intolerant to standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
67
143
93
143
143
143
EG013
Phase 2, Cohort 4: RET Mutant MTC Without Standard Therapy
Participants with RET mutant MTC without prior standard first line therapy or other kinase inhibitor(s) with anti-RET activity received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
18
116
65
116
116
116
EG014
Phase 2, Cohort 5: Advanced RET Altered Solid Tumor
Participants with RET altered solid tumor (cohorts 1-4, disease not measurable; MTC not eligible for Cohort 3 or 4; MTC syndrome spectrum cancer; circulating free tumor DNA [cfDNA+] for RET alteration not known to be present in tumor) received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
83
201
114
201
201
201
EG015
Phase 2, Cohort 6: RET Inhibitor-Discontinued Participants
Participants otherwise eligible for Cohorts 1-5 who discontinued other RET inhibitors received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
8
16
8
16
16
16
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG0030 affected12 at risk
EG0040 affected1 at risk
EG0050 affected20 at risk
EG0060 affected19 at risk
EG0072 affected764 at risk
EG0080 affected3 at risk
EG0090 affected6 at risk
EG0101 affected307 at risk
EG0110 affected74 at risk
EG0121 affected143 at risk
EG0130 affected116 at risk
EG0140 affected201 at risk
EG0150 affected16 at risk
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Accelerated idioventricular rhythm
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Acute left ventricular failure
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Atrioventricular block second degree
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Cardiac dysfunction
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hypertensive heart disease
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Mitral valve incompetence
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Papillary muscle rupture
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Restrictive cardiomyopathy
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Ventricular arrhythmia
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Intestinal malrotation
Congenital, familial and genetic disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Blindness unilateral
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Diplopia
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Retinal vascular occlusion
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Retinal vein occlusion
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Retinal vein thrombosis
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Ulcerative keratitis
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Vision blurred
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0002 affected6 at risk
EG0011 affected10 at risk
EG0021 affected16 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Apical granuloma
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Appendix disorder
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Diaphragmatic hernia
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Diverticular perforation
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Diverticulum intestinal haemorrhagic
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Duodenal obstruction
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Duodenal stenosis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Duodenitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Enterocutaneous fistula
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Enterovesical fistula
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Eosinophilic oesophagitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Incarcerated umbilical hernia
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Jejunal perforation
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Malabsorption
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Mechanical ileus
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Mesenteric artery embolism
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Oesophageal haemorrhage
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Oesophageal obstruction
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Oesophageal stenosis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pancreatic duct dilatation
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pneumatosis intestinalis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Retroperitoneal haematoma
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Asthenia
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Catheter site pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Chest pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Chills
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Complication associated with device
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Disease progression
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Drug intolerance
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Fatigue
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Gait disturbance
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
General physical health deterioration
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Generalised oedema
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Incarcerated hernia
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Influenza like illness
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Oedema peripheral
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pelvic mass
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Performance status decreased
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Peripheral swelling
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pyrexia
General disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Stenosis
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Sudden death
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Bile duct stenosis
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Biliary dilatation
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Gallbladder obstruction
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hepatic cyst ruptured
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hepatic haemorrhage
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hepatic mass
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hepatitis acute
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hepatobiliary disease
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Contrast media allergy
