A Phase 1/2, Open-label Study to Evaluate the Safety and... | NCT02118337 | Trialant
NCT02118337
Sponsor
MedImmune LLC
Status
Completed
Last Update Posted
Jun 1, 2021Actual
Enrollment
97Actual
Phase
Phase 1Phase 2
Conditions
Select Advanced Malignancies
Kidney Cancer
Clear Cell Renal Cell Carcinoma
Interventions
MEDI0680
Durvalumab
Nivolumab
Countries
United States
Australia
Canada
France
Netherlands
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02118337
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D6020C00001
Secondary IDs
Not provided
Brief Title
A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination With Durvalumab Versus Nivolumab Monotherapy in Participants With Select Advanced Malignancies
Official Title
A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination With Durvalumab Versus Nivolumab Monotherapy in Subjects With Select Advanced Malignancies
Acronym
Not provided
Organization
MedImmune LLCINDUSTRY
Status Module
Record Verification Date
May 2021
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
May 19, 2014Actual
Primary Completion Date
Mar 17, 2020Actual
Completion Date
Mar 17, 2020Actual
First Submitted Date
Apr 11, 2014
First Submission Date that Met QC Criteria
Apr 16, 2014
First Posted Date
Apr 21, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 17, 2021
Results First Submitted that Met QC Criteria
May 6, 2021
Results First Posted Date
Jun 1, 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
May 6, 2021
Last Update Posted Date
Jun 1, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
MedImmune LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
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
To evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination with Durvalumab versus Nivolumab Monotherapy in Participants with Select Advanced Malignancies.
Detailed Description
This is a multicenter, open-label, Phase 1/2 study to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of MEDI0680 in combination with durvalumab or nivolumab monotherapy in adult immunotherapy-naïve participants with selected advanced malignancies.
Conditions Module
Conditions
Select Advanced Malignancies
Kidney Cancer
Clear Cell Renal Cell Carcinoma
Keywords
select advanced malignancies,
kidney cancer,
clear cell renal cell carcinoma
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
97Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MEDI0680 0.1 mg/kg + Durvalumab 3 mg/kg
Experimental
Participants in dose-escalation phase will receive IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.
Biological: MEDI0680
Biological: Durvalumab
MEDI0680 0.1 mg/kg + Durvalumab 10 mg
Experimental
Participants in dose-escalation phase will receive IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
Biological: MEDI0680
Biological: Durvalumab
MEDI0680 0.5 mg/kg + Durvalumab 10 mg
Experimental
Participants in dose-escalation phase will receive IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
Biological: MEDI0680
Biological: Durvalumab
MEDI0680 2.5 mg/kg + Durvalumab 10 mg
Experimental
Participants in dose-escalation phase will receive IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
Biological: MEDI0680
Biological: Durvalumab
MEDI0680 10 mg/kg + Durvalumab 10 mg
Experimental
Participants in dose-escalation phase will receive IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MEDI0680
Biological
Participants will receive IV infusion of MEDI0680 0.1 or 0.5 or 2.5 or 10 or 20 mg/kg Q2W in dose-escalation phase and 20 mg/kg Q2W in dose-expansion phase.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose-escalation Phase
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase
Number of participants in dose-escalation phase with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters are defined as any abnormal finding during analysis of serum chemistry, hematology, coagulation, and urine.
Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAES in Dose-escalation Phase
Number of participants in dose-escalation phase with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs is defined as any abnormal finding in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate). Abnormal physical examination findings are defined as any abnormal finding in the following body systems: head and neck, respiratory, cardiovascular, gastrointestinal, urogenital, musculoskeletal, neurological, psychiatric, dermatological, hematologic/lymphatic, and endocrine systems, and weight.
Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs in Dose-escalation Phase
Secondary Outcomes
Measure
Description
Time Frame
Best Overall Response (BOR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase
The BOR includes CR, PR, stable disease (SD), progressive disease (PD), and non-evaluable (NE) based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. The PD is defined at least 20% decrease in the sum of diameters of target lesions (compared to baseline) and/or new lesion. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. The NE is defined as either when no or only a subset of lesion measurements are made at an assessment.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Must be 18 years or older
Eastern Cooperative Oncology Group performance status of 0-1
Adequate organ function
At least 1 prior line of therapy
Exclusion Criteria:
Concurrent enrollment in another clinical study, unless in follow-up period or it is an observational study
Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
Voss MH, Azad AA, Hansen AR, Gray JE, Welsh SJ, Song X, Kuziora M, Meinecke L, Blando J, Achour I, Wang Y, Walcott FL, Oosting SF. A Randomized Phase II Study of MEDI0680 in Combination with Durvalumab versus Nivolumab Monotherapy in Patients with Advanced or Metastatic Clear-cell Renal Cell Carcinoma. Clin Cancer Res. 2022 Jul 15;28(14):3032-3041. doi: 10.1158/1078-0432.CCR-21-4115.
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.
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 study is conducted in Australia, Canada, Europe and the USA.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
MEDI0680 0.1 mg/kg + Durvalumab 3 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.
FG001
MEDI0680 0.1 mg/kg + Durvalumab 10 mg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
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
Mar 29, 2017
Mar 17, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
South Korea
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel 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
Biological: MEDI0680
Biological: Durvalumab
MEDI0680 20 mg/kg + Durvalumab 10 mg
Experimental
Participants in dose-escalation phase will receive IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
Biological: MEDI0680
Biological: Durvalumab
MEDI0680 20 mg/kg
Experimental
Participants in dose-expansion phase will receive IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Biological: MEDI0680
MEDI0680 20 mg/kg + Durvalumab 750 mg
Experimental
Participants in dose-expansion phase will receive IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Biological: MEDI0680
Biological: Durvalumab
Nivolumab 240 mg
Active Comparator
Participants in dose-expansion phase will receive IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Biological: Nivolumab
MEDI0680 0.1 mg/kg + Durvalumab 10 mg
MEDI0680 0.1 mg/kg + Durvalumab 3 mg/kg
MEDI0680 0.5 mg/kg + Durvalumab 10 mg
MEDI0680 10 mg/kg + Durvalumab 10 mg
MEDI0680 2.5 mg/kg + Durvalumab 10 mg
MEDI0680 20 mg/kg
MEDI0680 20 mg/kg + Durvalumab 10 mg
MEDI0680 20 mg/kg + Durvalumab 750 mg
AMP-514
Durvalumab
Biological
Participants will receive IV infusion of durvalumab 3 and 10 mg Q2W in dose-escalation phase and 750 mg Q2W in dose-expansion phase.
MEDI0680 0.1 mg/kg + Durvalumab 10 mg
MEDI0680 0.1 mg/kg + Durvalumab 3 mg/kg
MEDI0680 0.5 mg/kg + Durvalumab 10 mg
MEDI0680 10 mg/kg + Durvalumab 10 mg
MEDI0680 2.5 mg/kg + Durvalumab 10 mg
MEDI0680 20 mg/kg + Durvalumab 10 mg
MEDI0680 20 mg/kg + Durvalumab 750 mg
Nivolumab
Biological
Participants will receive IV infusion of nivolumab 240 mg Q2W in dose-expansion phase.
Nivolumab 240 mg
Number of participants in dose-escalation phase with abnormal ECG parameters reported as TEAEs are reported.
Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Objective Response Rate (ORR) Based on Investigator-assessed Response Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Dose-expansion Phase
The ORR is defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression in-between.
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
Disease Control Rate (DCR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase
The DCR is defined as a BOR of confirmed CR, confirmed PR, or SD based on RECIST v1.1. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. The DCR at >= 8 weeks and >=24 weeks are reported.
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
Time to Response (TTR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase
The TTR is defined as the time from the first dose of treatment until the first documentation of a subsequently confirmed OR (confirmed CR or confirmed PR) based on RECIST v1.1. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The TTR was estimated using Kaplan-Meier method.
