Phase II Umbrella Study of Novel Anti-cancer Agents in Pa... | NCT03334617 | Trialant
NCT03334617
Sponsor
AstraZeneca
Status
Active, not recruiting
Last Update Posted
Oct 27, 2025Actual
Enrollment
528Actual
Phase
Phase 2
Conditions
Non-Small Cell Lung Cancer
Interventions
Durvalumab
Danvatirsen
Ceralasertib
Vistusertib
Olaparib
Oleclumab
Trastuzumab deruxtecan
Cediranib
Countries
United States
Austria
Canada
France
Germany
Israel
South Korea
Spain
Protocol Section
Identification Module
NCT ID
NCT03334617
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D6185C00001
Secondary IDs
ID
Type
Description
Link
138050
Registry Identifier
IND
2023-509004-15-00
Other Identifier
EU CT number
2017-002208-28
EudraCT Number
Brief Title
Phase II Umbrella Study of Novel Anti-cancer Agents in Participants With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy
Official Title
An Open-Label, Multi-Drug, Biomarker-Directed, Multi-Centre Phase II Umbrella Study in Patients With Non-Small Cell Lung Cancer, Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy (HUDSON).
Acronym
HUDSON
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
Oct 2025
Overall Recruitment Status or Expanded Access Status
Active, not recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 18, 2017Actual
Primary Completion Date
Sep 13, 2024Actual
Completion Date
Sep 11, 2026Estimated
First Submitted Date
Sep 22, 2017
First Submission Date that Met QC Criteria
Nov 3, 2017
First Posted Date
Nov 7, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Aug 27, 2025
Results First Submitted that Met QC Criteria
Oct 10, 2025
Results First Posted Date
Oct 27, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 10, 2025
Last Update Posted Date
Oct 27, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AstraZenecaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is an open-label, multi-centre, umbrella Phase II study in participants with metastatic NSCLC who have progressed on an anti-PD-1/PD-L1 containing therapy. This study is modular in design, allowing initial assessment of the efficacy, safety, and tolerability of multiple treatment arms.
Detailed Description
This is an open-label, multi-centre, umbrella Phase II study in participants with metastatic non-small cell lung cancer (NSCLC) who have progressed on an anti-programmed cell death-1/anti-programmed cell death ligand 1 (anti-PD-1/PD-L1) containing therapy. This study is modular in design, consisting of a number of treatment cohorts, allowing evaluation of the efficacy, safety, and tolerability of multiple treatment arms. There is currently no established therapy for participants who have received immune checkpoint inhibitors and platinum-doublet therapies, and novel treatments are urgently needed.
This protocol has a modular design, with the potential for future treatment arms to be added via protocol amendment.
Participants with detectable aberrations, mutation detected in a homologous recombination repair gene (HRRm) will receive IV infusion of durvalumab 1500 mg every 4 weeks (Q4W) in combination with oral olaparib 300 mg (2 × 150 mg) tablets twice a day (BD) until disease progression is confirmed.
Participants with detectable aberrations in liver kinase B1 (LKB1) will receive IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had anti-programmed cell death-1 (PD-1)/programmed cell death ligand 1 (PD-L1) containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (primary resistance; PRI) will receive IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (acquired resistance; ACQ) will receive IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Durvalumab
Drug
Participants will receive IV infusion of durvalumab as stated in arm description.
Percentage of Participants With Objective Response Per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1)
Objective response was defined as participants with a confirmed investigator-assessed response complete response (CR) or partial response (PR) based on RECIST v 1.1. The CR is defined as disappearance of all target (TL) and non-target lesions (NTL), and any pathological lymph node (whether target or nontarget) must have reduction in short axis to <10 mm. The PR is defined as at least a 30% decrease in the sum of the diameters of TLs, taking as reference the baseline sum diameters, as long as criteria for progressive disease (PD) are not met. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from date of first documentation. Percentage of participants with objective response was reported.
Baseline (<=28 days before treatment), then every 6 weeks for 24 weeks from Cycle 1 Day 1, then every 8 weeks (every 9 weeks in Module 6) until disease progression or 90 days after study drug discontinuation (approximately 2 years)
Secondary Outcomes
Measure
Description
Time Frame
Overall Survival (OS)
The OS is defined as the time from the first dose of any study drug until death due to any cause regardless of whether the participant withdraws from study treatment or receives subsequent cancer therapy. The overall survival was analyzed using the Kaplan-Meier method.
Every 3 months after safety follow-up visit (90 days after study drug discontinuation) until planned database lock for a module (either 12 months after last participant has started treatment or when 75% of participants died) (approximately up to 2 years)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
At least 18 years of age at the time of signing the informed consent form.
Participant must have histologically or cytologically confirmed metastatic or locally advanced and recurrent non-small-cell lung cancer (NSCLC) which is progressing.
Participants eligible for second- or later-line therapy, who must have received an anti-programmed cell death protein-1 (PD-1)/programmed death-ligand 1 (PD-L1) containing therapy and a platinum-doublet regimen for locally advanced or metastatic NSCLC either separately or in combination. Prior durvalumab is acceptable. The participant must have had disease progression on a prior line of anti-PD-1/PD-L1 therapy.
Eastern Cooperative Oncology Group/World Health Organization (ECOG/WHO) performance status of 0 to 1, and a minimum life expectancy of 12 weeks.
Participant must have at least 1 lesion that can be accurately measured. A previously irradiated lesion can be considered a target lesion if the lesion has clearly progressed.
Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal participants.
Exclusion Criteria:
Participants whose tumour samples have targetable alterations in epidermal growth factor receptor (EGFR) and/or anaplastic lymphoma kinase (ALK) at initial diagnosis are excluded. In addition, participants whose tumour samples are known to have targetable alterations in ROS1, BRAF, MET or RET, are to be excluded.
Active or prior documented autoimmune or inflammatory disorders.
Active infection including tuberculosis, hepatitis B (known positive hepatitis B virus [HBV] surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus (positive human immunodeficiency virus [HIV] 1/2 antibodies).
Female participant who are pregnant or breastfeeding, or male or female participants of reproductive potential who are not willing to employ effective birth control.
Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients, or history of severe hypersensitivity reactions to other monoclonal antibodies.
Participant has spinal cord compression or symptomatic brain metastases.
Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Participants may receive treatment with bisphosphonates or receptor activator of nuclear factor kappa-Î’ ligand (RANKL) inhibitors for the treatment of bone metastases.
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.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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.
Participants with detectable aberrations, mutation detected in a homologous recombination repair gene (HRRm) received IV infusion of durvalumab 1500 mg every 4 weeks (Q4W) in combination with oral olaparib 300 mg (2 × 150 mg) tablets twice a day (BD) until disease progression is confirmed.
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
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Oct 9, 2024
Aug 27, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is an open-label, multi-centre, umbrella Phase II study in participants with metastatic NSCLC who have progressed on an anti-PD-1/PD-L1 containing therapy. This study is modular in design, allowing initial assessment of the efficacy, safety, and tolerability of multiple treatment arms.
Within each module, there will be treatment cohorts.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) will receive IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants will receive AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) will receive IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants will receive AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who are ataxia telangiectasia mutated (ATM)-deficiecy will receive oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants will receive IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD in each cycle between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) will receive oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants will receive IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) will receive oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants will receive IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with detectable genetic amplifications in rapamycin-insensitive companion of mechanistic target of rapamycin complex-2 (RICTOR) will receive IV infusion of durvalumab 1500 mg Q4W in combination with oral vistusertib 125 mg tablets BD on an intermittent dosing schedule of 2 days on, 5 days off, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with high expression of cluster of differentiation 73 (CD73) will receive IV infusion of oleclumab 3000 mg every 2 weeks (Q2W) for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) will receive IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) will receive IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours express human epidermal growth factor receptor 2 (HER2) mutations will receive IV infusion of trastuzumab deruxtecan (T-DXd) 5.4 mg/kg every 3 weeks (Q3W) in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours harbour selected HER2 mutations will receive IV infusion of T-DXd 5.4 mg/kg Q3W in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) will receive IV infusion of durvalumab 1500 mg Q4W in combination with oral cediranib (AZD2171) 20 mg tablets daily for 5 days on, 2 days off (starting on Cycle 1 Day 1 of durvalumab), until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Drug: Durvalumab
Drug: Cediranib
Module 8 Cohort A.8.ATM: Ceralasertib 240 mg
Experimental
Participants who are ATM-deficient or with detectable aberrations in the ATM gene will receive oral ceralasertib (AZD6738) 240 mg tablets BD from Day 1 to Day 14 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) will receive IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) will receive IV infusion of durvalumab 1500 mg Q4W plus oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, will receive oral ceralasertib (AZD6738) 160 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants will receive IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 160 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, will receive oral ceralasertib (AZD6738) 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants will receive IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Drug: Durvalumab
Drug: Ceralasertib
Module 11 Cohort C.11.240: AZD6738 240 mg
Experimental
Participants, independent of their molecular aberration status, will receive oral AZD6738 tablet 240 mg for 7 days (Days 1 to 7) in each 28-day cycle until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
The PFS is defined as time from first dose of any study drug until date of objective disease progression (PD) per RECIST v1.1 or death by any cause, regardless of whether the participant withdraws from study therapy or receives another anti-cancer therapy prior to progression. The PD is defined as a >= 20% increase in the sum of diameters of TLs and an absolute increase of >= 5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters, or unequivocal progression of existing NTL. The PFS was analyzed using the Kaplan-Meier method
Every 3 months after safety follow-up visit (90 days after study drug discontinuation) until planned database lock for a module (either 12 months after last participant has started treatment or when 75% of participants died) (approximately up to 2 years)
Best Percentage Change From Baseline in Tumour Size
The best percentage change in tumour size from baseline i.e. the maximum reduction from baseline or the minimum increase from baseline in absence of a reduction from baseline based on all post baseline assessments is reported. Tumour size is sum of the longest diameters (or short axis measurements for lymph nodes) of the target lesions. Baseline was defined as last evaluable assessment prior to starting treatment. The percentage change in target lesion tumour size at each week X for which data are available was obtained for each participant taking the difference between the sum of the target lesions at each week X and the sum of the target lesions at baseline divided by the sum of the target lesions at baseline multiplied by 100 (i.e. [week X - baseline]/baseline * 100).
