Trial Outcomes & Findings for Phase 1/2 Study of Combination Immunotherapy and Messenger Ribonucleic Acid (mRNA) Vaccine in Subjects With NSCLC (NCT NCT03164772)

NCT ID: NCT03164772

Last Updated: 2022-10-10

Results Overview

Adverse events (AEs) were coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version 20.0 and classified by MedDRA system organ class (SOC) and preferred term. The severity was assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03. AEs were reported based on clinical laboratory tests, vital signs, physical examinations, and any other medically indicated assessments, including subject interviews, from the time informed consent was signed through 90 days after the last dose of study treatment. TEAEs are AEs that occurred or worsened in severity after administration of the first dose of study treatment. For each arm, the first 6 subjects were evaluated for dose limiting toxicities (DLTs). Deaths within the AE Reporting Period included all deaths that occurred during the study treatment period, or up to 90 days after the administration of the last dose of study drug or initiation of a new treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 61 participants
• Primary outcome timeframe: up to 15 months
• Results posted on: 2022-10-10

Participant Flow

61 subjects were enrolled; 24 into Arm A and 37 into Arm B. Of these 61 subjects, 57 were treated with at least one dose of study treatment; 23 in Arm A and 34 in Arm B. No dose adjustments were made and as a result all patients treated in each arm are presented.

Participant milestones

Measure	Arm A: BI 1361849 mRNA Vaccine + Durvalumab The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 BI 1361849: mRNA Vaccine	Arm B: BI 1361849 mRNA Vaccine + Durvalumab + Tremelimumab The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 was to be administered as an intravenous (IV) infusion every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 Tremelimumab: anti-CTLA-4 BI 1361849: mRNA Vaccine
Overall Study STARTED	23	34
Overall Study COMPLETED	5	3
Overall Study NOT COMPLETED	18	31

Reasons for withdrawal

Measure	Arm A: BI 1361849 mRNA Vaccine + Durvalumab The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 BI 1361849: mRNA Vaccine	Arm B: BI 1361849 mRNA Vaccine + Durvalumab + Tremelimumab The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 was to be administered as an intravenous (IV) infusion every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 Tremelimumab: anti-CTLA-4 BI 1361849: mRNA Vaccine
Overall Study Death	4	2
Overall Study Adverse Event	1	4
Overall Study Progressive Disease	11	21
Overall Study Physician Decision	2	0
Overall Study Withdrawal by Subject	0	4

Baseline Characteristics

Phase 1/2 Study of Combination Immunotherapy and Messenger Ribonucleic Acid (mRNA) Vaccine in Subjects With NSCLC

Baseline characteristics by cohort

Measure	Arm A: BI 1361849 mRNA Vaccine + Durvalumab n=23 Participants The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 BI 1361849: mRNA Vaccine	Arm B: BI 1361849 mRNA Vaccine + Durvalumab + Tremelimumab n=34 Participants The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 mg was to be administered every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 Tremelimumab: anti-CTLA-4 BI 1361849: mRNA Vaccine	Total n=57 Participants Total of all reporting groups
Age, Continuous	64.9 years STANDARD_DEVIATION 9.62 • n=5 Participants	64.5 years STANDARD_DEVIATION 11.76 • n=7 Participants	64.7 years STANDARD_DEVIATION 10.86 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	24 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	31 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 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
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	28 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants	34 participants n=7 Participants	57 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline PS 0	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline PS 1	15 Participants n=5 Participants	26 Participants n=7 Participants	41 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline PS 2	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 15 months

Population: All subjects who received at least one dose of study medication.

Adverse events (AEs) were coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version 20.0 and classified by MedDRA system organ class (SOC) and preferred term. The severity was assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03. AEs were reported based on clinical laboratory tests, vital signs, physical examinations, and any other medically indicated assessments, including subject interviews, from the time informed consent was signed through 90 days after the last dose of study treatment. TEAEs are AEs that occurred or worsened in severity after administration of the first dose of study treatment.

For each arm, the first 6 subjects were evaluated for dose limiting toxicities (DLTs).

Deaths within the AE Reporting Period included all deaths that occurred during the study treatment period, or up to 90 days after the administration of the last dose of study drug or initiation of a new treatment.

