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

• ClinicalTrials.gov Identifier: NCT02660034
• Recruitment Status: Completed
• First Posted: January 21, 2016
• Results First Posted: December 6, 2021
• Last Update Posted: December 6, 2021
• Sponsor: BeiGene
• Collaborator: Myriad Genetic Laboratories, Inc.
• Information provided by (Responsible Party): BeiGene

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Solid Tumors
• Interventions: Biological: Tislelizumab; Drug: Pamiparib
• Enrollment: 229

Participant Flow

Recruitment Details	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).
Pre-assignment Details

Arm/Group Title	Part A: Dose Escalation Phase - Cohort 1	Part A: Dose Escalation Phase - Cohort 2	Part A: Dose Escalation Phase - Cohort 3	Part A: Dose Escalation Phase - Cohort 4	Part A: Dose Escalation Phase - Cohort 5	Part B: Dose Expansion Phase - Arm 1a	Part B: Dose Expansion Phase - Arm 1b	Part B: Dose Expansion Phase - Arm 2	Part B: Dose Expansion Phase - Arm 3	Part B: Dose Expansion Phase - Arm 4	Part B: Dose Expansion Phase - Arm 5	Part B: Dose Expansion Phase - Arm 6	Part B: Dose Expansion Phase - Arm 7	Part B: Dose Expansion Phase - Arm 8
Arm/Group Description	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).	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Period Title: Overall Study
Started	12	12	6	13	6	23	23	19	20	23	20	21	21	10
Received At Least 1 Dose of Study Drug(s) [1]	12	12	6	13	6	23	23	19	20	23	20	21	21	10
Completed	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Not Completed	12	12	6	13	6	23	23	19	20	23	20	21	21	10
Reason Not Completed
Progressive Disease (Radiographic)	3	1	0	1	0	0	0	0	0	0	0	0	0	0
Progressive Disease (Clinical)	7	8	3	9	3	0	0	0	0	0	0	0	0	0
Lost to Follow-up	0	0	1	1	0	0	0	0	0	1	1	1	0	0
Participant moved into special access scheme	1	2	0	0	0	0	0	0	0	0	0	0	0	0
Adverse Event	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Sponsor Decision	0	1	2	2	3	0	0	0	0	0	0	0	0	1
Withdrawal by Subject	0	0	0	0	0	0	1	1	1	0	0	1	2	0
Death	0	0	0	0	0	13	14	10	9	21	17	15	18	7
Physician Decision	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Participants transferred to LTE	0	0	0	0	0	10	8	8	10	1	2	4	1	1
[1] Safety Analysis Set

Baseline Characteristics

Arm/Group Title		Part A: Dose Escalation Phase - Cohort 1	Part A: Dose Escalation Phase - Cohort 2	Part A: Dose Escalation Phase - Cohort 3	Part A: Dose Escalation Phase - Cohort 4	Part A: Dose Escalation Phase - Cohort 5	Part B: Dose Expansion Phase - Arm 1a	Part B: Dose Expansion Phase - Arm 1b	Part B: Dose Expansion Phase - Arm 2	Part B: Dose Expansion Phase - Arm 3	Part B: Dose Expansion Phase - Arm 4	Part B: Dose Expansion Phase - Arm 5	Part B: Dose Expansion Phase - Arm 6	Part B: Dose Expansion Phase - Arm 7	Part B: Dose Expansion Phase - Arm 8	Total
Arm/Group Description		Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	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.	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.	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.	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.	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.	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.	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.	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.	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 of all reporting groups
Overall Number of Baseline Participants		12	12	6	13	6	23	23	19	20	23	20	21	21	10	229
Baseline Analysis Population Description		Safety Analysis Set: all participants who received at least 1 dose of tislelizumab and/or pamiparib.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	12 participants	12 participants	6 participants	13 participants	6 participants	23 participants	23 participants	19 participants	20 participants	23 participants	20 participants	21 participants	21 participants	10 participants	229 participants
		61.9 (9.39)	58.6 (9.52)	54.5 (11.27)	61.8 (11.42)	64.3 (5.96)	59.5 (10.71)	69.1 (8.68)	50.4 (12.41)	68.0 (8.89)	64.2 (9.87)	58.5 (13.71)	68.9 (10.45)	63.3 (9.11)	60.1 (16.20)	62.3 (11.7)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	12 participants	12 participants	6 participants	13 participants	6 participants	23 participants	23 participants	19 participants	20 participants	23 participants	20 participants	21 participants	21 participants	10 participants	229 participants
	Female	9 75.0%	11 91.7%	5 83.3%	12 92.3%	5 83.3%	23 100.0%	23 100.0%	19 100.0%	0 0.0%	10 43.5%	3 15.0%	6 28.6%	9 42.9%	5 50.0%	140 61.1%
	Male	3 25.0%	1 8.3%	1 16.7%	1 7.7%	1 16.7%	0 0.0%	0 0.0%	0 0.0%	20 100.0%	13 56.5%	17 85.0%	15 71.4%	12 57.1%	5 50.0%	89 38.9%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	12 participants	12 participants	6 participants	13 participants	6 participants	23 participants	23 participants	19 participants	20 participants	23 participants	20 participants	21 participants	21 participants	10 participants	229 participants
	Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 4.3%	1 4.3%	2 10.5%	1 5.0%	0 0.0%	1 5.0%	1 4.8%	0 0.0%	0 0.0%	7 3.1%
	Not Hispanic or Latino	12 100.0%	12 100.0%	6 100.0%	13 100.0%	6 100.0%	22 95.7%	22 95.7%	16 84.2%	18 90.0%	21 91.3%	17 85.0%	17 81.0%	19 90.5%	9 90.0%	210 91.7%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 5.3%	1 5.0%	2 8.7%	2 10.0%	3 14.3%	2 9.5%	1 10.0%	12 5.2%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	12 participants	12 participants	6 participants	13 participants	6 participants	23 participants	23 participants	19 participants	20 participants	23 participants	20 participants	21 participants	21 participants	10 participants	229 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	2 16.7%	0 0.0%	1 16.7%	2 15.4%	0 0.0%	2 8.7%	0 0.0%	0 0.0%	0 0.0%	2 8.7%	1 5.0%	0 0.0%	0 0.0%	2 20.0%	12 5.2%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 4.3%	0 0.0%	0 0.0%	1 5.0%	1 4.3%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	3 1.3%
	Black or African American	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 5.0%	0 0.0%	2 9.5%	0 0.0%	3 1.3%
	White	10 83.3%	12 100.0%	5 83.3%	11 84.6%	6 100.0%	20 87.0%	23 100.0%	17 89.5%	18 90.0%	18 78.3%	16 80.0%	18 85.7%	19 90.5%	8 80.0%	201 87.8%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	2 10.5%	1 5.0%	2 8.7%	2 10.0%	3 14.3%	0 0.0%	0 0.0%	10 4.4%

Outcome Measures

1. Primary Outcome

Title	Part A: Number Of Participants Experiencing Adverse Events (AEs)
Description	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.
Time Frame	From Day 1 up to 4 years and 7 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part A: Dose Escalation Phase - Cohort 1	Part A: Dose Escalation Phase - Cohort 2	Part A: Dose Escalation Phase - Cohort 3	Part A: Dose Escalation Phase - Cohort 4	Part A: Dose Escalation Phase - Cohort 5
Arm/Group Description:	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
Overall Number of Participants Analyzed	12	12	6	13	6
Measure Type: Count of Participants; Unit of Measure: Participants
	12 100.0%	12 100.0%	6 100.0%	13 100.0%	6 100.0%

2. Primary Outcome

Title	Part A: Number Of Participants Experiencing Dose-limiting Toxicity (DLT)
Description	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.
Time Frame	21 days following the first dose of tislelizumab and pamiparib in Cycle 1

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part A: Dose Escalation Phase - Cohort 1	Part A: Dose Escalation Phase - Cohort 2	Part A: Dose Escalation Phase - Cohort 3	Part A: Dose Escalation Phase - Cohort 4	Part A: Dose Escalation Phase - Cohort 5
Arm/Group Description:	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
Overall Number of Participants Analyzed	12	12	6	13	6
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%	0 0.0%	2 15.4%	2 33.3%

3. Primary Outcome

Title	Part B: Objective Response Rate (ORR)
Description	ORR was defined as the percentage of participants with a best overall response of complete response (CR) and partial response (PR).
Time Frame	Starting from Day 1 until disease progression (up to 4 years and 7 months)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part B: Dose Expansion Phase - Arm 1a	Part B: Dose Expansion Phase - Arm 1b	Part B: Dose Expansion Phase - Arm 2	Part B: Dose Expansion Phase - Arm 3	Part B: Dose Expansion Phase - Arm 4	Part B: Dose Expansion Phase - Arm 5	Part B: Dose Expansion Phase - Arm 6	Part B: Dose Expansion Phase - Arm 7	Part B: Dose Expansion Phase - Arm 8
Arm/Group Description:	Participants with relapsed, platinum-sensitive, high-grade EOC with either known germline or somatic BRCA1/2 mutations or with HRD received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.	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.	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.	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.	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.	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.	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.	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.	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.
Overall Number of Participants Analyzed	23	23	19	20	23	20	21	21	10
Measure Type: Count of Participants; Unit of Measure: Participants
	7 30.4%	3 13.0%	9 47.4%	4 20.0%	2 8.7%	2 10.0%	6 28.6%	0 0.0%	3 30.0%