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
Duration of Response (DoR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase
The DoR is defined as the duration from the first documentation of OR (confirmed CR or confirmed PR) to the first documented disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The PD is defined at least 20% decrease in the sum of diameters of target lesions (compared to baseline) and/or new lesion. The DoR was estimated using Kaplan-Meier method.
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
Progression Free Survival (PFS) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase
The PFS is defined as the time from the start of study treatment until the first documentation of disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. The PFS was estimated using Kaplan-Meier method.
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
Overall Survival in Dose-expansion Phase
The OS is defined as the time from the start of study treatment until death due to any cause. The OS was estimated using Kaplan-Meier method.
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
BOR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase
The BOR includes CR, PR, SD, PD, and NE per Modified RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. The PD is defined at least 20% decrease in the sum of diameters of target lesions (compared to baseline) and/or new lesion. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. The NE is defined as either when no or only a subset of lesion measurements are made at an assessment.
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
ORR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase
The ORR is defined as best overall response of confirmed CR or confirmed PR based on modified RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression in-between.
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
DCR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase
The DCR is defined as a BOR of confirmed CR, confirmed PR, or SD based on modified RECIST v1.1. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. The DCR at >= 8 weeks and >=24 weeks are reported.
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
TTR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase
The TTR is defined as the time from the first dose of treatment until the first documentation of a subsequently confirmed OR (confirmed CR or confirmed PR) based on modified RECIST v1.1. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The TTR was estimated using Kaplan-Meier method.
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
DoR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase
The DoR is defined as the duration from the first documentation of OR (confirmed CR or confirmed PR) to the first documented disease progression based on modified RECIST v1.1 or death due to any cause, whichever occurred first. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The PD is defined at least 20% decrease in the sum of diameters of target lesions (compared to baseline) and/or new lesion. The DoR was estimated using Kaplan-Meier method.
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
PFS Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase
The PFS is defined as the time from the start of study treatment until the first documentation of disease progression based on modified RECIST v1.1 or death due to any cause, whichever occurred first. The PFS was estimated using Kaplan-Meier method.
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
OS in Dose-escalation Phase
The OS is defined as the time from the start of study treatment until death due to any cause. The OS was estimated using Kaplan-Meier method.
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
Number of Participants With TEAEs and TESAEs in Dose-expansion Phase
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase
Number of participants in dose-expansion phase with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of serum chemistry, hematology, coagulation, and urine.
Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Dose-expansion Phase
Number of participants in dose-expansion phase with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs is defined as any abnormal finding in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate). Abnormal physical examination findings are defined as any abnormal finding in the following body systems: head and neck, respiratory, cardiovascular, gastrointestinal, urogenital, musculoskeletal, neurological, psychiatric, dermatological, hematologic/lymphatic, and endocrine systems, and weight.
Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Number of Participants With Abnormal ECGs Reported as TEAEs in Dose-expansion Phase
Number of participants in dose-expansion phase with abnormal ECG parameters reported as TEAEs are reported.
Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Antitumor Activity of MEDI0680 and Durvalumab Versus Nivolumab Monotherapy in Immunotherapy-Naïve Participants With Advanced or Metastatic Clear-cell Renal Cell Carcinoma (ccRCC) Based on Blinded Independent Central Review (BICR) in Dose-expansion Phase
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
Percent Change From Baseline in Tumor Size in Dose-escalation Phase (Based on Investigator-assessed Modified RECIST v1.1) and Dose-expansion Phase (Based on Investigator-assessed RECIST v1.1)
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant for dose-escalation phase and approximately 5 years 10 months for dose-expansion phase)
Serum Concentration of MEDI0680 in Dose-escalation and Dose-expansion Phases
Serum concentration of MEDI0680 were assessed using parameters Cmin (pre-dose) and Cmax (end of infusion), where Cmin was trough concentration and Cmax was peak concentration.
Pre-dose and end of infusion on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1
Serum Concentration of Durvalumab in Dose-escalation and Dose-expansion Phases
Serum concentration of durvalumab were assessed using parameters Cmin (pre-dose) and Cmax (end of infusion), where Cmin was trough concentration and Cmax was peak concentration.
Pre-dose and end of infusion on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1
Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0680 in Dose-escalation and Dose-expansion Phases
Number of participants with positive ADAs to MEDI0680 are reported. Persistent positive is defined as positive at >= 2 post-baseline assessments (with >= 16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at >=2 post-baseline assessments (with <16 weeks between first and last positive).
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 5 Day 1, Cycle 8 Day 1, Cycle 11 Day 1, 90 and 180 days post end of treatment (approximately 5 years and 10 months)
Number of Participants With Positive ADA to Durvalumab in Dose-escalation and Dose-expansion Phases
Number of participants with positive ADA to durvalumab are reported. Persistent positive is defined as positive at >= 2 post-baseline assessments (with >= 16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at >=2 post-baseline assessments (with <16 weeks between first and last positive).
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 5 Day 1, Cycle 8 Day 1, Cycle 11 Day 1, 90 and 180 days post end of treatment (approximately 5 years and 10 months)
ORR for Participants With Programmed Cell Death Ligand 1 (PD-L1) Status Positive and Negative in Dose-expansion Phase
ORR for participants with PD-L1 status positive and negative are reported. The ORR is defined as best overall response of confirmed CR or confirmed PR based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression in-between.
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
FG002
MEDI0680 0.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
FG003
MEDI0680 2.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
FG004
MEDI0680 10 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
FG005
MEDI0680 20 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
FG006
MEDI0680 20 mg/kg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
FG007
MEDI0680 20 mg/kg + Durvalumab 750 mg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
FG008
Nivolumab 240 mg
Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
FG0004 subjects
FG0015 subjects
FG0023 subjects
FG0033 subjects
FG0049 subjects
FG0056 subjects
FG0064 subjects
FG00742 subjects
FG00821 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
NOT COMPLETED
FG0004 subjects
FG0015 subjects
FG0023 subjects
FG0033 subjects
FG0049 subjects
FG0056 subjects
FG0064 subjects
FG00742 subjects
FG00821 subjects
Type
Comment
Reasons
Other
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0042 subjects
FG0053 subjects
FG0061 subjects
FG00728 subjects
FG00815 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0013 subjects
FG0022 subjects
FG0031 subjects
FG004
Death
FG0002 subjects
FG0012 subjects
FG0021 subjects
FG0032 subjects
FG004
As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
MEDI0680 0.1 mg/kg + Durvalumab 3 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg Q2W for up to 12 months.
BG001
MEDI0680 0.1 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
BG002
MEDI0680 0.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
BG003
MEDI0680 2.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
BG004
MEDI0680 10 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
BG005
MEDI0680 20 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
BG006
MEDI0680 20 mg/kg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
BG007
MEDI0680 20 mg/kg + Durvalumab 750 mg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
BG008
Nivolumab 240 mg
Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG0015
BG0023
BG0033
BG0049
BG0056
BG0064
BG00742
BG00821
BG00997
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00060.5± 12.6
BG00167.4± 8.4
BG00252.3± 17.9
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0013
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
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose-escalation Phase
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.
Posted
Count of Participants
Participants
Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
ID
Title
Description
OG000
MEDI0680 0.1 mg/kg + Durvalumab 3 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.
OG001
MEDI0680 0.1 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG002
MEDI0680 0.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG003
MEDI0680 2.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG004
MEDI0680 10 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG005
MEDI0680 20 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
Units
Counts
Participants
OG0004
OG0015
OG0023
OG003
Title
Denominators
Categories
Any TEAE
Title
Measurements
OG0004
OG0015
OG0023
OG003
Primary
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase
Number of participants in dose-escalation phase with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters are defined as any abnormal finding during analysis of serum chemistry, hematology, coagulation, and urine.
As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.
Posted
Count of Participants
Participants
Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
ID
Title
Description
OG000
MEDI0680 0.1 mg/kg + Durvalumab 3 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.
