Trial Outcomes & Findings for Olaparib, Durvalumab, and Tremelimumab in Treating Patients With Recurrent or Refractory Ovarian, Fallopian Tube or Primary Peritoneal Cancer With BRCA1 or BRCA2 Mutation (NCT NCT02953457)

Last Updated: 2024-11-19

Results Overview

The maximum tolerated dose is defined as the highest dose studied, for which the observed incidence of DLT is less than 33%. Number of Participants with Dose-limiting Toxicities (DLTs) in Phase I and Phase II will be reported.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Up to 8 weeks

Results posted on

2024-11-19

Participant Flow

Participant milestones

Participant milestones
Measure	Phase I Treatment (Olaparib, Tremelimumab, Durvalumab) Durvalumab 1500 mg + Tremelimumab 75 mg + Olaparib 300 mg Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies Olaparib: Given PO Tremelimumab: Given IV	Phase II Treatment (Olaparib, Tremelimumab, Durvalumab) - Platinum Resistant Patients Durvalumab 1500 mg + Tremelimumab 75 mg + Olaparib 250 mg Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies Olaparib: Given PO Tremelimumab: Given IV Patients are Platinum Resistant	Phase II Treatment (Olaparib, Tremelimumab, Durvalumab) - Platinum Sensitive Patients Durvalumab 1500 mg + Tremelimumab 75 mg + Olaparib 250 mg Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies Olaparib: Given PO Tremelimumab: Given IV Patients are Platinum Sensitive
Overall Study STARTED	10	20	10
Overall Study COMPLETED	10	20	10
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Olaparib, Durvalumab, and Tremelimumab in Treating Patients With Recurrent or Refractory Ovarian, Fallopian Tube or Primary Peritoneal Cancer With BRCA1 or BRCA2 Mutation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I Treatment (Olaparib, Tremelimumab, Durvalumab) n=10 Participants Durvalumab 1500 mg + Tremelimumab 75 mg + Olaparib 300 mg Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies Olaparib: Given PO Tremelimumab: Given IV	Phase II Treatment (Olaparib, Tremelimumab, Durvalumab) - Platinum Resistant Patients n=20 Participants Durvalumab 1500 mg + Tremelimumab 75 mg + Olaparib 250 mg Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Patients are Platinum Sensitive. Laboratory Biomarker Analysis: Correlative studies Olaparib: Given PO Tremelimumab: Given IV Patients are Platinum Resistant	Phase II Treatment (Olaparib, Tremelimumab, Durvalumab) - Platinum Sensitive Patients n=10 Participants Durvalumab 1500 mg + Tremelimumab 75 mg + Olaparib 250 mg Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Patients are Platinum Sensitive. Laboratory Biomarker Analysis: Correlative studies Olaparib: Given PO Tremelimumab: Given IV Patients are Platinum Sensitive .	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	13 Participants n=7 Participants	7 Participants n=5 Participants	25 Participants n=4 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	15 Participants n=4 Participants
Age, Continuous	65 years STANDARD_DEVIATION 6.6 • n=5 Participants	61 years STANDARD_DEVIATION 10.0 • n=7 Participants	60 years STANDARD_DEVIATION 10.6 • n=5 Participants	61 years STANDARD_DEVIATION 9.5 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	20 Participants n=7 Participants	10 Participants n=5 Participants	40 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	19 Participants n=7 Participants	10 Participants n=5 Participants	39 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 8 weeks

Outcome measures

Outcome measures
Measure	Phase I Treatment (Olaparib, Tremelimumab, Durvalumab) n=10 Participants Durvalumab 1500 mg + Tremelimumab 75 mg + Olaparib 300 mg Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies Olaparib: Given PO Tremelimumab: Given IV	Phase II Treatment (Olaparib, Tremelimumab, Durvalumab) - Platinum Resistant Patients n=20 Participants Durvalumab 1500 mg + Tremelimumab 75 mg + Olaparib 250mg Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies Olaparib: Given PO Tremelimumab: Given IV Patients are Platinum Resistant	Phase II Treatment (Olaparib, Tremelimumab, Durvalumab) - Platinum Sensitive Patients n=10 Participants Durvalumab 1500 mg + Tremelimumab 75 mg + Olaparib 250 mg Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Patients are Platinum Sensitive. Laboratory Biomarker Analysis: Correlative studies Olaparib: Given PO Tremelimumab: Given IV Patients are Platinum Sensitive
Incidence of Dose-limiting Toxicities (DLTs) Defined as the Rate of Drug-related Grade 3-5 Adverse Events Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (Phase I)	2 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At 3 months

