Trial Outcomes & Findings for The Safety, Pharmacokinetics and Antitumor Activity of BGB-A317 in Combination With BGB-290 in Participants With Advanced Solid Tumors (NCT NCT02660034)

NCT ID: NCT02660034

Last Updated: 2021-12-06

Results Overview

An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not. All AEs reported are treatment-emergent, which was defined as having a reported onset time or worsening in severity on or after the date of the first dose of study treatment through 30 days after the last dose (permanent discontinuation of study treatment) or initiation of new anticancer therapy. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 229 participants
• Primary outcome timeframe: From Day 1 up to 4 years and 7 months
• Results posted on: 2021-12-06

Participant Flow

Part A: A total of 49 participants with advanced solid tumors were enrolled in Part A of the study (dose escalation phase) at a total of 5 sites or community oncology centers in Australia. Part B: A total of 180 participants with advanced solid tumors were enrolled in Part B of the study (dose expansion phase).

Participant milestones

Measure	Part A: Dose Escalation Phase - Cohort 1 Participants received tislelizumab (2 milligrams/kilogram \[mg/kg\] once every 3 weeks \[Q3W\] intravenously \[IV\]) with pamiparib (20 mg twice daily) (dose escalation) until determination of the maximum tolerated dose/recommended Phase 2 dose (MTD/RP2D).	Part A: Dose Escalation Phase - Cohort 2 Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 1a Participants with relapsed, platinum-sensitive, high-grade epithelial, non-mucinous, ovarian cancer, fallopian tube, or primary peritoneal cancer (EOC) with either known germline or somatic breast cancer susceptibility gene 1/2 (BRCA1/2) mutations or with homologous recombination deficiency (HRD) received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 1b Participants with relapsed, platinum-sensitive, high-grade EOC without either known germline or somatic BRCA1/2 mutations and without known HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants must have received at least 2 prior lines of platinum-containing chemotherapy.	Part B: Dose Expansion Phase - Arm 2 Participants with triple negative breast cancer (TNBC) with either known germline or somatic BRCA1/2 mutations or with documented HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants could have been treated with at least 1 but no more than 3 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 3 Participants with metastatic castration-resistant prostate cancer (mCRPC) with either known germline or somatic BRCA1/2 mutations or with documented HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Chemotherapy-naïve participants must have received prior abiraterone acetate or enzalutamide treatment.	Part B: Dose Expansion Phase - Arm 4 Participants with extensive-stage disease small cell lung cancer (SCLC) treated with at least 1 but no more than 2 prior lines of treatment, at least 1 must have included a platinum agent, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 5 Participants with human epidermal growth factor receptor-2 (HER2)-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 Participants who were expected to benefit from the combination of a poly (ADP-ribose) polymerase (PARP) inhibitor and a programmed cell death 1 (PD-1) inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be mismatch repair \[MMR\] deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Overall Study STARTED	12	12	6	13	6	23	23	19	20	23	20	21	21	10
Overall Study Received At Least 1 Dose of Study Drug(s)	12	12	6	13	6	23	23	19	20	23	20	21	21	10
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	12	12	6	13	6	23	23	19	20	23	20	21	21	10

Reasons for withdrawal

Measure	Part A: Dose Escalation Phase - Cohort 1 Participants received tislelizumab (2 milligrams/kilogram \[mg/kg\] once every 3 weeks \[Q3W\] intravenously \[IV\]) with pamiparib (20 mg twice daily) (dose escalation) until determination of the maximum tolerated dose/recommended Phase 2 dose (MTD/RP2D).	Part A: Dose Escalation Phase - Cohort 2 Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 1a Participants with relapsed, platinum-sensitive, high-grade epithelial, non-mucinous, ovarian cancer, fallopian tube, or primary peritoneal cancer (EOC) with either known germline or somatic breast cancer susceptibility gene 1/2 (BRCA1/2) mutations or with homologous recombination deficiency (HRD) received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 1b Participants with relapsed, platinum-sensitive, high-grade EOC without either known germline or somatic BRCA1/2 mutations and without known HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants must have received at least 2 prior lines of platinum-containing chemotherapy.	Part B: Dose Expansion Phase - Arm 2 Participants with triple negative breast cancer (TNBC) with either known germline or somatic BRCA1/2 mutations or with documented HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants could have been treated with at least 1 but no more than 3 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 3 Participants with metastatic castration-resistant prostate cancer (mCRPC) with either known germline or somatic BRCA1/2 mutations or with documented HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Chemotherapy-naïve participants must have received prior abiraterone acetate or enzalutamide treatment.	Part B: Dose Expansion Phase - Arm 4 Participants with extensive-stage disease small cell lung cancer (SCLC) treated with at least 1 but no more than 2 prior lines of treatment, at least 1 must have included a platinum agent, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 5 Participants with human epidermal growth factor receptor-2 (HER2)-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 Participants who were expected to benefit from the combination of a poly (ADP-ribose) polymerase (PARP) inhibitor and a programmed cell death 1 (PD-1) inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be mismatch repair \[MMR\] deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Overall Study Progressive Disease (Radiographic)	3	1	0	1	0	0	0	0	0	0	0	0	0	0
Overall Study Progressive Disease (Clinical)	7	8	3	9	3	0	0	0	0	0	0	0	0	0
Overall Study Lost to Follow-up	0	0	1	1	0	0	0	0	0	1	1	1	0	0
Overall Study Participant moved into special access scheme	1	2	0	0	0	0	0	0	0	0	0	0	0	0
Overall Study Adverse Event	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Overall Study Sponsor Decision	0	1	2	2	3	0	0	0	0	0	0	0	0	1
Overall Study Withdrawal by Subject	0	0	0	0	0	0	1	1	1	0	0	1	2	0
Overall Study Death	0	0	0	0	0	13	14	10	9	21	17	15	18	7
Overall Study Physician Decision	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Overall Study Participants transferred to LTE	0	0	0	0	0	10	8	8	10	1	2	4	1	1

Baseline Characteristics

The Safety, Pharmacokinetics and Antitumor Activity of BGB-A317 in Combination With BGB-290 in Participants With Advanced Solid Tumors