4. Primary Outcome

Title	Part B: Progression-free Survival (PFS)
Description	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.
Time Frame	Starting from Day 1 until disease progression (up to 4 years and 7 months)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part B: Dose Expansion Phase - Arm 1a	Part B: Dose Expansion Phase - Arm 1b	Part B: Dose Expansion Phase - Arm 2	Part B: Dose Expansion Phase - Arm 3	Part B: Dose Expansion Phase - Arm 4	Part B: Dose Expansion Phase - Arm 5	Part B: Dose Expansion Phase - Arm 6	Part B: Dose Expansion Phase - Arm 7	Part B: Dose Expansion Phase - Arm 8
Arm/Group Description:	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.	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.	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.	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.	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.	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.	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.	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.	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.
Overall Number of Participants Analyzed	23	23	19	20	23	20	21	21	7
Median (95% Confidence Interval); Unit of Measure: month
	8.2; (5.2 to 11.8)	3.5; (1.9 to 7.6)	8.4; (3.9 to 19.0)	10.4; (4.3 to 16.2)	2.0; (1.7 to 2.3)	2.1; (1.9 to 4.1)	3.5; (1.9 to 7.5)	1.9; (1.1 to 2.1)	2.2; (1.2 to 24.4)

5. Primary Outcome

Title	Part B: Duration Of Response (DOR)
Description	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.
Time Frame	Starting from Day 1 until disease progression (up to 4 years and 7 months)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part B: Dose Expansion Phase - Arm 1a	Part B: Dose Expansion Phase - Arm 1b	Part B: Dose Expansion Phase - Arm 2	Part B: Dose Expansion Phase - Arm 3	Part B: Dose Expansion Phase - Arm 4	Part B: Dose Expansion Phase - Arm 5	Part B: Dose Expansion Phase - Arm 6	Part B: Dose Expansion Phase - Arm 8
Arm/Group Description:	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.	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.	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.	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.	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.	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.	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.	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.
Overall Number of Participants Analyzed	7	3	9	4	2	2	6	3
Median (95% Confidence Interval); Unit of Measure: months
	11.2 [1]; (6.2 to NA)	6.2 [1]; (3.8 to NA)	17.1 [1]; (3.0 to NA)	NA [1]; (4.1 to NA)	6.2; (4.3 to 8.1)	NA [1]; (NA to NA)	NA [1]; (5.7 to NA)	NA [1]; (22.4 to NA)

[1]

NA = not estimable due to insufficient number of participants with events

6. Primary Outcome

Title	Part B: Disease Control Rate (DCR)
Description	DCR was defined as the percentage of participants with a best overall response of CR, PR, and stable disease (SD).
Time Frame	Starting from Day 1 until disease progression (up to 4 years and 7 months)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part B: Dose Expansion Phase - Arm 1a	Part B: Dose Expansion Phase - Arm 1b	Part B: Dose Expansion Phase - Arm 2	Part B: Dose Expansion Phase - Arm 3	Part B: Dose Expansion Phase - Arm 4	Part B: Dose Expansion Phase - Arm 5	Part B: Dose Expansion Phase - Arm 6	Part B: Dose Expansion Phase - Arm 7	Part B: Dose Expansion Phase - Arm 8
Arm/Group Description:	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.	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.	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.	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.	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.	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.	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.	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.	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.
Overall Number of Participants Analyzed	23	23	19	20	23	20	21	21	10
Measure Type: Count of Participants; Unit of Measure: Participants
	21 91.3%	11 47.8%	14 73.7%	15 75.0%	7 30.4%	7 35.0%	12 57.1%	2 9.5%	4 40.0%

7. Primary Outcome

Title	Part B: Clinical Benefit Rate (CBR)
Description	CBR was defined as the percentage of participants with a best overall response of CR, PR, and SD lasting ≥ 24 weeks.
Time Frame	Starting from Day 1 until disease progression (up to 4 years and 7 months)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part B: Dose Expansion Phase - Arm 1a	Part B: Dose Expansion Phase - Arm 1b	Part B: Dose Expansion Phase - Arm 2	Part B: Dose Expansion Phase - Arm 3	Part B: Dose Expansion Phase - Arm 4	Part B: Dose Expansion Phase - Arm 5	Part B: Dose Expansion Phase - Arm 6	Part B: Dose Expansion Phase - Arm 7	Part B: Dose Expansion Phase - Arm 8
Arm/Group Description:	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.	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.	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.	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.	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.	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.	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.	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.	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.
Overall Number of Participants Analyzed	23	23	19	20	23	20	21	21	10
Measure Type: Count of Participants; Unit of Measure: Participants
	15 65.2%	7 30.4%	11 57.9%	10 50.0%	4 17.4%	4 20.0%	8 38.1%	1 4.8%	3 30.0%

8. Primary Outcome

Title	Part B: Overall Survival (OS)
Description	OS was defined as the time from the date of first dose of study drug to death due to any cause.
Time Frame	From Day 1 Every 3 months following completion or discontinuation of the treatment (up to 4 years and 7 months)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part B: Dose Expansion Phase - Arm 1a	Part B: Dose Expansion Phase - Arm 1b	Part B: Dose Expansion Phase - Arm 2	Part B: Dose Expansion Phase - Arm 3	Part B: Dose Expansion Phase - Arm 4	Part B: Dose Expansion Phase - Arm 5	Part B: Dose Expansion Phase - Arm 6	Part B: Dose Expansion Phase - Arm 7	Part B: Dose Expansion Phase - Arm 8
Arm/Group Description:	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.	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.	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.	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.	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.	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.	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.	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.	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.
Overall Number of Participants Analyzed	23	23	19	20	23	20	21	21	10
Median (95% Confidence Interval); Unit of Measure: month
	20.9 [1]; (13.5 to NA)	18.7; (6.1 to 27.0)	15.8 [2]; (10.4 to NA)	21.2 [1]; (10.5 to NA)	6.9; (3.3 to 11.5)	7.4; (3.3 to 13.4)	8.4; (4.4 to 17.1)	4.1; (2.9 to 5.0)	4.1; (1.2 to 19.5)

[1]

NA = not estimable due to insufficient number of participants with events

[2]

NA =not estimable due to insufficient number of participants with events

9. Secondary Outcome

Title	Part A: Minimum Observed Plasma Concentration (Ctrough) Of Tislelizumab
Description	[Not Specified]
Time Frame	Cycle 4 Day 1 (0 hours and 4 hours) post dose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part A: Dose Escalation Phase - Cohort 1	Part A: Dose Escalation Phase - Cohort 2	Part A: Dose Escalation Phase - Cohort 3	Part A: Dose Escalation Phase - Cohort 4	Part A: Dose Escalation Phase - Cohort 5
Arm/Group Description:	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
Overall Number of Participants Analyzed	5	8	4	7	2
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: nanogram/milliliter
Cycle 4 Day 1 (Pre-dose)	23530; (48.02%)	26040; (58.04%)	26160; (23.69%)	30330; (58.28%)	53700; (81.62%)
Cycle 4 Day 1 (4 h)	74260; (20.70%)	66250; (47.28%)	69020; (16.47%)	104300; (35.31%)	119600; (33.83%)

10. Secondary Outcome

Title	Part A: Ctrough Of Pamiparib
Description	[Not Specified]
Time Frame	Cycle 2 Day 1 (Pre-dose and 7 hours Post-dose)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title		Part A: Dose Escalation Phase - Cohort 1	Part A: Dose Escalation Phase - Cohort 2	Part A: Dose Escalation Phase - Cohort 3	Part A: Dose Escalation Phase - Cohort 4	Part A: Dose Escalation Phase - Cohort 5
Arm/Group Description:		Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
Overall Number of Participants Analyzed		12	12	6	13	6
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: nanogram/milliliter
Cycle 2 Day 1 (Pre-dose)	Number Analyzed	10 participants	11 participants	5 participants	9 participants	4 participants
		772.9; (164.6%)	1258; (62.13%)	1209; (42.18%)	1876; (60.41%)	2754; (48.69%)
Cycle 2 Day 1 (7 h)	Number Analyzed	9 participants	11 participants	5 participants	11 participants	4 participants
		824.8; (130.6%)	1469; (38.14%)	1717; (55.56%)	2070; (47.36%)	2969; (48.77%)

11. Secondary Outcome

Title	Part A: Maximum Observed Plasma Concentration At Steady State (Cmax,ss) Of Pamiparib
Description	[Not Specified]
Time Frame	Cycle 2 Day 1 (Pre-dose and 7 hours Post-dose)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part A: Dose Escalation Phase - Cohort 1	Part A: Dose Escalation Phase - Cohort 2	Part A: Dose Escalation Phase - Cohort 3	Part A: Dose Escalation Phase - Cohort 4	Part A: Dose Escalation Phase - Cohort 5
Arm/Group Description:	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
Overall Number of Participants Analyzed	12	12	6	13	6
Measure Type: Number; Unit of Measure: nanogram/milliliter
	1457	2497	2985	2586	3189

