Phase I/II Study of PDR001 in Patients With Advanced Mali... | NCT02404441 | Trialant
NCT02404441
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Aug 3, 2022Actual
Enrollment
319Actual
Phase
Phase 1Phase 2
Conditions
Melanoma
Non-small Sell Lung Cancer (NSCLC)
Triple Negative Breast Cancer
Anaplastic Thyroid Cancer
Other Solid Tumors
Interventions
PDR001
Countries
United States
Canada
France
Germany
Hungary
Italy
Lebanon
Netherlands
Norway
Poland
Spain
Taiwan
Thailand
Turkey (Türkiye)
Protocol Section
Identification Module
NCT ID
NCT02404441
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CPDR001X2101
Secondary IDs
ID
Type
Description
Link
2014-003929-17
EudraCT Number
Brief Title
Phase I/II Study of PDR001 in Patients With Advanced Malignancies
Official Title
Open Label Multicenter Phase I/II Study of the Safety and Efficacy of PDR001 Administered to Patients With Advanced Malignancies
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Aug 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 27, 2015Actual
Primary Completion Date
Jul 21, 2020Actual
Completion Date
Jul 21, 2020Actual
First Submitted Date
Mar 20, 2015
First Submission Date that Met QC Criteria
Mar 30, 2015
First Posted Date
Mar 31, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 21, 2021
Results First Submitted that Met QC Criteria
Aug 31, 2021
Results First Posted Date
Sep 29, 2021Actual
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
Aug 2, 2022
Last Update Posted Date
Aug 3, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
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
The purpose of this "first-in-human" study of PDR001 was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of PDR001 administered i.v. as a single agent to adult patients with solid tumors.
By blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, PDR001 inhibits the PD-1 immune checkpoint, resulting in activation of an antitumor immune response by activating effector T-cells and inhibiting regulatory T-cells.
Detailed Description
This study was designed as a phase I/II, multi-center, open-label study starting with a phase I dose escalation part followed by a phase II part.
Although the study had 2 'arms', the phase I part of the study had 5 dosing cohorts and the phase ll part had 5 treatment groups for a total of 10 reporting groups.
PDR001 was administered every 2 weeks until patient experienced unacceptable toxicity, progressive disease per immune related Response Criteria (irRC) and/or treatment was discontinued at the discretion of the investigator or the patient.
Conditions Module
Conditions
Melanoma
Non-small Sell Lung Cancer (NSCLC)
Triple Negative Breast Cancer
Anaplastic Thyroid Cancer
Other Solid Tumors
Keywords
Phase I/II
PDR001
Checkpoint inhibitor
PD-1
PD-L1
NSCLC
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
319Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
patients with solid tumors
Other
Phase I Dose escalation cohorts
Biological: PDR001
Selected tumor types
Other
Phase II expansion: Selected tumor types: melanoma, NSCLC, triple negative breast cancer, anaplastic thyroid cancer
Biological: PDR001
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PDR001
Biological
anti-PD1 antibody
Selected tumor types
patients with solid tumors
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase l: The Exposure (AUC(0-336h)) After First Dose of Treatment at Cycle 3 (Each Cycle = 28 Days)
Estimated the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD) for PDR001.
AUC0-336h is the AUC from time zero to 336 hour post dose of a measurable concentration sampling time.
Phase l: Incidence of Dose Limiting Toxicities (DLTs)
DLT is defined as an adverse event (AE) or abnormal laboratory value of common terminology criteria for adverse events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications, which occurs within the first cycle of treatment with PDR001 during the dose escalation part of the study for which relationship to study treatment cannot be ruled out, with some exceptions.
8 months
Phase ll: Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
ORR is the percentage of participants with a best overall response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 CR = at least 2 determinations of CR at least 4 weeks apart before progression where confirmation required or 1 determination of CR prior to progression where confirmation not required.
PR = at least 2 determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) where confirmation required or 1 determination of PR prior to progression where confirmation not required.
RECIST criteria is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment.
AUC0-336h is the AUC from time zero to 336 hour post dose of a measurable concentration sampling time.
AUClast: The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1).
AUCinf: The AUC from time zero to infinity (mass x time x volume-1). AUCtau: The AUC calculated to the end of a dosing interval (tau) at steady-state (amount x time x volume-1).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Written informed consent must have been obtained prior to any screening procedures
Phase I part: Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST version 1.1 (refer to Appendix 1), who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists.
Phase II part: Patients with advanced/metastatic solid tumors, with at least one measurable lesion as determined by RECIST version 1.1, who have progressed following their last prior therapy, and fit into one of the following groups:
Group 1a and 1b: NSCLC:
Patients with NSCLC must have had disease recurrence or progression during or after no more than one prior systemic chemotherapy regimen (platinum doublet-based) for advanced or metastatic disease. Prior maintenance therapy is allowed (e.g. pemetrexed, erlotinib, bevacizumab).
Only patients with EGFR mutation-negative tumor are eligible (defined as negative for exon 19 deletions and for the L858R mutation in EGFR at a minimum; however, if more extensive EGFR mutation testing has been performed, the tumor must not harbor any known activating EGFR mutations in Exons 18-21 in order to be considered EGFR mutation-negative). All patients must be tested for EGFR mutational status and, for ALK translocation status if no mutation is detected in EGFR. Patients with ALK translocation-positive NSCLC must have had disease progression following treatment with a corresponding inhibitor and no more than one systemic chemotherapy regimen (platinum doublet-based), in any sequence.
Group 2: Melanoma:
All patients must have been tested for BRAF mutations. Patients with V600 mutation positive melanoma must have clinical or radiological evidence of disease progression during or after treatment with a BRAF inhibitor alone or in combination with other agents.
Group 3: Triple negatice breast cancer.
Group 4: Anaplastic thyroid cancer
Patients are not required to have received or progressed on a prior therapy.
Patients must not be at short term risk for life threatening complications (such as airway compromise or bleeding from locoregional or metastatic disease).
Chemoradiation and/or surgery should be considered prior to study entry for those patients with locally advanced disease if those therapies are considered to be in the best interest of the patient.
ECOG Performance Status ≤ 1.
Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy. Patient must be willing to undergo a new tumor biopsy at baseline or at molecular pre-screening if applicable, and during therapy on this study. For patients in the phase II part of the study, exceptions may be granted after documented discussion with Novartis. After a sufficient number of paired biopsies are collected, the decision may be taken to stop the collection of biopsies.
Exclusion Criteria:
History of severe hypersensitivity reactions to other mAbs
Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
Active infection requiring systemic antibiotic therapy.
HIV infection.
Active HBV or HCV infection.
