Study of Tremelimumab in Patients With Advanced Solid Tumors | NCT02527434 | Trialant
NCT02527434
Sponsor
AstraZeneca
Status
Completed
Last Update Posted
Nov 15, 2023Actual
Enrollment
64Actual
Phase
Phase 2
Conditions
Urothelial Bladder Cancer
Triple-negative Breast Cancer
Pancreatic Ductal Adenocarcinoma
Interventions
Tremelimumab monotherapy
MEDI4736 monotherapy
MEDI4736 + tremelimumab combination therapy
Countries
United States
Belgium
Netherlands
Poland
South Korea
Protocol Section
Identification Module
NCT ID
NCT02527434
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D4884C00001
Secondary IDs
ID
Type
Description
Link
2015-002934-32
EudraCT Number
Brief Title
Study of Tremelimumab in Patients With Advanced Solid Tumors
Official Title
A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients With Advanced Solid Tumors
Acronym
Not provided
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
Oct 2023
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
Nov 2, 2015Actual
Primary Completion Date
Feb 17, 2018Actual
Completion Date
Mar 28, 2023Actual
First Submitted Date
Aug 12, 2015
First Submission Date that Met QC Criteria
Aug 18, 2015
First Posted Date
Aug 19, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 13, 2019
Results First Submitted that Met QC Criteria
Feb 13, 2019
Results First Posted Date
Mar 5, 2019Actual
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
Nov 14, 2023
Last Update Posted Date
Nov 15, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AstraZenecaINDUSTRY
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
A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients with Advanced Solid Tumors
Detailed Description
This is an open-label, multi-center study to determine the efficacy and safety of tremelimumab in the treatment of different cohorts of patients with selected advanced solid tumors. If eligible and at the discretion of the Investigator, after confirmed disease progression on tremelimumab monotherapy or during follow-up, patients will have the option of being sequenced to MEDI4736 (MedImmune 4736) monotherapy or MEDI4736 + tremelimumab combination therapy, for up to 12 months or until disease progression, whichever comes sooner.
treme mono to be sequenced to MEDI4736 mono or combination
Experimental
tremelimumab monotherapy, with the option for eligible patients to be sequenced to MEDI4736 monotherapy or MEDI4736 + tremelimumab combination therapy after progressive disease (PD)
treme mono to be sequenced to MEDI4736 mono or combination
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Patients With Confirmed Overall Response During Tremelimumab Monotherapy Phase
Objective response rate (ORR) during the initial tremelimumab monotherapy phase was assessed by the site Investigator using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) and was defined as the percentage of patients with a confirmed overall response of complete response (CR) or partial response (PR) and was based on all treated patients who had measurable disease at baseline (Day 1). 95% confidence intervals (CIs) were calculated using the Clopper Pearson method.
From baseline to 12 months in the tremelimumab monotherapy phase
Secondary Outcomes
Measure
Description
Time Frame
Median Duration of Response (DoR) During Tremelimumab Monotherapy Phase
DoR during the initial tremelimumab monotherapy phase was assessed by the site Investigator using RECIST 1.1 and was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression. The time of the initial response was defined as the latest of the dates contributing toward the first visit response of CR or PR. If a patient did not progress following a response, then their DoR was censored at the progression-free survival (PFS) censoring time. DoR was not defined for those patients who did not have documented response. Median DoR was calculated using the Kaplan-Meier technique.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
1. histologically or cytologically documented solid tumor malignancies, including but not limited to 1 of the following: UBC, Metastatic PDAC, TNBC; Are intolerant, are ineligible for, or have refused treatment with standard first-line therapy; 2. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with computed tomography (CT) (preferred) or magnetic resonance imaging (MRI) scans and that is suitable for accurate repeated measurements.
Exclusion criteria:
1. Any concurrent chemotherapy, biologic, or hormonal therapy for cancer Treatment; 2. History of leptomeningeal carcinomatosis; 3. Active or prior documented autoimmune or inflammatory disorders; 4. Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 14 days prior to study treatment start; 5. QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms; 6. Known allergy or hypersensitivity to IP or any IP excipient
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Types
Study Protocol
Statistical Analysis Plan (SAP)
Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at:
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
The patients were split into 3 different analysis cohorts based on their tumor types: urothelial bladder cancer (UBC), triple-negative breast cancer (TNBC) and pancreatic ductal adenocarcinoma (PDAC).