12. Secondary Outcome

Title	Part A: Time To Reach Maximum Plasma Concentration At Steady State (Tmax,ss) Of Pamiparib
Description	[Not Specified]
Time Frame	Cycle 2 Day 1 (Pre-dose and 7 hours Post-dose)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part A: Dose Escalation Phase - Cohort 1	Part A: Dose Escalation Phase - Cohort 2	Part A: Dose Escalation Phase - Cohort 3	Part A: Dose Escalation Phase - Cohort 4	Part A: Dose Escalation Phase - Cohort 5
Arm/Group Description:	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
Overall Number of Participants Analyzed	12	12	6	13	6
Median (95% Confidence Interval); Unit of Measure: hour
	1.0; (0.60 to 6.2)	1.1; (0.42 to 4.0)	1.0; (1.0 to 7.1)	1.9; (0.45 to 7.0)	2.0; (0.92 to 3.8)

13. Secondary Outcome

Title	Part A: Ctrough At Steady State (Ctrough,ss) Of Pamiparib
Description	[Not Specified]
Time Frame	Cycle 2 Day 1 (Pre-dose and 7 hours Post-dose)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part A: Dose Escalation Phase - Cohort 1	Part A: Dose Escalation Phase - Cohort 2	Part A: Dose Escalation Phase - Cohort 3	Part A: Dose Escalation Phase - Cohort 4	Part A: Dose Escalation Phase - Cohort 5
Arm/Group Description:	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
Overall Number of Participants Analyzed	12	12	6	13	6
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: nanogram/milliliter
	494; (130%)	1170; (66%)	1151; (97%)	2135; (39%)	2554; (2.5%)

14. Secondary Outcome

Title	Part A: ORR
Description	ORR was defined as the percentage of participants with a best overall response of CR and PR.
Time Frame	Starting from Day 1 until disease progression (up to 4 years and 7 months)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part A: Dose Escalation Phase - Cohort 1	Part A: Dose Escalation Phase - Cohort 2	Part A: Dose Escalation Phase - Cohort 3	Part A: Dose Escalation Phase - Cohort 4	Part A: Dose Escalation Phase - Cohort 5
Arm/Group Description:	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
Overall Number of Participants Analyzed	12	12	6	13	6
Measure Type: Count of Participants; Unit of Measure: Participants
	1 8.3%	3 25.0%	0 0.0%	3 23.1%	3 50.0%

15. Secondary Outcome

Title	Part A: PFS
Description	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.
Time Frame	Starting from Day 1 until disease progression (up to 4 years and 7 months)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part A: Dose Escalation Phase - Cohort 1	Part A: Dose Escalation Phase - Cohort 2	Part A: Dose Escalation Phase - Cohort 3	Part A: Dose Escalation Phase - Cohort 4	Part A: Dose Escalation Phase - Cohort 5
Arm/Group Description:	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
Overall Number of Participants Analyzed	12	12	6	13	6
Median (95% Confidence Interval); Unit of Measure: Days
	64; (46 to 125)	77; (42 to 568)	190; (39 to 963)	107; (58 to 249)	373; (106 to 516)

16. Secondary Outcome

Title	Part A: DCR
Description	DCR was defined as the percentage of participants with a best overall response of CR, PR, and SD.
Time Frame	Starting from Day 1 until disease progression (up to 4 years and 7 months)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part A: Dose Escalation Phase - Cohort 1	Part A: Dose Escalation Phase - Cohort 2	Part A: Dose Escalation Phase - Cohort 3	Part A: Dose Escalation Phase - Cohort 4	Part A: Dose Escalation Phase - Cohort 5
Arm/Group Description:	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
Overall Number of Participants Analyzed	12	12	6	13	6
Measure Type: Count of Participants; Unit of Measure: Participants
	3 25.0%	6 50.0%	5 83.3%	7 53.8%	5 83.3%

17. Secondary Outcome

Title	Part A: CBR
Description	CBR was defined as the percentage of participants with a best overall response of CR, PR, and SD lasting ≥ 24 weeks.
Time Frame	Starting from Day 1 until disease progression (up to 4 years and 7 months)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part A: Dose Escalation Phase - Cohort 1	Part A: Dose Escalation Phase - Cohort 2	Part A: Dose Escalation Phase - Cohort 3	Part A: Dose Escalation Phase - Cohort 4	Part A: Dose Escalation Phase - Cohort 5
Arm/Group Description:	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
Overall Number of Participants Analyzed	12	12	6	13	6
Median (Standard Deviation); Unit of Measure: week
	2 (16.7)	5 (41.7)	4 (66.7)	4 (30.8)	4 (66.7)

18. Secondary Outcome

Title	Part A: OS
Description	OS was defined as the time from the date of first dose of study drug to death due to any cause.
Time Frame	Starting from Day 1 Every 3 months following completion or discontinuation of the treatment (up to 4 years and 7 months)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part A: Dose Escalation Phase - Cohort 1	Part A: Dose Escalation Phase - Cohort 2	Part A: Dose Escalation Phase - Cohort 3	Part A: Dose Escalation Phase - Cohort 4	Part A: Dose Escalation Phase - Cohort 5
Arm/Group Description:	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
Overall Number of Participants Analyzed	12	12	6	13	6
Median (95% Confidence Interval); Unit of Measure: Days
	259; (46 to 437)	413; (54 to 1127)	NA [1]; (107 to NA)	434; (128 to 577)	NA [1]; (178 to NA)

[1]

NA = Not estimable due to insufficient number of participants with events

19. Secondary Outcome

Title	Part A: Percentage Of Participants With Anti-drug Antibodies (ADAs) For Tislelizumab
Description	Immunogenicity was summarized by participants who were ADA positive and developed detectable ADAs.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part A: Dose Escalation Phase - Cohort 1	Part A: Dose Escalation Phase - Cohort 2	Part A: Dose Escalation Phase - Cohort 3	Part A: Dose Escalation Phase - Cohort 4	Part A: Dose Escalation Phase - Cohort 5
Arm/Group Description:	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.	Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.
Overall Number of Participants Analyzed	12	12	6	13	6
Measure Type: Count of Participants; Unit of Measure: Participants
	3 25.0%	1 8.3%	0 0.0%	1 7.7%	0 0.0%

20. Secondary Outcome

Title	Part B: Number Of Participants Experiencing AEs
Description	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.
Time Frame	Day 1 of Cycle 1 up to 4 years and 7 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part B: Dose Expansion Phase - Arm 1a	Part B: Dose Expansion Phase - Arm 1b	Part B: Dose Expansion Phase - Arm 2	Part B: Dose Expansion Phase - Arm 3	Part B: Dose Expansion Phase - Arm 4	Part B: Dose Expansion Phase - Arm 5	Part B: Dose Expansion Phase - Arm 6	Part B: Dose Expansion Phase - Arm 7	Part B: Dose Expansion Phase - Arm 8
Arm/Group Description:	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.	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.	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.	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.	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.	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.	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.	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.	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.
Overall Number of Participants Analyzed	23	23	19	20	23	20	21	21	10
Measure Type: Count of Participants; Unit of Measure: Participants
	23 100.0%	23 100.0%	19 100.0%	20 100.0%	23 100.0%	20 100.0%	21 100.0%	21 100.0%	9 90.0%

21. Secondary Outcome

Title	Part B: Ctrough Of Tislelizumab
Description	As pre-specified in the protocol, pharmacokinetic evaluations were performed for all Part B dose expansion arms combined.
Time Frame	Cycle 4 Day 1 ( 0 hours and 4 hours post dose)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part B: Dose Expansion Phase
Arm/Group Description:	Participants received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.
Overall Number of Participants Analyzed	180
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: nanogram/milliliter
	46060; (36%)

22. Secondary Outcome

Title	Part B: Maximum Observed Plasma Concentration (Cmax) Of Tislelizumab
Description	As pre-specified in the protocol, pharmacokinetic evaluations were performed for all Part B dose expansion arms combined.
Time Frame	Cycle 4 Day 1 ( 0 hours and 4 hours) post dose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part B: Dose Expansion Phase
Arm/Group Description:	Participants received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily
Overall Number of Participants Analyzed	180
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: nanogram/milliliter
	99408; (20%)

23. Secondary Outcome

Title	Part B: Ctrough Of Pamiparib
Description	As pre-specified in the protocol, pharmacokinetic evaluations were performed for all Part B dose expansion arms combined.
Time Frame	Cycle 2 Day 1 (7 hours Post-dose)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part B: Dose Expansion Phase
Arm/Group Description:	Participants received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.
Overall Number of Participants Analyzed	180
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: nanogram/milliliter
	1161; (80%)

24. Secondary Outcome

Title	Part B: Cmax Of Pamiparib
Description	As pre-specified in the protocol, pharmacokinetic evaluations were performed for all Part B dose expansion arms combined.
Time Frame	Cycle 2 (7 hours Post-dose)

Outcome Measure Data

Analysis Population Description

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..