Baseline (<=28 days prior to starting treatment) then every 6 weeks for first 24 weeks relative to the date of first dose/combination therapy (Cycle 1 Day 1), then every 8 weeks (except Module 6)/9 weeks (Module 6) thereafter (approximately up to 2 years)
Percentage of Participants With Disease Control (DC) Per RECIST v1.1
Module (M) 1, 4, 5, 6, 7, 8, 9, 11: DCR at 12 and 24 weeks is defined as percentage of participants who have best overall response (BoR) of CR or PR in first 13/25 weeks, respectively, post start of any study drug or with duration of SD for at least 11/23 weeks, respectively, after start of any study drug. M2, M3, M10: DCR at 12 and 24 weeks is defined as percentage of participants who have BoR of CR or PR within first 100 days (M2, M3, M10) or 184 days (M2, M3, M10) after start of any study drug, or have SD lasting at least 86 days (M2)/82 days (M3, M10), respectively, or 170 days (M2)/166 days (M3, M10), respectively, post start of any study drug. CR is defined as disappearance of all TL and NTLs, and any pathological lymph node (whether target or nontarget) must have reduction in short axis to <10 mm. PR is defined as at least 30% decrease in sum of diameters of TLs, taking as reference baseline sum diameters, as long as criteria for PD are not met.
At 12 and 24 weeks after the start of study drug
Duration of Response (DoR) Per RECIST v1.1
The DoR is defined as the time from the first documented confirmed response (CR or PR) until the first documented PD or death in the absence of disease progression. The CR is defined as disappearance of all TLs and NTLs, and any pathological lymph node (whether target or nontarget) must have reduction in short axis to <10 mm. The PR is defined as at least a 30 decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters, as long as criteria for PD are not met. The PD is defined as a >=20% increase in the sum of diameters of TLs and an absolute increase of >=5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters, or unequivocal progression of existing NTL. The DoR was analyzed using the Kaplan-Meier method.
Baseline (<=28 days before treatment), then every 6 weeks for 24 weeks from Cycle 1 Day 1, then every 8 weeks (every 9 weeks in Module 6) until disease progression or 90 days after study drug discontinuation (approximately 2 years)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (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 thorugh 58.6 months (maximum observed duration)
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs
Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of hematology, clinical chemistry, and urinalysis.
Day 1 thorugh 58.6 months (maximum observed duration)
Number of Participants With Abnormal Vital Signs Reported as TEAEs
Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (blood pressure, pulse rate, temperature, and respiration rate).
Day 1 thorugh 58.6 months (maximum observed duration)
Number of Participants With Abnormal Physical Examination Findings Reported as TEAEs
Number of participants with abnormal physical examination findings reported as TEAEs are reported. Any new or aggravated clinically relevant abnormal medical finding at a physical examination as compared with the pre-dose assessment was reported as an AE.
Day 1 thorugh 58.6 months (maximum observed duration)
Number of Participants With Abnormal Electrocardiogram (ECG) Parameters Reported as TEAEs
Number of participants with abnormal ECGs reported as TEAEs are reported.
Day 1 thorugh 58.6 months (maximum observed duration)
Participants with detectable aberrations in liver kinase B1 (LKB1) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had anti-programmed cell death-1 (PD-1)/programmed cell death ligand 1 (PD-L1) containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (primary resistance; PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (acquired resistance; ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who are ataxia telangiectasia mutated (ATM)-deficiecy received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD in each cycle between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with detectable genetic amplifications in rapamycin-insensitive companion of mechanistic target of rapamycin complex-2 (RICTOR) received IV infusion of durvalumab 1500 mg Q4W in combination with oral vistusertib 125 mg tablets BD on an intermittent dosing schedule of 2 days on, 5 days off, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with high expression of cluster of differentiation 73 (CD73) received IV infusion of oleclumab 3000 mg every 2 weeks (Q2W) for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours express human epidermal growth factor receptor 2 (HER2) mutations received IV infusion of trastuzumab deruxtecan (T-DXd) 5.4 mg/kg every 3 weeks (Q3W) in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours harbour selected HER2 mutations received IV infusion of T-DXd 5.4 mg/kg Q3W in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral cediranib (AZD2171) 20 mg tablets daily for 5 days on, 2 days off (starting on Cycle 1 Day 1 of durvalumab), until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
FG016
Module 8 Cohort A.8.ATM: Ceralasertib 240 mg
Participants who are ATM-deficient or with detectable aberrations in the ATM gene received oral ceralasertib (AZD6738) 240 mg tablets BD from Day 1 to Day 14 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W plus oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 160 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 160 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
FG021
Module 11 Cohort C.11.240: AZD6738 240 mg
Participants, independent of their molecular aberration status, received oral AZD6738 tablet 240 mg for 7 days (Days 1 to 7) in each 28-day cycle until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
FG00021 subjects
FG00121 subjects
FG00222 subjects
FG00323 subjects
FG00423 subjects
FG00522 subjects
FG00631 subjects
FG00738 subjects
FG00858 subjects
FG0091 subjects
FG01023 subjects
FG0119 subjects
FG01225 subjects
FG01323 subjects
FG01420 subjects
FG01522 subjects
FG01615 subjects
FG01719 subjects
FG01824 subjects
FG01934 subjects
FG02017 subjects
FG02138 subjects
COMPLETED
FG0002 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG0041 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0091 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0191 subjects
FG0200 subjects
FG0212 subjects
NOT COMPLETED
FG00019 subjects
FG00121 subjects
FG00220 subjects
FG00323 subjects
FG00422 subjects
FG00520 subjects
FG00631 subjects
FG00738 subjects
FG00857 subjects
FG0090 subjects
FG01023 subjects
FG0118 subjects
FG01225 subjects
FG01323 subjects
FG01420 subjects
FG01522 subjects
FG01615 subjects
FG01719 subjects
FG01824 subjects
FG01933 subjects
FG02017 subjects
FG02136 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
Death
FG00018 subjects
FG00118 subjects
FG00220 subjects
FG00321 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0031 subjects
FG004
Continuing study off treatment at data cut-off
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Intention to treat (ITT) analysis population included all enrolled participants who received at least 1 dose of the study drug and were analyzed according to their assigned cohort and planned treatment.
Participants with detectable aberrations, mutation detected in a homologous recombination repair gene (HRRm) received IV infusion of durvalumab 1500 mg every 4 weeks (Q4W) in combination with oral olaparib 300 mg (2 × 150 mg) tablets twice a day (BD) until disease progression is confirmed.
Participants with detectable aberrations in liver kinase B1 (LKB1) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had anti-programmed cell death-1 (PD-1)/programmed cell death ligand 1 (PD-L1) containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (primary resistance; PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (acquired resistance; ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who are ataxia telangiectasia mutated (ATM)-deficiecy received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD in each cycle between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with detectable genetic amplifications in rapamycin-insensitive companion of mechanistic target of rapamycin complex-2 (RICTOR) received IV infusion of durvalumab 1500 mg Q4W in combination with oral vistusertib 125 mg tablets BD on an intermittent dosing schedule of 2 days on, 5 days off, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with high expression of cluster of differentiation 73 (CD73) received IV infusion of oleclumab 3000 mg every 2 weeks (Q2W) for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours express human epidermal growth factor receptor 2 (HER2) mutations received IV infusion of trastuzumab deruxtecan (T-DXd) 5.4 mg/kg every 3 weeks (Q3W) in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours harbour selected HER2 mutations received IV infusion of T-DXd 5.4 mg/kg Q3W in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral cediranib (AZD2171) 20 mg tablets daily for 5 days on, 2 days off (starting on Cycle 1 Day 1 of durvalumab), until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
BG016
Module 8 Cohort A.8.ATM: Ceralasertib 240 mg
Participants who are ATM-deficient or with detectable aberrations in the ATM gene received oral ceralasertib (AZD6738) 240 mg tablets BD from Day 1 to Day 14 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W plus oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 160 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 160 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
BG021
Module 11 Cohort C.11.240: AZD6738 240 mg
Participants, independent of their molecular aberration status, received oral AZD6738 tablet 240 mg for 7 days (Days 1 to 7) in each 28-day cycle until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
BG022
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00021
BG00121
BG00222
BG00323
BG00423
BG00522
BG00631
BG00738
BG00858
BG0091
BG01023
BG0119
BG01225
BG01323
BG01420
BG01522
BG01615
BG01719
BG01824
BG01934
BG02017
BG02138
BG022529
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
BG00059.9± 10.4
BG00160.2± 11.6
BG00260.9± 7.6
BG003
Sex/Gender, Customized
Count of Participants
Participants
Title
Denominators
Categories
Female
Title
Measurements
BG0008
BG0019
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With Objective Response Per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1)
Objective response was defined as participants with a confirmed investigator-assessed response complete response (CR) or partial response (PR) based on RECIST v 1.1. The CR is defined as disappearance of all target (TL) and non-target lesions (NTL), and any pathological lymph node (whether target or nontarget) must have reduction in short axis to <10 mm. The PR is defined as at least a 30% decrease in the sum of the diameters of TLs, taking as reference the baseline sum diameters, as long as criteria for progressive disease (PD) are not met. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from date of first documentation. Percentage of participants with objective response was reported.
Evaluable for response population included all dosed participants who had measurable disease at baseline and who were analyzed according to their assigned cohort and planned treatment.
Posted
Number
80% Confidence Interval
Percentage of Participants
Baseline (<=28 days before treatment), then every 6 weeks for 24 weeks from Cycle 1 Day 1, then every 8 weeks (every 9 weeks in Module 6) until disease progression or 90 days after study drug discontinuation (approximately 2 years)
Participants with detectable aberrations, mutation detected in a homologous recombination repair gene (HRRm) received IV infusion of durvalumab 1500 mg every 4 weeks (Q4W) in combination with oral olaparib 300 mg (2 × 150 mg) tablets twice a day (BD) until disease progression is confirmed.
Participants with detectable aberrations in liver kinase B1 (LKB1) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had anti-programmed cell death-1 (PD-1)/programmed cell death ligand 1 (PD-L1) containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (primary resistance; PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (acquired resistance; ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Units
Counts
Participants
OG00021
OG00121
OG00222
OG003
Title
Denominators
Categories
Title
Measurements
OG0009.5(2.6 to 23.4)
OG0014.8(0.5 to 17.3)
OG0020(0.0 to 9.9)
OG003
Secondary
Overall Survival (OS)
The OS is defined as the time from the first dose of any study drug until death due to any cause regardless of whether the participant withdraws from study treatment or receives subsequent cancer therapy. The overall survival was analyzed using the Kaplan-Meier method.