Progression free survival (PFS) rate will be assessed at 3 months in the platinum resistant group using Kaplan-Meier methods. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Phase I Treatment (Olaparib, Tremelimumab, Durvalumab) n=10 Participants Durvalumab 1500 mg + Tremelimumab 75 mg + Olaparib 300 mg Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies Olaparib: Given PO Tremelimumab: Given IV	Phase II Treatment (Olaparib, Tremelimumab, Durvalumab) - Platinum Resistant Patients n=20 Participants Durvalumab 1500 mg + Tremelimumab 75 mg + Olaparib 250mg Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies Olaparib: Given PO Tremelimumab: Given IV Patients are Platinum Resistant	Phase II Treatment (Olaparib, Tremelimumab, Durvalumab) - Platinum Sensitive Patients n=10 Participants Durvalumab 1500 mg + Tremelimumab 75 mg + Olaparib 250 mg Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Patients are Platinum Sensitive. Laboratory Biomarker Analysis: Correlative studies Olaparib: Given PO Tremelimumab: Given IV Patients are Platinum Sensitive
3 Month Progression Free Survival (PFS) in the All Eligible Patients by Group/Arm	0.5 Proportion of participants Interval 0.23 to 0.72	0.42 Proportion of participants Interval 0.24 to 0.6	0.88 Proportion of participants Interval 0.5 to 0.97

PRIMARY outcome

Timeframe: At 6 months

6-month progression-free survival rate is the probability of patients remaining alive and progression-free at 6 months from study entry estimated using Kaplan-Meier methods. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesion

Outcome measures

Outcome measures
Measure	Phase I Treatment (Olaparib, Tremelimumab, Durvalumab) n=10 Participants Durvalumab 1500 mg + Tremelimumab 75 mg + Olaparib 300 mg Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies Olaparib: Given PO Tremelimumab: Given IV	Phase II Treatment (Olaparib, Tremelimumab, Durvalumab) - Platinum Resistant Patients n=20 Participants Durvalumab 1500 mg + Tremelimumab 75 mg + Olaparib 250mg Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies Olaparib: Given PO Tremelimumab: Given IV Patients are Platinum Resistant	Phase II Treatment (Olaparib, Tremelimumab, Durvalumab) - Platinum Sensitive Patients n=10 Participants Durvalumab 1500 mg + Tremelimumab 75 mg + Olaparib 250 mg Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Patients are Platinum Sensitive. Laboratory Biomarker Analysis: Correlative studies Olaparib: Given PO Tremelimumab: Given IV Patients are Platinum Sensitive
6 Month Progression Free Survival (PFS) in the Platinum Sensitive Group (Phase II)	0.27 Proportion of participants Interval 0.07 to 0.52	0.21 Proportion of participants Interval 0.08 to 0.38	0.60 Proportion of participants Interval 0.26 to 0.82

SECONDARY outcome

Timeframe: At 12 weeks

Tumor biopsy samples will be examined to evaluate the correlation between clinical activity and the expression level of PD-L1 and tumor-infiltrating lymphocytes changes in biopsies pre and post treatment.

Outcome measures

Outcome measures
Measure	Phase I Treatment (Olaparib, Tremelimumab, Durvalumab) n=10 Participants Durvalumab 1500 mg + Tremelimumab 75 mg + Olaparib 300 mg Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies Olaparib: Given PO Tremelimumab: Given IV	Phase II Treatment (Olaparib, Tremelimumab, Durvalumab) - Platinum Resistant Patients n=20 Participants Durvalumab 1500 mg + Tremelimumab 75 mg + Olaparib 250mg Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies Olaparib: Given PO Tremelimumab: Given IV Patients are Platinum Resistant	Phase II Treatment (Olaparib, Tremelimumab, Durvalumab) - Platinum Sensitive Patients n=10 Participants Durvalumab 1500 mg + Tremelimumab 75 mg + Olaparib 250 mg Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Patients are Platinum Sensitive. Laboratory Biomarker Analysis: Correlative studies Olaparib: Given PO Tremelimumab: Given IV Patients are Platinum Sensitive
Anti-tumor Immune Response of the Treatment Combination Assessed in Tumor Biopsy Immune-related Partial Response (irPR)	1 Participants	1 Participants	1 Participants
Anti-tumor Immune Response of the Treatment Combination Assessed in Tumor Biopsy Immune-related Stable Disease (irSD)	4 Participants	7 Participants	6 Participants
Anti-tumor Immune Response of the Treatment Combination Assessed in Tumor Biopsy Immune-related Progressive Disease(irPD)	4 Participants	6 Participants	1 Participants
Anti-tumor Immune Response of the Treatment Combination Assessed in Tumor Biopsy NE Not Evaluable	0 Participants	3 Participants	2 Participants
Anti-tumor Immune Response of the Treatment Combination Assessed in Tumor Biopsy Too early	1 Participants	3 Participants	0 Participants