Recruitment Details
A total of 64 patients with select advanced solid tumors were treated in this phase II, open-label, multi-center study from November 2015. Primary data cut off date: 17 February 2018. Final data cut off date: 31 December 2018.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
UBC Cohort
Patients with UBC entered the initial tremelimumab monotherapy phase and were administered tremelimumab via intravenous (IV) infusion at a dose of 750 milligrams (mg) once every 4 weeks (q4w) for 7 doses (cycles), then every 12 weeks (q12w) for 2 additional cycles, for up to a total of 12 months or until confirmed progressive disease (PD).
Eligible patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were given the option for retreatment with tremelimumab monotherapy or to be sequenced to receive MEDI4736 (durvalumab) + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months or to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Full Analysis Set (FAS)
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Sep 13, 2018
Feb 13, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
MEDI4736 monotherapy
Biological
IV infusion
treme mono to be sequenced to MEDI4736 mono or combination
MEDI4736 + tremelimumab combination therapy
Biological
IV infusion
treme mono to be sequenced to MEDI4736 mono or combination
From baseline to 12 months in the tremelimumab monotherapy phase
Disease Control Rate (DCR) During Tremelimumab Monotherapy Phase
DCR during the initial tremelimumab monotherapy phase was defined as the percentage of patients who had a best objective response (BoR) of CR or PR in the first 3 months (PDAC patients) or 4 months (UBC and TNBC patients) and 12 months (all patients), or who had demonstrated stable disease (SD) for a minimum interval of 3, 4 or 12 months following the start of study treatment. DCR was determined programmatically based on RECIST 1.1 using site Investigator data and all data up until the first progression event. 95% CIs were calculated using the Clopper Pearson method.
From baseline to 12 months in the tremelimumab monotherapy phase
Median PFS During Tremelimumab Monotherapy Phase
PFS during the initial tremelimumab monotherapy phase was assessed by the site Investigator using RECIST 1.1 and was defined as the time from the date of enrollment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from therapy or received another anticancer therapy prior to progression. Progression events that did not occur within 3 months (PDAC patients) or 4 months (UBC/TNBC patients) of the last evaluable assessment (or first dose) were censored. Median PFS was calculated using the Kaplan-Meier technique.
From baseline to 12 months in the tremelimumab monotherapy phase
Best Objective Response (BoR) During Tremelimumab Monotherapy Phase
BoR during the initial tremelimumab monotherapy phase was calculated based on the overall visit responses from each RECIST 1.1 assessment and was defined as the best response a patient had during their time in the study (from CR, PR, SD, PD or not evaluable [NE]) obtained among all tumor assessment visits from baseline until end of treatment or determination of PD. The BoR was summarized by percentage of patients for each category (CR, PR, SD, PD, and NE).
From baseline to 12 months in the tremelimumab monotherapy phase
Median Overall Survival (OS) During Tremelimumab Monotherapy Phase
OS was defined as the time from the date of first dose until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. OS is presented from start of tremelimumab monotherapy phase and includes the retreatment phase if the patient entered the corresponding treatment phase.
Median OS was calculated using the Kaplan-Meier technique.
From baseline to final data cut-off date
Percentage of Patients With Confirmed Overall Response During Retreatment Phase
ORR was assessed by the site Investigator using RECIST 1.1 and was defined as the percentage of patients with a confirmed overall response of CR or PR and was based on all treated patients who had measurable disease at baseline (Day 1) and who sequenced to durvalumab monotherapy (MEDI treatment phase) or durvalumab + tremelimumab combination therapy (COMBO treatment phase). 95% CIs were calculated using the Clopper Pearson method.