Baseline characteristics by cohort

Measure	Part A: Dose Escalation Phase - Cohort 1 n=12 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 n=12 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 n=6 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 n=13 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 n=6 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 1a n=23 Participants Participants with relapsed, platinum-sensitive, high-grade EOC with either known BRCA1/2 mutations or with HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 1b n=23 Participants Participants with relapsed, platinum-sensitive, high-grade EOC without either known germline or somatic BRCA1/2 mutations and without known HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants must have received at least 2 prior lines of platinum-containing chemotherapy.	Part B: Dose Expansion Phase - Arm 2 n=19 Participants Participants with TNBC with either known germline or somatic BRCA1/2 mutations or with documented HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants could have been treated with at least 1 but no more than 3 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 3 n=20 Participants Participants with mCRPC with either known germline or somatic BRCA1/2 mutations or with documented HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Chemotherapy-naïve participants must have received prior abiraterone acetate or enzalutamide treatment.	Part B: Dose Expansion Phase - Arm 4 n=23 Participants Participants with extensive-stage disease SCLC treated with at least 1 but no more than 2 prior lines of treatment, at least 1 must have included a platinum agent, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 5 n=20 Participants Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 n=21 Participants Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 n=21 Participants Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 n=10 Participants Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.	Total n=229 Participants Total of all reporting groups
Age, Continuous	61.9 years STANDARD_DEVIATION 9.39 • n=5 Participants	58.6 years STANDARD_DEVIATION 9.52 • n=7 Participants	54.5 years STANDARD_DEVIATION 11.27 • n=5 Participants	61.8 years STANDARD_DEVIATION 11.42 • n=4 Participants	64.3 years STANDARD_DEVIATION 5.96 • n=21 Participants	59.5 years STANDARD_DEVIATION 10.71 • n=8 Participants	69.1 years STANDARD_DEVIATION 8.68 • n=8 Participants	50.4 years STANDARD_DEVIATION 12.41 • n=24 Participants	68.0 years STANDARD_DEVIATION 8.89 • n=42 Participants	64.2 years STANDARD_DEVIATION 9.87 • n=42 Participants	58.5 years STANDARD_DEVIATION 13.71 • n=42 Participants	68.9 years STANDARD_DEVIATION 10.45 • n=42 Participants	63.3 years STANDARD_DEVIATION 9.11 • n=36 Participants	60.1 years STANDARD_DEVIATION 16.20 • n=36 Participants	62.3 years STANDARD_DEVIATION 11.7 • n=24 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	11 Participants n=7 Participants	5 Participants n=5 Participants	12 Participants n=4 Participants	5 Participants n=21 Participants	23 Participants n=8 Participants	23 Participants n=8 Participants	19 Participants n=24 Participants	0 Participants n=42 Participants	10 Participants n=42 Participants	3 Participants n=42 Participants	6 Participants n=42 Participants	9 Participants n=36 Participants	5 Participants n=36 Participants	140 Participants n=24 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	20 Participants n=42 Participants	13 Participants n=42 Participants	17 Participants n=42 Participants	15 Participants n=42 Participants	12 Participants n=36 Participants	5 Participants n=36 Participants	89 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	7 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	12 Participants n=7 Participants	6 Participants n=5 Participants	13 Participants n=4 Participants	6 Participants n=21 Participants	22 Participants n=8 Participants	22 Participants n=8 Participants	16 Participants n=24 Participants	18 Participants n=42 Participants	21 Participants n=42 Participants	17 Participants n=42 Participants	17 Participants n=42 Participants	19 Participants n=36 Participants	9 Participants n=36 Participants	210 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	3 Participants n=42 Participants	2 Participants n=36 Participants	1 Participants n=36 Participants	12 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	2 Participants n=36 Participants	12 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	3 Participants n=24 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=36 Participants	0 Participants n=36 Participants	3 Participants n=24 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	12 Participants n=7 Participants	5 Participants n=5 Participants	11 Participants n=4 Participants	6 Participants n=21 Participants	20 Participants n=8 Participants	23 Participants n=8 Participants	17 Participants n=24 Participants	18 Participants n=42 Participants	18 Participants n=42 Participants	16 Participants n=42 Participants	18 Participants n=42 Participants	19 Participants n=36 Participants	8 Participants n=36 Participants	201 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	3 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	10 Participants n=24 Participants

PRIMARY outcome

Timeframe: From Day 1 up to 4 years and 7 months

Population: The safety analysis set (SAF) included all participants (both parts) who received at least one dose of tislelizumab and/or pamiparib.

An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not. All AEs reported are treatment-emergent, which was defined as having a reported onset time or worsening in severity on or after the date of the first dose of study treatment through 30 days after the last dose (permanent discontinuation of study treatment) or initiation of new anticancer therapy. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

Outcome measures

Measure	Part A: Dose Escalation Phase - Cohort 1 n=12 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 n=12 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 n=6 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 n=13 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 n=6 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 5 Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Part A: Number Of Participants Experiencing Adverse Events (AEs)	12 Participants	12 Participants	6 Participants	13 Participants	6 Participants	—	—	—	—

PRIMARY outcome

Timeframe: 21 days following the first dose of tislelizumab and pamiparib in Cycle 1

Population: SAF included all participants (both parts) who received at least one dose of tislelizumab and/or pamiparib.

DLT was defined as an AE or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications, and occurs during the first 21 days following the first dose of tislelizumab and pamiparib in Cycle 1 and meets protocol-specified criteria. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

Outcome measures

Measure	Part A: Dose Escalation Phase - Cohort 1 n=12 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 n=12 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 n=6 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 n=13 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 n=6 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 5 Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Part A: Number Of Participants Experiencing Dose-limiting Toxicity (DLT)	0 Participants	0 Participants	0 Participants	2 Participants	2 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Starting from Day 1 until disease progression (up to 4 years and 7 months)

Population: The efficacy evaluable set (EFF) included participants in the SAF who had measurable or evaluable disease at baseline.

ORR was defined as the percentage of participants with a best overall response of complete response (CR) and partial response (PR).

Outcome measures

Measure	Part A: Dose Escalation Phase - Cohort 1 n=23 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 n=23 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 n=19 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 n=20 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 n=23 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 5 n=20 Participants Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 n=21 Participants Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 n=21 Participants Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 n=10 Participants Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Part B: Objective Response Rate (ORR)	7 Participants	3 Participants	9 Participants	4 Participants	2 Participants	2 Participants	6 Participants	0 Participants	3 Participants

PRIMARY outcome

Timeframe: Starting from Day 1 until disease progression (up to 4 years and 7 months)

Population: The efficacy evaluable set (EFF) included participants in the SAF who had measurable or evaluable disease at baseline.

PFS was defined as the time from first dose of study medication to the first documented objective disease progression or death due to any cause, whichever occurred first.

Outcome measures

Measure	Part A: Dose Escalation Phase - Cohort 1 n=23 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 n=23 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 n=19 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 n=20 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 n=23 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 5 n=20 Participants Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 n=21 Participants Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 n=21 Participants Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 n=7 Participants Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Part B: Progression-free Survival (PFS)	8.2 month Interval 5.2 to 11.8	3.5 month Interval 1.9 to 7.6	8.4 month Interval 3.9 to 19.0	10.4 month Interval 4.3 to 16.2	2.0 month Interval 1.7 to 2.3	2.1 month Interval 1.9 to 4.1	3.5 month Interval 1.9 to 7.5	1.9 month Interval 1.1 to 2.1	2.2 month Interval 1.2 to 24.4

PRIMARY outcome

Timeframe: Starting from Day 1 until disease progression (up to 4 years and 7 months)

Population: The efficacy evaluable set (EFF) included participants in the SAF who had measurable or evaluable disease at baseline.

DOR, defined as the time from the first determination of an objective response, was assessed by investigator per Response Evaluation Criteria in Solid Tumors v1.1 until the first documentation of progression or death, whichever occurred first. Results are reported only for arms with responders.

Outcome measures

Measure	Part A: Dose Escalation Phase - Cohort 1 n=7 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 n=3 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 n=9 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 n=4 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 n=2 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 5 n=2 Participants Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 n=6 Participants Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 n=3 Participants Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Part B: Duration Of Response (DOR)	11.2 months Interval 6.2 to NA = not estimable due to insufficient number of participants with events	6.2 months Interval 3.8 to NA = not estimable due to insufficient number of participants with events	17.1 months Interval 3.0 to NA = not estimable due to insufficient number of participants with events	NA months Interval 4.1 to NA = not estimable due to insufficient number of participants with events	6.2 months Interval 4.3 to 8.1	NA months NA = not estimable due to insufficient number of participants with events	NA months Interval 5.7 to NA = not estimable due to insufficient number of participants with events	NA months Interval 22.4 to NA = not estimable due to insufficient number of participants with events	—

PRIMARY outcome

Timeframe: Starting from Day 1 until disease progression (up to 4 years and 7 months)

Population: The efficacy evaluable set (EFF) included participants in the SAF who had measurable or evaluable disease at baseline.