Intention to treat (ITT) analysis population included all enrolled participants who received at least 1 dose of the study drug and were analyzed according to their assigned cohort and planned treatment.
Posted
Median
80% Confidence Interval
Months
Every 3 months after safety follow-up visit (90 days after study drug discontinuation) until planned database lock for a module (either 12 months after last participant has started treatment or when 75% of participants died) (approximately up to 2 years)
Participants with detectable aberrations, mutation detected in a homologous recombination repair gene (HRRm) received IV infusion of durvalumab 1500 mg every 4 weeks (Q4W) in combination with oral olaparib 300 mg (2 × 150 mg) tablets twice a day (BD) until disease progression is confirmed.
Participants with detectable aberrations in liver kinase B1 (LKB1) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Secondary
Progression-Free Survival (PFS) Per RECIST v1.1
The PFS is defined as time from first dose of any study drug until date of objective disease progression (PD) per RECIST v1.1 or death by any cause, regardless of whether the participant withdraws from study therapy or receives another anti-cancer therapy prior to progression. The PD is defined as a >= 20% increase in the sum of diameters of TLs and an absolute increase of >= 5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters, or unequivocal progression of existing NTL. The PFS was analyzed using the Kaplan-Meier method
The ITT analysis population included all enrolled participants who received at least 1 dose of the study drug and were analyzed according to their assigned cohort and planned treatment.
Posted
Median
80% Confidence Interval
Months
Every 3 months after safety follow-up visit (90 days after study drug discontinuation) until planned database lock for a module (either 12 months after last participant has started treatment or when 75% of participants died) (approximately up to 2 years)
Participants with detectable aberrations, mutation detected in a homologous recombination repair gene (HRRm) received IV infusion of durvalumab 1500 mg every 4 weeks (Q4W) in combination with oral olaparib 300 mg (2 × 150 mg) tablets twice a day (BD) until disease progression is confirmed.
Best Percentage Change From Baseline in Tumour Size
The best percentage change in tumour size from baseline i.e. the maximum reduction from baseline or the minimum increase from baseline in absence of a reduction from baseline based on all post baseline assessments is reported. Tumour size is sum of the longest diameters (or short axis measurements for lymph nodes) of the target lesions. Baseline was defined as last evaluable assessment prior to starting treatment. The percentage change in target lesion tumour size at each week X for which data are available was obtained for each participant taking the difference between the sum of the target lesions at each week X and the sum of the target lesions at baseline divided by the sum of the target lesions at baseline multiplied by 100 (i.e. [week X - baseline]/baseline * 100).
Evaluable for response population included all dosed participants who had measurable disease at baseline and who were analyzed according to their assigned cohort and planned treatment. Number of participants analyzed (N) denotes the number of participants evaluated for this outcome measure.
Posted
Mean
Standard Deviation
Percent Change in Tumor Size
Baseline (<=28 days prior to starting treatment) then every 6 weeks for first 24 weeks relative to the date of first dose/combination therapy (Cycle 1 Day 1), then every 8 weeks (except Module 6)/9 weeks (Module 6) thereafter (approximately up to 2 years)
Participants with detectable aberrations, mutation detected in a homologous recombination repair gene (HRRm) received IV infusion of durvalumab 1500 mg every 4 weeks (Q4W) in combination with oral olaparib 300 mg (2 × 150 mg) tablets twice a day (BD) until disease progression is confirmed.
Secondary
Percentage of Participants With Disease Control (DC) Per RECIST v1.1
Module (M) 1, 4, 5, 6, 7, 8, 9, 11: DCR at 12 and 24 weeks is defined as percentage of participants who have best overall response (BoR) of CR or PR in first 13/25 weeks, respectively, post start of any study drug or with duration of SD for at least 11/23 weeks, respectively, after start of any study drug. M2, M3, M10: DCR at 12 and 24 weeks is defined as percentage of participants who have BoR of CR or PR within first 100 days (M2, M3, M10) or 184 days (M2, M3, M10) after start of any study drug, or have SD lasting at least 86 days (M2)/82 days (M3, M10), respectively, or 170 days (M2)/166 days (M3, M10), respectively, post start of any study drug. CR is defined as disappearance of all TL and NTLs, and any pathological lymph node (whether target or nontarget) must have reduction in short axis to <10 mm. PR is defined as at least 30% decrease in sum of diameters of TLs, taking as reference baseline sum diameters, as long as criteria for PD are not met.
Evaluable for response population included all dosed participants who had measurable disease at baseline and who were analyzed according to their assigned cohort and planned treatment.
Participants with detectable aberrations, mutation detected in a homologous recombination repair gene (HRRm) received IV infusion of durvalumab 1500 mg every 4 weeks (Q4W) in combination with oral olaparib 300 mg (2 × 150 mg) tablets twice a day (BD) until disease progression is confirmed.
Secondary
Duration of Response (DoR) Per RECIST v1.1
The DoR is defined as the time from the first documented confirmed response (CR or PR) until the first documented PD or death in the absence of disease progression. The CR is defined as disappearance of all TLs and NTLs, and any pathological lymph node (whether target or nontarget) must have reduction in short axis to <10 mm. The PR is defined as at least a 30 decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters, as long as criteria for PD are not met. The PD is defined as a >=20% increase in the sum of diameters of TLs and an absolute increase of >=5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters, or unequivocal progression of existing NTL. The DoR was analyzed using the Kaplan-Meier method.
Evaluable for response population included all dosed participants who had measurable disease at baseline and who were analyzed according to their assigned cohort and planned treatment. The DoR was assessed for only those participants who had OR. Here, number of participants denotes those participants who had OR (confirmed CR or PR).
Posted
Median
Inter-Quartile Range
Months
Baseline (<=28 days before treatment), then every 6 weeks for 24 weeks from Cycle 1 Day 1, then every 8 weeks (every 9 weeks in Module 6) until disease progression or 90 days after study drug discontinuation (approximately 2 years)
Participants with detectable aberrations, mutation detected in a homologous recombination repair gene (HRRm) received IV infusion of durvalumab 1500 mg every 4 weeks (Q4W) in combination with oral olaparib 300 mg (2 × 150 mg) tablets twice a day (BD) until disease progression is confirmed.
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (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.
Safety analysis set included participants who received at least 1 dose of study drug and who were analyzed according to the actual treatment received and corresponding assigned cohort.
Posted
Count of Participants
Participants
Day 1 thorugh 58.6 months (maximum observed duration)
Participants with detectable aberrations, mutation detected in a homologous recombination repair gene (HRRm) received IV infusion of durvalumab 1500 mg every 4 weeks (Q4W) in combination with oral olaparib 300 mg (2 × 150 mg) tablets twice a day (BD) until disease progression is confirmed.
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs
Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of hematology, clinical chemistry, and urinalysis.
Safety analysis set included participants who received at least 1 dose of study drug and who were analyzed according to the actual treatment received and corresponding assigned cohort.
Posted
Count of Participants
Participants
Day 1 thorugh 58.6 months (maximum observed duration)
Participants with detectable aberrations, mutation detected in a homologous recombination repair gene (HRRm) received IV infusion of durvalumab 1500 mg every 4 weeks (Q4W) in combination with oral olaparib 300 mg (2 × 150 mg) tablets twice a day (BD) until disease progression is confirmed.
Participants with detectable aberrations in liver kinase B1 (LKB1) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Number of Participants With Abnormal Vital Signs Reported as TEAEs
Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (blood pressure, pulse rate, temperature, and respiration rate).
Safety analysis set included participants who received at least 1 dose of study drug and who were analyzed according to the actual treatment received and corresponding assigned cohort.
Posted
Count of Participants
Participants
Day 1 thorugh 58.6 months (maximum observed duration)
Participants with detectable aberrations, mutation detected in a homologous recombination repair gene (HRRm) received IV infusion of durvalumab 1500 mg every 4 weeks (Q4W) in combination with oral olaparib 300 mg (2 × 150 mg) tablets twice a day (BD) until disease progression is confirmed.
Participants with detectable aberrations in liver kinase B1 (LKB1) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Number of Participants With Abnormal Physical Examination Findings Reported as TEAEs
Number of participants with abnormal physical examination findings reported as TEAEs are reported. Any new or aggravated clinically relevant abnormal medical finding at a physical examination as compared with the pre-dose assessment was reported as an AE.
Safety analysis set included participants who received at least 1 dose of study drug and who were analyzed according to the actual treatment received and corresponding assigned cohort.
Posted
Count of Participants
Participants
Day 1 thorugh 58.6 months (maximum observed duration)
Participants with detectable aberrations, mutation detected in a homologous recombination repair gene (HRRm) received IV infusion of durvalumab 1500 mg every 4 weeks (Q4W) in combination with oral olaparib 300 mg (2 × 150 mg) tablets twice a day (BD) until disease progression is confirmed.
Participants with detectable aberrations in liver kinase B1 (LKB1) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
OG002
Secondary
Number of Participants With Abnormal Electrocardiogram (ECG) Parameters Reported as TEAEs
Number of participants with abnormal ECGs reported as TEAEs are reported.
Safety analysis set included participants who received at least 1 dose of study drug and who were analyzed according to the actual treatment received and corresponding assigned cohort.
Posted
Count of Participants
Participants
Day 1 thorugh 58.6 months (maximum observed duration)
Participants with detectable aberrations, mutation detected in a homologous recombination repair gene (HRRm) received IV infusion of durvalumab 1500 mg every 4 weeks (Q4W) in combination with oral olaparib 300 mg (2 × 150 mg) tablets twice a day (BD) until disease progression is confirmed.
Participants with detectable aberrations in liver kinase B1 (LKB1) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Day 1 through 61.55 months (maximum observed duration)
Description
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (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.
Participants with detectable aberrations, mutation detected in a homologous recombination repair gene (HRRm) received IV infusion of durvalumab 1500 mg every 4 weeks (Q4W) in combination with oral olaparib 300 mg (2 × 150 mg) tablets twice a day (BD) until disease progression is confirmed.