From baseline to 12 months in retreatment phase
Median DoR During Retreatment Phase
DoR during the retreatment phase was assessed by the site Investigator using RECIST 1.1 and was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression. The time of the initial response was defined as the latest of the dates contributing toward the first visit response of CR or PR. If a patient did not progress following a response, then their DoR was censored at the PFS censoring time. DoR was not defined for those patients who did not have documented response. Median DoR was calculated using the Kaplan-Meier technique.
From baseline to 12 months in retreatment phase
DCR During Retreatment Phase
DCR during the retreatment phase was defined as the percentage of patients who had a BoR of CR or PR in the first 3 months (PDAC patients) or 4 months (UBC and TNBC patients) or who had demonstrated SD for a minimum interval of 3 or 4 months following the start of study treatment. DCR was determined programmatically based on RECIST 1.1 using site Investigator data and all data up until the first progression event. 95% CIs were calculated using the Clopper Pearson method.
From baseline to 4 months in retreatment phase
Median PFS During Retreatment Phase
PFS during the retreatment phase was assessed by the site Investigator using RECIST 1.1 and defined as the time from the date of enrollment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from therapy or received another anticancer therapy prior to progression.
Progression events that did not occur within 3 months (PDAC patients) or 4 months (UBC/TNBC patients) of the last evaluable assessment (or first dose) were censored. Median PFS was calculated using the Kaplan-Meier technique.
From baseline to 12 months in retreatment phase
BoR During Retreatment Phase
BoR during the retreatment phase was calculated based on the overall visit responses from each RECIST 1.1 assessment and was defined as the best response a patient had during their time in the study (from CR, PR, SD, PD or NE) obtained among all tumor assessment visits from baseline until end of treatment or determination of PD. The BoR was summarized by percentage of patients for each category (CR, PR, SD, PD, and NE).
From baseline to 12 months in retreatment phase
Median OS During Retreatment Phase
OS during the retreatment phase was defined as the time from the date of first dose until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
From baseline in retreatment phase to final data cut-off date
Patients with TNBC entered the initial tremelimumab monotherapy phase and were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
Eligible patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were given the option for retreatment with tremelimumab monotherapy or to be sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months or to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
FG002
PDAC Cohort
Patients with PDAC entered the initial tremelimumab monotherapy phase and were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
Eligible patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were given the option for retreatment with tremelimumab monotherapy or to be sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months or to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
FG00032 subjects
FG00112 subjects
FG00220 subjects
Started Retreatment Phase (COMBO)
COMBO Analysis Set
FG0007 subjects
FG0015 subjects
FG0024 subjects
Started Retreatment Phase (MEDI)
MEDI Analysis Set
FG0004 subjects
FG0010 subjects
FG0021 subjects
COMPLETED
FG0004 subjects
FG0011 subjects
FG0020 subjects
NOT COMPLETED
FG00028 subjects
FG00111 subjects
FG00220 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0002 subjects
FG0012 subjects
FG0020 subjects
Death
FG00019 subjects
FG0016 subjects
FG00217 subjects
Withdrawal by Subject
FG0005 subjects
FG0013 subjects
FG0023 subjects
Reason Not Specified
FG0001 subjects
FG0010 subjects
FG0020 subjects
Site closure
FG0001 subjects
FG0010 subjects
FG0020 subjects
Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
UBC Cohort
Patients with UBC entered the initial tremelimumab monotherapy phase and were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
Eligible patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were given the option for retreatment with tremelimumab monotherapy or to be sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months or to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
BG001
TNBC Cohort
Patients with TNBC entered the initial tremelimumab monotherapy phase and were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
Eligible patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were given the option for retreatment with tremelimumab monotherapy or to be sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months or to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
BG002
PDAC Cohort
Patients with PDAC entered the initial tremelimumab monotherapy phase and were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
Eligible patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were given the option for retreatment with tremelimumab monotherapy or to be sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months or to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00032
BG00112
BG00220
BG00364
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG00112
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Patients With Confirmed Overall Response During Tremelimumab Monotherapy Phase
Objective response rate (ORR) during the initial tremelimumab monotherapy phase was assessed by the site Investigator using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) and was defined as the percentage of patients with a confirmed overall response of complete response (CR) or partial response (PR) and was based on all treated patients who had measurable disease at baseline (Day 1). 95% confidence intervals (CIs) were calculated using the Clopper Pearson method.
Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).
Posted
Number
95% Confidence Interval
Percentage of Patients
From baseline to 12 months in the tremelimumab monotherapy phase
ID
Title
Description
OG000
UBC - Tremelimumab Monotherapy
Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
OG001
TNBC - Tremelimumab Monotherapy
Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
OG002
PDAC - Tremelimumab Monotherapy
Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
Units
Counts
Participants
OG00032
OG00112
OG00220
Title
Denominators
Categories
Title
Measurements
OG00018.8(7.2 to 36.4)
OG0018.3(0.2 to 38.5)
OG0020.0(0.0 to 16.8)
Secondary
Median Duration of Response (DoR) During Tremelimumab Monotherapy Phase
DoR during the initial tremelimumab monotherapy phase was assessed by the site Investigator using RECIST 1.1 and was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression. The time of the initial response was defined as the latest of the dates contributing toward the first visit response of CR or PR. If a patient did not progress following a response, then their DoR was censored at the progression-free survival (PFS) censoring time. DoR was not defined for those patients who did not have documented response. Median DoR was calculated using the Kaplan-Meier technique.
Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).
Posted
Median
Inter-Quartile Range
Months
From baseline to 12 months in the tremelimumab monotherapy phase
ID
Title
Description
OG000
UBC - Tremelimumab Monotherapy
Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
OG001
TNBC - Tremelimumab Monotherapy
Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
Secondary
Disease Control Rate (DCR) During Tremelimumab Monotherapy Phase
DCR during the initial tremelimumab monotherapy phase was defined as the percentage of patients who had a best objective response (BoR) of CR or PR in the first 3 months (PDAC patients) or 4 months (UBC and TNBC patients) and 12 months (all patients), or who had demonstrated stable disease (SD) for a minimum interval of 3, 4 or 12 months following the start of study treatment. DCR was determined programmatically based on RECIST 1.1 using site Investigator data and all data up until the first progression event. 95% CIs were calculated using the Clopper Pearson method.
Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).
Posted
Number
95% Confidence Interval
Percentage of patients
From baseline to 12 months in the tremelimumab monotherapy phase
ID
Title
Description
OG000
UBC - Tremelimumab Monotherapy
Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
OG001
TNBC - Tremelimumab Monotherapy
Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
Secondary
Median PFS During Tremelimumab Monotherapy Phase
PFS during the initial tremelimumab monotherapy phase was assessed by the site Investigator using RECIST 1.1 and was defined as the time from the date of enrollment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from therapy or received another anticancer therapy prior to progression. Progression events that did not occur within 3 months (PDAC patients) or 4 months (UBC/TNBC patients) of the last evaluable assessment (or first dose) were censored. Median PFS was calculated using the Kaplan-Meier technique.
Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).
Posted
Median
Inter-Quartile Range
Months
From baseline to 12 months in the tremelimumab monotherapy phase
ID
Title
Description
OG000
UBC - Tremelimumab Monotherapy
Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
OG001
TNBC - Tremelimumab Monotherapy
Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
Secondary
Best Objective Response (BoR) During Tremelimumab Monotherapy Phase
BoR during the initial tremelimumab monotherapy phase was calculated based on the overall visit responses from each RECIST 1.1 assessment and was defined as the best response a patient had during their time in the study (from CR, PR, SD, PD or not evaluable [NE]) obtained among all tumor assessment visits from baseline until end of treatment or determination of PD. The BoR was summarized by percentage of patients for each category (CR, PR, SD, PD, and NE).
Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).
Posted
Number
Percentage of Patients
From baseline to 12 months in the tremelimumab monotherapy phase
ID
Title
Description
OG000
UBC - Tremelimumab Monotherapy
Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
OG001
TNBC - Tremelimumab Monotherapy
Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
OG002
PDAC - Tremelimumab Monotherapy
Secondary
Median Overall Survival (OS) During Tremelimumab Monotherapy Phase
OS was defined as the time from the date of first dose until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. OS is presented from start of tremelimumab monotherapy phase and includes the retreatment phase if the patient entered the corresponding treatment phase.