OG001
MEDI0680 0.1 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG002
MEDI0680 0.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
Primary
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAES in Dose-escalation Phase
Number of participants in dose-escalation phase with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs is defined as any abnormal finding in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate). Abnormal physical examination findings are defined as any abnormal finding in the following body systems: head and neck, respiratory, cardiovascular, gastrointestinal, urogenital, musculoskeletal, neurological, psychiatric, dermatological, hematologic/lymphatic, and endocrine systems, and weight.
As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.
Posted
Count of Participants
Participants
Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
ID
Title
Description
OG000
MEDI0680 0.1 mg/kg + Durvalumab 3 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.
OG001
MEDI0680 0.1 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
Primary
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs in Dose-escalation Phase
Number of participants in dose-escalation phase with abnormal ECG parameters reported as TEAEs are reported.
As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.
Posted
Count of Participants
Participants
Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
ID
Title
Description
OG000
MEDI0680 0.1 mg/kg + Durvalumab 3 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.
OG001
MEDI0680 0.1 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG002
MEDI0680 0.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG003
Primary
Objective Response Rate (ORR) Based on Investigator-assessed Response Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Dose-expansion Phase
The ORR is defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression in-between.
As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.
Posted
Number
95% Confidence Interval
Percentage of participants
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
ID
Title
Description
OG000
MEDI0680 20 mg/kg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OG001
MEDI0680 20 mg/kg + Durvalumab 750 mg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Secondary
Best Overall Response (BOR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase
The BOR includes CR, PR, stable disease (SD), progressive disease (PD), and non-evaluable (NE) based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. The PD is defined at least 20% decrease in the sum of diameters of target lesions (compared to baseline) and/or new lesion. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. The NE is defined as either when no or only a subset of lesion measurements are made at an assessment.
As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.
Posted
Count of Participants
Participants
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
ID
Title
Description
OG000
MEDI0680 20 mg/kg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OG001
MEDI0680 20 mg/kg + Durvalumab 750 mg
Secondary
Disease Control Rate (DCR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase
The DCR is defined as a BOR of confirmed CR, confirmed PR, or SD based on RECIST v1.1. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. The DCR at >= 8 weeks and >=24 weeks are reported.
As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.
Posted
Number
95% Confidence Interval
Percentage of participants
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
ID
Title
Description
OG000
MEDI0680 20 mg/kg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OG001
MEDI0680 20 mg/kg + Durvalumab 750 mg
Secondary
Time to Response (TTR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase
The TTR is defined as the time from the first dose of treatment until the first documentation of a subsequently confirmed OR (confirmed CR or confirmed PR) based on RECIST v1.1. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The TTR was estimated using Kaplan-Meier method.
As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received. The TTR was analyzed for those participants who achieved OR.
Posted
Median
95% Confidence Interval
Months
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
ID
Title
Description
OG000
MEDI0680 20 mg/kg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OG001
MEDI0680 20 mg/kg + Durvalumab 750 mg
Secondary
Duration of Response (DoR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase
The DoR is defined as the duration from the first documentation of OR (confirmed CR or confirmed PR) to the first documented disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The PD is defined at least 20% decrease in the sum of diameters of target lesions (compared to baseline) and/or new lesion. The DoR was estimated using Kaplan-Meier method.
As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received. The DoR was analyzed for those participants who achieved OR.
Posted
Median
95% Confidence Interval
Months
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
ID
Title
Description
OG000
MEDI0680 20 mg/kg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OG001
Secondary
Progression Free Survival (PFS) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase
The PFS is defined as the time from the start of study treatment until the first documentation of disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. The PFS was estimated using Kaplan-Meier method.
As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.
Posted
Median
95% Confidence Interval
Months
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
ID
Title
Description
OG000
MEDI0680 20 mg/kg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OG001
MEDI0680 20 mg/kg + Durvalumab 750 mg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OG002
Secondary
Overall Survival in Dose-expansion Phase
The OS is defined as the time from the start of study treatment until death due to any cause. The OS was estimated using Kaplan-Meier method.
As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.
Posted
Median
95% Confidence Interval
Months
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
ID
Title
Description
OG000
MEDI0680 20 mg/kg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OG001
MEDI0680 20 mg/kg + Durvalumab 750 mg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OG002
Nivolumab 240 mg
Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Secondary
BOR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase
The BOR includes CR, PR, SD, PD, and NE per Modified RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. The PD is defined at least 20% decrease in the sum of diameters of target lesions (compared to baseline) and/or new lesion. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. The NE is defined as either when no or only a subset of lesion measurements are made at an assessment.
As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.
Posted
Count of Participants
Participants
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
ID
Title
Description
OG000
MEDI0680 0.1 mg/kg + Durvalumab 3 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.
OG001
MEDI0680 0.1 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
Secondary
ORR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase
The ORR is defined as best overall response of confirmed CR or confirmed PR based on modified RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression in-between.
As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.
Posted
Number
95% Confidence Interval
Percentage of participants
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
ID
Title
Description
OG000
MEDI0680 0.1 mg/kg + Durvalumab 3 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.
OG001
MEDI0680 0.1 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG002
MEDI0680 0.5 mg/kg + Durvalumab 10 mg
Secondary
DCR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase
The DCR is defined as a BOR of confirmed CR, confirmed PR, or SD based on modified RECIST v1.1. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. The DCR at >= 8 weeks and >=24 weeks are reported.
As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.
Posted
Number
95% Confidence Interval
Percentage of participants
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
ID
Title
Description
OG000
MEDI0680 0.1 mg/kg + Durvalumab 3 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.
OG001
MEDI0680 0.1 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
Secondary
TTR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase
The TTR is defined as the time from the first dose of treatment until the first documentation of a subsequently confirmed OR (confirmed CR or confirmed PR) based on modified RECIST v1.1. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The TTR was estimated using Kaplan-Meier method.
As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received. The TTR was analyzed for those participants who achieved OR.
Posted
Median
95% Confidence Interval
Months
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
ID
Title
Description
OG000
MEDI0680 0.1 mg/kg + Durvalumab 3 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.
OG001
MEDI0680 0.1 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
Secondary
DoR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase
The DoR is defined as the duration from the first documentation of OR (confirmed CR or confirmed PR) to the first documented disease progression based on modified RECIST v1.1 or death due to any cause, whichever occurred first. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The PD is defined at least 20% decrease in the sum of diameters of target lesions (compared to baseline) and/or new lesion. The DoR was estimated using Kaplan-Meier method.
AAs-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received. The DoR was analyzed for those participants who achieved OR.
Posted
Median
95% Confidence Interval
Months
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
ID
Title
Description
OG000
MEDI0680 0.1 mg/kg + Durvalumab 3 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.
OG001
MEDI0680 0.1 mg/kg + Durvalumab 10 mg
Secondary
PFS Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase
The PFS is defined as the time from the start of study treatment until the first documentation of disease progression based on modified RECIST v1.1 or death due to any cause, whichever occurred first. The PFS was estimated using Kaplan-Meier method.
As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.
Posted
Median
95% Confidence Interval
Months
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
ID
Title
Description
OG000
MEDI0680 0.1 mg/kg + Durvalumab 3 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.
OG001
MEDI0680 0.1 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG002
MEDI0680 0.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
Secondary
OS in Dose-escalation Phase
The OS is defined as the time from the start of study treatment until death due to any cause. The OS was estimated using Kaplan-Meier method.
As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.
Posted
Median
95% Confidence Interval
Months
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
ID
Title
Description
OG000
MEDI0680 0.1 mg/kg + Durvalumab 3 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.
OG001
MEDI0680 0.1 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG002
MEDI0680 0.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG003
Secondary
Number of Participants With TEAEs and TESAEs in Dose-expansion Phase
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.