DCR was defined as the percentage of participants with a best overall response of CR, PR, and stable disease (SD).

Outcome measures

Measure	Part A: Dose Escalation Phase - Cohort 1 n=23 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 n=23 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 n=19 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 n=20 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 n=23 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 5 n=20 Participants Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 n=21 Participants Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 n=21 Participants Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 n=10 Participants Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Part B: Disease Control Rate (DCR)	21 Participants	11 Participants	14 Participants	15 Participants	7 Participants	7 Participants	12 Participants	2 Participants	4 Participants

PRIMARY outcome

Timeframe: Starting from Day 1 until disease progression (up to 4 years and 7 months)

Population: The efficacy evaluable set (EFF) included participants in the SAF who had measurable or evaluable disease at baseline.

CBR was defined as the percentage of participants with a best overall response of CR, PR, and SD lasting ≥ 24 weeks.

Outcome measures

Measure	Part A: Dose Escalation Phase - Cohort 1 n=23 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 n=23 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 n=19 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 n=20 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 n=23 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 5 n=20 Participants Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 n=21 Participants Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 n=21 Participants Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 n=10 Participants Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Part B: Clinical Benefit Rate (CBR)	15 Participants	7 Participants	11 Participants	10 Participants	4 Participants	4 Participants	8 Participants	1 Participants	3 Participants

PRIMARY outcome

Timeframe: From Day 1 Every 3 months following completion or discontinuation of the treatment (up to 4 years and 7 months)

Population: The efficacy evaluable set (EFF) included participants in the SAF who had measurable or evaluable disease at baseline.

OS was defined as the time from the date of first dose of study drug to death due to any cause.

Outcome measures

Measure	Part A: Dose Escalation Phase - Cohort 1 n=23 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 n=23 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 n=19 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 n=20 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 n=23 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 5 n=20 Participants Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 n=21 Participants Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 n=21 Participants Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 n=10 Participants Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Part B: Overall Survival (OS)	20.9 month Interval 13.5 to NA = not estimable due to insufficient number of participants with events	18.7 month Interval 6.1 to 27.0	15.8 month Interval 10.4 to NA =not estimable due to insufficient number of participants with events	21.2 month Interval 10.5 to NA = not estimable due to insufficient number of participants with events	6.9 month Interval 3.3 to 11.5	7.4 month Interval 3.3 to 13.4	8.4 month Interval 4.4 to 17.1	4.1 month Interval 2.9 to 5.0	4.1 month Interval 1.2 to 19.5

SECONDARY outcome

Timeframe: Cycle 4 Day 1 (0 hours and 4 hours) post dose

Population: The PK Analysis Set included participants in the Safety Analysis Set for whom at least one PK parameter can be derived for either pamiparib or tislelizumab.

Outcome measures

Measure	Part A: Dose Escalation Phase - Cohort 1 n=5 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 n=8 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 n=4 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 n=7 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 n=2 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 5 Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Part A: Minimum Observed Plasma Concentration (Ctrough) Of Tislelizumab Cycle 4 Day 1 (Pre-dose)	23530 nanogram/milliliter Geometric Coefficient of Variation 48.02	26040 nanogram/milliliter Geometric Coefficient of Variation 58.04	26160 nanogram/milliliter Geometric Coefficient of Variation 23.69	30330 nanogram/milliliter Geometric Coefficient of Variation 58.28	53700 nanogram/milliliter Geometric Coefficient of Variation 81.62	—	—	—	—
Part A: Minimum Observed Plasma Concentration (Ctrough) Of Tislelizumab Cycle 4 Day 1 (4 h)	74260 nanogram/milliliter Geometric Coefficient of Variation 20.70	66250 nanogram/milliliter Geometric Coefficient of Variation 47.28	69020 nanogram/milliliter Geometric Coefficient of Variation 16.47	104300 nanogram/milliliter Geometric Coefficient of Variation 35.31	119600 nanogram/milliliter Geometric Coefficient of Variation 33.83	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 2 Day 1 (Pre-dose and 7 hours Post-dose)

Population: The PK Analysis Set included participants in the Safety Analysis Set for whom at least one PK parameter can be derived for either pamiparib or tislelizumab.

Outcome measures

Measure	Part A: Dose Escalation Phase - Cohort 1 n=12 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 n=12 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 n=6 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 n=13 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 n=6 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 5 Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Part A: Ctrough Of Pamiparib Cycle 2 Day 1 (Pre-dose)	772.9 nanogram/milliliter Geometric Coefficient of Variation 164.6	1258 nanogram/milliliter Geometric Coefficient of Variation 62.13	1209 nanogram/milliliter Geometric Coefficient of Variation 42.18	1876 nanogram/milliliter Geometric Coefficient of Variation 60.41	2754 nanogram/milliliter Geometric Coefficient of Variation 48.69	—	—	—	—
Part A: Ctrough Of Pamiparib Cycle 2 Day 1 (7 h)	824.8 nanogram/milliliter Geometric Coefficient of Variation 130.6	1469 nanogram/milliliter Geometric Coefficient of Variation 38.14	1717 nanogram/milliliter Geometric Coefficient of Variation 55.56	2070 nanogram/milliliter Geometric Coefficient of Variation 47.36	2969 nanogram/milliliter Geometric Coefficient of Variation 48.77	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 2 Day 1 (Pre-dose and 7 hours Post-dose)

Population: The PK Analysis Set included participants in the Safety Analysis Set for whom at least one PK parameter can be derived for either pamiparib or tislelizumab.

Outcome measures

Measure	Part A: Dose Escalation Phase - Cohort 1 n=12 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 n=12 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 n=6 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 n=13 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 n=6 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 5 Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Part A: Maximum Observed Plasma Concentration At Steady State (Cmax,ss) Of Pamiparib	1457 nanogram/milliliter	2497 nanogram/milliliter	2985 nanogram/milliliter	2586 nanogram/milliliter	3189 nanogram/milliliter	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 2 Day 1 (Pre-dose and 7 hours Post-dose)

Population: The PK Analysis Set included participants in the Safety Analysis Set for whom at least one PK parameter can be derived for either pamiparib or tislelizumab.

Outcome measures

Measure	Part A: Dose Escalation Phase - Cohort 1 n=12 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 n=12 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 n=6 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 n=13 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 n=6 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 5 Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Part A: Time To Reach Maximum Plasma Concentration At Steady State (Tmax,ss) Of Pamiparib	1.0 hour Interval 0.6 to 6.2	1.1 hour Interval 0.42 to 4.0	1.0 hour Interval 1.0 to 7.1	1.9 hour Interval 0.45 to 7.0	2.0 hour Interval 0.92 to 3.8	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 2 Day 1 (Pre-dose and 7 hours Post-dose)

Population: The PK Analysis Set included participants in the Safety Analysis Set for whom at least one PK parameter can be derived for either pamiparib or tislelizumab.

Outcome measures

Measure	Part A: Dose Escalation Phase - Cohort 1 n=12 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 n=12 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 n=6 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 n=13 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 n=6 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 5 Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Part A: Ctrough At Steady State (Ctrough,ss) Of Pamiparib	494 nanogram/milliliter Geometric Coefficient of Variation 130	1170 nanogram/milliliter Geometric Coefficient of Variation 66	1151 nanogram/milliliter Geometric Coefficient of Variation 97	2135 nanogram/milliliter Geometric Coefficient of Variation 39	2554 nanogram/milliliter Geometric Coefficient of Variation 2.5	—	—	—	—

SECONDARY outcome

Timeframe: Starting from Day 1 until disease progression (up to 4 years and 7 months)

Population: EFF included participants in the SAF who had measurable or evaluable disease at baseline.