Median OS was calculated using the Kaplan-Meier technique.
Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).
Posted
Median
95% Confidence Interval
Months
From baseline to final data cut-off date
ID
Title
Description
OG000
UBC - Tremelimumab Monotherapy
Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
OG001
TNBC - Tremelimumab Monotherapy
Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
OG002
PDAC - Tremelimumab Monotherapy
Secondary
Percentage of Patients With Confirmed Overall Response During Retreatment Phase
ORR was assessed by the site Investigator using RECIST 1.1 and was defined as the percentage of patients with a confirmed overall response of CR or PR and was based on all treated patients who had measurable disease at baseline (Day 1) and who sequenced to durvalumab monotherapy (MEDI treatment phase) or durvalumab + tremelimumab combination therapy (COMBO treatment phase). 95% CIs were calculated using the Clopper Pearson method.
Analysis was performed on the MEDI and COMBO analysis sets (all patients who were treated with tremelimumab, received at least 1 dose of durvalumab monotherapy or durvalumab + tremelimumab combination therapy as applicable, and who had a baseline tumor assessment prior to dosing).
Posted
Number
95% Confidence Interval
Percentage of Patients
From baseline to 12 months in retreatment phase
ID
Title
Description
OG000
UBC - COMBO
Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.
OG001
TNBC - COMBO
Eligible TNBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.
Secondary
Median DoR During Retreatment Phase
DoR during the retreatment phase was assessed by the site Investigator using RECIST 1.1 and was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression. The time of the initial response was defined as the latest of the dates contributing toward the first visit response of CR or PR. If a patient did not progress following a response, then their DoR was censored at the PFS censoring time. DoR was not defined for those patients who did not have documented response. Median DoR was calculated using the Kaplan-Meier technique.
Analysis was performed on the MEDI and COMBO analysis sets (all patients who were treated with tremelimumab, received at least 1 dose of durvalumab monotherapy or durvalumab + tremelimumab combination therapy as applicable, and who had a baseline tumor assessment prior to dosing).
Posted
Median
Inter-Quartile Range
Months
From baseline to 12 months in retreatment phase
ID
Title
Description
OG000
UBC - COMBO
Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.
OG001
TNBC - COMBO
Secondary
DCR During Retreatment Phase
DCR during the retreatment phase was defined as the percentage of patients who had a BoR of CR or PR in the first 3 months (PDAC patients) or 4 months (UBC and TNBC patients) or who had demonstrated SD for a minimum interval of 3 or 4 months following the start of study treatment. DCR was determined programmatically based on RECIST 1.1 using site Investigator data and all data up until the first progression event. 95% CIs were calculated using the Clopper Pearson method.
Analysis was performed on the MEDI and COMBO analysis sets (all patients who were treated with tremelimumab, received at least 1 dose of durvalumab monotherapy or durvalumab + tremelimumab combination therapy as applicable, and who had a baseline tumor assessment prior to dosing).
Posted
Number
95% Confidence Interval
Percentage of Patients
From baseline to 4 months in retreatment phase
ID
Title
Description
OG000
UBC - COMBO
Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.
OG001
TNBC - COMBO
Eligible TNBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.
Secondary
Median PFS During Retreatment Phase
PFS during the retreatment phase was assessed by the site Investigator using RECIST 1.1 and defined as the time from the date of enrollment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from therapy or received another anticancer therapy prior to progression.
Progression events that did not occur within 3 months (PDAC patients) or 4 months (UBC/TNBC patients) of the last evaluable assessment (or first dose) were censored. Median PFS was calculated using the Kaplan-Meier technique.
Analysis was performed on the MEDI and COMBO analysis sets (all patients who were treated with tremelimumab, received at least 1 dose of durvalumab monotherapy or durvalumab + tremelimumab combination therapy as applicable, and who had a baseline tumor assessment prior to dosing).
Posted
Median
Inter-Quartile Range
Months
From baseline to 12 months in retreatment phase
ID
Title
Description
OG000
UBC - COMBO
Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.