Posted
Count of Participants
Participants
Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
ID
Title
Description
OG000
MEDI0680 20 mg/kg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OG001
MEDI0680 20 mg/kg + Durvalumab 750 mg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Secondary
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase
Number of participants in dose-expansion phase with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of serum chemistry, hematology, coagulation, and urine.
As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.
Posted
Count of Participants
Participants
Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
ID
Title
Description
OG000
MEDI0680 20 mg/kg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OG001
MEDI0680 20 mg/kg + Durvalumab 750 mg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OG002
Secondary
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Dose-expansion Phase
Number of participants in dose-expansion phase with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs is defined as any abnormal finding in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate). Abnormal physical examination findings are defined as any abnormal finding in the following body systems: head and neck, respiratory, cardiovascular, gastrointestinal, urogenital, musculoskeletal, neurological, psychiatric, dermatological, hematologic/lymphatic, and endocrine systems, and weight.
As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.
Posted
Count of Participants
Participants
Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
ID
Title
Description
OG000
MEDI0680 20 mg/kg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OG001
MEDI0680 20 mg/kg + Durvalumab 750 mg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Secondary
Number of Participants With Abnormal ECGs Reported as TEAEs in Dose-expansion Phase
Number of participants in dose-expansion phase with abnormal ECG parameters reported as TEAEs are reported.
As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.
Posted
Count of Participants
Participants
Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
ID
Title
Description
OG000
MEDI0680 20 mg/kg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OG001
MEDI0680 20 mg/kg + Durvalumab 750 mg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OG002
Nivolumab 240 mg
Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Secondary
Antitumor Activity of MEDI0680 and Durvalumab Versus Nivolumab Monotherapy in Immunotherapy-Naïve Participants With Advanced or Metastatic Clear-cell Renal Cell Carcinoma (ccRCC) Based on Blinded Independent Central Review (BICR) in Dose-expansion Phase
The study did not meet its primary endpoint of demonstrating superior antitumor effect of MEDI0680 in combination with durvalumab versus nivolumab monotherapy in immunotherapy-naïve participants with advanced or metastatic ccRCC as assessed by the investigator using RECIST v1.1. Therefore, the decision was made not to perform the BICR analysis for antitumor activity and hence data were not collected.
Posted
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
ID
Title
Description
OG000
MEDI0680 20 mg/kg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OG001
MEDI0680 20 mg/kg + Durvalumab 750 mg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OG002
Secondary
Percent Change From Baseline in Tumor Size in Dose-escalation Phase (Based on Investigator-assessed Modified RECIST v1.1) and Dose-expansion Phase (Based on Investigator-assessed RECIST v1.1)
Per the Statistical Analysis Plan, the data for percent change from baseline in target lesion was to be presented using Spider plot analysis. Hence, numeric data were not collected for this outcome measure.
Posted
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant for dose-escalation phase and approximately 5 years 10 months for dose-expansion phase)
ID
Title
Description
OG000
MEDI0680 0.1 mg/kg + Durvalumab 3 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.
OG001
MEDI0680 0.1 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG002
MEDI0680 0.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
Secondary
Serum Concentration of MEDI0680 in Dose-escalation and Dose-expansion Phases
Serum concentration of MEDI0680 were assessed using parameters Cmin (pre-dose) and Cmax (end of infusion), where Cmin was trough concentration and Cmax was peak concentration.
As-treated population included those participants who received MEDI0680 and grouped according to actual treatment received. The "Number of participants Analyzed" denotes the number of participants who had quantifiable and calculable serum samples at the specified time points.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Pre-dose and end of infusion on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1
ID
Title
Description
OG000
MEDI0680 0.1 mg/kg + Durvalumab 3 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.
OG001
MEDI0680 0.1 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG002
MEDI0680 0.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
Secondary
Serum Concentration of Durvalumab in Dose-escalation and Dose-expansion Phases
Serum concentration of durvalumab were assessed using parameters Cmin (pre-dose) and Cmax (end of infusion), where Cmin was trough concentration and Cmax was peak concentration.
As-treated population included those participants who received durvalumab and grouped according to actual treatment received. The "Number of participants Analyzed" denotes the number of participants who had quantifiable and calculable serum samples at the specified time points.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Pre-dose and end of infusion on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1
ID
Title
Description
OG000
MEDI0680 0.1 mg/kg + Durvalumab 3 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.
OG001
MEDI0680 0.1 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG002
MEDI0680 0.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
Secondary
Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0680 in Dose-escalation and Dose-expansion Phases
Number of participants with positive ADAs to MEDI0680 are reported. Persistent positive is defined as positive at >= 2 post-baseline assessments (with >= 16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at >=2 post-baseline assessments (with <16 weeks between first and last positive).
As-treated population included those participants who received MEDI0680 and grouped according to actual treatment received. The "Number of participants Analyzed" denotes the number of participants evaluated for this outcome measure.
Posted
Count of Participants
Participants
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 5 Day 1, Cycle 8 Day 1, Cycle 11 Day 1, 90 and 180 days post end of treatment (approximately 5 years and 10 months)
ID
Title
Description
OG000
MEDI0680 0.1 mg/kg + Durvalumab 3 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.
OG001
MEDI0680 0.1 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
Secondary
Number of Participants With Positive ADA to Durvalumab in Dose-escalation and Dose-expansion Phases
Number of participants with positive ADA to durvalumab are reported. Persistent positive is defined as positive at >= 2 post-baseline assessments (with >= 16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at >=2 post-baseline assessments (with <16 weeks between first and last positive).
As-treated population included those participants who received durvalumab and grouped according to actual treatment received. The "Number of participants Analyzed" denotes the number of participants evaluated for this outcome measure.
Posted
Count of Participants
Participants
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 5 Day 1, Cycle 8 Day 1, Cycle 11 Day 1, 90 and 180 days post end of treatment (approximately 5 years and 10 months)
ID
Title
Description
OG000
MEDI0680 0.1 mg/kg + Durvalumab 3 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.
OG001
MEDI0680 0.1 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
Secondary
ORR for Participants With Programmed Cell Death Ligand 1 (PD-L1) Status Positive and Negative in Dose-expansion Phase
ORR for participants with PD-L1 status positive and negative are reported. The ORR is defined as best overall response of confirmed CR or confirmed PR based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression in-between.
As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received. Participants with PD-L1 positive (> 1% tumor cell membrane or > 1% immune cell staining) and PD-L1 negative (<= 1% tumor cell membrane and <= 1% immune cell staining) were evaluated for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of Participants
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
ID
Title
Description
OG000
MEDI0680 20 mg/kg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OG001
MEDI0680 20 mg/kg + Durvalumab 750 mg
Time Frame
Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
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
MEDI0680 0.1 mg/kg + Durvalumab 3 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg Q2W for up to 12 months.