Immune system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Appendicitis perforated
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Bacterial sepsis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Brain abscess
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Bursitis infective
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Campylobacter gastroenteritis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Cholecystitis infective
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Corneal infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Corona virus infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Device related infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Empyema
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Enteritis infectious
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Escherichia infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Escherichia pyelonephritis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Extradural abscess
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Eye infection viral
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Gangrene
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Gastroenteritis norovirus
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Gastroenteritis salmonella
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Infective pericardial effusion
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Influenza
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Kidney infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Liver abscess
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Lung abscess
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Lung infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected10 at risk
EG0021 affected16 at risk
EG003
Meningitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Meningitis bacterial
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Necrotising fasciitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Paronychia
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Parotitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Peritonitis bacterial
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0022 affected16 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pneumonia pneumococcal
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pneumonia staphylococcal
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Sepsis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected10 at risk
EG0021 affected16 at risk
EG003
Septic shock
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Sialoadenitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Wound infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Acetabulum fracture
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Brain herniation
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected10 at risk
EG0021 affected16 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Fracture
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Procedural pneumothorax
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Subarachnoid haemorrhage
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Subdural haemorrhage
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Tracheal haemorrhage
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Traumatic haematoma
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Traumatic haemothorax
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Electrocardiogram qt prolonged
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Electrocardiogram t wave inversion
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Liver function test increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Oxygen saturation decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pancreatic enzymes increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Procalcitonin increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Staphylococcus test positive
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Troponin i increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Troponin increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Calciphylaxis
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Tetany
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Chondrocalcinosis pyrophosphate
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Gouty arthritis
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Myopathy
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Osteolysis
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Osteonecrosis of jaw
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Spinal instability
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Bowen's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Endometrial cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Malignant ascites
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Meningioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Non-small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pericardial effusion malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Squamous cell carcinoma of head and neck
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0012 affected10 at risk
EG0020 affected16 at risk
EG003
Thyroid neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0022 affected16 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Cauda equina syndrome
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Embolic stroke
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Haemorrhagic stroke
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Headache
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Normal pressure hydrocephalus
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Partial seizures
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Posterior reversible encephalopathy syndrome
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Seizure
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Serotonin syndrome
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Syncope
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Toxic encephalopathy
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Trigeminal neuralgia
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Vasogenic cerebral oedema
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Device dislocation
Product Issues
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0022 affected16 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Depression
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Mania