Participants with detectable aberrations in liver kinase B1 (LKB1) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had anti-programmed cell death-1 (PD-1)/programmed cell death ligand 1 (PD-L1) containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (primary resistance; PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (acquired resistance; ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who are ataxia telangiectasia mutated (ATM)-deficiecy received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD in each cycle between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with detectable genetic amplifications in rapamycin-insensitive companion of mechanistic target of rapamycin complex-2 (RICTOR) received IV infusion of durvalumab 1500 mg Q4W in combination with oral vistusertib 125 mg tablets BD on an intermittent dosing schedule of 2 days on, 5 days off, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with high expression of cluster of differentiation 73 (CD73) received IV infusion of oleclumab 3000 mg every 2 weeks (Q2W) for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours express human epidermal growth factor receptor 2 (HER2) mutations received IV infusion of trastuzumab deruxtecan (T-DXd) 5.4 mg/kg every 3 weeks (Q3W) in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours harbour selected HER2 mutations received IV infusion of T-DXd 5.4 mg/kg Q3W in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral cediranib (AZD2171) 20 mg tablets daily for 5 days on, 2 days off (starting on Cycle 1 Day 1 of durvalumab), until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
18
22
7
22
20
22
EG016
Module 8 Cohort A.8.ATM: Ceralasertib 240 mg
Participants who are ATM-deficient or with detectable aberrations in the ATM gene received oral ceralasertib (AZD6738) 240 mg tablets BD from Day 1 to Day 14 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W plus oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 160 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 160 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
14
17
1
17
16
17
EG021
Module 11 Cohort C.11.240: AZD6738 240 mg
Participants, independent of their molecular aberration status, received oral AZD6738 tablet 240 mg for 7 days (Days 1 to 7) in each 28-day cycle until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
27
38
17
38
38
38
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Normocytic anaemia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG0030 events0 affected23 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected22 at risk
EG0060 events0 affected31 at risk
EG0071 events1 affected38 at risk
EG0080 events0 affected58 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected23 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected23 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected22 at risk
EG0160 events0 affected15 at risk
EG0170 events0 affected19 at risk
EG0180 events0 affected24 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected17 at risk
EG0210 events0 affected38 at risk
Infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Infectious pleural effusion
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Klebsiella infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected21 at risk
EG0010 events0 affected21 at risk
EG0023 events3 affected22 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Salmonellosis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Septic shock
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Wound infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0012 events1 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Procedural pneumothorax
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Scapula fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Autoimmune pericarditis
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Traumatic haemothorax
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0013 events2 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Platelet count decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Cor pulmonale
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Immune-mediated myocarditis
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Altered state of consciousness
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Seizure
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Syncope
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Renal artery thrombosis
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Myopericarditis
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Alveolitis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0022 events2 affected22 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0004 events3 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Air embolism
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Embolism
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Hypertension
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Hypotension
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Superior vena cava syndrome
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Bone marrow failure
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Coagulopathy
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Febrile bone marrow aplasia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Oesophageal obstruction
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Rectal prolapse
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Chest pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Chills
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Fatigue
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
General physical health deterioration
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0022 events1 affected22 at risk
EG003
Oedema peripheral
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Pyrexia
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Hepatic cytolysis
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Adenovirus infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Covid-19 pneumonia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Coronavirus infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Device related infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Diarrhoea infectious
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Empyema
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Herpes simplex
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG0030 events0 affected23 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected22 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected38 at risk
EG0080 events0 affected58 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected23 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected23 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected22 at risk
EG0160 events0 affected15 at risk
EG0171 events1 affected19 at risk
EG0180 events0 affected24 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected17 at risk
EG0210 events0 affected38 at risk
Herpes zoster
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Influenza
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0022 events2 affected22 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Paronychia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0012 events1 affected21 at risk
EG0022 events2 affected22 at risk
EG003
Pneumonia streptococcal
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Amylase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0012 events1 affected21 at risk
EG0023 events3 affected22 at risk
EG003
Blood iron decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Blood lactate dehydrogenase decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Blood pressure systolic increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0012 events2 affected21 at risk
EG0020 events0 affected22 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Electrocardiogram qt prolonged
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Heart rate irregular
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Lipase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Liver function test increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Megakaryocytes abnormal
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Platelet count decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Urine output decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Weight decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0010 events0 affected21 at risk
EG0023 events3 affected22 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
White blood cell count increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0008 events8 affected21 at risk
EG0014 events4 affected21 at risk
EG0023 events3 affected22 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0013 events2 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0004 events4 affected21 at risk
EG0012 events2 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0022 events1 affected22 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0005 events4 affected21 at risk
EG0014 events4 affected21 at risk
EG0023 events3 affected22 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0011 events1 affected21 at risk
EG0024 events3 affected22 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0012 events2 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0010 events0 affected21 at risk
EG0022 events2 affected22 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG00011 events7 affected21 at risk
EG00112 events7 affected21 at risk
EG0025 events5 affected22 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Bell's palsy
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0012 events2 affected21 at risk
EG0024 events4 affected22 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0013 events2 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Headache
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0025 events5 affected22 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Hypotonia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0022 events2 affected22 at risk
EG003
Tremor
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Abnormal dreams
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0012 events2 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Depression
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0010 events0 affected21 at risk
EG0023 events3 affected22 at risk
EG003
Neuropsychological symptoms
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Urine odour abnormal
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0006 events6 affected21 at risk
EG0016 events5 affected21 at risk
EG0022 events2 affected22 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0005 events5 affected21 at risk
EG0012 events2 affected21 at risk
EG0023 events3 affected22 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Emphysema
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0023 events2 affected22 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0013 events2 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0012 events2 affected21 at risk
EG0022 events2 affected22 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected21 at risk
EG0022 events1 affected22 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Pulmonary pain
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0022 events2 affected22 at risk
EG003
Dermatitis psoriasiform
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0012 events2 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Hypertrichosis
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0011 events1 affected21 at risk
EG0022 events2 affected22 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0011 events1 affected21 at risk
EG0023 events1 affected22 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Haematoma
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Hot flush
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Hypertension
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0003 events2 affected21 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Hypotension
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0025 events3 affected22 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Otorrhoea
Ear and labyrinth disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Dry eye
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Visual impairment
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0022 events1 affected22 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0007 events7 affected21 at risk
EG0013 events3 affected21 at risk
EG0026 events5 affected22 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0006 events5 affected21 at risk
EG0013 events2 affected21 at risk
EG0026 events4 affected22 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG00013 events11 affected21 at risk
EG0018 events7 affected21 at risk
EG00214 events10 affected22 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG00012 events8 affected21 at risk
EG0016 events4 affected21 at risk
EG00212 events7 affected22 at risk
EG003
Asthenia
General disorders
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected21 at risk
EG0013 events2 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Catheter site rash
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Chest pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Chills
General disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Fatigue
General disorders
MedDRA 25.0
Systematic Assessment
EG00010 events10 affected21 at risk
EG0015 events5 affected21 at risk
EG0025 events5 affected22 at risk
EG003
Gait disturbance
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Inflammation
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Influenza like illness
General disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0012 events2 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0002 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Oedema peripheral
General disorders
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected21 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected22 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Pyrexia
General disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0011 events1 affected21 at risk
EG0023 events3 affected22 at risk
EG003
Hepatic cytolysis
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Contrast media allergy
Immune system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Contrast media reaction
Immune system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0022 events1 affected22 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0003 events2 affected21 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Covid-19
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0003 events1 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Coronavirus infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Fungal foot infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Genital herpes
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected22 at risk
EG003
Module 4 was prematurely discontinued by the sponsor for strategic reasons.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
AstraZeneca has 60 days to review results communications prior to public release and may delete information that compromises ongoing 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.
BG009NA± NAMean was not reported due to concern with participant's confidentiality. Standard deviation is not calculated as only one participant is involved in Module 4.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who are ataxia telangiectasia mutated (ATM)-deficiecy received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD in each cycle between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with detectable genetic amplifications in rapamycin-insensitive companion of mechanistic target of rapamycin complex-2 (RICTOR) received IV infusion of durvalumab 1500 mg Q4W in combination with oral vistusertib 125 mg tablets BD on an intermittent dosing schedule of 2 days on, 5 days off, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with high expression of cluster of differentiation 73 (CD73) received IV infusion of oleclumab 3000 mg every 2 weeks (Q2W) for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours express human epidermal growth factor receptor 2 (HER2) mutations received IV infusion of trastuzumab deruxtecan (T-DXd) 5.4 mg/kg every 3 weeks (Q3W) in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours harbour selected HER2 mutations received IV infusion of T-DXd 5.4 mg/kg Q3W in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral cediranib (AZD2171) 20 mg tablets daily for 5 days on, 2 days off (starting on Cycle 1 Day 1 of durvalumab), until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
OG016
Module 8 Cohort A.8.ATM: Ceralasertib 240 mg
Participants who are ATM-deficient or with detectable aberrations in the ATM gene received oral ceralasertib (AZD6738) 240 mg tablets BD from Day 1 to Day 14 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W plus oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 160 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 160 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
OG021
Module 11 Cohort C.11.240: AZD6738 240 mg
Participants, independent of their molecular aberration status, received oral AZD6738 tablet 240 mg for 7 days (Days 1 to 7) in each 28-day cycle until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
23
OG00423
OG00522
OG00631
OG00737
OG00858
OG0091
OG01023
OG0119
OG01225
OG01323
OG01420
OG01522
OG01615
OG01718
OG01824
OG01934
OG02017
OG02138
4.3
(0.5 to 15.9)
OG0040(0.0 to 9.5)
OG0050(0.0 to 9.9)
OG00625.8(15.7 to 38.5)
OG0078.1(3.0 to 17.2)
OG0088.6(4.3 to 15.4)
OG009NA(NA to NA)No efficacy data were collected as the module was prematurely discontinued by the sponsor for strategic reasons. At the time of decision to discontinue the module, only a single participant had received treatment, and only safety data were collected on that participant.