2
4
1
4
4
4
EG001
MEDI0680 0.1 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
2
5
1
5
5
5
EG002
MEDI0680 0.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
1
3
1
3
3
3
EG003
MEDI0680 2.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
2
3
2
3
3
3
EG004
MEDI0680 10 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
5
9
6
9
9
9
EG005
MEDI0680 20 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
1
6
0
6
6
6
EG006
MEDI0680 20 mg/kg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
2
4
3
4
4
4
EG007
MEDI0680 20 mg/kg + Durvalumab 750 mg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
9
42
22
42
41
42
EG008
Nivolumab 240 mg
Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
4
21
13
21
20
21
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial fibrillation
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected42 at risk
EG0080 events0 affected21 at risk
Pericardial effusion
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypercalcaemia of malignancy
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Eye pain
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Colitis microscopic
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Immune-mediated enterocolitis
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Immune-mediated pancreatitis
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Chest pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Chills
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hepatic haemorrhage
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hepatocellular injury
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Device related infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Spinal cord infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Electrocardiogram qt prolonged
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Transaminases increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Metastases to bone
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Cerebrospinal fluid leakage
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Encephalitis autoimmune
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Intracranial mass
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Seizure
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Diabetic foot
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0022 events1 affected3 at risk
EG0031 events1 affected3 at risk
EG0045 events3 affected9 at risk
EG0050 events0 affected6 at risk
EG0062 events1 affected4 at risk
EG00710 events6 affected42 at risk
EG00829 events5 affected21 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Ear disorder
Ear and labyrinth disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypercalcaemia of malignancy
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0013 events2 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Asthenopia
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Diplopia
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dry eye
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Episcleritis
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Eye irritation
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Eye pain
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Eye pruritus
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Eyelid ptosis
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Keratitis
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Periorbital swelling
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Photophobia
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Vision blurred
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Visual impairment
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal mass
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0002 events1 affected4 at risk
EG0012 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0012 events2 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0003 events1 affected4 at risk
EG0013 events2 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Duodenitis
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Faeces soft
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0002 events1 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Immune-mediated enterocolitis
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0003 events1 affected4 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Oral disorder
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Asthenia
General disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Axillary pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Catheter site pruritus
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Chest pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Chills
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Cyst
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Facial pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 22.1
Systematic Assessment
EG0002 events1 affected4 at risk
EG0013 events3 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Feeling hot
General disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Gait disturbance
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Inflammation
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Influenza like illness
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Infusion site pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Malaise
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Mass
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Nodule
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Oedema
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 22.1
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0022 events2 affected3 at risk
EG003
Secretion discharge
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Temperature intolerance
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hepatocellular injury
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Liver disorder
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Allergy to arthropod sting
Immune system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Contrast media reaction
Immune system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Abscess
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Ear infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0003 events2 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Eye infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Gastrointestinal fungal infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Influenza
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Kidney infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Lower respiratory tract infection bacterial
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Oral fungal infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Otitis media
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Viral infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Anaemia postoperative
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Chemical burn of skin
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Cystitis radiation
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Post procedural oedema
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Radiation skin injury
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Scratch
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Amylase decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Amylase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0003 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Blood creatine increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Blood fibrinogen decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Blood glucose increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Blood iron decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Blood testosterone decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Blood urea increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Blood urine present
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Eastern cooperative oncology group performance status worsened
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Electrocardiogram qt prolonged
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Electrocardiogram t wave abnormal
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
General physical condition abnormal
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Influenza b virus test positive
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Lipase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0023 events1 affected3 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Platelet count increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Procalcitonin increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Serum ferritin decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Tri-iodothyronine free abnormal
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Weight increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
White blood cell count increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Acidosis
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0002 events1 affected4 at risk
EG0011 events1 affected5 at risk
EG0022 events2 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Metabolic alkalosis
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0012 events2 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Bone lesion
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0003 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Tendon disorder
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Oesophageal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Head discomfort
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hyposmia
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Sensory disturbance
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Tremor
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Depression
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Mood altered
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Renal tubular necrosis
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract pain
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Urine abnormality
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Breast mass
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Galactorrhoea
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pruritus genital
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Laryngeal obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Oropharyngeal discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Painful respiration