Patients with ocular melanoma.
Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity, e.g. mitomycin C and nitrosoureas, 4 weeks washout period. For patients receiving anticancer immunotherapies such as CTLA-4 antagonists, 6 weeks is indicated as the washout period.
Prior PD-1- or PD-L1-directed therapy.
Patients requiring chronic treatment with systemic steroid therapy, other than replacement-dose steroids in the setting of adrenal insufficiency. Topical, inhaled, nasal and ophthalmic steroids are not prohibited.
Patients receiving systemic treatment with any immunosuppressive medication (other than steroids as described above).
Use of any vaccines against infectious diseases (e.g. influenza, varicella, pneumococcus) within 4 weeks of initiation of study treatment.
Presence of ≥ CTCAE grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if ≥ CTCAE grade 3) due to prior cancer therapy
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Johns Hopkins
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The study planned to analyze about 58 patients in Phase I and about 120 patients in Phase II.
Recruitment Details
58 patients were analyzed in Phase l and 261 patients were analyzed in Phase II of this study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
1mg/kg q2w
Phase I Dose escalation cohort patients who took PDR001 1 mg/kg q2w
FG001
3mg/kg q2w
Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q2w
Periods
Title
Milestones
Reasons Not Completed
Phase 1 Part
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
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
May 24, 2019
Jul 21, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Japan
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Although the study had 2 'arms', the phase I part of the study had 5 dosing cohorts and the phase ll part had 5 treatment groups for a total of 10 reporting groups.
AUC0-336h is the AUC from time zero to 336 hour post dose of a measurable concentration sampling time.
AUClast: The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1).
AUCinf: The AUC from time zero to infinity (mass x time x volume-1). AUCtau: The AUC calculated to the end of a dosing interval (tau) at steady-state (amount x time x volume-1).
Phase I: Presence and/or Concentration of Anti-PDR001
Assessed PDR001 anti-drug anti-body (ADA) incidence in Phase I patients - the emergence of anti-PDR001 antibodies following one or more intravenous (i.v.) infusions of PDR001. Each cycle = 28 days; End of treatment was expected to be on average 1 year after the start of study treatment.
42 months
Phase II: Presence and/or Concentration of Anti-PDR001
Assessed PDR001 anti-drug anti-body (ADA) incidence in Phase I patients - the emergence of anti-PDR001 antibodies following one or more intravenous (i.v.) infusions of PDR001. Each cycle = 28 days; End of treatment was expected to be on average 1 year after the start of study treatment.
For Treatment -induced ADA-positive, Percentage was based on subjects ADA-negative at baseline.
For Treatment-boosted ADA-positive, Percentage was based on subjects ADA-positive at baseline.
42 months
Phase l: Overall Response Rate (ORR) as Per Investigator Based on RECIST v1.1
ORR is the percentage of participants with a best overall response of complete response CR or partial response PR as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required.
PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) where confirmation required or one determination of PR prior to progression where confirmation not required.
RECIST criteria is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment.
27 months
Phase l: Disease Control Rate (DCR) as Per Investigator Based on RECIST v1.1
DCR is the percentage of patients with a best overall response of CR or PR or stable disease (SD).
CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) where confirmation required or one determination of PR prior to progression where confirmation not required.
SD = at least one SD assessment (or better) > 6 weeks after randomization/start of treatment (and not qualifying for CR or PR).
RECIST criteria is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment.
27 months
Phase l: Progression Free Survival (PFS) as Per RECIST v1.1
PFS is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. PFS is per Kaplan-Meier estimates.
RECIST criteria, published in February 2000 by an international collaboration including the European Organization for Research and Treatment of Cancer (EORTC), National Cancer Institute of the United States, and the National Cancer Institute of Canada Clinical Trials Group, is a Response evaluation criteria in solid tumors is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment.
RECIST criteria is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment.
27 months
Phase I: Duration of Response (DOR) as Per RECIST v1.1
DOR is measured from the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented. CR = at least 2 determinations of CR at least 4 weeks apart before progression where confirmation required or 1 determination of CR prior to progression where confirmation not required; PR = at least 2 determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) where confirmation required or 1 determination of PR prior to progression where confirmation not required; PD =progression <= 12 weeks after randomization/start of treatment (and not qualifying for CR, PR or SD). SD = at least 1 SD assessment (or better) > 6 weeks after randomization/start of treatment (and not qualifying for CR or PR). RECIST criteria is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment
27 months
Phase l Only: Overall Response Rate (ORR) as Per Investigator Based on Immune Related Response Criteria (irRC)
ORR is the percentage of participants with a best overall response of complete response (CR) or partial response (PR) as per irRC.
CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required.
PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) where confirmation required or one determination of PR prior to progression where confirmation not required.
The immune-related response criteria (irRC) is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment, where the compound being evaluated is an immuno-oncology drug.
27 months
Phase l Only: Disease Control Rate (DCR) as Per Investigator Based on irRC
DCR is the percentage of patients with a best overall response of CR or PR or stable disease (SD).
CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) where confirmation required or one determination of PR prior to progression where confirmation not required.
SD = at least one SD assessment (or better) > 6 weeks after randomization/start of treatment (and not qualifying for CR or PR).
The immune-related response criteria (irRC) is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment, where the compound being evaluated is an immuno-oncology drug.
27 months
Phase l Only: Progression Free Survival (PFS) as Per irRC
PFS is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. PFS is per Kaplan-Meier estimates.
The immune-related response criteria (irRC) is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment, where the compound being evaluated is an immuno-oncology drug.
27 months
Phase I: Duration of Response (DOR) as Per irRC
DOR: measured from time measurement criteria are met for CR or PR (whichever status is recorded first) until first date that recurrence or PD is objectively documented CR: at least 2 determinations of CR at least 4 weeks apart before progression where confirmation required or 1 determination of CR prior to progression where confirmation not required PR: at least 1 determination of PR or better at least 4 weeks apart before progression (& not qualifying for a CR) where confirmation required or 1 determination of PR prior to progression where confirmation not required PD: progression <= start of treatment (& not qualifying for CR, PR or SD) SD: at least 1 SD assessment (or better) > 6 weeks after randomization/start of treatment (& not qualifying for CR or PR) irRC is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment, where the compound being evaluated is an immuno-oncology drug
61 Days
Phase II: Disease Control Rate (DCR) as Per Investigator Based on RECIST v1.1
DCR is the percentage of patients with a best overall response of CR or PR or stable disease (SD).
CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) where confirmation required or one determination of PR prior to progression where confirmation not required.
SD = at least one SD assessment (or better) > 6 weeks after randomization/start of treatment (and not qualifying for CR or PR).