Outcome measures

Measure	Arm A: BI 1361849 mRNA Vaccine + Durvalumab n=23 Participants The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 BI 1361849: mRNA Vaccine	Arm B: BI 1361849 mRNA Vaccine + Durvalumab + Tremelimumab n=34 Participants The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose.The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 mg was to be administered every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 Tremelimumab: anti-CTLA-4 BI 1361849: mRNA Vaccine
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Treatment-emergent Adverse Event (TEAE)	23 Participants	33 Participants
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Treatment-related Adverse Event (TRAE)	13 Participants	19 Participants
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Treatment-emergent Serious Adverse Event (SAE)	14 Participants	22 Participants
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Treatment-related SAE	1 Participants	3 Participants
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) TEAE leading to treatment discontinuation	5 Participants	8 Participants
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Deaths Within the AE Reporting Period	5 Participants	7 Participants
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) DLTs	0 Participants	1 Participants

SECONDARY outcome

Timeframe: up to 15 months

Population: All subjects who received at least one dose of study medication.

Progression Free Survival (PFS) was measured from the date of the first dose of study treatment to the date of earliest disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or to the date of death, if disease progression did not occur. Per RECIST 1.1, progressive disease (PD) is defined as a ≥ 20% increase in the sum of the longest diameter of target lesions or the presence of new lesions.

Outcome measures

Measure	Arm A: BI 1361849 mRNA Vaccine + Durvalumab n=23 Participants The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 BI 1361849: mRNA Vaccine	Arm B: BI 1361849 mRNA Vaccine + Durvalumab + Tremelimumab n=34 Participants The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose.The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 mg was to be administered every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 Tremelimumab: anti-CTLA-4 BI 1361849: mRNA Vaccine
Median PFS by RECIST 1.1 as Estimated Using the Kaplan-Meier Method	2 months Interval 1.8 to 7.3	1.8 months Interval 1.2 to 2.8

SECONDARY outcome

Timeframe: up to 24 weeks

Population: All subjects who received at least one dose of study medication.

Progression-free Survival (PFS) was measured from the date of the first dose of study treatment to the date of earliest disease progression or to the date of death, if disease progression did not occur. Per RECIST 1.1, progressive disease (PD) is defined as a ≥ 20% increase in the sum of the longest diameter of target lesions or the presence of new lesions.

Outcome measures

Measure	Arm A: BI 1361849 mRNA Vaccine + Durvalumab n=23 Participants The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 BI 1361849: mRNA Vaccine	Arm B: BI 1361849 mRNA Vaccine + Durvalumab + Tremelimumab n=34 Participants The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose.The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 mg was to be administered every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 Tremelimumab: anti-CTLA-4 BI 1361849: mRNA Vaccine
Number of Subjects Without Progression at 8 and 24 Weeks by RECIST 1.1 Number of Subjects Without Progression at Week 8	11 Participants	11 Participants
Number of Subjects Without Progression at 8 and 24 Weeks by RECIST 1.1 Number of Subjects Without Progression at Week 24	8 Participants	3 Participants

SECONDARY outcome

Timeframe: up to 15 months

Population: All subjects who received at least one dose of study medication.

Progression-free Survival (PFS) was measured from the date of the first dose of study treatment to the date of earliest disease progression according to immune related Response Evaluation Criteria in Solid Tumors (irRECIST) or to the date of death, if disease progression did not occur. Per irRECIST, progressive disease (irPD) is defined as a ≥ 20% increase from nadir in the total measurable tumor burden (TMTB).

Outcome measures

Measure	Arm A: BI 1361849 mRNA Vaccine + Durvalumab n=23 Participants The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 BI 1361849: mRNA Vaccine	Arm B: BI 1361849 mRNA Vaccine + Durvalumab + Tremelimumab n=34 Participants The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose.The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 mg was to be administered every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 Tremelimumab: anti-CTLA-4 BI 1361849: mRNA Vaccine
Median PFS by irRECIST as Estimated Using the Kaplan-Meier Method	2 months Interval 1.8 to 13.6	1.8 months Interval 1.2 to 2.8

SECONDARY outcome

Timeframe: up to 24 weeks

Population: All subjects who received at least one dose of study medication.

Progression-free Survival (PFS) was measured from the date of the first dose of study treatment to the date of earliest disease progression or to the date of death, if disease progression did not occur. Per irRECIST, progressive disease (irPD) is defined as a ≥ 20% increase from nadir in the total measurable tumor burden (TMTB).