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Mental disorder
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Psychiatric symptom
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Focal segmental glomerulosclerosis
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Glomerulonephropathy
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Nephritis
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Renal cyst
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Adenomyosis
Reproductive system and breast disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Oedema genital
Reproductive system and breast disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Uterine haemorrhage
Reproductive system and breast disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Bronchial obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Choking
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Chylothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Emphysema
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Haemothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Laryngeal oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pleurocutaneous fistula
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Stridor
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Colostomy closure
Surgical and medical procedures
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Arterial haemorrhage
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Artery dissection
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Embolism
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hypertension
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hypotension
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Lymphatic fistula
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Peripheral venous disease
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Vascular compression
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0002 affected6 at risk
EG0011 affected10 at risk
EG0021 affected16 at risk
EG0032 affected12 at risk
EG0040 affected1 at risk
EG0055 affected20 at risk
EG0065 affected19 at risk
EG007115 affected764 at risk
EG0080 affected3 at risk
EG0092 affected6 at risk
EG01045 affected307 at risk
EG01112 affected74 at risk
EG01228 affected143 at risk
EG01317 affected116 at risk
EG01429 affected201 at risk
EG0152 affected16 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0022 affected16 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0024 affected16 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0022 affected16 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0021 affected16 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0022 affected16 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Pulmonary valve incompetence
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Eustachian tube obstruction
Ear and labyrinth disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0023 affected16 at risk
EG003
Blindness unilateral
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Dry eye
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0012 affected10 at risk
EG0022 affected16 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected10 at risk
EG0021 affected16 at risk
EG003
Vision blurred
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0013 affected10 at risk
EG0020 affected16 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0003 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0004 affected6 at risk
EG0014 affected10 at risk
EG0026 affected16 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected10 at risk
EG0022 affected16 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0002 affected6 at risk
EG0011 affected10 at risk
EG0021 affected16 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0002 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0015 affected10 at risk
EG0025 affected16 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0003 affected6 at risk
EG0015 affected10 at risk
EG0027 affected16 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0003 affected6 at risk
EG0015 affected10 at risk
EG0026 affected16 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected10 at risk
EG0021 affected16 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0013 affected10 at risk
EG0022 affected16 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected10 at risk
EG0021 affected16 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected10 at risk
EG0022 affected16 at risk
EG003
Glossitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0021 affected16 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0004 affected6 at risk
EG0014 affected10 at risk
EG0026 affected16 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0022 affected16 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0022 affected16 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0002 affected6 at risk
EG0016 affected10 at risk
EG0025 affected16 at risk
EG003
Asthenia
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0023 affected16 at risk
EG003
Catheter site pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Chest pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0021 affected16 at risk
EG003
Chills
General disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected10 at risk
EG0021 affected16 at risk
EG003
Face oedema
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0021 affected16 at risk
EG003
Fatigue
General disorders
MedDRA 21.0
Systematic Assessment
EG0003 affected6 at risk
EG0016 affected10 at risk
EG00211 affected16 at risk
EG003
General physical health deterioration
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Generalised oedema
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Influenza like illness
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected10 at risk
EG0022 affected16 at risk
EG003
Localised oedema
General disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Malaise
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected10 at risk
EG0020 affected16 at risk
EG003
Oedema peripheral
General disorders
MedDRA 21.0
Systematic Assessment
EG0004 affected6 at risk
EG0016 affected10 at risk
EG0024 affected16 at risk
EG003
Pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Performance status decreased
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Peripheral swelling
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pyrexia
General disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0013 affected10 at risk
EG0022 affected16 at risk
EG003
Xerosis