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Paranasal sinus hypersecretion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Rales
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0002 events1 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Diabetic foot
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Macule
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Perioral dermatitis
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0022 events1 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Scar pain
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Vitiligo
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Xeroderma
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Aortic occlusion
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Embolism
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Flushing
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hot flush
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Vena cava embolism
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 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
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on going studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D007674
Kidney Diseases
D014570
Urologic Diseases
D052801
Male Urogenital Diseases
D000230
Adenocarcinoma
D002277
Carcinoma
D009375
Neoplasms, Glandular and Epithelial
D009370
Neoplasms by Histologic Type
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000613593
durvalumab
D000077594
Nivolumab
Ancestor Terms
ID
Term
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
2 subjects
FG0052 subjects
FG0061 subjects
FG0074 subjects
FG0082 subjects
5 subjects
FG0051 subjects
FG0062 subjects
FG0079 subjects
FG0084 subjects
62.3
± 11.6
BG00462.1± 11.0
BG00569.5± 9.9
BG00664.8± 14.2
BG00761.0± 9.8
BG00859.1± 10.5
BG00961.5± 10.6
1
BG0031
BG0045
BG0052
BG0061
BG0079
BG0086
BG00929
Male
BG0003
BG0012
BG0022
BG0032
BG0044
BG0054
BG0063
BG00733
BG00815
BG00968
1
BG0030
BG0042
BG0050
BG0060
BG0071
BG0081
BG0096
Not Hispanic or Latino
BG0003
BG0015
BG0022
BG0032
BG0047
BG0056
BG0064
BG00740
BG00820
BG00989
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0031
BG0040
BG0050
BG0060
BG0071
BG0080
BG0092
0
BG0030
BG0040
BG0050
BG0061
BG0070
BG0080
BG0091
Asian
BG0000
BG0011
BG0020
BG0030
BG0040
BG0050
BG0060
BG0071
BG0080
BG0092
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0041
BG0050
BG0060
BG0070
BG0080
BG0091
Black or African American
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0083
BG0093
White
BG0004
BG0014
BG0023
BG0032
BG0048
BG0056
BG0063
BG00734
BG00816
BG00980
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0031
BG0040
BG0050
BG0060
BG0077
BG0082
BG00910
3
OG0049
OG0056
3
OG0049
OG0056
Any TESAE
Title
Measurements
OG0001
OG0011
OG0021
OG0032
OG0046
OG0050
OG003
MEDI0680 2.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG004
MEDI0680 10 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG005
MEDI0680 20 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
Units
Counts
Participants
OG0004
OG0015
OG0023
OG0033
OG0049
OG0056
Title
Denominators
Categories
Anaemia
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0043
OG0050
Iron deficiency anaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Leukocytosis
Title
Measurements
OG0001
OG0010
OG0020
OG003
Lymphopenia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Activated partial thromboplastin time prolonged
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood fibrinogen decreased
Title
Measurements
OG0001
OG0010
OG0020
OG003
International normalized ratio
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphocyte count decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Prothrombin time prolonged
Title
Measurements
OG0000
OG0010
OG0020
OG003
White blood cell count decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Alanine aminotransferase increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Amylase increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Aspartate aminotransferase increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood alkaline phosphatase increased
Title
Measurements
OG0001
OG0010
OG0021
OG003
Blood creatinine increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood phosphorus decreased
Title
Measurements
OG0001
OG0010
OG0020
OG003
Blood urea increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Gamma glutamyltransferase increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lipase increased
Title
Measurements
OG0001
OG0010
OG0021
OG003
Hypercalcaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hyperglycaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hyperkalaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypermagnesaemia
Title
Measurements
OG0000
OG0010
OG0021
OG003
Hyperuricaemia
Title
Measurements
OG0001
OG0010
OG0020
OG003
Hypoalbuminaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypokalaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypomagnesaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hyponatraemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
proteinuria
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
MEDI0680 0.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG003
MEDI0680 2.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG004
MEDI0680 10 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG005
MEDI0680 20 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
Units
Counts
Participants
OG0004
OG0015
OG0023
OG0033
OG0049
OG0056
Title
Denominators
Categories
Atrial fibrillation
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
Palpitations
Title
Measurements
OG0001
OG0010
OG0020
OG003
Sinus tachycardia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Tachycardia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Pyrexia
Title
Measurements
OG0000
OG0010
OG0022
OG003
Weight decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypertension
Title
Measurements
OG0001
OG0010
OG0020
OG003
MEDI0680 2.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG004
MEDI0680 10 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG005
MEDI0680 20 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
Units
Counts
Participants
OG0004
OG0015
OG0023
OG0033
OG0049
OG0056
Title
Denominators
Categories
Palpitations
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
Atrial fibrillation
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sinus tachycardia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Pericardial effusion
Title
Measurements
OG0000
OG0010
OG0020
OG003
Tachycardia
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
Nivolumab 240 mg
Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Units
Counts
Participants
OG0004
OG00142
OG00221
Title
Denominators
Categories
Title
Measurements
OG0000(0 to 60.2)
OG00116.7(7.0 to 31.4)
OG00223.8(8.2 to 47.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Fisher Exact
0.5494
Rate difference
-23.8
2-Sided
95
-72.8
31.1
Superiority
OG001
OG002
Fisher Exact
0.5130
Rate difference
-7.1
2-Sided
95
-33.6
20.0
Superiority
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OG002
Nivolumab 240 mg
Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Units
Counts
Participants
OG0004
OG00142
OG00221
Title
Denominators
Categories
CR
Title
Measurements
OG0000
OG0012
OG0020
PR
Title
Measurements
OG0000
OG0015
OG0025
SD
Title
Measurements
OG0003
OG00117
OG0028
PD
Title
Measurements
OG0001
OG00117
OG0026
NE
Title
Measurements
OG0000
OG0011
OG0022
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OG002
Nivolumab 240 mg
Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Units
Counts
Participants
OG0004
OG00142
OG00221
Title
Denominators
Categories
DCR at >=8 weeks
Title
Measurements
OG00075.0(19.4 to 99.4)
OG00157.1(41.0 to 72.3)
OG00261.9(38.4 to 81.9)
DCR at >=24 weeks
Title
Measurements
OG00050.0(6.8 to 93.2)
OG00138.1(23.6 to 54.4)
OG00238.1(18.1 to 61.6)
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OG002
Nivolumab 240 mg
Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Units
Counts
Participants
OG0000
OG0017
OG0025
Title
Denominators
Categories
Title
Measurements
OG0011.8(1.7 to 9.1)
OG0021.8(1.6 to 7.3)
MEDI0680 20 mg/kg + Durvalumab 750 mg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OG002
Nivolumab 240 mg
Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Units
Counts
Participants
OG0000
OG0017
OG0025
Title
Denominators
Categories
Title
Measurements
OG001NA(12.9 to NA)Median and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
OG002NA(4.4 to NA)Median and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
Nivolumab 240 mg
Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Units
Counts
Participants
OG0004
OG00142
OG00221
Title
Denominators
Categories
Title
Measurements
OG0005.5(2.2 to 7.4)
OG0013.6(2.0 to 5.5)
OG0023.6(1.9 to 13.0)
Units
Counts
Participants
OG0004
OG00142
OG00221
Title
Denominators
Categories
Title
Measurements
OG00019.9(7.0 to 19.9)
OG001NA(NA to NA)Median and lower and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
OG002NA(12.0 to NA)Median and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
OG002
MEDI0680 0.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG003
MEDI0680 2.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG004
MEDI0680 10 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG005
MEDI0680 20 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
Units
Counts
Participants
OG0004
OG0015
OG0023
OG0033
OG0049
OG0056
Title
Denominators
Categories
CR
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
PR
Title
Measurements
OG0002
OG0010
OG0021
OG003
SD
Title
Measurements
OG0001
OG0011
OG0020
OG003
PD
Title
Measurements
OG0001
OG0013
OG0022
OG003
NE
Title
Measurements
OG0000
OG0011
OG0020
OG003
Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG003
MEDI0680 2.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG004
MEDI0680 10 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG005
MEDI0680 20 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
Units
Counts
Participants
OG0004
OG0015
OG0023
OG0033
OG0049
OG0056
Title
Denominators
Categories
Title
Measurements
OG00050.0(6.8 to 93.2)
OG0010(0 to 52.2)
OG00233.3(0.8 to 90.6)
OG0030(0 to 70.8)
OG00444.4(13.7 to 78.8)
OG00566.7(22.3 to 95.7)
OG002
MEDI0680 0.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG003
MEDI0680 2.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG004
MEDI0680 10 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG005
MEDI0680 20 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
Units
Counts
Participants
OG0004
OG0015
OG0023
OG0033
OG0049
OG0056
Title
Denominators