Arm/Group Title	Part B: Dose Expansion Phase
Arm/Group Description:	Participants received tislelizumab 200 mg IV Q3W + pamiparib 40 mg orally twice daily.
Overall Number of Participants Analyzed	180
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: nanogram/milliliter
	1850; (63%)

25. Secondary Outcome

Title	Part B: Percentage Of Participants With ADAs For Tislelizumab
Description	Immunogenicity was summarized by participants who developed detectable ADAs. Treatment-emergent ADAs: sum of both treatment-induced ADAs and treatment-boosted ADAs.
Time Frame	24 hours predose of Day 1 of every cycle

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part B: Dose Expansion Phase - Arm 1a	Part B: Dose Expansion Phase - Arm 1b	Part B: Dose Expansion Phase - Arm 2	Part B: Dose Expansion Phase - Arm 3	Part B: Dose Expansion Phase - Arm 4	Part B: Dose Expansion Phase - Arm 5	Part B: Dose Expansion Phase - Arm 6	Part B: Dose Expansion Phase - Arm 7	Part B: Dose Expansion Phase - Arm 8
Arm/Group Description:	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.	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.	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.	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.	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.	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.	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.	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.	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.
Overall Number of Participants Analyzed	19	18	16	18	21	19	19	17	9
Measure Type: Count of Participants; Unit of Measure: Participants
Treatment-emergent ADA	0 0.0%	0 0.0%	1 6.3%	0 0.0%	1 4.8%	1 5.3%	0 0.0%	0 0.0%	2 22.2%
Treatment-boosted ADA	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Treatment-induced ADA	0 0.0%	0 0.0%	1 6.3%	0 0.0%	1 4.8%	1 5.3%	0 0.0%	0 0.0%	2 22.2%
Persistent ADA Response	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 5.3%	0 0.0%	0 0.0%	0 0.0%
Transient ADA Response	0 0.0%	0 0.0%	1 6.3%	0 0.0%	1 4.8%	0 0.0%	0 0.0%	0 0.0%	2 22.2%
NAb Positive	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

Adverse Events

Time Frame

Day 1 through 4 years and 7 months

Adverse Event Reporting Description

[Not Specified]

Arm/Group Title

Part A: Dose Escalation Phase - Cohort 1

Part A: Dose Escalation Phase - Cohort 2

Part A: Dose Escalation Phase - Cohort 3

Part A: Dose Escalation Phase - Cohort 4

Part A: Dose Escalation Phase - Cohort 5

Part B: Dose Expansion Phase - Arm 1a

Part B: Dose Expansion Phase - Arm 1b

Part B: Dose Expansion Phase - Arm 2

Part B: Dose Expansion Phase - Arm 3

Part B: Dose Expansion Phase - Arm 4

Part B: Dose Expansion Phase - Arm 5

Part B: Dose Expansion Phase - Arm 6

Part B: Dose Expansion Phase - Arm 7

Part B: Dose Expansion Phase - Arm 8

Arm/Group Description

Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (20 mg twice daily) (dose escalation) until determination of the MTD/RP2D.

Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.

Participants received tislelizumab (2 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.

Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (40 mg twice daily) (dose escalation) until determination of the MTD/RP2D.

Participants received tislelizumab (200 mg/kg Q3W IV) with pamiparib (60 mg twice daily) (dose escalation) until determination of the MTD/RP2D.

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.

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.

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.

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.

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.

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.

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.

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.

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.

All-Cause Mortality

Part A: Dose Escalation Phase - Cohort 1

Part A: Dose Escalation Phase - Cohort 2

Part A: Dose Escalation Phase - Cohort 3

Part A: Dose Escalation Phase - Cohort 4

Part A: Dose Escalation Phase - Cohort 5

Part B: Dose Expansion Phase - Arm 1a

Part B: Dose Expansion Phase - Arm 1b

Part B: Dose Expansion Phase - Arm 2

Part B: Dose Expansion Phase - Arm 3

Part B: Dose Expansion Phase - Arm 4

Part B: Dose Expansion Phase - Arm 5

Part B: Dose Expansion Phase - Arm 6

Part B: Dose Expansion Phase - Arm 7

Part B: Dose Expansion Phase - Arm 8

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Total

11/12 (91.67%)

9/12 (75.00%)

2/6 (33.33%)

10/13 (76.92%)

3/6 (50.00%)

13/23 (56.52%)

14/23 (60.87%)

10/19 (52.63%)

9/20 (45.00%)

21/23 (91.30%)

17/20 (85.00%)

15/21 (71.43%)

20/21 (95.24%)

8/10 (80.00%)

Serious Adverse Events

Part A: Dose Escalation Phase - Cohort 1

Part A: Dose Escalation Phase - Cohort 2

Part A: Dose Escalation Phase - Cohort 3

Part A: Dose Escalation Phase - Cohort 4

Part A: Dose Escalation Phase - Cohort 5

Part B: Dose Expansion Phase - Arm 1a

Part B: Dose Expansion Phase - Arm 1b

Part B: Dose Expansion Phase - Arm 2

Part B: Dose Expansion Phase - Arm 3

Part B: Dose Expansion Phase - Arm 4

Part B: Dose Expansion Phase - Arm 5

Part B: Dose Expansion Phase - Arm 6

Part B: Dose Expansion Phase - Arm 7

Part B: Dose Expansion Phase - Arm 8

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Total

5/12 (41.67%)

5/12 (41.67%)

3/6 (50.00%)

6/13 (46.15%)

5/6 (83.33%)

6/23 (26.09%)

16/23 (69.57%)

7/19 (36.84%)

8/20 (40.00%)

14/23 (60.87%)

10/20 (50.00%)

13/21 (61.90%)

8/21 (38.10%)

8/10 (80.00%)

Blood and lymphatic system disorders

Anaemia † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

2/19 (10.53%)

0/20 (0.00%)

1/23 (4.35%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Cardiac disorders

Atrial fibrillation † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

1/20 (5.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

1/10 (10.00%)

Supraventricular tachycardia † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

1/21 (4.76%)

1/21 (4.76%)

0/10 (0.00%)

Cardiac failure † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

1/10 (10.00%)

Coronary artery occlusion † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

1/21 (4.76%)

0/10 (0.00%)

Myocardial infarction † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

1/19 (5.26%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Myocarditis † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

1/20 (5.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Endocrine disorders

Hypophysitis † 1

0/12 (0.00%)

1/12 (8.33%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Gastrointestinal disorders

Ascites † 1

0/12 (0.00%)

1/12 (8.33%)

0/6 (0.00%)

1/13 (7.69%)

0/6 (0.00%)

1/23 (4.35%)

2/23 (8.70%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

2/21 (9.52%)

0/10 (0.00%)

Diarrhoea † 1

1/12 (8.33%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Intestinal obstruction † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

1/13 (7.69%)

0/6 (0.00%)

0/23 (0.00%)

1/23 (4.35%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

1/10 (10.00%)

Malignant gastrointestinal obstruction † 1

1/12 (8.33%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Nausea † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

1/13 (7.69%)

0/6 (0.00%)

0/23 (0.00%)

1/23 (4.35%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

1/20 (5.00%)

0/21 (0.00%)

1/21 (4.76%)

0/10 (0.00%)

Small intestinal obstruction † 1

1/12 (8.33%)

0/12 (0.00%)

0/6 (0.00%)

1/13 (7.69%)

0/6 (0.00%)

2/23 (8.70%)

4/23 (17.39%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

1/20 (5.00%)

0/21 (0.00%)

0/21 (0.00%)

1/10 (10.00%)

Vomiting † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

2/13 (15.38%)

1/6 (16.67%)

0/23 (0.00%)

1/23 (4.35%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

1/20 (5.00%)

0/21 (0.00%)

0/21 (0.00%)

1/10 (10.00%)

Constipation † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

1/20 (5.00%)

0/21 (0.00%)

1/21 (4.76%)

2/10 (20.00%)

Abdominal pain † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

1/23 (4.35%)

1/19 (5.26%)

0/20 (0.00%)

0/23 (0.00%)

1/20 (5.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Abdominal pain upper † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

1/20 (5.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Dysphagia † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

1/20 (5.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Gastritis † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

1/21 (4.76%)

0/21 (0.00%)

0/10 (0.00%)

Gastritis erosive † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

1/21 (4.76%)

0/21 (0.00%)

0/10 (0.00%)

Gastrooesophageal reflux disease † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

1/21 (4.76%)

0/21 (0.00%)

0/10 (0.00%)

Large intestinal obstruction † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

1/21 (4.76%)

0/10 (0.00%)

General disorders

General physical health deterioration † 1

0/12 (0.00%)

1/12 (8.33%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

1/23 (4.35%)

0/20 (0.00%)

1/21 (4.76%)

0/21 (0.00%)

0/10 (0.00%)

Pyrexia † 1

0/12 (0.00%)

1/12 (8.33%)

1/6 (16.67%)

0/13 (0.00%)

1/6 (16.67%)

0/23 (0.00%)

0/23 (0.00%)

1/19 (5.26%)

1/20 (5.00%)

1/23 (4.35%)

0/20 (0.00%)

2/21 (9.52%)

0/21 (0.00%)

0/10 (0.00%)

Fatigue † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

1/23 (4.35%)

0/19 (0.00%)

1/20 (5.00%)

1/23 (4.35%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Asthenia † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

1/23 (4.35%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Non-cardiac chest pain † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

1/20 (5.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Hepatobiliary disorders

Autoimmune hepatitis † 1

1/12 (8.33%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

1/6 (16.67%)

1/23 (4.35%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

1/23 (4.35%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Hepatitis † 1

1/12 (8.33%)

0/12 (0.00%)

0/6 (0.00%)

1/13 (7.69%)

0/6 (0.00%)

0/23 (0.00%)

1/23 (4.35%)

0/19 (0.00%)

0/20 (0.00%)

2/23 (8.70%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Immune-mediated hepatitis † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

1/6 (16.67%)

2/23 (8.70%)

3/23 (13.04%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

1/21 (4.76%)