Outcome measures

Measure	Arm A: BI 1361849 mRNA Vaccine + Durvalumab n=23 Participants The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 BI 1361849: mRNA Vaccine	Arm B: BI 1361849 mRNA Vaccine + Durvalumab + Tremelimumab n=34 Participants The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose.The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 mg was to be administered every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 Tremelimumab: anti-CTLA-4 BI 1361849: mRNA Vaccine
Number of Subjects Without Progression at 8 and 24 Weeks by irRECIST Number of Subjects Without Progression at Week 8	11 Participants	11 Participants
Number of Subjects Without Progression at 8 and 24 Weeks by irRECIST Number of Subjects Without Progression at Week 24	10 Participants	3 Participants

SECONDARY outcome

Timeframe: up to 15 months

Population: All subjects who received at least one dose of study medication, had baseline and at least one post-baseline tumor assessment.

Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5, 7, 9, and 11 during study treatment, and during on-study follow-up every 8 weeks starting 8 weeks after the last disease assessment. Per RECIST 1.1, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions; partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; PD: ≥ 20% increase in the sum of the longest diameter of target lesions or the presence of new lesions; stable disease (SD): small changes that do not meet above criteria.

Outcome measures

Measure	Arm A: BI 1361849 mRNA Vaccine + Durvalumab n=19 Participants The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 BI 1361849: mRNA Vaccine	Arm B: BI 1361849 mRNA Vaccine + Durvalumab + Tremelimumab n=27 Participants The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose.The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 mg was to be administered every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 Tremelimumab: anti-CTLA-4 BI 1361849: mRNA Vaccine
Number of Subjects With Best Overall Tumor Response By RECIST 1.1 CR	0 Participants	0 Participants
Number of Subjects With Best Overall Tumor Response By RECIST 1.1 PR	5 Participants	3 Participants
Number of Subjects With Best Overall Tumor Response By RECIST 1.1 SD	7 Participants	8 Participants
Number of Subjects With Best Overall Tumor Response By RECIST 1.1 PD	7 Participants	16 Participants

SECONDARY outcome

Timeframe: up to 24 weeks

Population: All subjects who received at least one dose of study medication.

Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5, 7, 9, and 11 during study treatment, and during on-study follow-up every 8 weeks starting 8 weeks after the last disease assessment. Per RECIST 1.1, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions; partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; PD: ≥ 20% increase in the sum of the longest diameter of target lesions or presence of new lesions; stable disease (SD): small changes that do not meet above criteria. An Objective Response is defined as a CR or PR over a period of at least 4 weeks.

Outcome measures

Measure	Arm A: BI 1361849 mRNA Vaccine + Durvalumab n=23 Participants The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 BI 1361849: mRNA Vaccine	Arm B: BI 1361849 mRNA Vaccine + Durvalumab + Tremelimumab n=34 Participants The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose.The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 mg was to be administered every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 Tremelimumab: anti-CTLA-4 BI 1361849: mRNA Vaccine
Number of Subjects With Objective Responses at 8 and 24 Weeks By RECIST 1.1 Week 8 · Number of Subjects With an Objective Response	5 Participants	0 Participants
Number of Subjects With Objective Responses at 8 and 24 Weeks By RECIST 1.1 Week 8 · Number of Subjects Without an Objective Response	18 Participants	34 Participants
Number of Subjects With Objective Responses at 8 and 24 Weeks By RECIST 1.1 Week 24 · Number of Subjects With an Objective Response	4 Participants	1 Participants
Number of Subjects With Objective Responses at 8 and 24 Weeks By RECIST 1.1 Week 24 · Number of Subjects Without an Objective Response	19 Participants	33 Participants

SECONDARY outcome

Timeframe: up to 15 months

Population: All subjects who received at least one dose of study medication, had baseline and at least one post-baseline tumor assessment and had a response of CR or PR.

Duration of Response (DoR) was defined as the interval between the date of earliest determination of CR or PR to the date of earliest determination of progressive disease (PD), clinical progression or death, whatever occurred first.