Categories
DCR at >= 8 weeks
Title
Measurements
OG00075.0(19.4 to 99.4)
OG00120.0(0.5 to 71.6)
OG00233.3(0.8 to 90.6)
OG00333.3(0.8 to 90.6)
OG00466.7(29.9 to 92.5)
OG00583.3(35.9 to 99.6)
DCR at >= 24 weeks
Title
Measurements
OG00050.0(6.8 to 93.2)
OG0010(0 to 52.2)
OG00233.3(0.8 to 90.6)
OG003
OG002
MEDI0680 0.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG003
MEDI0680 2.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG004
MEDI0680 10 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG005
MEDI0680 20 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
Units
Counts
Participants
OG0002
OG0010
OG0021
OG0030
OG0044
OG0054
Title
Denominators
Categories
Title
Measurements
OG0002.6(1.6 to 3.5)
OG0023.4(NA to NA)Lower and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
OG0043.5(1.6 to 3.5)
OG0053.2(1.7 to 10.8)
Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG002
MEDI0680 0.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG003
MEDI0680 2.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG004
MEDI0680 10 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG005
MEDI0680 20 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
Units
Counts
Participants
OG0002
OG0010
OG0021
OG0030
OG0044
OG0054
Title
Denominators
Categories
Title
Measurements
OG00016.8(NA to NA)Lower and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
OG002NA(NA to NA)Median and lower and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
OG0047.4(5.6 to NA)Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
OG005NA(5.6 to NA)Median and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
OG003
MEDI0680 2.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG004
MEDI0680 10 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG005
MEDI0680 20 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
Units
Counts
Participants
OG0004
OG0015
OG0023
OG0033
OG0049
OG0056
Title
Denominators
Categories
Title
Measurements
OG00020.2(1.6 to 20.2)
OG0011.7(1.6 to 3.5)
OG0021.6(1.6 to NA)Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
OG0031.8(1.5 to 3.4)
OG0047.0(1.6 to NA)Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
OG00523.4(1.8 to NA)Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
MEDI0680 2.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG004
MEDI0680 10 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG005
MEDI0680 20 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
Units
Counts
Participants
OG0004
OG0015
OG0023
OG0033
OG0049
OG0056
Title
Denominators
Categories
Title
Measurements
OG00016.3(3.6 to NA)Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
OG001NA(4.2 to NA)Median and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
OG00214.7(NA to NA)Lower and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
OG0037.9(1.5 to 7.9)
OG00412.8(3.1 to NA)Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
OG005NA(29.6 to NA)Median and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
OG002
Nivolumab 240 mg
Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Units
Counts
Participants
OG0004
OG00142
OG00221
Title
Denominators
Categories
Any TEAE
Title
Measurements
OG0004
OG00142
OG00220
Any TESAE
Title
Measurements
OG0003
OG00122
OG00213
Nivolumab 240 mg
Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Units
Counts
Participants
OG0004
OG00142
OG00221
Title
Denominators
Categories
Anaemia
Title
Measurements
OG0001
OG0016
OG0025
Neutropenia
Title
Measurements
OG0000
OG0011
OG0020
Blood iron decreased
Title
Measurements
OG0000
OG0010
OG0021
Lymphocyte count decreased
Title
Measurements
OG0000
OG0010
OG0021
Neutrophil count decreased
Title
Measurements
OG0001
OG0011
OG0020
Platelet count decreased
Title
Measurements
OG0000
OG0010
OG0021
Platelet count increased
Title
Measurements
OG0000
OG0010
OG0021
Prothrombin time prolonged
Title
Measurements
OG0000
OG0010
OG0021
White blood cell count increased
Title
Measurements
OG0000
OG0010
OG0021
Alanine aminotransferase increased
Title
Measurements
OG0001
OG0011
OG0023
Amylase decreased
Title
Measurements
OG0000
OG0010
OG0021
Amylase increased
Title
Measurements
OG0001
OG0013
OG0023
Aspartate aminotransferase increased
Title
Measurements
OG0001
OG0012
OG0023
Blood alkaline phosphatase increased
Title
Measurements
OG0000
OG0010
OG0021
Blood bilirubin increased
Title
Measurements
OG0000
OG0010
OG0021
Blood creatine increased
Title
Measurements
OG0001
OG0011
OG0020
Blood creatine phosphokinase increased
Title
Measurements
OG0000
OG0011
OG0020
Blood creatinine increased
Title
Measurements
OG0001
OG0014
OG0023
Blood glucose increased
Title
Measurements
OG0000
OG0010
OG0021
Blood triglycerides increased
Title
Measurements
OG0000
OG0011
OG0021
C-reactive protein increased
Title
Measurements
OG0000
OG0011
OG0021
Lipase increased
Title
Measurements
OG0001
OG0014
OG0022
Transaminases increased
Title
Measurements
OG0000
OG0011
OG0020
Hypercalcaemia
Title
Measurements
OG0000
OG0016
OG0022
Hyperglycaemia
Title
Measurements
OG0000
OG0011
OG0020
Hyperkalaemia
Title
Measurements
OG0000
OG0012
OG0022
Hypertriglyceridaemia
Title
Measurements
OG0000
OG0011
OG0020
Hypoalbuminaemia
Title
Measurements
OG0000
OG0012
OG0020
Hypocalcaemia
Title
Measurements
OG0000
OG0011
OG0020
Hypoglycaemia
Title
Measurements
OG0000
OG0011
OG0020
Hypokalaemia
Title
Measurements
OG0000
OG0015
OG0022
Hypomagnesaemia
Title
Measurements
OG0000
OG0014
OG0022
Hyponatraemia
Title
Measurements
OG0001
OG0013
OG0021
Hypophosphataemia
Title
Measurements
OG0000
OG0011
OG0023
Urine abnormality
Title
Measurements
OG0000
OG0011
OG0020
Blood thyroid stimulating hormone increased
Title
Measurements
OG0000
OG0012
OG0022
Blood urine present
Title
Measurements
OG0000
OG0010
OG0021
OG002
Nivolumab 240 mg
Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Units
Counts
Participants
OG0004
OG00142
OG00221
Title
Denominators
Categories
Atrial fibrillation
Title
Measurements
OG0000
OG0012
OG0021
Tachycardia
Title
Measurements
OG0000
OG0011
OG0020
Pyrexia
Title
Measurements
OG0002
OG0019
OG0022
Weight decreased
Title
Measurements
OG0000
OG0015
OG0020
Weight increased
Title
Measurements
OG0000
OG0013
OG0020
Hypoxia
Title
Measurements
OG0000
OG0011
OG0021
Hypertension
Title
Measurements
OG0001
OG0015
OG0020
Hypotension
Title
Measurements
OG0001
OG0012
OG0021
Units
Counts
Participants
OG0004
OG00142
OG00221
Title
Denominators
Categories
Angina pectoris
Title
Measurements
OG0001
OG0011
OG0020
Tachycardia
Title
Measurements
OG0000
OG0011
OG0020
Atrial fibrillation
Title
Measurements
OG0000
OG0012
OG0021
Cardiac failure congestive
Title
Measurements
OG0000
OG0010
OG0021
Nivolumab 240 mg
Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
MEDI0680 2.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG004
MEDI0680 10 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG005
MEDI0680 20 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG006
MEDI0680 20 mg/kg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OG007
MEDI0680 20 mg/kg + Durvalumab 750 mg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OG008
Nivolumab 240 mg
Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG003
MEDI0680 2.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG004
MEDI0680 10 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG005
MEDI0680 20 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG006
MEDI0680 20 mg/kg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OG007
MEDI0680 20 mg/kg + Durvalumab 750 mg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Units
Counts
Participants
OG0004
OG0015
OG0023
OG0033
OG0049
OG0056
OG0064
OG00740
Title
Denominators
Categories
Cmin at Cycle1 Day1
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0049
ParticipantsOG0056
ParticipantsOG0064
ParticipantsOG00740
Title
Measurements
OG000NA± NAThe sample was not quantifiable; therefore, not calculable.
OG001NA± NAThe sample was not quantifiable; therefore, not calculable.
OG002NA± NAThe sample was not quantifiable; therefore, not calculable.
OG003
Cmax at Cycle1 Day1
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0023
ParticipantsOG0033
Cmin at Cycle1 Day15
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cmax at Cycle1 Day15
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cmin at Cycle2 Day1
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0033
Cmax at Cycle2 Day1
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0033
OG003
MEDI0680 2.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG004
MEDI0680 10 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG005
MEDI0680 20 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG006
MEDI0680 20 mg/kg + Durvalumab 750 mg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Units
Counts
Participants
OG0004
OG0015
OG0023
OG0033
OG0049
OG0056
OG00641
Title
Denominators
Categories
Cmin at Cycle1 Day1
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0049
ParticipantsOG0056
ParticipantsOG00638
Title
Measurements
OG000NA± NAThe sample was not quantifiable; therefore, not calculable.
OG001NA± NAThe sample was not quantifiable; therefore, not calculable.
OG002NA± NAThe sample was not quantifiable; therefore, not calculable.
OG003
Cmax at Cycle1 Day1
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0023
ParticipantsOG0033
Cmin at Cycle1 Day15
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cmax at Cycle1 Day15
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cmin at Cycle2 Day1
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0033
Cmax at Cycle2 Day1
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0033
OG002
MEDI0680 0.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG003
MEDI0680 2.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG004
MEDI0680 10 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG005
MEDI0680 20 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG006
MEDI0680 20 mg/kg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OG007
MEDI0680 20 mg/kg + Durvalumab 750 mg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Units
Counts
Participants
OG0004
OG0015
OG0023
OG0033
OG0048
OG0056
OG0064
OG00739
Title
Denominators
Categories
ADA positive post-baseline
Title
Measurements
OG0002
OG0010
OG0022
OG0030
OG0040
OG0050
OG0060
OG0072
Persistent Positive
Title
Measurements
OG0002
OG0010
OG0022
OG003
Transient Positive
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
MEDI0680 0.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG003
MEDI0680 2.5 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG004
MEDI0680 10 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG005
MEDI0680 20 mg/kg + Durvalumab 10 mg
Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.