0/21 (0.00%)

0/10 (0.00%)

Malignant biliary obstruction † 1

0/12 (0.00%)

0/12 (0.00%)

1/6 (16.67%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Bile duct obstruction † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

1/23 (4.35%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Hepatic failure † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

1/20 (5.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Jaundice † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

1/21 (4.76%)

0/10 (0.00%)

Infections and infestations

Abdominal sepsis † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

1/13 (7.69%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Escherichia bacteraemia † 1

0/12 (0.00%)

0/12 (0.00%)

1/6 (16.67%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Lower respiratory tract infection viral † 1

0/12 (0.00%)

0/12 (0.00%)

1/6 (16.67%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Pneumocystis jirovecii pneumonia † 1

0/12 (0.00%)

0/12 (0.00%)

1/6 (16.67%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Pneumonia † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

1/13 (7.69%)

0/6 (0.00%)

0/23 (0.00%)

1/23 (4.35%)

1/19 (5.26%)

1/20 (5.00%)

2/23 (8.70%)

1/20 (5.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Pyoderma streptococcal † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

1/13 (7.69%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Urinary tract infection † 1

0/12 (0.00%)

0/12 (0.00%)

1/6 (16.67%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

1/20 (5.00%)

2/21 (9.52%)

0/21 (0.00%)

0/10 (0.00%)

Sepsis † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

1/23 (4.35%)

0/20 (0.00%)

1/21 (4.76%)

0/21 (0.00%)

0/10 (0.00%)

Biliary tract infection † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

1/21 (4.76%)

0/10 (0.00%)

Corneal abscess † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

1/21 (4.76%)

0/21 (0.00%)

0/10 (0.00%)

Gastroenteritis † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

1/23 (4.35%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Osteomyelitis † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

1/20 (5.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Periorbital cellulitis † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

1/20 (5.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Pneumococcal infection † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

1/20 (5.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Pneumonia klebsiella † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

1/21 (4.76%)

0/10 (0.00%)

Pulmonary sepsis † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

1/20 (5.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Sinobronchitis † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

1/23 (4.35%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Lower respiratory tract infection † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

2/19 (10.53%)

0/20 (0.00%)

1/23 (4.35%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Injury, poisoning and procedural complications

Lumbar vertebral fracture † 1

1/12 (8.33%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Femur fracture † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

1/20 (5.00%)

1/21 (4.76%)

0/21 (0.00%)

0/10 (0.00%)

Fall † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

1/23 (4.35%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Gastroenteritis radiation † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

1/19 (5.26%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Humerus fracture † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

1/23 (4.35%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Post procedural haemorrhage † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

1/21 (4.76%)

0/21 (0.00%)

0/10 (0.00%)

Procedural pain † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

1/19 (5.26%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Investigations

Alanine aminotransferase increased † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

1/23 (4.35%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

1/21 (4.76%)

0/21 (0.00%)

0/10 (0.00%)

Aspartate aminotransferase increased † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

1/23 (4.35%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

1/21 (4.76%)

0/21 (0.00%)

0/10 (0.00%)

Blood bilirubin increased † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

1/10 (10.00%)

Troponin T increased † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

1/20 (5.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Metabolism and nutrition disorders

Hypomagnesaemia † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

1/13 (7.69%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Dehydration † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

1/20 (5.00%)

0/23 (0.00%)

2/20 (10.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Hypoglycaemia † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

1/23 (4.35%)

0/20 (0.00%)

1/21 (4.76%)

0/21 (0.00%)

0/10 (0.00%)

Cachexia † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

1/20 (5.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Diabetic ketoacidosis † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

1/21 (4.76%)

0/21 (0.00%)

0/10 (0.00%)

Hypokalaemia † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

1/23 (4.35%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Malnutrition † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

1/20 (5.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Musculoskeletal and connective tissue disorders

Flank pain † 1

0/12 (0.00%)

1/12 (8.33%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Polymyalgia rheumatica † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

1/6 (16.67%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Back pain † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

1/23 (4.35%)

1/19 (5.26%)

0/20 (0.00%)

1/23 (4.35%)

1/20 (5.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Musculoskeletal chest pain † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

1/19 (5.26%)

1/20 (5.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Groin pain † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

1/23 (4.35%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Osteonecrosis † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

1/23 (4.35%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Pathological fracture † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

1/10 (10.00%)

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Infected neoplasm † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

1/10 (10.00%)

Squamous cell carcinoma of skin † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

1/21 (4.76%)

0/10 (0.00%)

Nervous system disorders

Spinal cord compression † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

3/20 (15.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Headache † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

1/20 (5.00%)

0/21 (0.00%)

0/21 (0.00%)

1/10 (10.00%)

Cerebrovascular accident † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

1/10 (10.00%)

Depressed level of consciousness † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

1/21 (4.76%)

0/21 (0.00%)

0/10 (0.00%)

Hemiplegia † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

1/23 (4.35%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Seizure † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

1/20 (5.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Syncope † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

1/10 (10.00%)

Transient ischaemic attack † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

1/23 (4.35%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Psychiatric disorders

Delirium † 1

0/12 (0.00%)

1/12 (8.33%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Substance-induced psychotic disorder † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

1/6 (16.67%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Renal and urinary disorders

Acute kidney injury † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

1/13 (7.69%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

2/21 (9.52%)

1/21 (4.76%)

0/10 (0.00%)

Ureteric obstruction † 1

0/12 (0.00%)

1/12 (8.33%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Haematuria † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

1/20 (5.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Nephrolithiasis † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

1/21 (4.76%)

0/21 (0.00%)

0/10 (0.00%)

Urinary tract obstruction † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

1/21 (4.76%)

0/21 (0.00%)

0/10 (0.00%)

Reproductive system and breast disorders

Pelvic pain † 1

0/12 (0.00%)

1/12 (8.33%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Vaginal haemorrhage † 1

0/9 (0.00%)

0/11 (0.00%)

0/5 (0.00%)

1/12 (8.33%)

0/5 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/0

0/10 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/9 (0.00%)

0/5 (0.00%)

Respiratory, thoracic and mediastinal disorders

Atelectasis † 1

0/12 (0.00%)

1/12 (8.33%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Pleural effusion † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

1/6 (16.67%)

0/23 (0.00%)

0/23 (0.00%)

1/19 (5.26%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

1/21 (4.76%)

0/10 (0.00%)

Pulmonary embolism † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

1/23 (4.35%)

0/19 (0.00%)

1/20 (5.00%)

0/23 (0.00%)

2/20 (10.00%)

0/21 (0.00%)

1/21 (4.76%)

0/10 (0.00%)

Pneumonitis † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

1/19 (5.26%)

1/20 (5.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

1/10 (10.00%)

Dyspnoea † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

2/23 (8.70%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Pleuritic pain † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

1/20 (5.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Pneumonia aspiration † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

1/19 (5.26%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Pneumothorax † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

1/20 (5.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Respiratory distress † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

1/21 (4.76%)

0/21 (0.00%)

0/10 (0.00%)

Respiratory failure † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

1/23 (4.35%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Skin and subcutaneous tissue disorders

Rash macular † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

1/19 (5.26%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Rash maculo-papular † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

1/23 (4.35%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Vascular disorders

Hypotension † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

1/6 (16.67%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

1/23 (4.35%)

1/20 (5.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Embolism arterial † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

1/21 (4.76%)

0/10 (0.00%)

Haematoma † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

1/10 (10.00%)

Superior vena cava occlusion † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

1/23 (4.35%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Superior vena cava syndrome † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

1/23 (4.35%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

1 Term from vocabulary, MedDRA 22.0; † Indicates events were collected by systematic assessment

Other (Not Including Serious) Adverse Events

Frequency Threshold for Reporting Other Adverse Events

3%

Part A: Dose Escalation Phase - Cohort 1

Part A: Dose Escalation Phase - Cohort 2

Part A: Dose Escalation Phase - Cohort 3

Part A: Dose Escalation Phase - Cohort 4

Part A: Dose Escalation Phase - Cohort 5

Part B: Dose Expansion Phase - Arm 1a

Part B: Dose Expansion Phase - Arm 1b

Part B: Dose Expansion Phase - Arm 2

Part B: Dose Expansion Phase - Arm 3

Part B: Dose Expansion Phase - Arm 4

Part B: Dose Expansion Phase - Arm 5

Part B: Dose Expansion Phase - Arm 6

Part B: Dose Expansion Phase - Arm 7

Part B: Dose Expansion Phase - Arm 8

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Total

12/12 (100.00%)

11/12 (91.67%)

5/6 (83.33%)

12/13 (92.31%)

6/6 (100.00%)

21/23 (91.30%)

22/23 (95.65%)

16/19 (84.21%)

13/20 (65.00%)

15/23 (65.22%)

17/20 (85.00%)

14/21 (66.67%)

18/21 (85.71%)

5/10 (50.00%)

Blood and lymphatic system disorders

Anaemia † 1

2/12 (16.67%)

2/12 (16.67%)

2/6 (33.33%)

4/13 (30.77%)

3/6 (50.00%)

5/23 (21.74%)

2/23 (8.70%)

10/19 (52.63%)

5/20 (25.00%)

3/23 (13.04%)

2/20 (10.00%)

5/21 (23.81%)

5/21 (23.81%)

2/10 (20.00%)

Lymphopenia † 1

0/12 (0.00%)