Participants who had anti-programmed cell death-1 (PD-1)/programmed cell death ligand 1 (PD-L1) containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (primary resistance; PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (acquired resistance; ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who are ataxia telangiectasia mutated (ATM)-deficiecy received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD in each cycle between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with detectable genetic amplifications in rapamycin-insensitive companion of mechanistic target of rapamycin complex-2 (RICTOR) received IV infusion of durvalumab 1500 mg Q4W in combination with oral vistusertib 125 mg tablets BD on an intermittent dosing schedule of 2 days on, 5 days off, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with high expression of cluster of differentiation 73 (CD73) received IV infusion of oleclumab 3000 mg every 2 weeks (Q2W) for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours express human epidermal growth factor receptor 2 (HER2) mutations received IV infusion of trastuzumab deruxtecan (T-DXd) 5.4 mg/kg every 3 weeks (Q3W) in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours harbour selected HER2 mutations received IV infusion of T-DXd 5.4 mg/kg Q3W in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral cediranib (AZD2171) 20 mg tablets daily for 5 days on, 2 days off (starting on Cycle 1 Day 1 of durvalumab), until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
OG016
Module 8 Cohort A.8.ATM: Ceralasertib 240 mg
Participants who are ATM-deficient or with detectable aberrations in the ATM gene received oral ceralasertib (AZD6738) 240 mg tablets BD from Day 1 to Day 14 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W plus oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 160 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 160 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
OG021
Module 11 Cohort C.11.240: AZD6738 240 mg
Participants, independent of their molecular aberration status, received oral AZD6738 tablet 240 mg for 7 days (Days 1 to 7) in each 28-day cycle until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Units
Counts
Participants
OG00021
OG00121
OG00222
OG00323
OG00423
OG00522
OG00631
OG00738
OG00858
OG0091
OG01023
OG0119
OG01225
OG01323
OG01420
OG01522
OG01615
OG01719
OG01824
OG01934
OG02017
OG02138
Title
Denominators
Categories
Title
Measurements
OG0009.63(5.26 to 15.97)
OG0015.75(5.29 to 10.84)
OG0027.16(4.93 to 10.28)
OG00315.51(9.33 to 20.86)
OG0046.01(3.55 to 6.51)
OG00511.20(9.72 to 12.55)
OG00615.80(14.16 to 22.80)
OG00710.22(5.82 to 11.30)
OG00811.37(9.13 to 15.80)
OG009NA(NA to NA)No efficacy data were collected as the module was prematurely discontinued by the sponsor for strategic reasons. At the time of decision to discontinue the module, only a single participant had received treatment, and only safety data were collected on that participant.
OG01010.97(7.59 to 15.74)
OG0117.06(4.90 to 11.99)
OG01212.78(7.39 to 20.96)
OG0139.53(6.57 to 12.42)
OG01410.61(8.90 to 20.60)
OG01514.19(11.86 to 19.88)
OG01614.23(6.08 to 17.18)
OG0177.95(5.59 to 8.64)
OG01812.91(7.39 to 20.50)
OG0195.95(4.01 to 10.05)
OG0207.03(4.37 to 12.71)
OG0216.60(5.85 to 9.13)
Participants with detectable aberrations in liver kinase B1 (LKB1) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had anti-programmed cell death-1 (PD-1)/programmed cell death ligand 1 (PD-L1) containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (primary resistance; PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (acquired resistance; ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who are ataxia telangiectasia mutated (ATM)-deficiecy received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD in each cycle between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with detectable genetic amplifications in rapamycin-insensitive companion of mechanistic target of rapamycin complex-2 (RICTOR) received IV infusion of durvalumab 1500 mg Q4W in combination with oral vistusertib 125 mg tablets BD on an intermittent dosing schedule of 2 days on, 5 days off, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with high expression of cluster of differentiation 73 (CD73) received IV infusion of oleclumab 3000 mg every 2 weeks (Q2W) for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours express human epidermal growth factor receptor 2 (HER2) mutations received IV infusion of trastuzumab deruxtecan (T-DXd) 5.4 mg/kg every 3 weeks (Q3W) in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours harbour selected HER2 mutations received IV infusion of T-DXd 5.4 mg/kg Q3W in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral cediranib (AZD2171) 20 mg tablets daily for 5 days on, 2 days off (starting on Cycle 1 Day 1 of durvalumab), until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
OG016
Module 8 Cohort A.8.ATM: Ceralasertib 240 mg
Participants who are ATM-deficient or with detectable aberrations in the ATM gene received oral ceralasertib (AZD6738) 240 mg tablets BD from Day 1 to Day 14 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W plus oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 160 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 160 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
OG021
Module 11 Cohort C.11.240: AZD6738 240 mg
Participants, independent of their molecular aberration status, received oral AZD6738 tablet 240 mg for 7 days (Days 1 to 7) in each 28-day cycle until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Units
Counts
Participants
OG00021
OG00121
OG00222
OG00323
OG00423
OG00522
OG00631
OG00738
OG00858
OG0091
OG01023
OG0119
OG01225
OG01323
OG01420
OG01522
OG01615
OG01719
OG01824
OG01934
OG02017
OG02138
Title
Denominators
Categories
Title
Measurements
OG0002.79(1.41 to 5.26)
OG0011.41(1.38 to 1.81)
OG0023.38(2.10 to 4.93)
OG0034.17(2.69 to 4.37)
OG0041.68(1.64 to 2.99)
OG0053.09(2.83 to 6.14)
OG0067.43(5.59 to 9.43)
OG0072.96(1.91 to 3.09)
OG0084.21(3.02 to 4.96)
OG009NA(NA to NA)No efficacy data were collected as the module was prematurely discontinued by the sponsor for strategic reasons. At the time of decision to discontinue the module, only a single participant had received treatment, and only safety data were collected on that participant.
Participants with detectable aberrations in liver kinase B1 (LKB1) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had anti-programmed cell death-1 (PD-1)/programmed cell death ligand 1 (PD-L1) containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (primary resistance; PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (acquired resistance; ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who are ataxia telangiectasia mutated (ATM)-deficiecy received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD in each cycle between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with detectable genetic amplifications in rapamycin-insensitive companion of mechanistic target of rapamycin complex-2 (RICTOR) received IV infusion of durvalumab 1500 mg Q4W in combination with oral vistusertib 125 mg tablets BD on an intermittent dosing schedule of 2 days on, 5 days off, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with high expression of cluster of differentiation 73 (CD73) received IV infusion of oleclumab 3000 mg every 2 weeks (Q2W) for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours express human epidermal growth factor receptor 2 (HER2) mutations received IV infusion of trastuzumab deruxtecan (T-DXd) 5.4 mg/kg every 3 weeks (Q3W) in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours harbour selected HER2 mutations received IV infusion of T-DXd 5.4 mg/kg Q3W in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral cediranib (AZD2171) 20 mg tablets daily for 5 days on, 2 days off (starting on Cycle 1 Day 1 of durvalumab), until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
OG016
Module 8 Cohort A.8.ATM: Ceralasertib 240 mg
Participants who are ATM-deficient or with detectable aberrations in the ATM gene received oral ceralasertib (AZD6738) 240 mg tablets BD from Day 1 to Day 14 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W plus oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 160 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 160 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
OG021
Module 11 Cohort C.11.240: AZD6738 240 mg
Participants, independent of their molecular aberration status, received oral AZD6738 tablet 240 mg for 7 days (Days 1 to 7) in each 28-day cycle until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Units
Counts
Participants
OG00021
OG00121
OG00222
OG00323
OG00423
OG00521
OG00631
OG00737
OG00858
OG0091
OG01023
OG0119
OG01225
OG01323
OG01420
OG01522
OG01615
OG01717
OG01823
OG01934
OG02017
OG02138
Title
Denominators
Categories
Title
Measurements
OG000-0.79± 25.706
OG00110.24± 25.197
OG0027.19± 21.082
OG003-3.55± 20.879
OG00416.36± 20.732
OG0053.06± 19.015
OG006-10.12± 33.560
OG0073.39± 29.846
OG008-0.03± 29.952
OG009NA± NANo efficacy data were collected as the module was prematurely discontinued by the sponsor for strategic reasons. At the time of decision to discontinue the module, only a single participant had received treatment, and only safety data were collected on that participant.
Participants with detectable aberrations in liver kinase B1 (LKB1) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had anti-programmed cell death-1 (PD-1)/programmed cell death ligand 1 (PD-L1) containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (primary resistance; PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (acquired resistance; ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who are ataxia telangiectasia mutated (ATM)-deficiecy received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD in each cycle between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with detectable genetic amplifications in rapamycin-insensitive companion of mechanistic target of rapamycin complex-2 (RICTOR) received IV infusion of durvalumab 1500 mg Q4W in combination with oral vistusertib 125 mg tablets BD on an intermittent dosing schedule of 2 days on, 5 days off, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with high expression of cluster of differentiation 73 (CD73) received IV infusion of oleclumab 3000 mg every 2 weeks (Q2W) for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours express human epidermal growth factor receptor 2 (HER2) mutations received IV infusion of trastuzumab deruxtecan (T-DXd) 5.4 mg/kg every 3 weeks (Q3W) in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours harbour selected HER2 mutations received IV infusion of T-DXd 5.4 mg/kg Q3W in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral cediranib (AZD2171) 20 mg tablets daily for 5 days on, 2 days off (starting on Cycle 1 Day 1 of durvalumab), until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
OG016
Module 8 Cohort A.8.ATM: Ceralasertib 240 mg
Participants who are ATM-deficient or with detectable aberrations in the ATM gene received oral ceralasertib (AZD6738) 240 mg tablets BD from Day 1 to Day 14 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W plus oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 160 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 160 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
OG021
Module 11 Cohort C.11.240: AZD6738 240 mg
Participants, independent of their molecular aberration status, received oral AZD6738 tablet 240 mg for 7 days (Days 1 to 7) in each 28-day cycle until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Units
Counts
Participants
OG00021
OG00121
OG00222
OG00323
OG00423
OG00522
OG00631
OG00737
OG00858
OG0091
OG01023
OG0119
OG01225
OG01323
OG01420
OG01522
OG01615
OG01718
OG01824
OG01934
OG02017
OG02138
Title
Denominators
Categories
At 12 weeks
Title
Measurements
OG00038.1(23.6 to 54.4)
OG0019.5(2.6 to 23.4)
OG00245.5(30.5 to 61.1)
OG00352.2(37.0 to 67.0)
OG00413.0(4.9 to 26.8)
OG00540.9(26.4 to 56.8)
OG00667.7(54.7 to 78.9)
OG00754.1(42.3 to 65.5)
OG00858.6(49.4 to 67.4)
OG009NA(NA to NA)No efficacy data were collected as the module was prematurely discontinued by the sponsor for strategic reasons. At the time of decision to discontinue the module, only a single participant had received treatment, and only safety data were collected on that participant.