Outcome measures

Measure	Arm A: BI 1361849 mRNA Vaccine + Durvalumab n=5 Participants The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 BI 1361849: mRNA Vaccine	Arm B: BI 1361849 mRNA Vaccine + Durvalumab + Tremelimumab n=3 Participants The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose.The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 mg was to be administered every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 Tremelimumab: anti-CTLA-4 BI 1361849: mRNA Vaccine
Duration of Response (DoR) By RECIST 1.1	43.1 weeks Interval 24.1 to 53.5	25.1 weeks Interval 23.2 to 27.5

SECONDARY outcome

Timeframe: up to 15 months

Population: All subjects who received at least one dose of study medication, had baseline and at least one post-baseline tumor assessment.

Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5, 7, 9, and 11 during study treatment, and during on-study follow-up every 8 weeks starting 8 weeks after the last disease assessment. Per irRECIST, responses are categorized as follows: Complete Response (irCR): Complete disappearance of all target lesions; Partial Response (irPR): ≥ 30% decrease from baseline in the total measurable tumor burden (TMTB); Progressive Disease (irPD): ≥ 20% increase from nadir in TMTB; Stable Disease (irSD): not meeting above criteria.

Outcome measures

Measure	Arm A: BI 1361849 mRNA Vaccine + Durvalumab n=19 Participants The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 BI 1361849: mRNA Vaccine	Arm B: BI 1361849 mRNA Vaccine + Durvalumab + Tremelimumab n=27 Participants The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose.The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 mg was to be administered every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 Tremelimumab: anti-CTLA-4 BI 1361849: mRNA Vaccine
Number of Subjects With Best Overall Tumor Response By irRECIST irSD	7 Participants	8 Participants
Number of Subjects With Best Overall Tumor Response By irRECIST irCR	0 Participants	0 Participants
Number of Subjects With Best Overall Tumor Response By irRECIST irPR	5 Participants	3 Participants
Number of Subjects With Best Overall Tumor Response By irRECIST irPD	7 Participants	16 Participants

SECONDARY outcome

Timeframe: up to 24 weeks

Population: All subjects who received at least one dose of study medication.

Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5, 7, 9, and 11 during study treatment, and during on-study follow-up every 8 weeks starting 8 weeks after the last disease assessment. Per irRECIST, responses are categorized as follows: irCR: Complete disappearance of all target lesions; irPR: ≥ 30% decrease from baseline in the total measurable tumor burden (TMTB); irPD: ≥ 20% increase from nadir in TMTB; irSD: not meeting above criteria.

An Objective Response is defined as an irCR or irPR over a period of at least 4 weeks.

Outcome measures

Measure	Arm A: BI 1361849 mRNA Vaccine + Durvalumab n=23 Participants The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 BI 1361849: mRNA Vaccine	Arm B: BI 1361849 mRNA Vaccine + Durvalumab + Tremelimumab n=34 Participants The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose.The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 mg was to be administered every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 Tremelimumab: anti-CTLA-4 BI 1361849: mRNA Vaccine
Number of Subjects With Objective Responses at 8 and 24 Weeks By irRECIST Week 8 · Number of Subjects With an Objective Response	5 Participants	0 Participants
Number of Subjects With Objective Responses at 8 and 24 Weeks By irRECIST Week 8 · Number of Subjects Without an Objective Response	18 Participants	34 Participants
Number of Subjects With Objective Responses at 8 and 24 Weeks By irRECIST Week 24 · Number of Subjects With an Objective Response	4 Participants	1 Participants
Number of Subjects With Objective Responses at 8 and 24 Weeks By irRECIST Week 24 · Number of Subjects Without an Objective Response	19 Participants	33 Participants

SECONDARY outcome

Timeframe: Up tp 15 months

Population: All subjects who received at least one dose of study medication, had baseline and at least one post-baseline tumor assessment and had a response of irCR or irPR.

Duration of Response (DoR) was defined as the interval between the date of earliest determination of irCR or irPR to the date of earliest determination of progressive disease (irPD), clinical progression or death, whatever occurred first.

Outcome measures

Measure	Arm A: BI 1361849 mRNA Vaccine + Durvalumab n=5 Participants The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 BI 1361849: mRNA Vaccine	Arm B: BI 1361849 mRNA Vaccine + Durvalumab + Tremelimumab n=3 Participants The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose.The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 mg was to be administered every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 Tremelimumab: anti-CTLA-4 BI 1361849: mRNA Vaccine
Duration of Response (DoR) by irRECIST	43.1 weeks Interval 24.1 to 53.5	25.1 weeks Interval 23.2 to 27.5

SECONDARY outcome

Timeframe: up to October 29, 2021

Population: All subjects who received at least one dose of study medication.