OG006
MEDI0680 20 mg/kg + Durvalumab 750 mg
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Units
Counts
Participants
OG0004
OG0015
OG0023
OG0033
OG0048
OG0056
OG00639
Title
Denominators
Categories
ADA positive post-baseline
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0062
Persistent Positive
Title
Measurements
OG0001
OG0010
OG0020
OG003
Transient Positive
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OG002
Nivolumab 240 mg
Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Units
Counts
Participants
OG0004
OG00142
OG00221
Title
Denominators
Categories
Participants with PD-L1 positive
ParticipantsOG0001
ParticipantsOG0015
ParticipantsOG0028
Title
Measurements
OG0000(0 to 97.5)
OG00140.0(5.3 to 85.3)
OG00237.5(8.5 to 75.5)
Participants with PD-L1 negative
ParticipantsOG0003
ParticipantsOG00137
ParticipantsOG00213
Title
Measurements
OG000
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected42 at risk
EG0081 events1 affected21 at risk
0 events
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3 at risk
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EG0060 events0 affected4 at risk
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3 at risk
EG0041 events1 affected9 at risk
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EG0080 events0 affected21 at risk
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3 at risk
EG0041 events1 affected9 at risk
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1 events
1 affected
3 at risk
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0 events
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3 at risk
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3 at risk
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3 at risk
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3 at risk
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0 affected
3 at risk
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0 affected
3 at risk
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0 events
0 affected
3 at risk
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EG0060 events0 affected4 at risk
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0 events
0 affected
3 at risk
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EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
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EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
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EG0081 events1 affected21 at risk
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0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
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EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected4 at risk
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EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
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EG0081 events1 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
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0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
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EG0060 events0 affected4 at risk
EG0071 events1 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
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EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
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EG0081 events1 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
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EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected4 at risk
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EG0080 events0 affected21 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0072 events1 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0072 events1 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
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EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
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0 affected
3 at risk
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0 affected
3 at risk
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EG0081 events1 affected21 at risk
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0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
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EG0072 events2 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
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0 affected
3 at risk
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EG0050 events0 affected6 at risk
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0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
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0 affected
3 at risk
EG0040 events0 affected9 at risk
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0 affected
3 at risk
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0 affected
3 at risk
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EG0081 events1 affected21 at risk
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0 affected
3 at risk
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0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
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EG0080 events0 affected21 at risk
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0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
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EG0080 events0 affected21 at risk
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0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
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EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
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0 events
0 affected
3 at risk
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0 affected
3 at risk
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0 affected
3 at risk
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0 affected
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0 affected
3 at risk
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1 events
1 affected
3 at risk
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0 affected
3 at risk
EG0041 events1 affected9 at risk
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3 at risk
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3 at risk
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EG0050 events0 affected6 at risk
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3 at risk
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0 affected
3 at risk
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0 affected
3 at risk
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0 affected
3 at risk
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3 at risk
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3 at risk
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3 at risk
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3 at risk
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0 affected
3 at risk
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0 affected
3 at risk
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EG0050 events0 affected6 at risk
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EG0080 events0 affected21 at risk
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0 affected
3 at risk
EG0040 events0 affected9 at risk
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EG0080 events0 affected21 at risk
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0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected4 at risk
EG0071 events1 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
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EG0081 events1 affected21 at risk
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0 affected
3 at risk
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EG0081 events1 affected21 at risk
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3 at risk
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3 at risk
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3 at risk
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3 at risk
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3 at risk
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3 at risk
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3 at risk
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3 at risk
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0 affected
3 at risk
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3 at risk
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3 at risk
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0 affected
3 at risk
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0 affected
3 at risk
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0 affected
3 at risk
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0 affected
3 at risk
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0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
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EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
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EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0052 events1 affected6 at risk
EG0060 events0 affected4 at risk
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0 events
0 affected
3 at risk
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0 events
0 affected
3 at risk
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0 affected
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0 affected
3 at risk
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0 affected
3 at risk
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0 affected
3 at risk
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0 events
0 affected
3 at risk
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0 affected
3 at risk
EG0041 events1 affected9 at risk
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EG0081 events1 affected21 at risk
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3 at risk
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3 at risk
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3 at risk
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1 events
1 affected
3 at risk
EG0040 events0 affected9 at risk
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EG00716 events12 affected42 at risk
EG0087 events6 affected21 at risk
0 events
0 affected
3 at risk
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EG0060 events0 affected4 at risk
EG0071 events1 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected42 at risk
EG0081 events1 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0072 events2 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected42 at risk
EG0082 events2 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0074 events1 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected4 at risk
EG0075 events5 affected42 at risk
EG0084 events4 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected42 at risk
EG0084 events1 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected4 at risk
EG0073 events3 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected42 at risk
EG0081 events1 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0072 events2 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected42 at risk
EG0080 events0 affected21 at risk
1 events
1 affected
3 at risk
EG00410 events5 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG00710 events7 affected42 at risk
EG0084 events3 affected21 at risk
1 events
1 affected
3 at risk
EG0044 events4 affected9 at risk
EG0052 events2 affected6 at risk
EG0060 events0 affected4 at risk
EG0079 events7 affected42 at risk
EG0084 events4 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0075 events2 affected42 at risk
EG0085 events4 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected42 at risk
EG0081 events1 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected42 at risk
EG0081 events1 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected6 at risk
EG0062 events1 affected4 at risk
EG0071 events1 affected42 at risk
EG0081 events1 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected42 at risk
EG0081 events1 affected21 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected42 at risk
EG0081 events1 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected42 at risk
EG0081 events1 affected21 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected9 at risk
EG0053 events1 affected6 at risk
EG0061 events1 affected4 at risk
EG0077 events5 affected42 at risk
EG0080 events0 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected4 at risk
EG0072 events2 affected42 at risk
EG0081 events1 affected21 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected42 at risk
EG0080 events0 affected21 at risk
0
OG0041
OG0050
0
OG0040
OG0050
0
OG0041
OG0050
0
OG0040
OG0051
0
OG0040
OG0051
0
OG0040
OG0051
0
OG0040
OG0051
0
OG0040
OG0051
0
OG0040
OG0051
0
OG0041
OG0050
0
OG0041
OG0051
0
OG0042
OG0050
0
OG0041
OG0050
0
OG0042
OG0051
0
OG0040
OG0050
0
OG0041
OG0050
0
OG0041
OG0050
0
OG0041
OG0050
0
OG0041
OG0051
0
OG0041
OG0050
0
OG0041
OG0050
0
OG0040
OG0050
0
OG0041
OG0050
0
OG0041
OG0050
0
OG0042
OG0050
0
OG0042
OG0050
0
OG0042
OG0051
0
OG0041
OG0050
0
OG0040
OG0050
0
OG0041
OG0050
0
OG0040
OG0051
0
OG0043
OG0051
0
OG0041
OG0051
0
OG0041
OG0051
0
OG0041
OG0050
0
OG0041
OG0050
0
OG0041
OG0050
0
OG0040
OG0051
0
OG0043
OG0054
1
OG0042
OG0051
1
OG0042
OG0051
1
OG0041
OG0050
0
(0 to 70.8)
OG00444.4(13.7 to 78.8)
OG00583.3(35.9 to 99.6)
NA
± NA
The sample was not quantifiable; therefore, not calculable.
OG004NA± NAThe sample was not quantifiable; therefore, not calculable.
OG005NA± NAThe sample was not quantifiable; therefore, not calculable.
OG006NA± NAThe sample was not quantifiable; therefore, not calculable.
OG007NA± NAThe sample was not quantifiable; therefore, not calculable.
ParticipantsOG0049
ParticipantsOG0054
ParticipantsOG0064
ParticipantsOG00738
Title
Measurements
OG0004.330± 26.18
OG0013.877± 54.68
OG00216.36± 26.46
OG00369.28± 24.76
OG004272.4± 24.62
OG005529.9± 29.84
OG006668.8± 21.04
OG007135.9± 4007
ParticipantsOG0048
ParticipantsOG0055
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0001.143± 22.70
OG0010.9937± 35.93
OG0024.428± 62.38
OG00318.67± 12.88
OG00446.87± 559.4
OG005205.8± 24.56
ParticipantsOG0048
ParticipantsOG0055
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0005.420± 21.61
OG0013.835± 25.30
OG00220.52± 26.26
OG00387.78± 20.69
OG004348.1± 27.78
OG005716.8± 26.72
ParticipantsOG0047
ParticipantsOG0056
ParticipantsOG0064
ParticipantsOG00736
Title
Measurements
OG0001.645± 49.08
OG0011.361± 38.07
OG0027.879± 52.74
OG00331.81± 4.480
OG004155.7± 24.20
OG005378.0± 17.95
OG006308.6± 30.45
OG007253.9± 52.11
ParticipantsOG0047
ParticipantsOG0056
ParticipantsOG0064
ParticipantsOG00734
Title
Measurements
OG0003.515± 145.9
OG0013.688± 80.17
OG00217.28± 56.32
OG00392.07± 17.72
OG004440.7± 28.18
OG005860.8± 13.82
OG006936.1± 24.91
OG007586.6± 63.42
NA
± NA
The sample was not quantifiable; therefore, not calculable.
OG004NA± NAThe sample was not quantifiable; therefore, not calculable.
OG005NA± NAThe sample was not quantifiable; therefore, not calculable.
OG006NA± NAThe sample was not quantifiable; therefore, not calculable.