Participants with detectable aberrations in liver kinase B1 (LKB1) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had anti-programmed cell death-1 (PD-1)/programmed cell death ligand 1 (PD-L1) containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (primary resistance; PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (acquired resistance; ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who are ataxia telangiectasia mutated (ATM)-deficiecy received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD in each cycle between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with detectable genetic amplifications in rapamycin-insensitive companion of mechanistic target of rapamycin complex-2 (RICTOR) received IV infusion of durvalumab 1500 mg Q4W in combination with oral vistusertib 125 mg tablets BD on an intermittent dosing schedule of 2 days on, 5 days off, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with high expression of cluster of differentiation 73 (CD73) received IV infusion of oleclumab 3000 mg every 2 weeks (Q2W) for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours express human epidermal growth factor receptor 2 (HER2) mutations received IV infusion of trastuzumab deruxtecan (T-DXd) 5.4 mg/kg every 3 weeks (Q3W) in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours harbour selected HER2 mutations received IV infusion of T-DXd 5.4 mg/kg Q3W in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral cediranib (AZD2171) 20 mg tablets daily for 5 days on, 2 days off (starting on Cycle 1 Day 1 of durvalumab), until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
OG016
Module 8 Cohort A.8.ATM: Ceralasertib 240 mg
Participants who are ATM-deficient or with detectable aberrations in the ATM gene received oral ceralasertib (AZD6738) 240 mg tablets BD from Day 1 to Day 14 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W plus oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 160 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 160 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
OG021
Module 11 Cohort C.11.240: AZD6738 240 mg
Participants, independent of their molecular aberration status, received oral AZD6738 tablet 240 mg for 7 days (Days 1 to 7) in each 28-day cycle until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Units
Counts
Participants
OG0002
OG0011
OG0020
OG0031
OG0040
OG0050
OG0068
OG0073
OG0085
OG0090
OG0101
OG0110
OG0121
OG0135
OG0147
OG0155
OG0160
OG0173
OG0182
OG0190
OG0202
OG0211
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Number of responders were less than 3, hence median and the quartiles of were not calculated.
OG001NA(NA to NA)Number of responders were less than 3, hence median and the quartiles were not calculated.
OG003NA(NA to NA)Number of responders were less than 3, hence median and the quartiles were not calculated.
OG0066.57(5.95 to 13.24)
OG00710.45(3.94 to 10.45)
OG00834.83(7.85 to 34.83)
OG010NA(NA to NA)Number of responders were less than 3, hence median and the quartiles were not calculated.
OG012NA(NA to NA)Number of responders were less than 3, hence median and the quartiles were not calculated.
OG0136.60(4.17 to NA)Third quartile was not calculated as percentage of events associated with that quartile was not met by end of study follow-up.
OG0144.14(2.79 to 5.32)
OG01511.10(6.18 to 19.68)
OG017NA(1.87 to NA)Median and third quartile were not calculated as percentage of events associated with that median and quartile were not met by end of study follow-up.
OG018NA(NA to NA)Number of responders were less than 3, hence median and the quartiles were not calculated.
OG020NA(NA to NA)Number of responders were less than 3, hence median and the quartiles were not calculated.
OG021NA(NA to NA)Number of responders were less than 3, hence median and the quartiles were not calculated.
Participants with detectable aberrations in liver kinase B1 (LKB1) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had anti-programmed cell death-1 (PD-1)/programmed cell death ligand 1 (PD-L1) containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (primary resistance; PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (acquired resistance; ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who are ataxia telangiectasia mutated (ATM)-deficiecy received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD in each cycle between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with detectable genetic amplifications in rapamycin-insensitive companion of mechanistic target of rapamycin complex-2 (RICTOR) received IV infusion of durvalumab 1500 mg Q4W in combination with oral vistusertib 125 mg tablets BD on an intermittent dosing schedule of 2 days on, 5 days off, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with high expression of cluster of differentiation 73 (CD73) received IV infusion of oleclumab 3000 mg every 2 weeks (Q2W) for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours express human epidermal growth factor receptor 2 (HER2) mutations received IV infusion of trastuzumab deruxtecan (T-DXd) 5.4 mg/kg every 3 weeks (Q3W) in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours harbour selected HER2 mutations received IV infusion of T-DXd 5.4 mg/kg Q3W in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral cediranib (AZD2171) 20 mg tablets daily for 5 days on, 2 days off (starting on Cycle 1 Day 1 of durvalumab), until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
OG016
Module 8 Cohort A.8.ATM: Ceralasertib 240 mg
Participants who are ATM-deficient or with detectable aberrations in the ATM gene received oral ceralasertib (AZD6738) 240 mg tablets BD from Day 1 to Day 14 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W plus oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 160 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 160 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
OG021
Module 11 Cohort C.11.240: AZD6738 240 mg
Participants, independent of their molecular aberration status, received oral AZD6738 tablet 240 mg for 7 days (Days 1 to 7) in each 28-day cycle until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Units
Counts
Participants
OG00021
OG00121
OG00222
OG00323
OG00423
OG00522
OG00631
OG00738
OG00858
OG0091
OG01023
OG0119
OG01225
OG01323
OG01420
OG01522
OG01615
OG01719
OG01824
OG01934
OG02017
OG02138
Title
Denominators
Categories
Any TEAEs
Title
Measurements
OG00020
OG00119
OG00220
OG00321
OG00423
OG00520
OG00631
OG00735
OG00856
OG0091
OG01021
OG0115
OG01222
OG01323
OG01420
OG01521
OG01615
OG01717
OG01824
OG01932
OG02016
OG02138
Any TESAEs
Title
Measurements
OG00010
OG0017
OG0028
OG003
Participants who had anti-programmed cell death-1 (PD-1)/programmed cell death ligand 1 (PD-L1) containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (primary resistance; PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (acquired resistance; ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who are ataxia telangiectasia mutated (ATM)-deficiecy received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD in each cycle between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with detectable genetic amplifications in rapamycin-insensitive companion of mechanistic target of rapamycin complex-2 (RICTOR) received IV infusion of durvalumab 1500 mg Q4W in combination with oral vistusertib 125 mg tablets BD on an intermittent dosing schedule of 2 days on, 5 days off, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with high expression of cluster of differentiation 73 (CD73) received IV infusion of oleclumab 3000 mg every 2 weeks (Q2W) for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours express human epidermal growth factor receptor 2 (HER2) mutations received IV infusion of trastuzumab deruxtecan (T-DXd) 5.4 mg/kg every 3 weeks (Q3W) in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours harbour selected HER2 mutations received IV infusion of T-DXd 5.4 mg/kg Q3W in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral cediranib (AZD2171) 20 mg tablets daily for 5 days on, 2 days off (starting on Cycle 1 Day 1 of durvalumab), until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
OG016
Module 8 Cohort A.8.ATM: Ceralasertib 240 mg
Participants who are ATM-deficient or with detectable aberrations in the ATM gene received oral ceralasertib (AZD6738) 240 mg tablets BD from Day 1 to Day 14 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W plus oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 160 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 160 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
OG021
Module 11 Cohort C.11.240: AZD6738 240 mg
Participants, independent of their molecular aberration status, received oral AZD6738 tablet 240 mg for 7 days (Days 1 to 7) in each 28-day cycle until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Units
Counts
Participants
OG00021
OG00121
OG00222
OG00323
OG00423
OG00522
OG00631
OG00738
OG00858
OG0091
OG01023
OG0119
OG01225
OG01323
OG01420
OG01522
OG01615
OG01719
OG01824
OG01934
OG02017
OG02138
Title
Denominators
Categories
Anaemia
Title
Measurements
OG0007
OG0017
OG0025
OG0037
OG0044
OG0054
OG00610
OG0079
OG00819
OG0090
OG0101
OG0111
OG0123
OG0137
OG01412
OG0151
OG01612
OG0178
OG01812
OG0195
OG0207
OG02115
Thrombocytopenia
Title
Measurements
OG0001
OG0011
OG0020
OG003
Hyponatraemia
Title
Measurements
OG0000
OG0012
OG0021
OG003
Hypokalaemia
Title
Measurements
OG0004
OG0012
OG0021
OG003
Aspartate aminotransferase increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood creatinine increased
Title
Measurements
OG0002
OG0011
OG0023
OG003
Hypoalbuminaemia
Title
Measurements
OG0000
OG0011
OG0021
OG003
Platelet count decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Alanine aminotransferase increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
C-reactive protein increased
Title
Measurements
OG0000
OG0010
OG0021
OG003
Hypomagnesaemia
Title
Measurements
OG0000
OG0010
OG0021
OG003
Hyperglycaemia
Title
Measurements
OG0002
OG0010
OG0021
OG003
Lymphocyte count decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lipase increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutrophil count decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood alkaline phosphatase increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypophosphataemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutropenia
Title
Measurements
OG0001
OG0010
OG0020
OG003
White blood cell count decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Amylase increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Gamma-glutamyltransferase increased
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hypercalcaemia
Title
Measurements
OG0001
OG0010
OG0021
OG003
Hypocalcaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood bilirubin increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hyperkalaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphopenia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood thyroid stimulating hormone increased
Title
Measurements
OG0000
OG0012
OG0020
OG003
Hypoglycaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Liver function test increased
Title
Measurements
OG0000
OG0010
OG0021
OG003
Blood phosphorus decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Febrile neutropenia
Title
Measurements
OG0001
OG0010
OG0020
OG003
Pancytopenia
Title
Measurements
OG0000
OG0010
OG0020
OG003
White blood cell count increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood creatine phosphokinase increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hepatic enzyme increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypertransaminasaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Leukopenia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Proteinuria
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood albumin decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood iron decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood lactate dehydrogenase decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
International normalised ratio increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Megakaryocytes abnormal
Title
Measurements
OG0000
OG0010
OG0020
OG003
Normocytic anaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Prothrombin time prolonged
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypothyroidism
Title
Measurements
OG0000
OG0010
OG0021
OG003
Hepatic cytolysis
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood lactate dehydrogenase increased
Title
Measurements
OG0000
OG0011
OG0020
OG003
Pollakiuria
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood urea increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Haematuria
Title
Measurements
OG0000
OG0010
OG0021
OG003
Renal failure
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hyperthyroidism
Title
Measurements
OG0000
OG0010
OG0020
OG003
Myocardial infarction
Title
Measurements
OG0000
OG0010
OG0020
OG003
Adrenal insufficiency
Title
Measurements
OG0000
OG0010
OG0020
OG003
Creatinine renal clearance decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Eosinophil count increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Haemoglobin decreased
Title
Measurements
OG0000
OG0010
OG0021
OG003
Hypernatraemia
Title
Measurements
OG0000
OG0010
OG0021
OG003
Lymphadenopathy
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutrophil count increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Pancreatitis