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Contrast media allergy
Immune system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Anal fungal infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected10 at risk
EG0020 affected16 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Corona virus infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0025 affected16 at risk
EG003
Cystitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Genital infection fungal
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Influenza
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Kidney infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Liver abscess
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Lung infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0002 affected6 at risk
EG0012 affected10 at risk
EG0022 affected16 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Paronychia
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected10 at risk
EG0023 affected16 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Sepsis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected10 at risk
EG0021 affected16 at risk
EG003
Sialoadenitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0022 affected16 at risk
EG003
Skin infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0002 affected6 at risk
EG0014 affected10 at risk
EG0020 affected16 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0002 affected6 at risk
EG0014 affected10 at risk
EG0025 affected16 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Viral infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Wound infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0021 affected16 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0021 affected16 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0002 affected6 at risk
EG0012 affected10 at risk
EG0025 affected16 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Fracture
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Procedural pneumothorax
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pubis fracture
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Subarachnoid haemorrhage
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected10 at risk
EG0022 affected16 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0003 affected6 at risk
EG0012 affected10 at risk
EG0025 affected16 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0022 affected16 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0022 affected16 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0023 affected16 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Blood phosphorus increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Electrocardiogram qt prolonged
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0022 affected16 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Liver function test increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0021 affected16 at risk
EG003
Weight decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0015 affected10 at risk
EG0021 affected16 at risk
EG003
Weight increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected10 at risk
EG0020 affected16 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0002 affected6 at risk
EG0012 affected10 at risk
EG0025 affected16 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0013 affected10 at risk
EG0022 affected16 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected10 at risk
EG0021 affected16 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0021 affected16 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected10 at risk
EG0022 affected16 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected10 at risk
EG0022 affected16 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected10 at risk
EG0024 affected16 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0014 affected10 at risk
EG0022 affected16 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0022 affected16 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0002 affected6 at risk
EG0011 affected10 at risk
EG0021 affected16 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Vitamin d deficiency
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0015 affected10 at risk
EG0026 affected16 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0012 affected10 at risk
EG0027 affected16 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Gouty arthritis
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected10 at risk
EG0020 affected16 at risk
EG003
Muscle contracture
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected10 at risk
EG0022 affected16 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0012 affected10 at risk
EG0027 affected16 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0023 affected16 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0012 affected10 at risk
EG0024 affected16 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected10 at risk
EG0023 affected16 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0012 affected10 at risk
EG0022 affected16 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Slipping rib syndrome
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected16 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected16 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected16 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0001 affected6 at risk
EG0012 affected10 at risk
EG0021 affected16 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
developed a secondary malignancy and is no longer qualified for this study
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
FG0130 subjects
FG0141 subjects
FG0150 subjects
0
BG0040
BG0051
BG0060
BG0072
BG0080
BG0090
BG0103
Between 18 and 65 years
BG0005
BG0016
BG00211
BG0039
BG0040
BG00511
BG00613
BG007495
BG0082
BG0094
BG010556
>=65 years
BG0001
BG0014
BG0025
BG0033
BG0041
BG0058
BG0066
BG007267
BG0081
BG0092
BG010298
7
BG0035
BG0040
BG0057
BG00610
BG007378
BG0081
BG0094
BG010421
Male
BG0002
BG0015
BG0029
BG0037
BG0041
BG00513
BG0069
BG007386
BG0082
BG0092
BG010436
0
BG0030
BG0040
BG0050
BG0061
BG00738
BG0080
BG0090
BG01040
Not Hispanic or Latino
BG0006
BG0019
BG00215
BG00312
BG0041
BG00520
BG00618
BG007700
BG0083
BG0096
BG010790
Unknown or Not Reported
BG0000
BG0010
BG0021
BG0030
BG0040
BG0050
BG0060
BG00726
BG0080
BG0090
BG01027
0
BG0030
BG0040
BG0050
BG0060
BG0072
BG0080
BG0090
BG0102
Asian
BG0001
BG0010
BG0021
BG0031
BG0040
BG0052
BG0063
BG007198
BG0080
BG0091
BG010207
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0072
BG0080
BG0090
BG0102
Black or African American