1/12 (8.33%)

0/6 (0.00%)

0/13 (0.00%)

1/6 (16.67%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Neutropenia † 1

2/12 (16.67%)

0/12 (0.00%)

1/6 (16.67%)

1/13 (7.69%)

1/6 (16.67%)

1/23 (4.35%)

1/23 (4.35%)

2/19 (10.53%)

1/20 (5.00%)

0/23 (0.00%)

1/20 (5.00%)

1/21 (4.76%)

0/21 (0.00%)

0/10 (0.00%)

Thrombocytopenia † 1

0/12 (0.00%)

0/12 (0.00%)

3/6 (50.00%)

0/13 (0.00%)

2/6 (33.33%)

3/23 (13.04%)

1/23 (4.35%)

2/19 (10.53%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

1/21 (4.76%)

0/21 (0.00%)

0/10 (0.00%)

Endocrine disorders

Hyperthyroidism † 1

1/12 (8.33%)

0/12 (0.00%)

1/6 (16.67%)

1/13 (7.69%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Hypothyroidism † 1

1/12 (8.33%)

1/12 (8.33%)

1/6 (16.67%)

1/13 (7.69%)

2/6 (33.33%)

4/23 (17.39%)

0/23 (0.00%)

2/19 (10.53%)

0/20 (0.00%)

2/23 (8.70%)

1/20 (5.00%)

0/21 (0.00%)

1/21 (4.76%)

0/10 (0.00%)

Eye disorders

Dry eye † 1

1/12 (8.33%)

0/12 (0.00%)

0/6 (0.00%)

1/13 (7.69%)

0/6 (0.00%)

0/23 (0.00%)

1/23 (4.35%)

3/19 (15.79%)

0/20 (0.00%)

0/23 (0.00%)

1/20 (5.00%)

1/21 (4.76%)

0/21 (0.00%)

0/10 (0.00%)

Vision blurred † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

2/13 (15.38%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Gastrointestinal disorders

Abdominal discomfort † 1

1/12 (8.33%)

0/12 (0.00%)

0/6 (0.00%)

1/13 (7.69%)

0/6 (0.00%)

1/23 (4.35%)

2/23 (8.70%)

2/19 (10.53%)

0/20 (0.00%)

1/23 (4.35%)

1/20 (5.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Abdominal distension † 1

1/12 (8.33%)

1/12 (8.33%)

1/6 (16.67%)

0/13 (0.00%)

1/6 (16.67%)

0/23 (0.00%)

2/23 (8.70%)

1/19 (5.26%)

0/20 (0.00%)

2/23 (8.70%)

1/20 (5.00%)

0/21 (0.00%)

1/21 (4.76%)

0/10 (0.00%)

Abdominal pain † 1

2/12 (16.67%)

1/12 (8.33%)

2/6 (33.33%)

1/13 (7.69%)

1/6 (16.67%)

3/23 (13.04%)

5/23 (21.74%)

3/19 (15.79%)

1/20 (5.00%)

0/23 (0.00%)

4/20 (20.00%)

1/21 (4.76%)

1/21 (4.76%)

1/10 (10.00%)

Abdominal pain lower † 1

0/12 (0.00%)

1/12 (8.33%)

1/6 (16.67%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Abdominal pain upper † 1

0/12 (0.00%)

1/12 (8.33%)

1/6 (16.67%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

1/23 (4.35%)

2/20 (10.00%)

0/21 (0.00%)

2/21 (9.52%)

1/10 (10.00%)

Ascites † 1

0/12 (0.00%)

1/12 (8.33%)

0/6 (0.00%)

1/13 (7.69%)

1/6 (16.67%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Constipation † 1

4/12 (33.33%)

3/12 (25.00%)

1/6 (16.67%)

1/13 (7.69%)

1/6 (16.67%)

4/23 (17.39%)

8/23 (34.78%)

5/19 (26.32%)

6/20 (30.00%)

3/23 (13.04%)

8/20 (40.00%)

3/21 (14.29%)

5/21 (23.81%)

0/10 (0.00%)

Diarrhoea † 1

1/12 (8.33%)

6/12 (50.00%)

4/6 (66.67%)

5/13 (38.46%)

3/6 (50.00%)

10/23 (43.48%)

6/23 (26.09%)

8/19 (42.11%)

4/20 (20.00%)

4/23 (17.39%)

6/20 (30.00%)

6/21 (28.57%)

3/21 (14.29%)

1/10 (10.00%)

Dry mouth † 1

2/12 (16.67%)

0/12 (0.00%)

1/6 (16.67%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Dyspepsia † 1

0/12 (0.00%)

1/12 (8.33%)

0/6 (0.00%)

0/13 (0.00%)

1/6 (16.67%)

1/23 (4.35%)

2/23 (8.70%)

2/19 (10.53%)

0/20 (0.00%)

1/23 (4.35%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Gastrooesophageal reflux disease † 1

1/12 (8.33%)

3/12 (25.00%)

1/6 (16.67%)

1/13 (7.69%)

0/6 (0.00%)

0/23 (0.00%)

2/23 (8.70%)

0/19 (0.00%)

1/20 (5.00%)

1/23 (4.35%)

4/20 (20.00%)

2/21 (9.52%)

0/21 (0.00%)

2/10 (20.00%)

Nausea † 1

5/12 (41.67%)

10/12 (83.33%)

4/6 (66.67%)

10/13 (76.92%)

5/6 (83.33%)

18/23 (78.26%)

17/23 (73.91%)

15/19 (78.95%)

8/20 (40.00%)

8/23 (34.78%)

7/20 (35.00%)

12/21 (57.14%)

12/21 (57.14%)

3/10 (30.00%)

Oesophagitis † 1

0/12 (0.00%)

1/12 (8.33%)

0/6 (0.00%)

1/13 (7.69%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Rectal haemorrhage † 1

1/12 (8.33%)

1/12 (8.33%)

1/6 (16.67%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Toothache † 1

1/12 (8.33%)

0/12 (0.00%)

0/6 (0.00%)

1/13 (7.69%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Vomiting † 1

1/12 (8.33%)

7/12 (58.33%)

1/6 (16.67%)

5/13 (38.46%)

3/6 (50.00%)

6/23 (26.09%)

5/23 (21.74%)

8/19 (42.11%)

3/20 (15.00%)

2/23 (8.70%)

4/20 (20.00%)

4/21 (19.05%)

3/21 (14.29%)

2/10 (20.00%)

Dysphagia † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

4/20 (20.00%)

1/21 (4.76%)

1/21 (4.76%)

0/10 (0.00%)

General disorders

Chills † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

1/13 (7.69%)

1/6 (16.67%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Fatigue † 1

7/12 (58.33%)

7/12 (58.33%)

3/6 (50.00%)

7/13 (53.85%)

4/6 (66.67%)

10/23 (43.48%)

15/23 (65.22%)

12/19 (63.16%)

12/20 (60.00%)

5/23 (21.74%)

11/20 (55.00%)

9/21 (42.86%)

9/21 (42.86%)

5/10 (50.00%)

Influenza like illness † 1

2/12 (16.67%)

1/12 (8.33%)

0/6 (0.00%)

1/13 (7.69%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Pyrexia † 1

4/12 (33.33%)

2/12 (16.67%)

2/6 (33.33%)

0/13 (0.00%)

1/6 (16.67%)

3/23 (13.04%)

1/23 (4.35%)

2/19 (10.53%)

1/20 (5.00%)

0/23 (0.00%)

2/20 (10.00%)

2/21 (9.52%)

1/21 (4.76%)

0/10 (0.00%)

Asthenia † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

1/23 (4.35%)

2/23 (8.70%)

4/19 (21.05%)

0/20 (0.00%)

3/23 (13.04%)

1/20 (5.00%)

1/21 (4.76%)

0/21 (0.00%)

0/10 (0.00%)

Non-cardiac chest pain † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

2/23 (8.70%)

0/23 (0.00%)

0/19 (0.00%)

1/20 (5.00%)

0/23 (0.00%)

1/20 (5.00%)

1/21 (4.76%)

1/21 (4.76%)

0/10 (0.00%)

Oedema peripheral † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

3/23 (13.04%)

5/23 (21.74%)

1/19 (5.26%)

2/20 (10.00%)

1/23 (4.35%)

0/20 (0.00%)

3/21 (14.29%)

6/21 (28.57%)

3/10 (30.00%)

Hepatobiliary disorders

Autoimmune hepatitis † 1

1/12 (8.33%)

1/12 (8.33%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Hepatitis † 1

1/12 (8.33%)

0/12 (0.00%)

0/6 (0.00%)

1/13 (7.69%)

0/6 (0.00%)

3/23 (13.04%)

1/23 (4.35%)

1/19 (5.26%)

0/20 (0.00%)

3/23 (13.04%)

0/20 (0.00%)

3/21 (14.29%)

0/21 (0.00%)

0/10 (0.00%)

Infections and infestations

Lower respiratory tract infection bacterial † 1

0/12 (0.00%)

1/12 (8.33%)

0/6 (0.00%)

1/13 (7.69%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Nasopharyngitis † 1

2/12 (16.67%)

1/12 (8.33%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Oral candidiasis † 1

0/12 (0.00%)

1/12 (8.33%)

0/6 (0.00%)

2/13 (15.38%)

1/6 (16.67%)

1/23 (4.35%)