RECIST criteria is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment.
61 months
Phase II: Progression Free Survival as Per Investigator Based on RECIST v1.1
PFS is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. PFS is per Kaplan-Meier estimates.
RECIST criteria, published in February 2000 by an international collaboration including the European Organization for Research and Treatment of Cancer (EORTC), National Cancer Institute of the United States, and the National Cancer Institute of Canada Clinical Trials Group, is a Response evaluation criteria in solid tumors is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment.
61 months
Phase II: Duration of Response (DOR) as Per Investigator Based on RECIST v1.1
DOR is measured from the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented.
CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) where confirmation required or one determination of PR prior to progression where confirmation not required.
PD = progression <= start of treatment (and not qualifying for CR, PR or SD). SD = at least one SD assessment (or better) > 6 weeks after randomization/start of treatment (and not qualifying for CR or PR).
RECIST criteria is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment.
61 months
Phase II: Overall Response Rate (ORR) as Per Investigator Based on irRC
ORR is the percentage of participants with a best overall response CR or PR as per irRC.
CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required.
PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) where confirmation required or one determination of PR prior to progression where confirmation not required.
The immune-related response criteria (irRC) is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment, where the compound being evaluated is an immuno-oncology drug.
61 months
Phase II: Disease Control Rate (DCR) as Per Investigator Based on irRC
DCR is the percentage of patients with a best overall response of CR or PR or stable disease (SD).
CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) where confirmation required or one determination of PR prior to progression where confirmation not required.
SD = at least one SD assessment (or better) > 6 weeks after randomization/start of treatment (and not qualifying for CR or PR).
The immune-related response criteria (irRC) is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment, where the compound being evaluated is an immuno-oncology drug.
61 months
Phase II: Progression Free Survival (PFS) Per irRC
PFS is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. PFS is per Kaplan-Meier estimates.
The immune-related response criteria (irRC) is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment, where the compound being evaluated is an immuno-oncology drug.
61 months
Phase II: Duration of Response (DOR) Per irRC
DOR: measured from time measurement criteria are met for CR or PR (whichever status is recorded first) until first date that recurrence or PD is objectively documented CR: at least 2 determinations of CR at least 4 weeks apart before progression where confirmation required or 1 determination of CR prior to progression where confirmation not required PR: at least 1 determination of PR or better at least 4 weeks apart before progression (& not qualifying for a CR) where confirmation required or 1 determination of PR prior to progression where confirmation not required PD: progression <= start of treatment (& not qualifying for CR, PR or SD) SD: at least 1 SD assessment (or better) > 6 weeks after randomization/start of treatment (& not qualifying for CR or PR) irRC is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment, where the compound being evaluated is an immuno-oncology drug
61 months
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Oregon Health and Science University SC-10
Portland
Oregon
97239
United States
Sarah Cannon Research Institute SCRI RC
Nashville
Tennessee
37203
United States
University of Texas MD Anderson Cancer Center MD Anderson PSC
Houston
Texas
77030
United States
Huntsman Cancer Institute Univ. of Utah HCI
Salt Lake City
Utah
84112-0550
United States
Novartis Investigative Site
Toronto
Ontario
M5G 1Z6
Canada
Novartis Investigative Site
Paris
75475
France
Novartis Investigative Site
Toulouse
31059
France
Novartis Investigative Site
Villejuif
94800
France
Novartis Investigative Site
Essen
45147
Germany
Novartis Investigative Site
Jena
07740
Germany
Novartis Investigative Site
Ulm
89081
Germany
Novartis Investigative Site
Budapest
1134
Hungary
Novartis Investigative Site
Debrecen
4032
Hungary
Novartis Investigative Site
Bologna
BO
40138
Italy
Novartis Investigative Site
Milan
MI
20132
Italy
Novartis Investigative Site
Rozzano
MI
20089
Italy
Novartis Investigative Site
Modena
MO
41124
Italy
Novartis Investigative Site
Naples
80131
Italy
Novartis Investigative Site
El Achrafiyé
166830
Lebanon
Novartis Investigative Site
Amsterdam
1066 CX
Netherlands
Novartis Investigative Site
Leiden
2300 RC
Netherlands
Novartis Investigative Site
Oslo
0310
Norway
Novartis Investigative Site
Gdansk
80 952
Poland
Novartis Investigative Site
Poznan
60-693
Poland
Novartis Investigative Site
Rzeszów
35-021
Poland
Novartis Investigative Site
Warsaw
02 781
Poland
Novartis Investigative Site
Barcelona
Catalonia
08035
Spain
Novartis Investigative Site
Madrid
28034
Spain
Novartis Investigative Site
Madrid
28041
Spain
Novartis Investigative Site
Madrid
28050
Spain
Novartis Investigative Site
Tainan
Taiwan ROC
70403
Taiwan
Novartis Investigative Site
Taipei
10002
Taiwan
Novartis Investigative Site
Songkhla
Hat Yai
90110
Thailand
Novartis Investigative Site
Bangkok
10330
Thailand
Novartis Investigative Site
Adana
01250
Turkey (Türkiye)
Novartis Investigative Site
Edirne
22030
Turkey (Türkiye)
Novartis Investigative Site
Istanbul
34303
Turkey (Türkiye)
Novartis Investigative Site
Istanbul
34890
Turkey (Türkiye)
Novartis Investigative Site
Izmir
35040
Turkey (Türkiye)
Derived
Naing A, Gainor JF, Gelderblom H, Forde PM, Butler MO, Lin CC, Sharma S, Ochoa de Olza M, Varga A, Taylor M, Schellens JHM, Wu H, Sun H, Silva AP, Faris J, Mataraza J, Cameron S, Bauer TM. A first-in-human phase 1 dose escalation study of spartalizumab (PDR001), an anti-PD-1 antibody, in patients with advanced solid tumors. J Immunother Cancer. 2020 Mar;8(1):e000530. doi: 10.1136/jitc-2020-000530.