ORR was defined as the percentage of participants with a best overall response of CR and PR.

Outcome measures

Measure	Part A: Dose Escalation Phase - Cohort 1 n=12 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 n=12 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 n=6 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 n=13 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 n=6 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 5 Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Part A: ORR	1 Participants	3 Participants	0 Participants	3 Participants	3 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Starting from Day 1 until disease progression (up to 4 years and 7 months)

Population: EFF included participants in the SAF who had measurable or evaluable disease at baseline.

PFS was defined as the time from first dose of study medication to the first documented objective disease progression or death due to any cause, whichever occurred first.

Outcome measures

Measure	Part A: Dose Escalation Phase - Cohort 1 n=12 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 n=12 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 n=6 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 n=13 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 n=6 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 5 Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Part A: PFS	64 Days Interval 46.0 to 125.0	77 Days Interval 42.0 to 568.0	190 Days Interval 39.0 to 963.0	107 Days Interval 58.0 to 249.0	373 Days Interval 106.0 to 516.0	—	—	—	—

SECONDARY outcome

Timeframe: Starting from Day 1 until disease progression (up to 4 years and 7 months)

Population: The efficacy evaluable set (EFF) included participants in the SAF who had measurable or evaluable disease at baseline.

DCR was defined as the percentage of participants with a best overall response of CR, PR, and SD.

Outcome measures

Measure	Part A: Dose Escalation Phase - Cohort 1 n=12 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 n=12 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 n=6 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 n=13 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 n=6 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 5 Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Part A: DCR	3 Participants	6 Participants	5 Participants	7 Participants	5 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Starting from Day 1 until disease progression (up to 4 years and 7 months)

Population: The efficacy evaluable set (EFF) included participants in the SAF who had measurable or evaluable disease at baseline.

CBR was defined as the percentage of participants with a best overall response of CR, PR, and SD lasting ≥ 24 weeks.

Outcome measures

Measure	Part A: Dose Escalation Phase - Cohort 1 n=12 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 n=12 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 n=6 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 n=13 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 n=6 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 5 Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Part A: CBR	2 week Standard Deviation 16.7	5 week Standard Deviation 41.7	4 week Standard Deviation 66.7	4 week Standard Deviation 30.8	4 week Standard Deviation 66.7	—	—	—	—

SECONDARY outcome

Timeframe: Starting from Day 1 Every 3 months following completion or discontinuation of the treatment (up to 4 years and 7 months)

Population: The efficacy evaluable set (EFF) included participants in the SAF who had measurable or evaluable disease at baseline.

OS was defined as the time from the date of first dose of study drug to death due to any cause.

Outcome measures

Measure	Part A: Dose Escalation Phase - Cohort 1 n=12 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 n=12 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 n=6 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 n=13 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 n=6 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 5 Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Part A: OS	259 Days Interval 46.0 to 437.0	413 Days Interval 54.0 to 1127.0	NA Days Interval 107.0 to NA = Not estimable due to insufficient number of participants with events	434 Days Interval 128.0 to 577.0	NA Days Interval 178.0 to NA = Not estimable due to insufficient number of participants with events	—	—	—	—

SECONDARY outcome

Timeframe: Within 24 hours before the start of the first dose of tislelizumab in Cycle 1, Day 8 of Cycle 1, and Day 1 of Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 9, and Cycle 17

Population: The Antidrug Antibody (ADA) Analysis Set included participants who received ≥ 1 dose of study drug.

Immunogenicity was summarized by participants who were ADA positive and developed detectable ADAs.

Outcome measures

Measure	Part A: Dose Escalation Phase - Cohort 1 n=12 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 n=12 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 n=6 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 n=13 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 n=6 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 5 Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Part A: Percentage Of Participants With Anti-drug Antibodies (ADAs) For Tislelizumab	3 Participants	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 up to 4 years and 7 months

Population: SAF will include all participants (both parts) who received at least one dose of tislelizumab and/or pamiparib.

An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not. All AEs reported are treatment-emergent, which was defined as having a reported onset time or worsening in severity on or after the date of the first dose of study treatment through 30 days after the last dose (permanent discontinuation of study treatment) or initiation of new anticancer therapy. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

Outcome measures

Measure	Part A: Dose Escalation Phase - Cohort 1 n=23 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 n=23 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 n=19 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 n=20 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 n=23 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 5 n=20 Participants Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 n=21 Participants Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 n=21 Participants Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 n=10 Participants Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Part B: Number Of Participants Experiencing AEs	23 Participants	23 Participants	19 Participants	20 Participants	23 Participants	20 Participants	21 Participants	21 Participants	9 Participants

SECONDARY outcome

Timeframe: Cycle 4 Day 1 ( 0 hours and 4 hours post dose)

Population: The PK Analysis Set included participants in the Safety Analysis Set for whom at least one PK parameter can be derived for either pamiparib or tislelizumab.

As pre-specified in the protocol, pharmacokinetic evaluations were performed for all Part B dose expansion arms combined.

Outcome measures

Measure	Part A: Dose Escalation Phase - Cohort 1 n=180 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 5 Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Part B: Ctrough Of Tislelizumab	46060 nanogram/milliliter Geometric Coefficient of Variation 36	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 4 Day 1 ( 0 hours and 4 hours) post dose

Population: The PK Analysis Set included participants in the Safety Analysis Set for whom at least one PK parameter can be derived for either pamiparib or tislelizumab.

As pre-specified in the protocol, pharmacokinetic evaluations were performed for all Part B dose expansion arms combined.

Outcome measures

Measure	Part A: Dose Escalation Phase - Cohort 1 n=180 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 5 Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Part B: Maximum Observed Plasma Concentration (Cmax) Of Tislelizumab	99408 nanogram/milliliter Geometric Coefficient of Variation 20	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 2 Day 1 (7 hours Post-dose)

Population: The PK Analysis Set included participants in the Safety Analysis Set for whom at least one PK parameter can be derived for either pamiparib or tislelizumab.

As pre-specified in the protocol, pharmacokinetic evaluations were performed for all Part B dose expansion arms combined.

Outcome measures

Measure	Part A: Dose Escalation Phase - Cohort 1 n=180 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 5 Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Part B: Ctrough Of Pamiparib	1161 nanogram/milliliter Geometric Coefficient of Variation 80	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 2 (7 hours Post-dose)

Population: The PK Analysis Set included participants in the Safety Analysis Set for whom at least one PK parameter can be derived for either pamiparib or tislelizumab..

As pre-specified in the protocol, pharmacokinetic evaluations were performed for all Part B dose expansion arms combined.

Outcome measures

Measure	Part A: Dose Escalation Phase - Cohort 1 n=180 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 5 Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Part B: Cmax Of Pamiparib	1850 nanogram/milliliter Geometric Coefficient of Variation 63	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 24 hours predose of Day 1 of every cycle

Population: The Antidrug Antibody (ADA) Analysis Set included participants who received ≥ 1 dose of study drug.

Immunogenicity was summarized by participants who developed detectable ADAs. Treatment-emergent ADAs: sum of both treatment-induced ADAs and treatment-boosted ADAs.