SECONDARY outcome

Timeframe: 35 months

OS will be summarized and analyzed descriptively via summary frequencies and Kaplan-Meier estimators.

Outcome measures

Outcome measures
Measure	Phase I Treatment (Olaparib, Tremelimumab, Durvalumab) n=10 Participants Durvalumab 1500 mg + Tremelimumab 75 mg + Olaparib 300 mg Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies Olaparib: Given PO Tremelimumab: Given IV	Phase II Treatment (Olaparib, Tremelimumab, Durvalumab) - Platinum Resistant Patients n=20 Participants Durvalumab 1500 mg + Tremelimumab 75 mg + Olaparib 250mg Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies Olaparib: Given PO Tremelimumab: Given IV Patients are Platinum Resistant	Phase II Treatment (Olaparib, Tremelimumab, Durvalumab) - Platinum Sensitive Patients n=10 Participants Durvalumab 1500 mg + Tremelimumab 75 mg + Olaparib 250 mg Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Patients are Platinum Sensitive. Laboratory Biomarker Analysis: Correlative studies Olaparib: Given PO Tremelimumab: Given IV Patients are Platinum Sensitive
Overall Survival (OS)	14.9 Months Interval 4.6 to 34.2	9.1 Months Interval 5.9 to 14.0	21.6 Months Interval 10.8 to Upper limit of median Overall Survival is not reached

Adverse Events

Phase I Treatment (Olaparib, Tremelimumab, Durvalumab)

Serious events: 1 serious events

Other events: 10 other events

Deaths: 8 deaths

Phase II Treatment (Olaparib, Tremelimumab, Durvalumab) - Platinum Resistant Patients

Serious events: 8 serious events

Other events: 20 other events

Deaths: 15 deaths

Phase II Treatment (Olaparib, Tremelimumab, Durvalumab) - Platinum Sensitive Patients

Serious events: 7 serious events

Other events: 9 other events

Deaths: 4 deaths

Serious adverse events

Other adverse events

Additional Information

Katy Wang

Roswell Park Comprehensive Cancer Center

Phone: 716-845-1300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Phase I Treatment (Olaparib, Tremelimumab, Durvalumab) n=10 participants at risk Durvalumab 1500 mg + Tremelimumab 75 mg + Olaparib 300 mg Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies Olaparib: Given PO Tremelimumab: Given IV	Phase II Treatment (Olaparib, Tremelimumab, Durvalumab) - Platinum Resistant Patients n=20 participants at risk Durvalumab 1500 mg + Tremelimumab 75 mg + Olaparib 250mg Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies Olaparib: Given PO Tremelimumab: Given IV Patients are Platinum Resistant	Phase II Treatment (Olaparib, Tremelimumab, Durvalumab) - Platinum Sensitive Patients n=10 participants at risk Durvalumab 1500 mg + Tremelimumab 75 mg + Olaparib 250 mg Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Patients are Platinum Sensitive. Laboratory Biomarker Analysis: Correlative studies Olaparib: Given PO Tremelimumab: Given IV Patients are Platinum Sensitive
Cardiac disorders Atrial fibrillation	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Endocrine disorders Adrenal insufficiency	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/20 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Endocrine disorders Hypothyroidism	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/20 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Eye disorders Optic nerve disorder	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/20 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Gastrointestinal disorders Abdominal pain	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Gastrointestinal disorders Ascites	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/20 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Gastrointestinal disorders Diarrhoea	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Gastrointestinal disorders Intestinal perforation	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Gastrointestinal disorders Pancreatitis	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Gastrointestinal disorders Small intestinal obstruction	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	20.0% 2/10 • Number of events 2 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Gastrointestinal disorders Vomiting	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/20 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
General disorders Fatigue	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Immune system disorders Autoimmune disorder	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/20 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Infections and infestations Lung infection	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/20 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Infections and infestations Sepsis	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Infections and infestations Urosepsis	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Metabolism and nutrition disorders Dehydration	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/20 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Nervous system disorders Cerebrovascular accident	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Nervous system disorders Seizure	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Reproductive system and breast disorders Pelvic pain	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.