FG002
10mg/kg q2w
Phase I Dose escalation cohort patients who took PRD001 10 mg/kg q2w
FG003
3mg/kg q4w
Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q4w
FG004
5mg/kg q4w
Phase I Dose escalation cohort patients who took PRD001 5 mg/kg q4w
FG005
NSCLC 400mg/q4w
Phase II: non-small cell cancer patients who took PDR001 400 mg/q4w
FG006
Melanoma 400mg/q4w
Phase II: Melanoma patients who took PDR001 400 mg/q4w
FG007
TNBC 400mg/q4w
Phase II: Triple negative breast cancer (TNBC) patients who took PDR001 400 mg/q4w
FG008
NSCLC 300mg/q3w
Phase II: non-small cell cancer patients who took PDR001 300 mg/q3w
FG009
ATC 400 mg/q4w
Patients in Phase II with anaplastic thyroid cancer (ATC) who took PDR001 400 mg/q4w
FG00016 subjects
FG00115 subjects
FG00211 subjects
FG0036 subjects
FG00410 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
Completed = Treatment Discontinued
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG00016 subjects
FG00115 subjects
FG00211 subjects
FG0036 subjects
FG00410 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Progressive Disease
FG00014 subjects
FG00111 subjects
FG0027 subjects
FG0036 subjects
FG004
Subject/Guardian Decision
FG0000 subjects
FG0012 subjects
FG0023 subjects
FG0030 subjects
FG004
Death
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Phase 2 Part
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00559 subjects
FG00661 subjects
FG00740 subjects
FG00859 subjects
FG00942 subjects
Entered Post-treatment Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
No Longer Being Followed for Post-treatment Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Entered Survival Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
COMPLETED
Completed = Treatment Discontinued
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Full Analysis Set (FAS): The FAS included all subjects who received at least one dose of spartalizumab. Subjects were analyzed according to the planned treatment (dose level and regimen).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
1mg/kg q2w
Phase I Dose escalation cohort patients who took PDR001 1 mg/kg q2w
BG001
3mg/kg q2w
Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q2w
BG002
10mg/kg q2w
Phase I Dose escalation cohort patients who took PDR001 10 mg/kg q2w
BG003
3mg/kg q4w
Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q4w
BG004
5mg/kg q4w
Phase I Dose escalation cohort patients who took PRD001 5 mg/kg q4w
BG005
NSCLC 400mg/q4w
Phase II: non-small cell cancer patients who took PDR001 400 mg/q4w
BG006
Melanoma 400mg/q4w
Phase II: Melanoma patients who took PDR001 400 mg/q4w
BG007
TNBC 400mg/q4w
Phase II: Triple negative breast cancer (TNBC) patients who took PDR001 400 mg/q4w
BG008
NSCLC 300mg/q3w
Phase II: non-small cell cancer patients who took PDR001 300 mg/q3w
BG009
ATC 400 mg/q4w
Patients in Phase II with anaplastic thyroid cancer (ATC) who took PDR001 400 mg/q4w
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00016
BG00115
BG00211
BG0036
BG00410
BG00559
BG00661
BG00740
BG00859
BG00942
BG010319
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
Participants
Title
Denominators
Categories
< 65 years
Title
Measurements
BG00012
BG0019
BG0028
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0009
BG0017
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
Caucasian
Title
Measurements
BG00010
BG00114
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 l: The Exposure (AUC(0-336h)) After First Dose of Treatment at Cycle 3 (Each Cycle = 28 Days)
Estimated the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD) for PDR001.
AUC0-336h is the AUC from time zero to 336 hour post dose of a measurable concentration sampling time.
Pharmacokinetic analysis set (PAS): The PAS consisted of all subjects who had at least one blood sample providing evaluable PK data.
Phase I Dose escalation cohort patients who took PDR001 1 mg/kg q2w
OG001
3mg/kg q2w
Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q2w
OG002
10mg/kg q2w
Phase I Dose escalation cohort patients who took PDR001 10 mg/kg q2w
OG003
3mg/kg q4w
Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q4w
OG004
5mg/kg q4w
Phase I Dose escalation cohort patients who took PRD001 5 mg/kg q4w
Units
Counts
Participants
OG0008
OG0014
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG000270± 52.5
OG0011150± 51.1
OG0023110± 33.1
OG003
Primary
Phase l: Incidence of Dose Limiting Toxicities (DLTs)
DLT is defined as an adverse event (AE) or abnormal laboratory value of common terminology criteria for adverse events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications, which occurs within the first cycle of treatment with PDR001 during the dose escalation part of the study for which relationship to study treatment cannot be ruled out, with some exceptions.
Safety Set: The Safety Set included all subjects from the FAS who received at least one dose of spartalizumab and had at least one valid post-baseline safety assessment.
Posted
Number
Participants
8 months
ID
Title
Description
OG000
1mg/kg q2w
Phase I Dose escalation cohort patients who took PDR001 1 mg/kg q2w
OG001
3mg/kg q2w
Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q2w
OG002
10mg/kg q2w
Phase I Dose escalation cohort patients who took PDR001 10 mg/kg q2w
OG003
3mg/kg q4w
Primary
Phase ll: Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
ORR is the percentage of participants with a best overall response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 CR = at least 2 determinations of CR at least 4 weeks apart before progression where confirmation required or 1 determination of CR prior to progression where confirmation not required.
PR = at least 2 determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) where confirmation required or 1 determination of PR prior to progression where confirmation not required.
RECIST criteria is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment.
Full Analysis Set (FAS): The FAS included all subjects who received at least one dose of spartalizumab. Subjects were analyzed according to the planned treatment (dose level and regimen).
Posted
Number
90% Confidence Interval
Percentage of participants
61 months
ID
Title
Description
OG000
NSCLC 400 mg/q4w
Patients in Phase II with non-small cell cancer who took PDR001 400 mg/q4w
OG001
Melanoma 400 mg/q4w
Patients in Phase II with Melanoma who took PDR001 400 mg/q4w
AUC0-336h is the AUC from time zero to 336 hour post dose of a measurable concentration sampling time.
AUClast: The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1).
AUCinf: The AUC from time zero to infinity (mass x time x volume-1). AUCtau: The AUC calculated to the end of a dosing interval (tau) at steady-state (amount x time x volume-1).
Pharmacokinetic analysis set (PAS): The PAS consisted of all subjects who had at least one blood sample providing evaluable PK data.
AUC0-336h is the AUC from time zero to 336 hour post dose of a measurable concentration sampling time.
AUClast: The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1).
AUCinf: The AUC from time zero to infinity (mass x time x volume-1). AUCtau: The AUC calculated to the end of a dosing interval (tau) at steady-state (amount x time x volume-1).
Pharmacokinetic analysis set (PAS): The PAS consisted of all subjects who had at least one blood sample providing evaluable PK data.
Patients in Phase II with non-small cell cancer who took PDR001 400 mg/q4w
OG001
Melanoma 400 mg/q4w
Patients in Phase II with Melanoma who took PDR001 400 mg/q4w
OG002
TNBC 400 mg/q4w
Patients in Phase II with TNBC who took PDR001 400 mg/q4w
OG003
NSCLC 300 mg/q3w
Patients in Phase II with non-small cell cancer who took PDR001 300 mg/q3w
OG004
Secondary
Phase I: Presence and/or Concentration of Anti-PDR001
Assessed PDR001 anti-drug anti-body (ADA) incidence in Phase I patients - the emergence of anti-PDR001 antibodies following one or more intravenous (i.v.) infusions of PDR001. Each cycle = 28 days; End of treatment was expected to be on average 1 year after the start of study treatment.