Outcome measures

Measure	Part A: Dose Escalation Phase - Cohort 1 n=19 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 n=18 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 n=16 Participants Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 n=18 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 n=21 Participants Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 5 n=19 Participants Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 n=19 Participants Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 n=17 Participants Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum naïve.	Part B: Dose Expansion Phase - Arm 8 n=9 Participants Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Part B: Percentage Of Participants With ADAs For Tislelizumab NAb Positive	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Percentage Of Participants With ADAs For Tislelizumab Treatment-emergent ADA	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Part B: Percentage Of Participants With ADAs For Tislelizumab Treatment-boosted ADA	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Percentage Of Participants With ADAs For Tislelizumab Treatment-induced ADA	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Part B: Percentage Of Participants With ADAs For Tislelizumab Persistent ADA Response	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Part B: Percentage Of Participants With ADAs For Tislelizumab Transient ADA Response	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants

Adverse Events

Part A: Dose Escalation Phase - Cohort 1

Serious events: 5 serious events

Other events: 12 other events

Deaths: 11 deaths

Part A: Dose Escalation Phase - Cohort 2

Serious events: 5 serious events

Other events: 11 other events

Deaths: 9 deaths

Part A: Dose Escalation Phase - Cohort 3

Serious events: 3 serious events

Other events: 5 other events

Deaths: 2 deaths

Part A: Dose Escalation Phase - Cohort 4

Serious events: 6 serious events

Other events: 12 other events

Deaths: 10 deaths

Part A: Dose Escalation Phase - Cohort 5

Serious events: 5 serious events

Other events: 6 other events

Deaths: 3 deaths

Part B: Dose Expansion Phase - Arm 1a

Serious events: 6 serious events

Other events: 21 other events

Deaths: 13 deaths

Part B: Dose Expansion Phase - Arm 1b

Serious events: 16 serious events

Other events: 22 other events

Deaths: 14 deaths

Part B: Dose Expansion Phase - Arm 2

Serious events: 7 serious events

Other events: 16 other events

Deaths: 10 deaths

Part B: Dose Expansion Phase - Arm 3

Serious events: 8 serious events

Other events: 13 other events

Deaths: 9 deaths

Part B: Dose Expansion Phase - Arm 4

Serious events: 14 serious events

Other events: 15 other events

Deaths: 21 deaths

Part B: Dose Expansion Phase - Arm 5

Serious events: 10 serious events

Other events: 17 other events

Deaths: 17 deaths

Part B: Dose Expansion Phase - Arm 6

Serious events: 13 serious events

Other events: 14 other events

Deaths: 15 deaths

Part B: Dose Expansion Phase - Arm 7

Serious events: 8 serious events

Other events: 18 other events

Deaths: 20 deaths

Part B: Dose Expansion Phase - Arm 8

Serious events: 8 serious events

Other events: 5 other events

Deaths: 8 deaths

Serious adverse events

Measure	Part A: Dose Escalation Phase - Cohort 1 n=12 participants at risk Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 n=12 participants at risk Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 n=6 participants at risk Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 n=13 participants at risk Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 n=6 participants at risk Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 1a n=23 participants at risk Participants with relapsed, platinum-sensitive, high-grade EOC with either known BRCA1/2 mutations or with HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 1b n=23 participants at risk Participants with relapsed, platinum-sensitive, high-grade EOC without either known germline or somatic BRCA1/2 mutations and without known HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants must have received at least 2 prior lines of platinum-containing chemotherapy.	Part B: Dose Expansion Phase - Arm 2 n=19 participants at risk Participants with TNBC with either known germline or somatic BRCA1/2 mutations or with documented HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants could have been treated with at least 1 but no more than 3 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 3 n=20 participants at risk Participants with mCRPC with either known germline or somatic BRCA1/2 mutations or with documented HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Chemotherapy-naïve participants must have received prior abiraterone acetate or enzalutamide treatment.	Part B: Dose Expansion Phase - Arm 4 n=23 participants at risk Participants with extensive-stage disease SCLC treated with at least 1 but no more than 2 prior lines of treatment, at least 1 must have included a platinum agent, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 5 n=20 participants at risk Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 n=21 participants at risk Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 n=21 participants at risk Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum-naïve.	Part B: Dose Expansion Phase - Arm 8 n=10 participants at risk Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Endocrine disorders Hypophysitis	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Ascites	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	9.5% 2/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Diarrhoea	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Intestinal obstruction	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Malignant gastrointestinal obstruction	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Nausea	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Small intestinal obstruction	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	17.4% 4/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Vomiting	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	15.4% 2/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months
General disorders General physical health deterioration	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
General disorders Pyrexia	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	9.5% 2/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Hepatobiliary disorders Autoimmune hepatitis	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Hepatobiliary disorders Hepatitis	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	13.0% 3/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Hepatobiliary disorders Malignant biliary obstruction	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Infections and infestations Abdominal sepsis	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Infections and infestations Escherichia bacteraemia	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Infections and infestations Lower respiratory tract infection viral	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Infections and infestations Pneumonia	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Infections and infestations Pyoderma streptococcal	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Infections and infestations Urinary tract infection	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	9.5% 2/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Injury, poisoning and procedural complications Lumbar vertebral fracture	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Psychiatric disorders Delirium	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Psychiatric disorders Substance-induced psychotic disorder	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Renal and urinary disorders Acute kidney injury	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	9.5% 2/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Renal and urinary disorders Ureteric obstruction	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Reproductive system and breast disorders Pelvic pain	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/9 • Day 1 through 4 years and 7 months	0.00% 0/11 • Day 1 through 4 years and 7 months	0.00% 0/5 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/5 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	— 0/0 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months	0.00% 0/3 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/9 • Day 1 through 4 years and 7 months	0.00% 0/5 • Day 1 through 4 years and 7 months
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Vascular disorders Hypotension	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Blood and lymphatic system disorders Anaemia	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	10.5% 2/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Cardiac disorders Atrial fibrillation	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months
Cardiac disorders Supraventricular tachycardia	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Cardiac disorders Cardiac failure	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months
Cardiac disorders Coronary artery occlusion	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Cardiac disorders Myocardial infarction	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Cardiac disorders Myocarditis	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Constipation	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	20.0% 2/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Abdominal pain	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Abdominal pain upper	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Dysphagia	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Gastritis	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Gastritis erosive	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
General disorders Fatigue	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
General disorders Asthenia	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
General disorders Non-cardiac chest pain	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Hepatobiliary disorders Bile duct obstruction	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Hepatobiliary disorders Hepatic failure	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Hepatobiliary disorders Jaundice	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Infections and infestations Sepsis	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Infections and infestations Biliary tract infection	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Infections and infestations Corneal abscess	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Infections and infestations Gastroenteritis	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Infections and infestations Osteomyelitis	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Infections and infestations Periorbital cellulitis	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Infections and infestations Pneumococcal infection	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Infections and infestations Pneumonia klebsiella	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Infections and infestations Pulmonary sepsis	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Infections and infestations Sinobronchitis	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Injury, poisoning and procedural complications Femur fracture	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Injury, poisoning and procedural complications Fall	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Injury, poisoning and procedural complications Gastroenteritis radiation	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Injury, poisoning and procedural complications Procedural pain	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Investigations Alanine aminotransferase increased	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Investigations Aspartate aminotransferase increased	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Investigations Blood bilirubin increased	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months
Investigations Troponin T increased	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Metabolism and nutrition disorders Dehydration	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	10.0% 2/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Metabolism and nutrition disorders Cachexia	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Metabolism and nutrition disorders Malnutrition	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Nervous system disorders Spinal cord compression	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	15.0% 3/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Nervous system disorders Headache	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months
Nervous system disorders Cerebrovascular accident	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months
Nervous system disorders Depressed level of consciousness	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Nervous system disorders Hemiplegia	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Nervous system disorders Seizure	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Nervous system disorders Syncope	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months
Nervous system disorders Transient ischaemic attack	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Renal and urinary disorders Haematuria	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Renal and urinary disorders Nephrolithiasis	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Renal and urinary disorders Urinary tract obstruction	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	10.0% 2/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Vascular disorders Embolism arterial	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Vascular disorders Haematoma	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months
Vascular disorders Superior vena cava occlusion	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Vascular disorders Superior vena cava syndrome	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Infections and infestations Lower respiratory tract infection	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	10.5% 2/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months