After completion of treatment, all subjects were followed for survival every 6 months following initiation of study treatment until October 29, 2021 when all post-study follow-up was completed. OS was measured from the date of the first dose of study treatment to the date of death or last follow-up. Subjects lost to follow-up were censored on the date when they were last known to be alive.

Outcome measures

Measure	Arm A: BI 1361849 mRNA Vaccine + Durvalumab n=23 Participants The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 BI 1361849: mRNA Vaccine	Arm B: BI 1361849 mRNA Vaccine + Durvalumab + Tremelimumab n=34 Participants The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose.The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 mg was to be administered every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 Tremelimumab: anti-CTLA-4 BI 1361849: mRNA Vaccine
Median Overall Survival (OS) as Estimated Using the Kaplan-Meier Method	23.5 months Interval 3.5 to Upper limit of confidence interval was not estimable due to small number of subjects with events.	7.5 months Interval 3.4 to 10.5

Adverse Events

Arm A: BI 1361849 mRNA Vaccine + Durvalumab

Serious events: 14 serious events

Other events: 23 other events

Deaths: 12 deaths

Arm B: BI 1361849 mRNA Vaccine + Durvalumab + Tremelimumab

Serious events: 22 serious events

Other events: 33 other events

Deaths: 22 deaths

Serious adverse events

Measure	Arm A: BI 1361849 mRNA Vaccine + Durvalumab n=23 participants at risk The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 BI 1361849: mRNA Vaccine	Arm B: BI 1361849 mRNA Vaccine + Durvalumab + Tremelimumab n=34 participants at risk The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 mg was to be administered as an intravenous (IV) infusion every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 Tremelimumab: anti-CTLA-4 BI 1361849: mRNA Vaccine
Cardiac disorders Atrial flutter	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Cardiac disorders Myocardial infarction	4.3% 1/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Cardiac disorders Myocarditis	4.3% 1/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Eye disorders Periorbital oedema	4.3% 1/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Dysphagia	4.3% 1/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Pancreatitis	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Death	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Non-cardiac chest pain	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Sudden death	4.3% 1/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Infections and infestations Pneumonia	17.4% 4/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	11.8% 4/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Infections and infestations Lung infection	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Infections and infestations Urinary tract infection	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Injury, poisoning and procedural complications Postoperative thoracic procedure complication	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Injury, poisoning and procedural complications Spine fracture	4.3% 1/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Amylase increased	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Lipase increased	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Musculoskeletal and connective tissue disorders Back pain	8.7% 2/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	5.9% 2/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Musculoskeletal and connective tissue disorders Arthralgia	4.3% 1/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	17.4% 4/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	17.6% 6/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Cerebrovascular accident	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Encephalopathy	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Seizure	4.3% 1/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Renal and urinary disorders Urinary incontinence	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.7% 2/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	8.8% 3/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Pleural effusion	4.3% 1/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	8.8% 3/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	4.3% 1/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	4.3% 1/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Surgical and medical procedures Stent placement	4.3% 1/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Vascular disorders Embolism	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Vascular disorders Embolism arterial	4.3% 1/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.