Title
Measurements
OG0001
OG0010
OG0020
OG003
Platelet count increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Troponin increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Type 1 diabetes mellitus
Title
Measurements
OG0000
OG0010
OG0020
OG003
Vitamin B12 deficiency
Title
Measurements
OG0000
OG0011
OG0020
OG003
Azotaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Bilirubin conjugated increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood calcium decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood calcium increased
Title
Measurements
OG0000
OG0010
OG0021
OG003
Blood chloride decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood chloride increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood fibrinogen decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood fibrinogen increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood glucose increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood magnesium decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood phosphorus increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood sodium decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood thrombin increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Brain natriuretic peptide increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Coagulation time prolonged
Title
Measurements
OG0000
OG0010
OG0020
OG003
Coagulopathy
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cushingoid
Title
Measurements
OG0000
OG0010
OG0020
OG003
Febrile bone marrow aplasia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Folate deficiency
Title
Measurements
OG0001
OG0010
OG0020
OG003
Haematocrit increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Haptoglobin increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hepatocellular injury
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hydronephrosis
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypercholesterolaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hyperlipasaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypophysitis
Title
Measurements
OG0000
OG0010
OG0020
OG003
Iron deficiency
Title
Measurements
OG0000
OG0010
OG0020
OG003
Pancreatitis acute
Title
Measurements
OG0001
OG0010
OG0020
OG003
Procalcitonin increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Protein total decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Prothrombin time ratio increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Red blood cell count decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Red blood cells urine positive
Title
Measurements
OG0000
OG0010
OG0020
OG003
Renal disorder
Title
Measurements
OG0000
OG0010
OG0020
OG003
Thyroiditis
Title
Measurements
OG0000
OG0010
OG0020
OG003
Tri-iodothyronine increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Troponin T increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Type 2 diabetes mellitus
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants who had anti-programmed cell death-1 (PD-1)/programmed cell death ligand 1 (PD-L1) containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (primary resistance; PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (acquired resistance; ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who are ataxia telangiectasia mutated (ATM)-deficiecy received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD in each cycle between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with detectable genetic amplifications in rapamycin-insensitive companion of mechanistic target of rapamycin complex-2 (RICTOR) received IV infusion of durvalumab 1500 mg Q4W in combination with oral vistusertib 125 mg tablets BD on an intermittent dosing schedule of 2 days on, 5 days off, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with high expression of cluster of differentiation 73 (CD73) received IV infusion of oleclumab 3000 mg every 2 weeks (Q2W) for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours express human epidermal growth factor receptor 2 (HER2) mutations received IV infusion of trastuzumab deruxtecan (T-DXd) 5.4 mg/kg every 3 weeks (Q3W) in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours harbour selected HER2 mutations received IV infusion of T-DXd 5.4 mg/kg Q3W in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral cediranib (AZD2171) 20 mg tablets daily for 5 days on, 2 days off (starting on Cycle 1 Day 1 of durvalumab), until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
OG016
Module 8 Cohort A.8.ATM: Ceralasertib 240 mg
Participants who are ATM-deficient or with detectable aberrations in the ATM gene received oral ceralasertib (AZD6738) 240 mg tablets BD from Day 1 to Day 14 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W plus oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 160 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 160 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
OG021
Module 11 Cohort C.11.240: AZD6738 240 mg
Participants, independent of their molecular aberration status, received oral AZD6738 tablet 240 mg for 7 days (Days 1 to 7) in each 28-day cycle until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had anti-programmed cell death-1 (PD-1)/programmed cell death ligand 1 (PD-L1) containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (primary resistance; PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (acquired resistance; ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who are ataxia telangiectasia mutated (ATM)-deficiecy received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD in each cycle between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with detectable genetic amplifications in rapamycin-insensitive companion of mechanistic target of rapamycin complex-2 (RICTOR) received IV infusion of durvalumab 1500 mg Q4W in combination with oral vistusertib 125 mg tablets BD on an intermittent dosing schedule of 2 days on, 5 days off, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with high expression of cluster of differentiation 73 (CD73) received IV infusion of oleclumab 3000 mg every 2 weeks (Q2W) for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours express human epidermal growth factor receptor 2 (HER2) mutations received IV infusion of trastuzumab deruxtecan (T-DXd) 5.4 mg/kg every 3 weeks (Q3W) in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours harbour selected HER2 mutations received IV infusion of T-DXd 5.4 mg/kg Q3W in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral cediranib (AZD2171) 20 mg tablets daily for 5 days on, 2 days off (starting on Cycle 1 Day 1 of durvalumab), until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
OG016
Module 8 Cohort A.8.ATM: Ceralasertib 240 mg
Participants who are ATM-deficient or with detectable aberrations in the ATM gene received oral ceralasertib (AZD6738) 240 mg tablets BD from Day 1 to Day 14 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W plus oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 160 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 160 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
OG021
Module 11 Cohort C.11.240: AZD6738 240 mg
Participants, independent of their molecular aberration status, received oral AZD6738 tablet 240 mg for 7 days (Days 1 to 7) in each 28-day cycle until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Units
Counts
Participants
OG00021
OG00121
OG00222
OG00323
OG00423
OG00522
OG00631
OG00738
OG00858
OG0091
OG01023
OG0119
OG01225
OG01323
OG01420
OG01522
OG01615
OG01719
OG01824
OG01934
OG02017
OG02138
Title
Denominators
Categories
Weight decreased
Title
Measurements
OG0002
OG0010
OG0023
OG0031
OG0044
OG0052
OG0062
OG0073
OG00810
OG0090
OG0102
OG0110
OG0121
OG0135
OG0142
OG0155
OG0164
OG0171
OG0184
OG0191
OG0201
OG0219
Headache
Title
Measurements
OG0001
OG0010
OG0025
OG003
Dizziness
Title
Measurements
OG0001
OG0012
OG0024
OG003
Rash
Title
Measurements
OG0002
OG0011
OG0021
OG003
Dry skin
Title
Measurements
OG0002
OG0012
OG0020
OG003
Alopecia
Title
Measurements
OG0001
OG0011
OG0021
OG003
Dehydration
Title
Measurements
OG0000
OG0012
OG0020
OG003
Hypoxia
Title
Measurements
OG0001
OG0012
OG0020
OG003
Myalgia
Title
Measurements
OG0002
OG0011
OG0020
OG003
Rash maculo-papular
Title
Measurements
OG0001
OG0010
OG0020
OG003
Chronic obstructive pulmonary disease
Title
Measurements
OG0000
OG0010
OG0020
OG003
Tremor
Title
Measurements
OG0000
OG0010
OG0021
OG003
Erythema
Title
Measurements
OG0000
OG0010
OG0020
OG003
Rash pruritic
Title
Measurements
OG0001
OG0010
OG0020
OG003
Skin lesion
Title
Measurements
OG0000
OG0010
OG0020
OG003
Eczema
Title
Measurements
OG0000
OG0010
OG0020
OG003
Haematoma
Title
Measurements
OG0000
OG0010
OG0020
OG003
Skin hyperpigmentation
Title
Measurements
OG0000
OG0010
OG0020
OG003
Psoriasis
Title
Measurements
OG0000
OG0010
OG0020
OG003
Skin exfoliation
Title
Measurements
OG0000
OG0010
OG0020
OG003
Skin irritation
Title
Measurements
OG0000
OG0011
OG0020
OG003
Decubitus ulcer
Title
Measurements
OG0000
OG0010
OG0022
OG003
Orthostatic hypotension
Title
Measurements
OG0000
OG0010
OG0020
OG003
Skin disorder
Title
Measurements
OG0000
OG0010
OG0020
OG003
Urticaria
Title
Measurements
OG0000
OG0010
OG0020
OG003
Vena cava thrombosis
Title
Measurements
OG0000
OG0010
OG0020
OG003
Breath sounds
Title
Measurements
OG0000
OG0011
OG0020
OG003
Cardiac murmur
Title
Measurements
OG0000
OG0010
OG0020
OG003
Depressed level of consciousness
Title
Measurements
OG0000
OG0010
OG0020
OG003
Dermatitis acneiform
Title
Measurements
OG0000
OG0010
OG0020
OG003
Dermatitis allergic
Title
Measurements
OG0000
OG0010
OG0020
OG003
Dermatitis psoriasiform
Title
Measurements
OG0000
OG0010
OG0020
OG003
Ecchymosis
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphoedema
Title
Measurements
OG0000
OG0010
OG0020
OG003
Nail disorder
Title
Measurements
OG0000
OG0011
OG0020
OG003
Peripheral ischaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Petechiae
Title
Measurements
OG0000
OG0010
OG0020
OG003
Photosensitivity reaction
Title
Measurements
OG0000
OG0010
OG0020
OG003
Rash erythematous
Title
Measurements
OG0000
OG0010
OG0020
OG003
Rash macular
Title
Measurements
OG0000
OG0010
OG0020
OG003
Rash papular
Title
Measurements
OG0000
OG0010
OG0020
OG003
Rash pustular
Title
Measurements
OG0000
OG0010
OG0020
OG003
Seborrhoeic dermatitis
Title
Measurements
OG0000
OG0010
OG0020
OG003
Skin discolouration
Title
Measurements
OG0000
OG0010
OG0021
OG003
Skin induration
Title
Measurements
OG0000
OG0010
OG0020
OG003
Skin mass
Title
Measurements
OG0000
OG0010
OG0020
OG003
Skin ulcer
Title
Measurements
OG0000
OG0010
OG0020
OG003
Superior vena cava syndrome
Title
Measurements
OG0000
OG0010
OG0020
OG003
Transient ischaemic attack
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants who had anti-programmed cell death-1 (PD-1)/programmed cell death ligand 1 (PD-L1) containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (primary resistance; PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (acquired resistance; ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants received AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who are ataxia telangiectasia mutated (ATM)-deficiecy received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD in each cycle between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with detectable genetic amplifications in rapamycin-insensitive companion of mechanistic target of rapamycin complex-2 (RICTOR) received IV infusion of durvalumab 1500 mg Q4W in combination with oral vistusertib 125 mg tablets BD on an intermittent dosing schedule of 2 days on, 5 days off, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants with high expression of cluster of differentiation 73 (CD73) received IV infusion of oleclumab 3000 mg every 2 weeks (Q2W) for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours express human epidermal growth factor receptor 2 (HER2) mutations received IV infusion of trastuzumab deruxtecan (T-DXd) 5.4 mg/kg every 3 weeks (Q3W) in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants whose tumours harbour selected HER2 mutations received IV infusion of T-DXd 5.4 mg/kg Q3W in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W in combination with oral cediranib (AZD2171) 20 mg tablets daily for 5 days on, 2 days off (starting on Cycle 1 Day 1 of durvalumab), until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
OG016
Module 8 Cohort A.8.ATM: Ceralasertib 240 mg
Participants who are ATM-deficient or with detectable aberrations in the ATM gene received oral ceralasertib (AZD6738) 240 mg tablets BD from Day 1 to Day 14 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants who had progressive disease > 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) received IV infusion of durvalumab 1500 mg Q4W plus oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 160 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 160 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Participants, independent of their molecular aberration status, received oral ceralasertib (AZD6738) 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants received IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
OG021
Module 11 Cohort C.11.240: AZD6738 240 mg
Participants, independent of their molecular aberration status, received oral AZD6738 tablet 240 mg for 7 days (Days 1 to 7) in each 28-day cycle until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.