OG001
TNBC - COMBO
Secondary
BoR During Retreatment Phase
BoR during the retreatment phase was calculated based on the overall visit responses from each RECIST 1.1 assessment and was defined as the best response a patient had during their time in the study (from CR, PR, SD, PD or NE) obtained among all tumor assessment visits from baseline until end of treatment or determination of PD. The BoR was summarized by percentage of patients for each category (CR, PR, SD, PD, and NE).
Analysis was performed on the MEDI and COMBO analysis sets (all patients who were treated with tremelimumab, received at least 1 dose of durvalumab monotherapy or durvalumab + tremelimumab combination therapy as applicable, and who had a baseline tumor assessment prior to dosing).
Posted
Number
Percentage of Patients
From baseline to 12 months in retreatment phase
ID
Title
Description
OG000
UBC - COMBO
Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.
OG001
TNBC - COMBO
Eligible TNBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.
Secondary
Median OS During Retreatment Phase
OS during the retreatment phase was defined as the time from the date of first dose until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
Analysis was performed on the MEDI and COMBO analysis sets (all patients who were treated with tremelimumab, received at least 1 dose of durvalumab monotherapy or durvalumab + tremelimumab combination therapy as applicable, and who had a baseline tumor assessment prior to dosing).
Posted
Median
95% Confidence Interval
Months
From baseline in retreatment phase to final data cut-off date
ID
Title
Description
OG000
UBC - COMBO
Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.
OG001
TNBC - COMBO
Eligible TNBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.
Time Frame
Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
UBC- Tremelimumab Monotherapy
Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
13
32
18
32
30
32
EG001
TNBC - Tremelimumab Monotherapy
Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
4
12
4
12
10
12
EG002
PDAC- Tremelimumab Monotherapy
Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
12
20
11
20
19
20
EG003
UBC - COMBO
Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.
4
7
3
7
7
7
EG004
TNBC - COMBO
Eligible TNBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.
2
5
2
5
5
5
EG005
PDAC - COMBO
Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.
4
4
3
4
4
4
EG006
UBC- MEDI
Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
4
4
1
4
4
4
EG007
PDAC - MEDI
Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
1
1
0
1
1
1
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected1 at risk
Hypophysitis
Endocrine disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected20 at risk
EG003
Autoimmune colitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0003 events3 affected32 at risk
EG0010 events0 affected12 at risk
EG0022 events1 affected20 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0004 events4 affected32 at risk
EG0010 events0 affected12 at risk
EG0023 events3 affected20 at risk
EG003
Diarrhoea haemorrhagic
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Duodenal obstruction
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected20 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Asthenia
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Euthanasia
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected20 at risk
EG003
Malaise
General disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Pyrexia
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected20 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected20 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected20 at risk
EG003
Kidney infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Meningitis aseptic
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Peritonitis bacterial
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected20 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected20 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0012 events2 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Neuritis
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected20 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected20 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0009 events7 affected32 at risk
EG0011 events1 affected12 at risk
EG0023 events2 affected20 at risk
EG0032 events2 affected7 at risk
EG0041 events1 affected5 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected1 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 21.0
Systematic Assessment
EG0003 events3 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0012 events2 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected12 at risk
EG0022 events2 affected20 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0004 events4 affected32 at risk
EG0012 events2 affected12 at risk
EG0026 events6 affected20 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0012 events2 affected12 at risk
EG0022 events2 affected20 at risk
EG003
Anal inflammation
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0011 events1 affected12 at risk
EG0021 events1 affected20 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0004 events4 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0009 events9 affected32 at risk
EG0015 events5 affected12 at risk
EG0023 events3 affected20 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0009 events8 affected32 at risk
EG0013 events2 affected12 at risk
EG0027 events4 affected20 at risk
EG003
Diarrhoea haemorrhagic
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0004 events3 affected32 at risk
EG0011 events1 affected12 at risk
EG0021 events1 affected20 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG00013 events11 affected32 at risk
EG0011 events1 affected12 at risk
EG0024 events4 affected20 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0005 events4 affected32 at risk
EG0012 events2 affected12 at risk
EG0022 events2 affected20 at risk
EG003
Asthenia
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected20 at risk
EG003
Face oedema
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Fatigue
General disorders
MedDRA 21.0