Other adverse events

Measure	Part A: Dose Escalation Phase - Cohort 1 n=12 participants at risk Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 2 n=12 participants at risk Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 3 n=6 participants at risk Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 4 n=13 participants at risk Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part A: Dose Escalation Phase - Cohort 5 n=6 participants at risk Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Part B: Dose Expansion Phase - Arm 1a n=23 participants at risk Participants with relapsed, platinum-sensitive, high-grade EOC with either known BRCA1/2 mutations or with HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 1b n=23 participants at risk Participants with relapsed, platinum-sensitive, high-grade EOC without either known germline or somatic BRCA1/2 mutations and without known HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants must have received at least 2 prior lines of platinum-containing chemotherapy.	Part B: Dose Expansion Phase - Arm 2 n=19 participants at risk Participants with TNBC with either known germline or somatic BRCA1/2 mutations or with documented HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants could have been treated with at least 1 but no more than 3 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 3 n=20 participants at risk Participants with mCRPC with either known germline or somatic BRCA1/2 mutations or with documented HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Chemotherapy-naïve participants must have received prior abiraterone acetate or enzalutamide treatment.	Part B: Dose Expansion Phase - Arm 4 n=23 participants at risk Participants with extensive-stage disease SCLC treated with at least 1 but no more than 2 prior lines of treatment, at least 1 must have included a platinum agent, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 5 n=20 participants at risk Participants with HER2-negative gastric or gastroesophageal junction cancer received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. Participants with HER2-negative disease could be treated with at least 1 but no more than 2 prior lines of treatment.	Part B: Dose Expansion Phase - Arm 6 n=21 participants at risk Participants with locally advanced or metastatic urothelial (muscle invasive bladder, ureter, urethra, or renal pelvis) cancer treated with at least 1 but no more than 2 prior lines of treatment, including a prior platinum-containing chemotherapy, received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	Part B: Dose Expansion Phase - Arm 7 n=21 participants at risk Participants with advanced or metastatic pancreatic adenocarcinoma treated with at least 1 but no more than 2 prior lines of therapy received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent. Any potential participant with a known deleterious germline or somatic BRCA was eligible even if platinum-naïve.	Part B: Dose Expansion Phase - Arm 8 n=10 participants at risk Participants who were expected to benefit from the combination of a PARP inhibitor and a PD-1 inhibitor received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily. This arm included participants with recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix, and participants with tumors known to be MMR deficient or HRD positive) that were not eligible for inclusion in any other arms of the study. This was an exploratory signal seeking arm.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.3% 1/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	15.8% 3/19 • Day 1 through 4 years and 7 months	10.0% 2/20 • Day 1 through 4 years and 7 months	17.4% 4/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	14.3% 3/21 • Day 1 through 4 years and 7 months	14.3% 3/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	15.4% 2/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	16.7% 2/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	9.5% 2/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	14.3% 3/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Investigations Alanine aminotransferase increased	8.3% 1/12 • Day 1 through 4 years and 7 months	16.7% 2/12 • Day 1 through 4 years and 7 months	50.0% 3/6 • Day 1 through 4 years and 7 months	23.1% 3/13 • Day 1 through 4 years and 7 months	50.0% 3/6 • Day 1 through 4 years and 7 months	17.4% 4/23 • Day 1 through 4 years and 7 months	13.0% 3/23 • Day 1 through 4 years and 7 months	15.8% 3/19 • Day 1 through 4 years and 7 months	15.0% 3/20 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	10.0% 2/20 • Day 1 through 4 years and 7 months	38.1% 8/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	20.0% 2/10 • Day 1 through 4 years and 7 months
Investigations Aspartate aminotransferase increased	8.3% 1/12 • Day 1 through 4 years and 7 months	16.7% 2/12 • Day 1 through 4 years and 7 months	50.0% 3/6 • Day 1 through 4 years and 7 months	23.1% 3/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	13.0% 3/23 • Day 1 through 4 years and 7 months	13.0% 3/23 • Day 1 through 4 years and 7 months	15.8% 3/19 • Day 1 through 4 years and 7 months	15.0% 3/20 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	10.0% 2/20 • Day 1 through 4 years and 7 months	42.9% 9/21 • Day 1 through 4 years and 7 months	9.5% 2/21 • Day 1 through 4 years and 7 months	20.0% 2/10 • Day 1 through 4 years and 7 months
Investigations Blood alkaline phosphatase increased	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Investigations Blood bilirubin increased	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	15.8% 3/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months
Investigations Gamma-glutamyltransferase increased	0.00% 0/12 • Day 1 through 4 years and 7 months	16.7% 2/12 • Day 1 through 4 years and 7 months	33.3% 2/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	9.5% 2/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Investigations Weight decreased	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	10.0% 2/20 • Day 1 through 4 years and 7 months	14.3% 3/21 • Day 1 through 4 years and 7 months	14.3% 3/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Investigations Blood creatine phosphokinase increased	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	13.0% 3/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	15.0% 3/20 • Day 1 through 4 years and 7 months	9.5% 2/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Investigations Blood creatinine increased	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	9.5% 2/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Metabolism and nutrition disorders Decreased appetite	0.00% 0/12 • Day 1 through 4 years and 7 months	16.7% 2/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	15.4% 2/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	26.1% 6/23 • Day 1 through 4 years and 7 months	17.4% 4/23 • Day 1 through 4 years and 7 months	10.5% 2/19 • Day 1 through 4 years and 7 months	10.0% 2/20 • Day 1 through 4 years and 7 months	34.8% 8/23 • Day 1 through 4 years and 7 months	15.0% 3/20 • Day 1 through 4 years and 7 months	14.3% 3/21 • Day 1 through 4 years and 7 months	23.8% 5/21 • Day 1 through 4 years and 7 months	20.0% 2/10 • Day 1 through 4 years and 7 months
Metabolism and nutrition disorders Dehydration	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	15.0% 3/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	9.5% 2/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Metabolism and nutrition disorders Hypercalcaemia	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Metabolism and nutrition disorders Hypokalaemia	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	15.4% 2/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	21.1% 4/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	10.0% 2/20 • Day 1 through 4 years and 7 months	9.5% 2/21 • Day 1 through 4 years and 7 months	9.5% 2/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months
Metabolism and nutrition disorders Hypophosphataemia	8.3% 1/12 • Day 1 through 4 years and 7 months	16.7% 2/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Endocrine disorders Hyperthyroidism	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Endocrine disorders Hypothyroidism	8.3% 1/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	33.3% 2/6 • Day 1 through 4 years and 7 months	17.4% 4/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	10.5% 2/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Injury, poisoning and procedural complications Fall	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Psychiatric disorders Anxiety	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	9.5% 2/21 • Day 1 through 4 years and 7 months	14.3% 3/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months
Psychiatric disorders Insomnia	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	25.0% 5/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	10.0% 2/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months