Units
Counts
Participants
OG00021
OG00121
OG00222
OG00323
OG00423
OG00522
OG00631
OG00738
OG00858
OG0091
OG01023
OG0119
OG01225
OG01323
OG01420
OG01522
OG01615
OG01719
OG01824
OG01934
OG02017
OG02138
Title
Denominators
Categories
Sinus tachycardia
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0062
OG0071
OG0082
OG0090
OG0100
OG0110
OG0120
OG0131
OG0141
OG0150
OG0160
OG0170
OG0180
OG0191
OG0200
OG0215
Tachycardia
Title
Measurements
OG0000
OG0010
OG0021
OG003
Atrial fibrillation
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cardiac failure
Title
Measurements
OG0000
OG0012
OG0020
OG003
Electrocardiogram QT prolonged
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cardiac arrest
Title
Measurements
OG0000
OG0010
OG0020
OG003
Arrhythmia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Ventricular extrasystoles
Title
Measurements
OG0000
OG0010
OG0020
OG003
Acute myocardial infarction
Title
Measurements
OG0000
OG0010
OG0020
OG003
Angina pectoris
Title
Measurements
OG0000
OG0010
OG0020
OG003
Atrial flutter
Title
Measurements
OG0000
OG0010
OG0020
OG003
Atrioventricular block second degree
Title
Measurements
OG0000
OG0010
OG0020
OG003
Bradycardia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Bundle branch block right
Title
Measurements
OG0000
OG0010
OG0020
OG003
Electrocardiogram RR interval prolonged
Title
Measurements
OG0000
OG0010
OG0020
OG003
Heart rate irregular
Title
Measurements
OG0000
OG0010
OG0020
OG003
Myocardial ischaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Myocarditis
Title
Measurements
OG0000
OG0010
OG0020
OG003
Myopericarditis
Title
Measurements
OG0000
OG0011
OG0020
OG003
Supraventricular tachycardia
Title
Measurements
OG0000
OG0010
OG0020
OG003
0 events
0 affected
23 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected22 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected38 at risk
EG0080 events0 affected58 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected23 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected23 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected22 at risk
EG0161 events1 affected15 at risk
EG0170 events0 affected19 at risk
EG0183 events3 affected24 at risk
EG0192 events2 affected34 at risk
EG0200 events0 affected17 at risk
EG0210 events0 affected38 at risk
0 events
0 affected
23 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected22 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected38 at risk
EG0080 events0 affected58 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected23 at risk
EG0110 events0 affected9 at risk
EG0121 events1 affected25 at risk
EG0130 events0 affected23 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected22 at risk
EG0160 events0 affected15 at risk
EG0170 events0 affected19 at risk
EG0180 events0 affected24 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected17 at risk
EG0210 events0 affected38 at risk
0 events
0 affected
23 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected22 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected38 at risk
EG0080 events0 affected58 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected23 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected23 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected22 at risk
EG0160 events0 affected15 at risk
EG0170 events0 affected19 at risk
EG0180 events0 affected24 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected17 at risk
EG0210 events0 affected38 at risk
0 events
0 affected
23 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected22 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected38 at risk
EG0080 events0 affected58 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected23 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected23 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected22 at risk
EG0160 events0 affected15 at risk
EG0170 events0 affected19 at risk
EG0180 events0 affected24 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected17 at risk
EG0211 events1 affected38 at risk
0 events
0 affected
23 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected22 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected38 at risk
EG0080 events0 affected58 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected23 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected23 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected22 at risk
EG0160 events0 affected15 at risk
EG0170 events0 affected19 at risk
EG0181 events1 affected24 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected17 at risk
EG0210 events0 affected38 at risk
0 events
0 affected
23 at risk
EG0041 events1 affected23 at risk
EG0050 events0 affected22 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected38 at risk
EG0080 events0 affected58 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected23 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected23 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected22 at risk
EG0160 events0 affected15 at risk
EG0170 events0 affected19 at risk
EG0180 events0 affected24 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected17 at risk
EG0210 events0 affected38 at risk
0 events
0 affected
23 at risk
EG0041 events1 affected23 at risk
EG0053 events2 affected22 at risk
EG0063 events2 affected31 at risk
EG0073 events3 affected38 at risk
EG0086 events5 affected58 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected23 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected25 at risk
EG0131 events1 affected23 at risk
EG0141 events1 affected20 at risk
EG0150 events0 affected22 at risk
EG0160 events0 affected15 at risk
EG0171 events1 affected19 at risk
EG0181 events1 affected24 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected17 at risk
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EG0080 events0 affected58 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected23 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected23 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected22 at risk
EG0160 events0 affected15 at risk
EG0170 events0 affected19 at risk
EG0180 events0 affected24 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected17 at risk
EG0210 events0 affected38 at risk
0 events
0 affected
23 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected22 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected38 at risk
EG0080 events0 affected58 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected23 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected23 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected22 at risk
EG0160 events0 affected15 at risk
EG0170 events0 affected19 at risk
EG0180 events0 affected24 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected17 at risk
EG0210 events0 affected38 at risk
0 events
0 affected
23 at risk
EG0041 events1 affected23 at risk
EG0050 events0 affected22 at risk
EG0062 events2 affected31 at risk
EG0071 events1 affected38 at risk
EG0081 events1 affected58 at risk
EG0090 events0 affected1 at risk
EG0102 events2 affected23 at risk
EG0110 events0 affected9 at risk
EG0123 events2 affected25 at risk
EG0131 events1 affected23 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected22 at risk
EG0161 events1 affected15 at risk
EG0170 events0 affected19 at risk
EG0182 events2 affected24 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected17 at risk
EG0210 events0 affected38 at risk
0 events
0 affected
23 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected22 at risk
EG0060 events0 affected31 at risk
EG0072 events2 affected38 at risk
EG0084 events3 affected58 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected23 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected25 at risk
EG0131 events1 affected23 at risk
EG0142 events2 affected20 at risk
EG0150 events0 affected22 at risk
EG0164 events4 affected15 at risk
EG0170 events0 affected19 at risk
EG0183 events3 affected24 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected17 at risk
EG0212 events2 affected38 at risk
0 events
0 affected
23 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected22 at risk
EG0061 events1 affected31 at risk
EG0071 events1 affected38 at risk
EG0081 events1 affected58 at risk
EG0090 events0 affected1 at risk
EG0102 events1 affected23 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected23 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected22 at risk
EG0163 events2 affected15 at risk
EG0175 events1 affected19 at risk
EG0182 events2 affected24 at risk
EG0190 events0 affected34 at risk
EG0201 events1 affected17 at risk
EG0212 events2 affected38 at risk
0 events
0 affected
23 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected22 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected38 at risk
EG0080 events0 affected58 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected23 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected23 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected22 at risk
EG0160 events0 affected15 at risk
EG0171 events1 affected19 at risk
EG0181 events1 affected24 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected17 at risk
EG0210 events0 affected38 at risk
0 events
0 affected
23 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected22 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected38 at risk
EG0080 events0 affected58 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected23 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected23 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected22 at risk
EG0160 events0 affected15 at risk
EG0170 events0 affected19 at risk
EG0180 events0 affected24 at risk
EG0190 events0 affected34 at risk
EG0201 events1 affected17 at risk
EG0210 events0 affected38 at risk
0 events
0 affected
23 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected22 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected38 at risk
EG0080 events0 affected58 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected23 at risk
EG0110 events0 affected9 at risk
EG0121 events1 affected25 at risk
EG0130 events0 affected23 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected22 at risk
EG0160 events0 affected15 at risk
EG0171 events1 affected19 at risk
EG0180 events0 affected24 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected17 at risk
EG0210 events0 affected38 at risk
0 events
0 affected
23 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected22 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected38 at risk
EG0080 events0 affected58 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected23 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected23 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected22 at risk
EG0161 events1 affected15 at risk
EG0170 events0 affected19 at risk
EG0180 events0 affected24 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected17 at risk
EG0210 events0 affected38 at risk
0 events
0 affected
23 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected22 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected38 at risk
EG0080 events0 affected58 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected23 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected23 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected22 at risk
EG0160 events0 affected15 at risk
EG0171 events1 affected19 at risk
EG0180 events0 affected24 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected17 at risk
EG0210 events0 affected38 at risk
0 events
0 affected
23 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected22 at risk
EG0060 events0 affected31 at risk
EG0071 events1 affected38 at risk
EG0080 events0 affected58 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected23 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected23 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected22 at risk
EG0160 events0 affected15 at risk
EG0170 events0 affected19 at risk
EG0182 events2 affected24 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected17 at risk
EG0210 events0 affected38 at risk
26.1
(14.3 to 41.3)
OG0040(0.0 to 9.5)
OG00527.3(15.0 to 43.0)
OG00658.1(45.0 to 70.3)
OG00727.0(17.5 to 38.5)
OG00834.5(26.2 to 43.7)
OG009NA(NA to NA)No efficacy data were collected as the module was prematurely discontinued by the sponsor for strategic reasons. At the time of decision to discontinue the module, only a single participant had received treatment, and only safety data were collected on that participant.