Systematic Assessment
EG00020 events15 affected32 at risk
EG0011 events1 affected12 at risk
EG0026 events6 affected20 at risk
EG003
Influenza like illness
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Malaise
General disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Oedema
General disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Oedema peripheral
General disorders
MedDRA 21.0
Systematic Assessment
EG0004 events4 affected32 at risk
EG0010 events0 affected12 at risk
EG0022 events2 affected20 at risk
EG003
Pyrexia
General disorders
MedDRA 21.0
Systematic Assessment
EG0004 events4 affected32 at risk
EG0013 events2 affected12 at risk
EG0022 events2 affected20 at risk
EG003
Catheter site infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Oral infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Paronychia
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0004 events4 affected32 at risk
EG0012 events2 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Wound infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Radiation skin injury
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected12 at risk
EG0023 events3 affected20 at risk
EG003
Amylase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0004 events2 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected12 at risk
EG0022 events2 affected20 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected20 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected12 at risk
EG0023 events2 affected20 at risk
EG003
Lipase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0004 events3 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Weight decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0004 events4 affected32 at risk
EG0010 events0 affected12 at risk
EG0022 events2 affected20 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0009 events7 affected32 at risk
EG0012 events2 affected12 at risk
EG0025 events5 affected20 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0004 events4 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0006 events6 affected32 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected20 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected20 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0003 events2 affected32 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected20 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0007 events5 affected32 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected20 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0004 events3 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0012 events2 affected12 at risk
EG0023 events3 affected20 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0005 events4 affected32 at risk
EG0010 events0 affected12 at risk
EG0023 events3 affected20 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0003 events3 affected32 at risk
EG0011 events1 affected12 at risk
EG0021 events1 affected20 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Headache
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0003 events3 affected32 at risk
EG0012 events2 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected20 at risk
EG003
Depression
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected12 at risk
EG0022 events2 affected20 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0003 events3 affected32 at risk
EG0012 events2 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Bladder spasm
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0003 events3 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Urinary tract pain
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0009 events8 affected32 at risk
EG0011 events1 affected12 at risk
EG0021 events1 affected20 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0002 events1 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0005 events4 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Laryngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Laryngospasm
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0013 events3 affected12 at risk
EG0022 events1 affected20 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0012 events2 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected20 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0005 events5 affected32 at risk
EG0010 events0 affected12 at risk
EG0022 events1 affected20 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0009 events8 affected32 at risk
EG0015 events5 affected12 at risk
EG0027 events7 affected20 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0003 events2 affected32 at risk
EG0012 events2 affected12 at risk
EG0026 events5 affected20 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0003 events2 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Embolism
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Hot flush
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Hypertension
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Hypotension
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Vascular fragility
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected20 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Publication of any or all of the results of the Research by the PI requires prior written consent of the Sponsor.
Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
Units
Counts
Participants
OG00032
OG00112
OG00220
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)DoR was not estimable in this cohort
OG00112.9(12.9 to 12.9)
OG002NA(NA to NA)DoR was not estimable in this cohort
OG002
PDAC - Tremelimumab Monotherapy
Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
Units
Counts
Participants
OG00032
OG00112
OG00220
Title
Denominators
Categories
DCR at 3 or 4 months
Title
Measurements
OG00025.0(11.46 to 43.40)
OG0018.3(0.21 to 38.48)
OG0020.0(0.00 to 16.84)
DCR at 12 months
Title
Measurements
OG00021.9(9.28 to 39.97)
OG0018.3(0.21 to 38.48)
OG0020.0(0.00 to 16.84)
OG002
PDAC - Tremelimumab Monotherapy
Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
Units
Counts
Participants
OG00032
OG00112
OG00220
Title
Denominators
Categories
Title
Measurements
OG0002.63(1.77 to NA)The upper limit was not estimable in this cohort.