Other adverse events

Measure	Arm A: BI 1361849 mRNA Vaccine + Durvalumab n=23 participants at risk The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 BI 1361849: mRNA Vaccine	Arm B: BI 1361849 mRNA Vaccine + Durvalumab + Tremelimumab n=34 participants at risk The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 mg was to be administered as an intravenous (IV) infusion every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles. Durvalumab: anti-PD-L1 Tremelimumab: anti-CTLA-4 BI 1361849: mRNA Vaccine
Blood and lymphatic system disorders Anaemia	30.4% 7/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	8.8% 3/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Cardiac disorders Palpitations	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	5.9% 2/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Endocrine disorders Hypothyroidism	4.3% 1/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	5.9% 2/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Eye disorders Vision blurred	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	5.9% 2/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Nausea	21.7% 5/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	32.4% 11/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Vomiting	26.1% 6/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	23.5% 8/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Diarrhoea	26.1% 6/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	17.6% 6/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Constipation	17.4% 4/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	17.6% 6/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Abdominal pain	8.7% 2/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	11.8% 4/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Dysphagia	4.3% 1/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	5.9% 2/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Dry mouth	8.7% 2/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Fatigue	34.8% 8/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	32.4% 11/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Chills	30.4% 7/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	8.8% 3/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Pyrexia	21.7% 5/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	8.8% 3/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Oedema peripheral	13.0% 3/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	8.8% 3/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Injection site reaction	4.3% 1/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	11.8% 4/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Influenza like illness	13.0% 3/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Non-cardiac chest pain	8.7% 2/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Chest pain	4.3% 1/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	5.9% 2/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Pain	4.3% 1/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	5.9% 2/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Axillary pain	8.7% 2/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Infections and infestations Pneumonia	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	5.9% 2/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Infections and infestations Urinary tract infection	8.7% 2/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	8.8% 3/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Injury, poisoning and procedural complications Contusion	13.0% 3/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Injury, poisoning and procedural complications Fall	13.0% 3/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Aspartate aminotransferase increased	21.7% 5/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	5.9% 2/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Lipase increased	13.0% 3/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	5.9% 2/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Weight decreased	13.0% 3/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	8.8% 3/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Amylase increased	17.4% 4/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Blood alkaline phosphatase increased	8.7% 2/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	8.8% 3/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Alanine aminotransferase increased	8.7% 2/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	5.9% 2/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Blood creatinine increased	8.7% 2/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	5.9% 2/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Lymphocyte count decreased	13.0% 3/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Weight increased	17.4% 4/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Neutrophil count decreased	8.7% 2/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Metabolism and nutrition disorders Decreased appetite	34.8% 8/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	26.5% 9/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Metabolism and nutrition disorders Hyponatraemia	26.1% 6/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	5.9% 2/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Metabolism and nutrition disorders Hypokalaemia	21.7% 5/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	8.8% 3/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Metabolism and nutrition disorders Hyperglycaemia	8.7% 2/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	11.8% 4/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Metabolism and nutrition disorders Hypercalcaemia	21.7% 5/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Metabolism and nutrition disorders Hyperkalaemia	8.7% 2/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	8.8% 3/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Metabolism and nutrition disorders Dehydration	4.3% 1/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	8.8% 3/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Metabolism and nutrition disorders Hypomagnesaemia	8.7% 2/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	5.9% 2/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Metabolism and nutrition disorders Hypoalbuminaemia	13.0% 3/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Metabolism and nutrition disorders Hypernatraemia	8.7% 2/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Musculoskeletal and connective tissue disorders Back pain	13.0% 3/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	23.5% 8/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Musculoskeletal and connective tissue disorders Arthralgia	8.7% 2/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	11.8% 4/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Musculoskeletal and connective tissue disorders Pain in extremity	17.4% 4/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	5.9% 2/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.7% 5/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Musculoskeletal and connective tissue disorders Myalgia	8.7% 2/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Musculoskeletal and connective tissue disorders Neck pain	8.7% 2/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	8.7% 2/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Dizziness	21.7% 5/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	11.8% 4/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Headache	13.0% 3/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	5.9% 2/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Peripheral sensory neuropathy	4.3% 1/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	8.8% 3/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Psychiatric disorders Insomnia	8.7% 2/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	5.9% 2/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Psychiatric disorders Anxiety	4.3% 1/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	5.9% 2/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Psychiatric disorders Depression	4.3% 1/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	5.9% 2/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Dyspnoea	26.1% 6/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	26.5% 9/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Cough	13.0% 3/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	35.3% 12/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	8.8% 3/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Productive cough	13.0% 3/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Wheezing	4.3% 1/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	8.8% 3/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Nasal congestion	8.7% 2/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	5.9% 2/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	5.9% 2/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	5.9% 2/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Skin and subcutaneous tissue disorders Pruritus	26.1% 6/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	23.5% 8/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Skin and subcutaneous tissue disorders Dry Skin	17.4% 4/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	2.9% 1/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Skin and subcutaneous tissue disorders Rash	13.0% 3/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	5.9% 2/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	11.8% 4/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Skin and subcutaneous tissue disorders Dermatitis acneiform	4.3% 1/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	5.9% 2/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Vascular disorders Hypotension	13.0% 3/23 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	5.9% 2/34 • up to 15 months All AEs occurring between the signing of informed consent and the off-study date (i.e., 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug. All cause mortality includes all deaths which were reported up until October 29, 2021. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.

Additional Information

Jonathan Skipper PhD

Ludwig Institute for Cancer Research

Phone: 12124501539

Email: jskipper@lcr.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place