2/23 (8.70%)

1/19 (5.26%)

2/20 (10.00%)

1/23 (4.35%)

1/20 (5.00%)

2/21 (9.52%)

1/21 (4.76%)

0/10 (0.00%)

Rhinitis † 1

0/12 (0.00%)

0/12 (0.00%)

1/6 (16.67%)

0/13 (0.00%)

1/6 (16.67%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Upper respiratory tract infection † 1

3/12 (25.00%)

3/12 (25.00%)

2/6 (33.33%)

2/13 (15.38%)

1/6 (16.67%)

5/23 (21.74%)

1/23 (4.35%)

7/19 (36.84%)

3/20 (15.00%)

2/23 (8.70%)

0/20 (0.00%)

1/21 (4.76%)

0/21 (0.00%)

1/10 (10.00%)

Urinary tract infection † 1

0/12 (0.00%)

2/12 (16.67%)

2/6 (33.33%)

3/13 (23.08%)

2/6 (33.33%)

4/23 (17.39%)

3/23 (13.04%)

1/19 (5.26%)

3/20 (15.00%)

1/23 (4.35%)

3/20 (15.00%)

4/21 (19.05%)

0/21 (0.00%)

1/10 (10.00%)

Vulvovaginal candidiasis † 1

0/9 (0.00%)

1/11 (9.09%)

2/5 (40.00%)

0/12 (0.00%)

0/5 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/0

0/10 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/9 (0.00%)

0/5 (0.00%)

Bronchitis † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

2/19 (10.53%)

3/20 (15.00%)

0/23 (0.00%)

0/20 (0.00%)

1/21 (4.76%)

0/21 (0.00%)

0/10 (0.00%)

Lower respiratory tract infection † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

1/23 (4.35%)

1/19 (5.26%)

1/20 (5.00%)

2/23 (8.70%)

0/20 (0.00%)

1/21 (4.76%)

0/21 (0.00%)

0/10 (0.00%)

Injury, poisoning and procedural complications

Fall † 1

0/12 (0.00%)

1/12 (8.33%)

1/6 (16.67%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Investigations

Alanine aminotransferase increased † 1

1/12 (8.33%)

2/12 (16.67%)

3/6 (50.00%)

3/13 (23.08%)

3/6 (50.00%)

4/23 (17.39%)

3/23 (13.04%)

3/19 (15.79%)

3/20 (15.00%)

2/23 (8.70%)

2/20 (10.00%)

8/21 (38.10%)

1/21 (4.76%)

2/10 (20.00%)

Aspartate aminotransferase increased † 1

1/12 (8.33%)

2/12 (16.67%)

3/6 (50.00%)

3/13 (23.08%)

1/6 (16.67%)

3/23 (13.04%)

3/23 (13.04%)

3/19 (15.79%)

3/20 (15.00%)

2/23 (8.70%)

2/20 (10.00%)

9/21 (42.86%)

2/21 (9.52%)

2/10 (20.00%)

Blood alkaline phosphatase increased † 1

0/12 (0.00%)

1/12 (8.33%)

1/6 (16.67%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Blood bilirubin increased † 1

0/12 (0.00%)

1/12 (8.33%)

1/6 (16.67%)

0/13 (0.00%)

0/6 (0.00%)

1/23 (4.35%)

1/23 (4.35%)

3/19 (15.79%)

0/20 (0.00%)

1/23 (4.35%)

0/20 (0.00%)

1/21 (4.76%)

1/21 (4.76%)

1/10 (10.00%)

Gamma-glutamyltransferase increased † 1

0/12 (0.00%)

2/12 (16.67%)

2/6 (33.33%)

0/13 (0.00%)

1/6 (16.67%)

1/23 (4.35%)

1/23 (4.35%)

1/19 (5.26%)

0/20 (0.00%)

2/23 (8.70%)

0/20 (0.00%)

2/21 (9.52%)

0/21 (0.00%)

0/10 (0.00%)

Weight decreased † 1

0/12 (0.00%)

1/12 (8.33%)

0/6 (0.00%)

1/13 (7.69%)

1/6 (16.67%)

0/23 (0.00%)

2/23 (8.70%)

1/19 (5.26%)

0/20 (0.00%)

0/23 (0.00%)

2/20 (10.00%)

3/21 (14.29%)

3/21 (14.29%)

0/10 (0.00%)

Blood creatine phosphokinase increased † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

3/23 (13.04%)

0/23 (0.00%)

1/19 (5.26%)

0/20 (0.00%)

0/23 (0.00%)

3/20 (15.00%)

2/21 (9.52%)

0/21 (0.00%)

0/10 (0.00%)

Blood creatinine increased † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

2/23 (8.70%)

0/23 (0.00%)

0/19 (0.00%)

1/20 (5.00%)

1/23 (4.35%)

1/20 (5.00%)

2/21 (9.52%)

0/21 (0.00%)

0/10 (0.00%)

Metabolism and nutrition disorders

Decreased appetite † 1

0/12 (0.00%)

2/12 (16.67%)

0/6 (0.00%)

2/13 (15.38%)

0/6 (0.00%)

6/23 (26.09%)

4/23 (17.39%)

2/19 (10.53%)

2/20 (10.00%)

8/23 (34.78%)

3/20 (15.00%)

3/21 (14.29%)

5/21 (23.81%)

2/10 (20.00%)

Dehydration † 1

0/12 (0.00%)

1/12 (8.33%)

0/6 (0.00%)

1/13 (7.69%)

0/6 (0.00%)

0/23 (0.00%)

1/23 (4.35%)

0/19 (0.00%)

1/20 (5.00%)

2/23 (8.70%)

3/20 (15.00%)

1/21 (4.76%)

2/21 (9.52%)

0/10 (0.00%)

Hypercalcaemia † 1

1/12 (8.33%)

0/12 (0.00%)

0/6 (0.00%)

1/13 (7.69%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Hypokalaemia † 1

1/12 (8.33%)

0/12 (0.00%)

0/6 (0.00%)

2/13 (15.38%)

0/6 (0.00%)

0/23 (0.00%)

1/23 (4.35%)

4/19 (21.05%)

0/20 (0.00%)

0/23 (0.00%)

2/20 (10.00%)

2/21 (9.52%)

2/21 (9.52%)

1/10 (10.00%)

Hypophosphataemia † 1

1/12 (8.33%)

2/12 (16.67%)

0/6 (0.00%)

1/13 (7.69%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Musculoskeletal and connective tissue disorders

Arthralgia † 1

1/12 (8.33%)

2/12 (16.67%)

1/6 (16.67%)

2/13 (15.38%)

1/6 (16.67%)

5/23 (21.74%)

3/23 (13.04%)

3/19 (15.79%)

5/20 (25.00%)

1/23 (4.35%)

1/20 (5.00%)

1/21 (4.76%)

2/21 (9.52%)

2/10 (20.00%)

Back pain † 1

1/12 (8.33%)

3/12 (25.00%)

3/6 (50.00%)

0/13 (0.00%)

3/6 (50.00%)

8/23 (34.78%)

3/23 (13.04%)

5/19 (26.32%)

5/20 (25.00%)

5/23 (21.74%)

4/20 (20.00%)

3/21 (14.29%)

3/21 (14.29%)

0/10 (0.00%)

Flank pain † 1

0/12 (0.00%)

2/12 (16.67%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Groin pain † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

1/13 (7.69%)

1/6 (16.67%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Muscle spasms † 1

1/12 (8.33%)

0/12 (0.00%)

1/6 (16.67%)

2/13 (15.38%)

0/6 (0.00%)

3/23 (13.04%)

6/23 (26.09%)

4/19 (21.05%)

1/20 (5.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

1/21 (4.76%)

0/10 (0.00%)

Muscular weakness † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

1/13 (7.69%)

1/6 (16.67%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Musculoskeletal chest pain † 1

0/12 (0.00%)

0/12 (0.00%)

2/6 (33.33%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

3/19 (15.79%)

3/20 (15.00%)

2/23 (8.70%)

2/20 (10.00%)

0/21 (0.00%)

0/21 (0.00%)

1/10 (10.00%)

Myalgia † 1

0/12 (0.00%)

1/12 (8.33%)

0/6 (0.00%)

1/13 (7.69%)

1/6 (16.67%)

5/23 (21.74%)

0/23 (0.00%)

1/19 (5.26%)

0/20 (0.00%)

1/23 (4.35%)

0/20 (0.00%)

1/21 (4.76%)

1/21 (4.76%)

0/10 (0.00%)

Neck pain † 1

0/12 (0.00%)

2/12 (16.67%)

1/6 (16.67%)

0/13 (0.00%)

1/6 (16.67%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Pain in extremity † 1

0/12 (0.00%)

1/12 (8.33%)

0/6 (0.00%)

3/13 (23.08%)

1/6 (16.67%)

1/23 (4.35%)

0/23 (0.00%)

3/19 (15.79%)

3/20 (15.00%)

0/23 (0.00%)

1/20 (5.00%)

1/21 (4.76%)

0/21 (0.00%)

1/10 (10.00%)

Musculoskeletal pain † 1

1/12 (8.33%)

1/12 (8.33%)

2/6 (33.33%)

1/13 (7.69%)

0/6 (0.00%)

0/23 (0.00%)

1/23 (4.35%)

0/19 (0.00%)

2/20 (10.00%)

0/23 (0.00%)