BG0000
BG0010
BG0022
BG0031
BG0040
BG0050
BG0060
BG00724
BG0080
BG0090
BG01027
White
BG0005
BG00110
BG00213
BG00310
BG0041
BG00516
BG00615
BG007502
BG0083
BG0095
BG010580
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0052
BG0061
BG00736
BG0080
BG0090
BG01039
827
Title
Denominators
Categories
Title
Measurements
OG000160
Participants with RET Fusion solid tumor without standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG002
Phase 2, Cohort 3: RET Mutant MTC
Participants with RET mutant medullary thyroid cancer (MTC) progressed on/intolerant to standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG003
Phase 2, Cohort 4: RET Mutant MTC Without Standard Therapy
Participants with RET mutant MTC without prior standard first line therapy or other kinase inhibitor(s) with anti-RET activity received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG004
Phase 2, Cohort 5: Advanced RET Altered Solid Tumor
Participants with RET altered solid tumor (cohorts 1-4, disease not measurable; MTC not eligible for Cohort 3 or 4; MTC syndrome spectrum cancer; circulating free tumor DNA [cfDNA+] for RET alteration not known to be present in tumor) received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG005
Phase 2, Cohort 6: RET Inhibitor-Discontinued Participants
Participants otherwise eligible for Cohorts 1-5 who discontinued other RET inhibitors received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Units
Counts
Participants
OG000307
OG00174
OG002143
OG003116
OG004201
OG00516
Title
Denominators
Categories
Title
Measurements
OG00062.9(57.2 to 68.3)
OG00179.7(68.8 to 88.2)
OG00277.6(69.9 to 84.2)
OG00382.8(74.6 to 89.1)
OG00457.2(50.1 to 64.2)
OG00531.3(11.0 to 58.7)
OG003
Phase 1: 60 mg Selpercatinib BID
Participants received Selpercatinib 60 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG004
Phase 1: 160 mg Selpercatinib QD
Participants received Selpercatinib 160 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG005
Phase 1: 80 mg Selpercatinib BID
Participants received Selpercatinib 80 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG006
Phase 1: 120 mg Selpercatinib BID
Participants received Selpercatinib 120 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG007
Phase 1: 160 mg Selpercatinib BID
Participants received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG008
Phase 1: 200 mg Selpercatinib BID
Participants received Selpercatinib 200 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG009
Phase 1: 240 mg Selpercatinib BID
Participants received Selpercatinib 240 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Units
Counts
Participants
OG0006
OG00110
OG00216
OG00312
OG0041
OG00520
OG00619
OG007764
OG0083
OG0096
Title
Denominators
Categories
Title
Measurements
OG0003
OG0019
OG00214
OG00312
OG0041
OG00518
OG00617
OG007733
OG0083
OG0096
Phase 1: 60 mg Selpercatinib BID
Participants received Selpercatinib 60 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG004
Phase 1: 160 mg Selpercatinib QD
Participants received Selpercatinib 160 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG005
Phase 1: 80 mg Selpercatinib BID
Participants received Selpercatinib 80 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG006
Phase 1: 120 mg Selpercatinib BID
Participants received Selpercatinib 120 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG007
Phase 1: 160 mg Selpercatinib BID
Participants received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG008
Phase 1: 200 mg Selpercatinib BID
Participants received Selpercatinib 200 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG009
Phase 1: 240 mg Selpercatinib BID
Participants received Selpercatinib 240 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Units
Counts
Participants
OG0006
OG00110
OG00216
OG00312
OG0041
OG00520
OG00619
OG007764
OG0083
OG0096
Title
Denominators
Categories
Title
Measurements
OG0006
OG00110
OG00214
OG00312
OG0041
OG00520
OG00619
OG007764
OG0083
OG0096
OG003
Phase 1: 60 mg Selpercatinib BID
Participants received Selpercatinib 60 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG004
Phase 1: 160 mg Selpercatinib QD
Participants received Selpercatinib 160 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG005
Phase 1: 80 mg Selpercatinib BID
Participants received Selpercatinib 80 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG006
Phase 1: 120 mg Selpercatinib BID
Participants received Selpercatinib 120 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG007
Phase 1: 160 mg Selpercatinib BID
Participants received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG008
Phase 1: 200 mg Selpercatinib BID
Participants received Selpercatinib 200 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG009
Phase 1: 240 mg Selpercatinib BID
Participants received Selpercatinib 240 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Units
Counts
Participants
OG0004
OG0019
OG00212
OG00311
OG0040
OG00515
OG00610
OG007480
OG0082
OG0093
Title
Denominators
Categories
Title
Measurements
OG0002240± 36
OG0014570± 50
OG0028450± 53
OG00317100± 46
OG00519400± 49
OG00642200± 40
OG00753700± 53
OG008NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated as there were only two participants. Individual values reported: 43200 ng\*h/mL; 33100 ng\*h/mL.
OG00987900± 20
OG003
Phase 1: 60 mg Selpercatinib BID
Participants received Selpercatinib 60 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG004
Phase 1: 160 mg Selpercatinib QD
Participants received Selpercatinib 160 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG005
Phase 1: 80 mg Selpercatinib BID
Participants received Selpercatinib 80 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG006
Phase 1: 120 mg Selpercatinib BID
Participants received Selpercatinib 120 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG007
Phase 1: 160 mg Selpercatinib BID
Participants received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG008
Phase 1: 200 mg Selpercatinib BID
Participants received Selpercatinib 200 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
OG009
Phase 1: 240 mg Selpercatinib BID
Participants received Selpercatinib 240 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Units
Counts
Participants
OG0004
OG0019
OG00212
OG00311
OG0040
OG00515
OG00610
OG007486
OG0082
OG0093
Title
Denominators
Categories
Title
Measurements
OG000220± 14
OG001275± 53
OG002528± 55
OG0031040± 46
OG0051250± 45
OG0062680± 27
OG0073080± 48
OG008NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated as there were only two participants. Individual values reported: 3760 ng/mL;1630 ng/mL.