OG0013.58(1.40 to 4.04)
OG0021.77(1.38 to 2.92)
Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
Units
Counts
Participants
OG00032
OG00112
OG00220
Title
Denominators
Categories
CR
Title
Measurements
OG0006.3
OG0010.0
OG0020.0
PR
Title
Measurements
OG00012.5
OG0018.3
OG0020.0
SD
Title
Measurements
OG0009.4
OG0010.0
OG0020.0
PD
Title
Measurements
OG00068.8
OG00191.7
OG00290.0
NE
Title
Measurements
OG0003.1
OG0010.0
OG00210.0
Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.
Units
Counts
Participants
OG00032
OG00112
OG00220
Title
Denominators
Categories
Title
Measurements
OG00010.32(5.91 to 24.61)
OG00112.88(2.53 to NA)Upper limit was not estimable in this cohort.
OG0023.98(2.83 to 5.13)
OG002
PDAC - COMBO
Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.
OG003
UBC- MEDI
Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
OG004
PDAC - MEDI
Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
Units
Counts
Participants
OG0007
OG0015
OG0024
OG0034
OG0041
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 41.0)
OG0010.0(0.0 to 52.2)
OG0020.0(0.0 to 60.2)
OG00325.0(0.6 to 80.6)
OG0040.0(0.0 to 97.5)
Eligible TNBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.
OG002
PDAC - COMBO
Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.
OG003
UBC- MEDI
Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
OG004
PDAC - MEDI
Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
Units
Counts
Participants
OG0007
OG0015
OG0024
OG0034
OG0041
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)No DoR data were available for this cohort.
OG001NA(NA to NA)No DoR data were available for this cohort.
OG002NA(NA to NA)No DoR data were available for this cohort.
OG0037.3(7.3 to 7.3)
OG004NA(NA to NA)DoR was not estimable in this cohort
OG002
PDAC - COMBO
Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.
OG003
UBC- MEDI
Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
OG004
PDAC - MEDI
Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
Units
Counts
Participants
OG0007
OG0015
OG0024
OG0034
OG0041
Title
Denominators
Categories
Title
Measurements
OG00028.6(3.67 to 70.96)
OG00120.0(0.51 to 71.64)
OG00225.0(0.63 to 80.59)
OG00325.0(0.63 to 80.59)
OG0040.0(0.00 to 97.50)
Eligible TNBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.
OG002
PDAC - COMBO
Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.
OG003
UBC- MEDI
Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
OG004
PDAC - MEDI
Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
Units
Counts
Participants
OG0007
OG0015
OG0024
OG0034
OG0041
Title
Denominators
Categories
Title
Measurements
OG0002.83(1.81 to 3.65)
OG0010.99(0.92 to NA)Upper limit was not estimable in this cohort.
OG0022.86(1.87 to 3.52)
OG0032.86(1.81 to 6.62)
OG0041.84(1.84 to 1.84)
OG002
PDAC - COMBO
Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.
OG003
UBC- MEDI
Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
OG004
PDAC - MEDI
Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
Units
Counts
Participants
OG0007
OG0015
OG0024
OG0034
OG0041
Title
Denominators
Categories
CR
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG0030.0
OG0040.0
PR
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
SD
Title
Measurements
OG00014.3
OG00120.0
OG0020.0
OG003
PD
Title
Measurements
OG00071.4
OG00180.0
OG002100.0
OG003
NE
Title
Measurements
OG00014.3
OG0010.0
OG0020.0
OG003
OG002
PDAC - COMBO
Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.
OG003
UBC- MEDI
Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
OG004
PDAC - MEDI
Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.
Units
Counts
Participants
OG0007
OG0015
OG0024
OG0034
OG0041
Title
Denominators
Categories
Title
Measurements
OG00011.86(5.91 to NA)Median and upper limit was not estimable in this cohort.
OG00133.05(9.69 to 33.05)
OG0027.18(3.98 to 18.76)
OG00316.53(7.56 to 32.39)
OG0044.14(NA to NA)Lower and upper limits were not estimable in this cohort.