Psychiatric disorders Depression	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	10.0% 2/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Vascular disorders Deep vein thrombosis	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Vascular disorders Hot flush	16.7% 2/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Vascular disorders Hypertension	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	10.0% 2/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months
Vascular disorders Hypotension	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	15.0% 3/20 • Day 1 through 4 years and 7 months	9.5% 2/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months
Eye disorders Dry eye	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	15.8% 3/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Eye disorders Vision blurred	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	15.4% 2/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Hepatobiliary disorders Autoimmune hepatitis	8.3% 1/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Hepatobiliary disorders Hepatitis	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	13.0% 3/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	13.0% 3/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	14.3% 3/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Renal and urinary disorders Dysuria	8.3% 1/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Reproductive system and breast disorders Vaginal haemorrhage	11.1% 1/9 • Day 1 through 4 years and 7 months	0.00% 0/11 • Day 1 through 4 years and 7 months	0.00% 0/5 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/5 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	— 0/0 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months	0.00% 0/3 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/9 • Day 1 through 4 years and 7 months	0.00% 0/5 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Abdominal discomfort	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	10.5% 2/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Abdominal distension	8.3% 1/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Abdominal pain	16.7% 2/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	33.3% 2/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	13.0% 3/23 • Day 1 through 4 years and 7 months	21.7% 5/23 • Day 1 through 4 years and 7 months	15.8% 3/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	20.0% 4/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Abdominal pain lower	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Abdominal pain upper	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	10.0% 2/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	9.5% 2/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Ascites	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Constipation	33.3% 4/12 • Day 1 through 4 years and 7 months	25.0% 3/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	17.4% 4/23 • Day 1 through 4 years and 7 months	34.8% 8/23 • Day 1 through 4 years and 7 months	26.3% 5/19 • Day 1 through 4 years and 7 months	30.0% 6/20 • Day 1 through 4 years and 7 months	13.0% 3/23 • Day 1 through 4 years and 7 months	40.0% 8/20 • Day 1 through 4 years and 7 months	14.3% 3/21 • Day 1 through 4 years and 7 months	23.8% 5/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Diarrhoea	8.3% 1/12 • Day 1 through 4 years and 7 months	50.0% 6/12 • Day 1 through 4 years and 7 months	66.7% 4/6 • Day 1 through 4 years and 7 months	38.5% 5/13 • Day 1 through 4 years and 7 months	50.0% 3/6 • Day 1 through 4 years and 7 months	43.5% 10/23 • Day 1 through 4 years and 7 months	26.1% 6/23 • Day 1 through 4 years and 7 months	42.1% 8/19 • Day 1 through 4 years and 7 months	20.0% 4/20 • Day 1 through 4 years and 7 months	17.4% 4/23 • Day 1 through 4 years and 7 months	30.0% 6/20 • Day 1 through 4 years and 7 months	28.6% 6/21 • Day 1 through 4 years and 7 months	14.3% 3/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Dry mouth	16.7% 2/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Dyspepsia	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	10.5% 2/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Gastrooesophageal reflux disease	8.3% 1/12 • Day 1 through 4 years and 7 months	25.0% 3/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	20.0% 4/20 • Day 1 through 4 years and 7 months	9.5% 2/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	20.0% 2/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Nausea	41.7% 5/12 • Day 1 through 4 years and 7 months	83.3% 10/12 • Day 1 through 4 years and 7 months	66.7% 4/6 • Day 1 through 4 years and 7 months	76.9% 10/13 • Day 1 through 4 years and 7 months	83.3% 5/6 • Day 1 through 4 years and 7 months	78.3% 18/23 • Day 1 through 4 years and 7 months	73.9% 17/23 • Day 1 through 4 years and 7 months	78.9% 15/19 • Day 1 through 4 years and 7 months	40.0% 8/20 • Day 1 through 4 years and 7 months	34.8% 8/23 • Day 1 through 4 years and 7 months	35.0% 7/20 • Day 1 through 4 years and 7 months	57.1% 12/21 • Day 1 through 4 years and 7 months	57.1% 12/21 • Day 1 through 4 years and 7 months	30.0% 3/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Oesophagitis	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Rectal haemorrhage	8.3% 1/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Toothache	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Vomiting	8.3% 1/12 • Day 1 through 4 years and 7 months	58.3% 7/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	38.5% 5/13 • Day 1 through 4 years and 7 months	50.0% 3/6 • Day 1 through 4 years and 7 months	26.1% 6/23 • Day 1 through 4 years and 7 months	21.7% 5/23 • Day 1 through 4 years and 7 months	42.1% 8/19 • Day 1 through 4 years and 7 months	15.0% 3/20 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	20.0% 4/20 • Day 1 through 4 years and 7 months	19.0% 4/21 • Day 1 through 4 years and 7 months	14.3% 3/21 • Day 1 through 4 years and 7 months	20.0% 2/10 • Day 1 through 4 years and 7 months
Gastrointestinal disorders Dysphagia	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	20.0% 4/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
General disorders Chills	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
General disorders Fatigue	58.3% 7/12 • Day 1 through 4 years and 7 months	58.3% 7/12 • Day 1 through 4 years and 7 months	50.0% 3/6 • Day 1 through 4 years and 7 months	53.8% 7/13 • Day 1 through 4 years and 7 months	66.7% 4/6 • Day 1 through 4 years and 7 months	43.5% 10/23 • Day 1 through 4 years and 7 months	65.2% 15/23 • Day 1 through 4 years and 7 months	63.2% 12/19 • Day 1 through 4 years and 7 months	60.0% 12/20 • Day 1 through 4 years and 7 months	21.7% 5/23 • Day 1 through 4 years and 7 months	55.0% 11/20 • Day 1 through 4 years and 7 months	42.9% 9/21 • Day 1 through 4 years and 7 months	42.9% 9/21 • Day 1 through 4 years and 7 months	50.0% 5/10 • Day 1 through 4 years and 7 months
General disorders Influenza like illness	16.7% 2/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
General disorders Pyrexia	33.3% 4/12 • Day 1 through 4 years and 7 months	16.7% 2/12 • Day 1 through 4 years and 7 months	33.3% 2/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	13.0% 3/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	10.5% 2/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	10.0% 2/20 • Day 1 through 4 years and 7 months	9.5% 2/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Infections and infestations Lower respiratory tract infection bacterial	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Infections and infestations Nasopharyngitis	16.7% 2/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Infections and infestations Oral candidiasis	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	15.4% 2/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	10.0% 2/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	9.5% 2/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Infections and infestations Rhinitis	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Infections and infestations Upper respiratory tract infection	25.0% 3/12 • Day 1 through 4 years and 7 months	25.0% 3/12 • Day 1 through 4 years and 7 months	33.3% 2/6 • Day 1 through 4 years and 7 months	15.4% 2/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	21.7% 5/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	36.8% 7/19 • Day 1 through 4 years and 7 months	15.0% 3/20 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months
Infections and infestations Urinary tract infection	0.00% 0/12 • Day 1 through 4 years and 7 months	16.7% 2/12 • Day 1 through 4 years and 7 months	33.3% 2/6 • Day 1 through 4 years and 7 months	23.1% 3/13 • Day 1 through 4 years and 7 months	33.3% 2/6 • Day 1 through 4 years and 7 months	17.4% 4/23 • Day 1 through 4 years and 7 months	13.0% 3/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	15.0% 3/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	15.0% 3/20 • Day 1 through 4 years and 7 months	19.0% 4/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months