Immunogenicity incidence Set: The Immunogenicity incidence set includes all subjects in FAS with a determinant baseline immunoglobulin (IG) sample and at least one determinant post-baseline IG sample.
Treatment-induced ADA-positive was performed on ADA-positive patients only. Treatment-boosted ADA-positive was performed on ADA-positive patients only.
Posted
Number
Participants
42 months
ID
Title
Description
OG000
1mg/kg q2w
Phase I Dose escalation cohort patients who took PDR001 1 mg/kg q2w
OG001
3mg/kg q2w
Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q2w
OG002
10mg/kg q2w
Phase I Dose escalation cohort patients who took PDR001 10 mg/kg q2w
OG003
All Phase I q2w
Secondary
Phase II: Presence and/or Concentration of Anti-PDR001
Assessed PDR001 anti-drug anti-body (ADA) incidence in Phase I patients - the emergence of anti-PDR001 antibodies following one or more intravenous (i.v.) infusions of PDR001. Each cycle = 28 days; End of treatment was expected to be on average 1 year after the start of study treatment.
For Treatment -induced ADA-positive, Percentage was based on subjects ADA-negative at baseline.
For Treatment-boosted ADA-positive, Percentage was based on subjects ADA-positive at baseline.
Immunogenicity incidence Set: The Immunogenicity incidence set includes all subjects in FAS with a determinant baseline immunoglobulin (IG) sample and at least one determinant post-baseline IG sample.
Posted
Number
Participants
42 months
ID
Title
Description
OG000
NSCLC 400 mg/q4w
Patients in Phase II with non-small cell cancer who took PDR001 400 mg/q4w
OG001
Melanoma 400 mg/q4w
Patients in Phase II with Melanoma who took PDR001 400 mg/q4w
OG002
TNBC 400 mg/q4w
Patients in Phase II with TNBC who took PDR001 400 mg/q4w
OG003
Secondary
Phase l: Overall Response Rate (ORR) as Per Investigator Based on RECIST v1.1
ORR is the percentage of participants with a best overall response of complete response CR or partial response PR as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required.
PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) where confirmation required or one determination of PR prior to progression where confirmation not required.
RECIST criteria is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment.
Full Analysis Set (FAS): The FAS included all subjects who received at least one dose of spartalizumab. Subjects were analyzed according to the planned treatment (dose level and regimen).
Posted
Number
90% Confidence Interval
Percentage of participants
27 months
ID
Title
Description
OG000
1mg/kg q2w
Phase I Dose escalation cohort patients who took PDR001 1 mg/kg q2w
OG001
3mg/kg q2w
Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q2w
OG002
Secondary
Phase l: Disease Control Rate (DCR) as Per Investigator Based on RECIST v1.1
DCR is the percentage of patients with a best overall response of CR or PR or stable disease (SD).
CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) where confirmation required or one determination of PR prior to progression where confirmation not required.
SD = at least one SD assessment (or better) > 6 weeks after randomization/start of treatment (and not qualifying for CR or PR).
RECIST criteria is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment.
Full Analysis Set (FAS): The FAS included all subjects who received at least one dose of spartalizumab. Subjects were analyzed according to the planned treatment (dose level and regimen).
Posted
Number
90% Confidence Interval
Percentage of participants
27 months
ID
Title
Description
OG000
1mg/kg q2w
Phase I Dose escalation cohort patients who took PDR001 1 mg/kg q2w
OG001
3mg/kg q2w
Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q2w
Secondary
Phase l: Progression Free Survival (PFS) as Per RECIST v1.1
PFS is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. PFS is per Kaplan-Meier estimates.
RECIST criteria, published in February 2000 by an international collaboration including the European Organization for Research and Treatment of Cancer (EORTC), National Cancer Institute of the United States, and the National Cancer Institute of Canada Clinical Trials Group, is a Response evaluation criteria in solid tumors is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment.
RECIST criteria is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment.
Full Analysis Set (FAS): The FAS included all subjects who received at least one dose of spartalizumab. Subjects were analyzed according to the planned treatment (dose level and regimen).
Posted
Median
90% Confidence Interval
Percentage of participants
27 months
ID
Title
Description
OG000
1mg/kg q2w
Phase I Dose escalation cohort patients who took PDR001 1 mg/kg q2w
OG001
3mg/kg q2w
Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q2w
Secondary
Phase I: Duration of Response (DOR) as Per RECIST v1.1
DOR is measured from the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented. CR = at least 2 determinations of CR at least 4 weeks apart before progression where confirmation required or 1 determination of CR prior to progression where confirmation not required; PR = at least 2 determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) where confirmation required or 1 determination of PR prior to progression where confirmation not required; PD =progression <= 12 weeks after randomization/start of treatment (and not qualifying for CR, PR or SD). SD = at least 1 SD assessment (or better) > 6 weeks after randomization/start of treatment (and not qualifying for CR or PR). RECIST criteria is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment
Full analysis set - Dose escalation
Posted
Mean
Full Range
days
27 months
ID
Title
Description
OG000
3mg/kg q2w
Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q2w
OG001
10mg/kg q2w
Phase I Dose escalation cohort patients who took PRD001 10 mg/kg q2w
OG002
Secondary
Phase l Only: Overall Response Rate (ORR) as Per Investigator Based on Immune Related Response Criteria (irRC)
ORR is the percentage of participants with a best overall response of complete response (CR) or partial response (PR) as per irRC.
CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required.
PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) where confirmation required or one determination of PR prior to progression where confirmation not required.
The immune-related response criteria (irRC) is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment, where the compound being evaluated is an immuno-oncology drug.
Full Analysis Set (FAS): The FAS included all subjects who received at least one dose of spartalizumab. Subjects were analyzed according to the planned treatment (dose level and regimen).
Posted
Number
90% Confidence Interval
Percentage of participants
27 months
ID
Title
Description
OG000
1mg/kg q2w
Phase I Dose escalation cohort patients who took PDR001 1 mg/kg q2w
OG001
3mg/kg q2w
Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q2w
Secondary
Phase l Only: Disease Control Rate (DCR) as Per Investigator Based on irRC
DCR is the percentage of patients with a best overall response of CR or PR or stable disease (SD).
CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) where confirmation required or one determination of PR prior to progression where confirmation not required.