Other adverse events
Measure	Phase I Treatment (Olaparib, Tremelimumab, Durvalumab) n=10 participants at risk Durvalumab 1500 mg + Tremelimumab 75 mg + Olaparib 300 mg Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies Olaparib: Given PO Tremelimumab: Given IV	Phase II Treatment (Olaparib, Tremelimumab, Durvalumab) - Platinum Resistant Patients n=20 participants at risk Durvalumab 1500 mg + Tremelimumab 75 mg + Olaparib 250mg Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies Olaparib: Given PO Tremelimumab: Given IV Patients are Platinum Resistant	Phase II Treatment (Olaparib, Tremelimumab, Durvalumab) - Platinum Sensitive Patients n=10 participants at risk Durvalumab 1500 mg + Tremelimumab 75 mg + Olaparib 250 mg Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Patients are Platinum Sensitive. Laboratory Biomarker Analysis: Correlative studies Olaparib: Given PO Tremelimumab: Given IV Patients are Platinum Sensitive
Investigations Weight increased	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	10.0% 2/20 • Number of events 2 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Metabolism and nutrition disorders Decreased appetite	30.0% 3/10 • Number of events 3 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	45.0% 9/20 • Number of events 9 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	30.0% 3/10 • Number of events 3 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Musculoskeletal and connective tissue disorders Arthralgia	30.0% 3/10 • Number of events 3 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Musculoskeletal and connective tissue disorders Back pain	10.0% 1/10 • Number of events 2 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	20.0% 4/20 • Number of events 5 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	20.0% 2/10 • Number of events 2 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Musculoskeletal and connective tissue disorders Limb discomfort	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/20 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/20 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/20 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Nervous system disorders Dizziness	20.0% 2/10 • Number of events 2 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	20.0% 4/20 • Number of events 4 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Nervous system disorders Dysgeusia	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	15.0% 3/20 • Number of events 3 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Nervous system disorders Facial paralysis	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Nervous system disorders Headache	30.0% 3/10 • Number of events 3 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	15.0% 3/20 • Number of events 3 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	20.0% 2/10 • Number of events 4 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Nervous system disorders Neuropathy peripheral	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Nervous system disorders Syncope	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	15.0% 3/20 • Number of events 3 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Psychiatric disorders Anxiety	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/20 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Psychiatric disorders Confusional state	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Psychiatric disorders Depression	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Psychiatric disorders Insomnia	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	15.0% 3/20 • Number of events 3 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Psychiatric disorders Mood altered	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/20 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Renal and urinary disorders Dysuria	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	10.0% 1/10 • Number of events 2 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Renal and urinary disorders Micturition urgency	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/20 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Renal and urinary disorders Pollakiuria	20.0% 2/10 • Number of events 2 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/20 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Renal and urinary disorders Urinary incontinence	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/20 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Renal and urinary disorders Urinary tract disorder	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Reproductive system and breast disorders Pelvic pain	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/20 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Respiratory, thoracic and mediastinal disorders Cough	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	30.0% 6/20 • Number of events 6 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Respiratory, thoracic and mediastinal disorders Dyspnoea	30.0% 3/10 • Number of events 3 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	25.0% 5/20 • Number of events 6 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	20.0% 2/10 • Number of events 2 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	10.0% 2/20 • Number of events 2 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	15.0% 3/20 • Number of events 6 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Respiratory, thoracic and mediastinal disorders Pneumonitis	10.0% 1/10 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Blood and lymphatic system disorders Anaemia	20.0% 2/10 • Number of events 10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	35.0% 7/20 • Number of events 7 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Blood and lymphatic system disorders Leukopenia	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	15.0% 3/20 • Number of events 4 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.
Cardiac disorders Atrial fibrillation	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	5.0% 1/20 • Number of events 1 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.	0.00% 0/10 • All-Cause Morality was assessed up to 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 8 weeks. An adverse event or adverse experience (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product.