Infections and infestations Vulvovaginal candidiasis	0.00% 0/9 • Day 1 through 4 years and 7 months	9.1% 1/11 • Day 1 through 4 years and 7 months	40.0% 2/5 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/5 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	— 0/0 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months	0.00% 0/3 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/9 • Day 1 through 4 years and 7 months	0.00% 0/5 • Day 1 through 4 years and 7 months
General disorders Asthenia	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	21.1% 4/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	13.0% 3/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
General disorders Non-cardiac chest pain	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
General disorders Oedema peripheral	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	13.0% 3/23 • Day 1 through 4 years and 7 months	21.7% 5/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	10.0% 2/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	14.3% 3/21 • Day 1 through 4 years and 7 months	28.6% 6/21 • Day 1 through 4 years and 7 months	30.0% 3/10 • Day 1 through 4 years and 7 months
Infections and infestations Bronchitis	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	10.5% 2/19 • Day 1 through 4 years and 7 months	15.0% 3/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Infections and infestations Lower respiratory tract infection	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Musculoskeletal and connective tissue disorders Arthralgia	8.3% 1/12 • Day 1 through 4 years and 7 months	16.7% 2/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	15.4% 2/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	21.7% 5/23 • Day 1 through 4 years and 7 months	13.0% 3/23 • Day 1 through 4 years and 7 months	15.8% 3/19 • Day 1 through 4 years and 7 months	25.0% 5/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	9.5% 2/21 • Day 1 through 4 years and 7 months	20.0% 2/10 • Day 1 through 4 years and 7 months
Musculoskeletal and connective tissue disorders Back pain	8.3% 1/12 • Day 1 through 4 years and 7 months	25.0% 3/12 • Day 1 through 4 years and 7 months	50.0% 3/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	50.0% 3/6 • Day 1 through 4 years and 7 months	34.8% 8/23 • Day 1 through 4 years and 7 months	13.0% 3/23 • Day 1 through 4 years and 7 months	26.3% 5/19 • Day 1 through 4 years and 7 months	25.0% 5/20 • Day 1 through 4 years and 7 months	21.7% 5/23 • Day 1 through 4 years and 7 months	20.0% 4/20 • Day 1 through 4 years and 7 months	14.3% 3/21 • Day 1 through 4 years and 7 months	14.3% 3/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/12 • Day 1 through 4 years and 7 months	16.7% 2/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Musculoskeletal and connective tissue disorders Muscle spasms	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	15.4% 2/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	13.0% 3/23 • Day 1 through 4 years and 7 months	26.1% 6/23 • Day 1 through 4 years and 7 months	21.1% 4/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	33.3% 2/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	15.8% 3/19 • Day 1 through 4 years and 7 months	15.0% 3/20 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	10.0% 2/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	21.7% 5/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/12 • Day 1 through 4 years and 7 months	16.7% 2/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	23.1% 3/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	15.8% 3/19 • Day 1 through 4 years and 7 months	15.0% 3/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months
Musculoskeletal and connective tissue disorders Musculoskeletal pain	8.3% 1/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	33.3% 2/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	10.0% 2/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	9.5% 2/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Nervous system disorders Dizziness	8.3% 1/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	10.5% 2/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	15.0% 3/20 • Day 1 through 4 years and 7 months	9.5% 2/21 • Day 1 through 4 years and 7 months	19.0% 4/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Nervous system disorders Dysgeusia	8.3% 1/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	33.3% 2/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	10.5% 2/19 • Day 1 through 4 years and 7 months	10.0% 2/20 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Nervous system disorders Headache	25.0% 3/12 • Day 1 through 4 years and 7 months	25.0% 3/12 • Day 1 through 4 years and 7 months	33.3% 2/6 • Day 1 through 4 years and 7 months	15.4% 2/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	21.7% 5/23 • Day 1 through 4 years and 7 months	13.0% 3/23 • Day 1 through 4 years and 7 months	26.3% 5/19 • Day 1 through 4 years and 7 months	15.0% 3/20 • Day 1 through 4 years and 7 months	13.0% 3/23 • Day 1 through 4 years and 7 months	15.0% 3/20 • Day 1 through 4 years and 7 months	9.5% 2/21 • Day 1 through 4 years and 7 months	9.5% 2/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Nervous system disorders Paraesthesia	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	15.8% 3/19 • Day 1 through 4 years and 7 months	10.0% 2/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	10.0% 2/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Skin and subcutaneous tissue disorders Dry skin	8.3% 1/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Skin and subcutaneous tissue disorders Pruritus	8.3% 1/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	15.4% 2/13 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	13.0% 3/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	5.3% 1/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	21.7% 5/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Skin and subcutaneous tissue disorders Rash	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	13.0% 3/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	21.1% 4/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	9.5% 2/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Skin and subcutaneous tissue disorders Rash macular	8.3% 1/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/12 • Day 1 through 4 years and 7 months	16.7% 2/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Blood and lymphatic system disorders Anaemia	16.7% 2/12 • Day 1 through 4 years and 7 months	16.7% 2/12 • Day 1 through 4 years and 7 months	33.3% 2/6 • Day 1 through 4 years and 7 months	30.8% 4/13 • Day 1 through 4 years and 7 months	50.0% 3/6 • Day 1 through 4 years and 7 months	21.7% 5/23 • Day 1 through 4 years and 7 months	8.7% 2/23 • Day 1 through 4 years and 7 months	52.6% 10/19 • Day 1 through 4 years and 7 months	25.0% 5/20 • Day 1 through 4 years and 7 months	13.0% 3/23 • Day 1 through 4 years and 7 months	10.0% 2/20 • Day 1 through 4 years and 7 months	23.8% 5/21 • Day 1 through 4 years and 7 months	23.8% 5/21 • Day 1 through 4 years and 7 months	20.0% 2/10 • Day 1 through 4 years and 7 months
Blood and lymphatic system disorders Lymphopenia	0.00% 0/12 • Day 1 through 4 years and 7 months	8.3% 1/12 • Day 1 through 4 years and 7 months	0.00% 0/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Blood and lymphatic system disorders Neutropenia	16.7% 2/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	10.5% 2/19 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	5.0% 1/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/12 • Day 1 through 4 years and 7 months	0.00% 0/12 • Day 1 through 4 years and 7 months	50.0% 3/6 • Day 1 through 4 years and 7 months	0.00% 0/13 • Day 1 through 4 years and 7 months	33.3% 2/6 • Day 1 through 4 years and 7 months	13.0% 3/23 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	10.5% 2/19 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	0.00% 0/23 • Day 1 through 4 years and 7 months	0.00% 0/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	0.00% 0/21 • Day 1 through 4 years and 7 months	0.00% 0/10 • Day 1 through 4 years and 7 months
Respiratory, thoracic and mediastinal disorders Cough	33.3% 4/12 • Day 1 through 4 years and 7 months	16.7% 2/12 • Day 1 through 4 years and 7 months	33.3% 2/6 • Day 1 through 4 years and 7 months	7.7% 1/13 • Day 1 through 4 years and 7 months	16.7% 1/6 • Day 1 through 4 years and 7 months	4.3% 1/23 • Day 1 through 4 years and 7 months	13.0% 3/23 • Day 1 through 4 years and 7 months	26.3% 5/19 • Day 1 through 4 years and 7 months	15.0% 3/20 • Day 1 through 4 years and 7 months	26.1% 6/23 • Day 1 through 4 years and 7 months	10.0% 2/20 • Day 1 through 4 years and 7 months	4.8% 1/21 • Day 1 through 4 years and 7 months	14.3% 3/21 • Day 1 through 4 years and 7 months	10.0% 1/10 • Day 1 through 4 years and 7 months

Additional Information

Study Director

BeiGene

Phone: +1-877-828-5568

Email: clinicaltrials@beigene.com

Results disclosure agreements

• Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights.
• Publication restrictions are in place

Restriction type: OTHER