SD = at least one SD assessment (or better) > 6 weeks after randomization/start of treatment (and not qualifying for CR or PR).
The immune-related response criteria (irRC) is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment, where the compound being evaluated is an immuno-oncology drug.
Full Analysis Set (FAS): The FAS included all subjects who received at least one dose of spartalizumab. Subjects were analyzed according to the planned treatment (dose level and regimen).
Posted
Number
90% Confidence Interval
Percentage of participants
27 months
ID
Title
Description
OG000
1mg/kg q2w
Phase I Dose escalation cohort patients who took PDR001 1 mg/kg q2w
OG001
3mg/kg q2w
Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q2w
Secondary
Phase l Only: Progression Free Survival (PFS) as Per irRC
PFS is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. PFS is per Kaplan-Meier estimates.
The immune-related response criteria (irRC) is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment, where the compound being evaluated is an immuno-oncology drug.
Full Analysis Set (FAS): The FAS included all subjects who received at least one dose of spartalizumab. Subjects were analyzed according to the planned treatment (dose level and regimen).
Posted
Median
90% Confidence Interval
Percentage of participants
27 months
ID
Title
Description
OG000
1mg/kg q2w
Phase I Dose escalation cohort patients who took PDR001 1 mg/kg q2w
OG001
3mg/kg q2w
Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q2w
OG002
10mg/kg q2w
Phase I Dose escalation cohort patients who took PDR001 10 mg/kg q2w
OG003
Secondary
Phase I: Duration of Response (DOR) as Per irRC
DOR: measured from time measurement criteria are met for CR or PR (whichever status is recorded first) until first date that recurrence or PD is objectively documented CR: at least 2 determinations of CR at least 4 weeks apart before progression where confirmation required or 1 determination of CR prior to progression where confirmation not required PR: at least 1 determination of PR or better at least 4 weeks apart before progression (& not qualifying for a CR) where confirmation required or 1 determination of PR prior to progression where confirmation not required PD: progression <= start of treatment (& not qualifying for CR, PR or SD) SD: at least 1 SD assessment (or better) > 6 weeks after randomization/start of treatment (& not qualifying for CR or PR) irRC is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment, where the compound being evaluated is an immuno-oncology drug
Full analysis set - Dose escalation
Posted
Mean
Full Range
days
61 Days
ID
Title
Description
OG000
3mg/kg q2w
Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q2w
OG001
10mg/kg q2w
Phase I Dose escalation cohort patients who took PRD001 10 mg/kg q2w
OG002
Secondary
Phase II: Disease Control Rate (DCR) as Per Investigator Based on RECIST v1.1
DCR is the percentage of patients with a best overall response of CR or PR or stable disease (SD).
CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) where confirmation required or one determination of PR prior to progression where confirmation not required.
SD = at least one SD assessment (or better) > 6 weeks after randomization/start of treatment (and not qualifying for CR or PR).
RECIST criteria is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment.
Full Analysis Set (FAS): The FAS included all subjects who received at least one dose of spartalizumab. Subjects were analyzed according to the planned treatment (dose level and regimen).
Posted
Number
90% Confidence Interval
Percentage of participants
61 months
ID
Title
Description
OG000
NSCLC 400 mg/q4w
Patients in Phase II with non-small cell cancer who took PDR001 400 mg/q4w
OG001
Melanoma 400 mg/q4w
Patients in Phase II with Melanoma who took PDR001 400 mg/q4w
Secondary
Phase II: Progression Free Survival as Per Investigator Based on RECIST v1.1
PFS is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. PFS is per Kaplan-Meier estimates.
RECIST criteria, published in February 2000 by an international collaboration including the European Organization for Research and Treatment of Cancer (EORTC), National Cancer Institute of the United States, and the National Cancer Institute of Canada Clinical Trials Group, is a Response evaluation criteria in solid tumors is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment.
Full Analysis Set (FAS): The FAS included all subjects who received at least one dose of spartalizumab. Subjects were analyzed according to the planned treatment (dose level and regimen).
Posted
Median
90% Confidence Interval
Percentage of participants
61 months
ID
Title
Description
OG000
NSCLC 400 mg/q4w
Patients in Phase II with non-small cell cancer who took PDR001 400 mg/q4w
OG001
Melanoma 400 mg/q4w
Patients in Phase II with Melanoma who took PDR001 400 mg/q4w
OG002
TNBC 400 mg/q4w
Secondary
Phase II: Duration of Response (DOR) as Per Investigator Based on RECIST v1.1
DOR is measured from the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented.
CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) where confirmation required or one determination of PR prior to progression where confirmation not required.
PD = progression <= start of treatment (and not qualifying for CR, PR or SD). SD = at least one SD assessment (or better) > 6 weeks after randomization/start of treatment (and not qualifying for CR or PR).
RECIST criteria is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment.
Full Analysis Set (FAS): The FAS included all subjects who received at least one dose of spartalizumab. Subjects were analyzed according to the planned treatment (dose level and regimen).
Posted
Mean
Full Range
months
61 months
ID
Title
Description
OG000
NSCLC 400 mg/q4w
Patients in Phase II with non-small cell cancer who took PDR001 400 mg/q4w
OG001
Melanoma 400 mg/q4w
Patients in Phase II with Melanoma who took PDR001 400 mg/q4w
Secondary
Phase II: Overall Response Rate (ORR) as Per Investigator Based on irRC
ORR is the percentage of participants with a best overall response CR or PR as per irRC.
CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required.
PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) where confirmation required or one determination of PR prior to progression where confirmation not required.
The immune-related response criteria (irRC) is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment, where the compound being evaluated is an immuno-oncology drug.
Full Analysis Set (FAS): The FAS included all subjects who received at least one dose of spartalizumab. Subjects were analyzed according to the planned treatment (dose level and regimen).
Posted
Number
90% Confidence Interval
Percentage of participants
61 months
ID
Title
Description
OG000
NSCLC 400 mg/q4w
Patients in Phase II with non-small cell cancer who took PDR001 400 mg/q4w
OG001
Melanoma 400 mg/q4w
Patients in Phase II with Melanoma who took PDR001 400 mg/q4w
OG002
Secondary
Phase II: Disease Control Rate (DCR) as Per Investigator Based on irRC
DCR is the percentage of patients with a best overall response of CR or PR or stable disease (SD).
CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) where confirmation required or one determination of PR prior to progression where confirmation not required.
SD = at least one SD assessment (or better) > 6 weeks after randomization/start of treatment (and not qualifying for CR or PR).
The immune-related response criteria (irRC) is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment, where the compound being evaluated is an immuno-oncology drug.