1/20 (5.00%)

2/21 (9.52%)

1/21 (4.76%)

0/10 (0.00%)

Nervous system disorders

Dizziness † 1

1/12 (8.33%)

1/12 (8.33%)

0/6 (0.00%)

1/13 (7.69%)

0/6 (0.00%)

2/23 (8.70%)

2/23 (8.70%)

2/19 (10.53%)

0/20 (0.00%)

1/23 (4.35%)

3/20 (15.00%)

2/21 (9.52%)

4/21 (19.05%)

0/10 (0.00%)

Dysgeusia † 1

1/12 (8.33%)

1/12 (8.33%)

0/6 (0.00%)

0/13 (0.00%)

2/6 (33.33%)

0/23 (0.00%)

1/23 (4.35%)

2/19 (10.53%)

2/20 (10.00%)

2/23 (8.70%)

0/20 (0.00%)

0/21 (0.00%)

1/21 (4.76%)

0/10 (0.00%)

Headache † 1

3/12 (25.00%)

3/12 (25.00%)

2/6 (33.33%)

2/13 (15.38%)

1/6 (16.67%)

5/23 (21.74%)

3/23 (13.04%)

5/19 (26.32%)

3/20 (15.00%)

3/23 (13.04%)

3/20 (15.00%)

2/21 (9.52%)

2/21 (9.52%)

0/10 (0.00%)

Paraesthesia † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

1/23 (4.35%)

0/23 (0.00%)

3/19 (15.79%)

2/20 (10.00%)

1/23 (4.35%)

2/20 (10.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Peripheral sensory neuropathy † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

1/23 (4.35%)

1/23 (4.35%)

1/19 (5.26%)

0/20 (0.00%)

1/23 (4.35%)

0/20 (0.00%)

1/21 (4.76%)

1/21 (4.76%)

0/10 (0.00%)

Psychiatric disorders

Anxiety † 1

0/12 (0.00%)

1/12 (8.33%)

1/6 (16.67%)

0/13 (0.00%)

0/6 (0.00%)

2/23 (8.70%)

0/23 (0.00%)

0/19 (0.00%)

1/20 (5.00%)

0/23 (0.00%)

1/20 (5.00%)

2/21 (9.52%)

3/21 (14.29%)

1/10 (10.00%)

Insomnia † 1

1/12 (8.33%)

0/12 (0.00%)

1/6 (16.67%)

0/13 (0.00%)

1/6 (16.67%)

1/23 (4.35%)

2/23 (8.70%)

1/19 (5.26%)

5/20 (25.00%)

0/23 (0.00%)

2/20 (10.00%)

1/21 (4.76%)

1/21 (4.76%)

1/10 (10.00%)

Depression † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

1/23 (4.35%)

0/23 (0.00%)

0/19 (0.00%)

1/20 (5.00%)

1/23 (4.35%)

2/20 (10.00%)

1/21 (4.76%)

0/21 (0.00%)

0/10 (0.00%)

Renal and urinary disorders

Dysuria † 1

1/12 (8.33%)

1/12 (8.33%)

1/6 (16.67%)

0/13 (0.00%)

1/6 (16.67%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Reproductive system and breast disorders

Vaginal haemorrhage † 1

1/9 (11.11%)

0/11 (0.00%)

0/5 (0.00%)

1/12 (8.33%)

0/5 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/0

0/10 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/9 (0.00%)

0/5 (0.00%)

Respiratory, thoracic and mediastinal disorders

Cough † 1

4/12 (33.33%)

2/12 (16.67%)

2/6 (33.33%)

1/13 (7.69%)

1/6 (16.67%)

1/23 (4.35%)

3/23 (13.04%)

5/19 (26.32%)

3/20 (15.00%)

6/23 (26.09%)

2/20 (10.00%)

1/21 (4.76%)

3/21 (14.29%)

1/10 (10.00%)

Dyspnoea † 1

1/12 (8.33%)

1/12 (8.33%)

0/6 (0.00%)

1/13 (7.69%)

1/6 (16.67%)

2/23 (8.70%)

2/23 (8.70%)

3/19 (15.79%)

2/20 (10.00%)

4/23 (17.39%)

0/20 (0.00%)

3/21 (14.29%)

3/21 (14.29%)

1/10 (10.00%)

Epistaxis † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

2/13 (15.38%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Oropharyngeal pain † 1

2/12 (16.67%)

0/12 (0.00%)

1/6 (16.67%)

1/13 (7.69%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Productive cough † 1

0/12 (0.00%)

1/12 (8.33%)

1/6 (16.67%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Pulmonary embolism † 1

0/12 (0.00%)

1/12 (8.33%)

0/6 (0.00%)

1/13 (7.69%)

0/6 (0.00%)

1/23 (4.35%)

1/23 (4.35%)

1/19 (5.26%)

0/20 (0.00%)

0/23 (0.00%)

1/20 (5.00%)

0/21 (0.00%)

2/21 (9.52%)

0/10 (0.00%)

Rhinorrhoea † 1

0/12 (0.00%)

1/12 (8.33%)

0/6 (0.00%)

0/13 (0.00%)

1/6 (16.67%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Pleural effusion † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

1/23 (4.35%)

0/23 (0.00%)

1/19 (5.26%)

0/20 (0.00%)

1/23 (4.35%)

1/20 (5.00%)

1/21 (4.76%)

3/21 (14.29%)

0/10 (0.00%)

Skin and subcutaneous tissue disorders

Dermatitis † 1

0/12 (0.00%)

0/12 (0.00%)

1/6 (16.67%)

1/13 (7.69%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Dry skin † 1

1/12 (8.33%)

1/12 (8.33%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Pruritus † 1

1/12 (8.33%)

1/12 (8.33%)

1/6 (16.67%)

2/13 (15.38%)

0/6 (0.00%)

3/23 (13.04%)

1/23 (4.35%)

1/19 (5.26%)

1/20 (5.00%)

5/23 (21.74%)

0/20 (0.00%)

1/21 (4.76%)

1/21 (4.76%)

0/10 (0.00%)

Rash † 1

1/12 (8.33%)

0/12 (0.00%)

1/6 (16.67%)

1/13 (7.69%)

1/6 (16.67%)

3/23 (13.04%)

0/23 (0.00%)

4/19 (21.05%)

1/20 (5.00%)

1/23 (4.35%)

1/20 (5.00%)

0/21 (0.00%)

2/21 (9.52%)

0/10 (0.00%)

Rash macular † 1

1/12 (8.33%)

1/12 (8.33%)

0/6 (0.00%)

0/13 (0.00%)

1/6 (16.67%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Rash maculo-papular † 1

0/12 (0.00%)

2/12 (16.67%)

1/6 (16.67%)

1/13 (7.69%)

1/6 (16.67%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Vascular disorders

Deep vein thrombosis † 1

1/12 (8.33%)

0/12 (0.00%)

0/6 (0.00%)

1/13 (7.69%)

0/6 (0.00%)

0/23 (0.00%)

0/23 (0.00%)

0/19 (0.00%)

0/20 (0.00%)

0/23 (0.00%)

0/20 (0.00%)

0/21 (0.00%)

0/21 (0.00%)

0/10 (0.00%)

Hot flush † 1

2/12 (16.67%)

0/12 (0.00%)

0/6 (0.00%)

1/13 (7.69%)

0/6 (0.00%)

2/23 (8.70%)

2/23 (8.70%)

0/19 (0.00%)

1/20 (5.00%)

0/23 (0.00%)

0/20 (0.00%)

1/21 (4.76%)

0/21 (0.00%)

0/10 (0.00%)

Hypertension † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

1/23 (4.35%)

0/23 (0.00%)

0/19 (0.00%)

2/20 (10.00%)

1/23 (4.35%)

0/20 (0.00%)

0/21 (0.00%)

1/21 (4.76%)

1/10 (10.00%)

Hypotension † 1

0/12 (0.00%)

0/12 (0.00%)

0/6 (0.00%)

0/13 (0.00%)

0/6 (0.00%)

1/23 (4.35%)

2/23 (8.70%)

1/19 (5.26%)

0/20 (0.00%)

1/23 (4.35%)

3/20 (15.00%)

2/21 (9.52%)

0/21 (0.00%)

1/10 (10.00%)

1 Term from vocabulary, MedDRA 22.0; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

• Name/Title: Study Director
• Organization: BeiGene
• Phone: +1-877-828-5568
• EMail: clinicaltrials@beigene.com

Publications of Results:

Friedlander M, Meniawy T, Markman B, Mileshkin L, Harnett P, Millward M, Lundy J, Freimund A, Norris C, Mu S, Wu J, Paton V, Gao B. Pamiparib in combination with tislelizumab in patients with advanced solid tumours: results from the dose-escalation stage of a multicentre, open-label, phase 1a/b trial. Lancet Oncol. 2019 Sep;20(9):1306-1315. doi: 10.1016/S1470-2045(19)30396-1. Epub 2019 Aug 1.

• Responsible Party: BeiGene
• ClinicalTrials.gov Identifier: NCT02660034
• Other Study ID Numbers: BGB-A317/BGB-290_Study_001; 2017-003580-35 ( EudraCT Number )
• First Submitted: January 11, 2016
• First Posted: January 21, 2016
• Results First Submitted: September 7, 2021
• Results First Posted: December 6, 2021
• Last Update Posted: December 6, 2021