Full Analysis Set (FAS): The FAS included all subjects who received at least one dose of spartalizumab. Subjects were analyzed according to the planned treatment (dose level and regimen).
Posted
Number
90% Confidence Interval
Percentage of participants
61 months
ID
Title
Description
OG000
NSCLC 400 mg/q4w
Patients in Phase II with non-small cell cancer who took PDR001 400 mg/q4w
OG001
Melanoma 400 mg/q4w
Patients in Phase II with Melanoma who took PDR001 400 mg/q4w
Secondary
Phase II: Progression Free Survival (PFS) Per irRC
PFS is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. PFS is per Kaplan-Meier estimates.
The immune-related response criteria (irRC) is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment, where the compound being evaluated is an immuno-oncology drug.
Full Analysis Set (FAS): The FAS included all subjects who received at least one dose of spartalizumab. Subjects were analyzed according to the planned treatment (dose level and regimen).
Posted
Median
90% Confidence Interval
Percentage of participants
61 months
ID
Title
Description
OG000
NSCLC 400 mg/q4w
Patients in Phase II with non-small cell cancer who took PDR001 400 mg/q4w
OG001
Melanoma 400 mg/q4w
Patients in Phase II with Melanoma who took PDR001 400 mg/q4w
OG002
TNBC 400 mg/q4w
Patients in Phase II with TNBC who took PDR001 400 mg/q4w
OG003
Secondary
Phase II: Duration of Response (DOR) Per irRC
DOR: measured from time measurement criteria are met for CR or PR (whichever status is recorded first) until first date that recurrence or PD is objectively documented CR: at least 2 determinations of CR at least 4 weeks apart before progression where confirmation required or 1 determination of CR prior to progression where confirmation not required PR: at least 1 determination of PR or better at least 4 weeks apart before progression (& not qualifying for a CR) where confirmation required or 1 determination of PR prior to progression where confirmation not required PD: progression <= start of treatment (& not qualifying for CR, PR or SD) SD: at least 1 SD assessment (or better) > 6 weeks after randomization/start of treatment (& not qualifying for CR or PR) irRC is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment, where the compound being evaluated is an immuno-oncology drug
Full Analysis Set (FAS): The FAS included all subjects who received at least one dose of spartalizumab. Subjects were analyzed according to the planned treatment (dose level and regimen).
Posted
Mean
Full Range
months
61 months
ID
Title
Description
OG000
NSCLC 400 mg/q4w
Patients in Phase II with non-small cell cancer who took PDR001 400 mg/q4w
OG001
Melanoma 400 mg/q4w
Patients in Phase II with Melanoma who took PDR001 400 mg/q4w
Post-Hoc
All Collected Deaths
On treatment deaths were collected from the start of study treatment up to 30 days after last study treatment exposure, for a maximum duration of 114.3 weeks for Phase I part (treatment duration ranged from 2 to 110.3 weeks) and a maximum duration of 194.9 weeks for Phase II part (treatment duration ranged from 0.6 tp 190.9 weeks).
Total deaths were collected from the start of treatment up to end of follow-up phase (approx. 70 months).
Clinical database population: All treated patients
Posted
Number
Participants
On treatment deaths: approx. 114.3 weeks (Phase I) & 194.9 weeks (phase II), all deaths: approx. 70 months
ID
Title
Description
OG000
1mg/kg q2w
Phase I Dose escalation cohort patients who took PDR001 1 mg/kg q2w
OG001
3mg/kg q2w
Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q2w
OG002
10mg/kg q2w
Phase I Dose escalation cohort patients who took PDR001 10 mg/kg q2w
OG003
3mg/kg q4w
Time Frame
On treatment deaths were collected from the start of study treatment up to 30 days after last study treatment exposure, for a maximum duration of 114.3 weeks for the Part I phase (treatment duration ranged from 2 to 110.3 weeks) and for a maximum duration of 194.9 weeks for the Phase II part (treatment duration ranged from 0.6 to 190.9 weeks).
Description
AE: Any sign or symptom that occurs during treatment plus 30 days post treatment.
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
1mg/kg q2w
Phase I Dose escalation cohort patients who took PDR001 1 mg/kg q2w
2
16
9
16
16
16
EG001
3mg/kg q2w
Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q2w
2
15
7
15
15
15
EG002
10mg/kg q2w
Phase I Dose escalation cohort patients who took PRD001 10 mg/kg q2w
1
11
4
11
11
11
EG003
All Phase I q2w
Phase I dose Cohorts - All patients in Phase I who took PDR001 q2w
5
42
20
42
42
42
EG004
3mg/kg q4w
Phase I Dose escalation cohort patients who took PRD001 3 mg/kg q4w
1
6
2
6
6
6
EG005
5mg/kg q4w
Phase I Dose escalation cohort patients who took PRD001 5 mg/kg q4w
2
10
2
10
10
10
EG006
All Phase I q4w
Phase I dose Cohorts - All patients in Phase I who took PDR001 q4w
3
16
4
16
16
16
EG007
All Phase I Patients
All patients in Phase I regardless of how they took PDR001
8
58
24
58
58
58
EG008
NSCLC 400mg/q4w
Phase II: non-small cell cancer patients who took PDR001 400 mg/q4w
4
59
27
59
54
59
EG009
Melanoma 400mg/q4w
Phase II: Melanoma patients who took PDR001 400 mg/q4w
4
61
22
61
55
61
EG010
TNBC 400mg/q4w
Phase II: Triple negative breast cancer (TNBC) patients who took PDR001 400 mg/q4w
4
40
18
40
37
40
EG011
NSCLC 300mg/q3w
Phase II: non-small cell cancer patients who took PDR001 300 mg/q3w
12
59
37
59
56
59
EG012
ATC 400 mg/q4w
Patients in Phase II with anaplastic thyroid cancer (ATC) who took PDR001 400 mg/q4w
11
42
22
42
39
42
EG013
All Phase II Patients
All patients in Phase II regardless of how they took PDR001
35
261
126
261
241
261
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (23.0)
Systematic Assessment
EG0002 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG0032 affected42 at risk
EG0040 affected6 at risk
EG0050 affected10 at risk
EG0060 affected16 at risk
EG0072 affected58 at risk
EG0081 affected59 at risk
EG0090 affected61 at risk
EG0100 affected40 at risk
EG0110 affected59 at risk
EG0121 affected42 at risk
EG0132 affected261 at risk
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Diplopia
Eye disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0012 affected15 at risk
EG0020 affected11 at risk
EG003
Autoimmune colitis
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Asthenia
General disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Complication of device insertion
General disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Fatigue
General disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Oedema peripheral
General disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Pain
General disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Peripheral swelling
General disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Pyrexia
General disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Sarcoidosis
Immune system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Empyema
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Localised infection
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Sepsis
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Septic shock
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Tracheal obstruction
Injury, poisoning and procedural complications
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Fistula
Musculoskeletal and connective tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Sjogren's syndrome
Musculoskeletal and connective tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Intracranial tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Second primary malignancy
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Tumour inflammation
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Ataxia
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Carotid artery occlusion
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Central nervous system lesion
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Intracranial pressure increased
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Seizure
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Depression
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Bronchial obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Obstructive airways disorder
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Pharyngeal haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0021 affected11 at risk
EG003
Tracheal stenosis
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Embolism
Vascular disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Hypotension
Vascular disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Lymphorrhoea
Vascular disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Superior vena cava syndrome
Vascular disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (23.0)
Systematic Assessment
EG0005 affected16 at risk
EG0017 affected15 at risk
EG0022 affected11 at risk
EG00314 affected42 at risk
EG0041 affected6 at risk
EG0053 affected10 at risk
EG0064 affected16 at risk
EG00718 affected58 at risk
EG00816 affected59 at risk
EG00913 affected61 at risk
EG0106 affected40 at risk
EG0118 affected59 at risk
EG01211 affected42 at risk
EG01354 affected261 at risk
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Eosinophilia
Blood and lymphatic system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0012 affected15 at risk
EG0020 affected11 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Otorrhoea
Ear and labyrinth disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (23.0)
Systematic Assessment
EG0003 affected16 at risk
EG0013 affected15 at risk
EG0021 affected11 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Photopsia
Eye disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Vision blurred
Eye disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0021 affected11 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0003 affected16 at risk
EG0012 affected15 at risk
EG0022 affected11 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0021 affected11 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Autoimmune colitis
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0005 affected16 at risk
EG0015 affected15 at risk
EG0020 affected11 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0007 affected16 at risk
EG0016 affected15 at risk
EG0021 affected11 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0003 affected16 at risk
EG0011 affected15 at risk
EG0021 affected11 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0012 affected15 at risk
EG0020 affected11 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0002 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0007 affected16 at risk
EG0014 affected15 at risk
EG0023 affected11 at risk
EG003
Pancreatic duct dilatation
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0006 affected16 at risk
EG0011 affected15 at risk
EG0023 affected11 at risk
EG003
Asthenia
General disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Chills
General disorders
MedDRA (23.0)
Systematic Assessment
EG0002 affected16 at risk
EG0011 affected15 at risk
EG0021 affected11 at risk
EG003
Face oedema
General disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Fatigue
General disorders
MedDRA (23.0)
Systematic Assessment
EG00010 affected16 at risk
EG0013 affected15 at risk
EG0022 affected11 at risk
EG003
Inflammation
General disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Influenza like illness
General disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Malaise
General disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0012 affected15 at risk
EG0021 affected11 at risk
EG003
Oedema
General disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Oedema peripheral
General disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0012 affected15 at risk
EG0022 affected11 at risk
EG003
Pain
General disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Peripheral swelling
General disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Pyrexia
General disorders
MedDRA (23.0)
Systematic Assessment
EG0002 affected16 at risk
EG0012 affected15 at risk
EG0021 affected11 at risk
EG003
Swelling face
General disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Food allergy
Immune system disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Influenza
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Laryngitis bacterial
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Otitis media
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Peritonitis
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0012 affected15 at risk
EG0020 affected11 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0013 affected15 at risk
EG0020 affected11 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Post-traumatic pain
Injury, poisoning and procedural complications
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA (23.0)
Systematic Assessment
EG0002 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (23.0)
Systematic Assessment
EG0002 affected16 at risk
EG0011 affected15 at risk
EG0022 affected11 at risk
EG003
Bacterial test positive
Investigations
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (23.0)
Systematic Assessment
EG0003 affected16 at risk
EG0012 affected15 at risk
EG0020 affected11 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Blood creatinine decreased
Investigations
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Transaminases increased
Investigations
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Weight decreased
Investigations
MedDRA (23.0)
Systematic Assessment
EG0004 affected16 at risk
EG0012 affected15 at risk
EG0021 affected11 at risk
EG003
Weight increased
Investigations
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (23.0)
Systematic Assessment
EG0005 affected16 at risk
EG0011 affected15 at risk
EG0023 affected11 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0012 affected15 at risk
EG0021 affected11 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0022 affected11 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (23.0)
Systematic Assessment
EG0003 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0012 affected15 at risk
EG0021 affected11 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (23.0)
Systematic Assessment
EG0002 affected16 at risk
EG0013 affected15 at risk
EG0021 affected11 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0012 affected15 at risk
EG0021 affected11 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0013 affected15 at risk
EG0021 affected11 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0002 affected16 at risk
EG0012 affected15 at risk
EG0020 affected11 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Coccydynia
Musculoskeletal and connective tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0012 affected15 at risk
EG0020 affected11 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0002 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0021 affected11 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0002 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0022 affected11 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0012 affected15 at risk
EG0020 affected11 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0021 affected11 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0012 affected15 at risk
EG0022 affected11 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.0)
Systematic Assessment
EG0002 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Amnesia
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Aphasia
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0004 affected16 at risk
EG0016 affected15 at risk
EG0020 affected11 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0012 affected15 at risk
EG0020 affected11 at risk
EG003
Headache
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0014 affected15 at risk
EG0021 affected11 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Lethargy
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Paralysis
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Tremor
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Affective disorder
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Agitation
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Depression
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Azotaemia
Renal and urinary disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Vulvovaginal pain
Reproductive system and breast disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0003 affected16 at risk
EG0014 affected15 at risk
EG0020 affected11 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0005 affected16 at risk
EG0017 affected15 at risk
EG0022 affected11 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0003 affected16 at risk
EG0011 affected15 at risk
EG0021 affected11 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Cold sweat
Skin and subcutaneous tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Lichen planus
Skin and subcutaneous tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0003 affected16 at risk
EG0015 affected15 at risk
EG0021 affected11 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0012 affected15 at risk
EG0020 affected11 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Vitiligo
Skin and subcutaneous tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Hot flush
Vascular disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected11 at risk
EG003
Hypotension
Vascular disorders
MedDRA (23.0)
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected11 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA (23.0)
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected11 at risk
EG003
Although the study had 2 'arms', the phase I part of the study had 5 dosing cohorts and the phase ll part had 5 treatment groups for a total of 10 reporting groups.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.