Trial Outcomes & Findings for Study of AMG 910 in Subjects With CLDN18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma (NCT NCT04260191)

Last Updated: 2024-01-25

Results Overview

All DLTs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. DLTs were defined as any AEs at least possibly related to AMG 910 with an onset within the first 28 days following first dose with any of the following: * Grade 2 gastric perforation or fistula * Grade ≥ 3 non-hematologic AEs including laboratory abnormalities * Re-challenge with AMG 910 after treatment interruption due to any stomach toxicity results in at least same stomach toxicity and is of CTCAE grade ≥ 3 or grade 2 and ongoing for more than 3 days despite optimal supportive treatment * Grade 4 thrombocytopenia or grade 3 thrombocytopenia with bleeding * Grade 4 neutropenia lasting \> 28 days * Febrile neutropenia of any grade * Anemia requiring transfusion per local or international guidelines in the absence of bleeding * Grade 5 toxicity * Any other toxicity related to AMG 910 considered significant enough to be qualified as DLT in the opinion of the investigator

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

15 participants

Primary outcome timeframe

Day 1 to Day 28

Results posted on

2024-01-25

Participant Flow

A total of 15 participants were enrolled and received AMG 910 at 10 centers in Europe, South Korea, Taiwan and the United States between 29 June 2020 and 02 June 2022.

Participant milestones

Participant milestones
Measure	Cohort 1: AMG 910 6.5 µg For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Cohort 1b: AMG 910 6.5 µg For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Cohort 2b: AMG 910 15 µg For Cycle 1 Week 1, participants received AMG 910 as an eIV infusion (approximately 96 hours) at a dose of 15 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 15 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
Overall Study STARTED	6	4	5
Overall Study Received AMG 910	6	4	5
Overall Study COMPLETED	1	0	0
Overall Study NOT COMPLETED	5	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: AMG 910 6.5 µg For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Cohort 1b: AMG 910 6.5 µg For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Cohort 2b: AMG 910 15 µg For Cycle 1 Week 1, participants received AMG 910 as an eIV infusion (approximately 96 hours) at a dose of 15 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 15 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
Overall Study Decision by Sponsor	0	1	0
Overall Study Withdrawal by Subject	1	0	3
Overall Study Death	4	3	2

Baseline Characteristics

Study of AMG 910 in Subjects With CLDN18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: AMG 910 6.5 µg n=6 Participants For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Cohort 1b: AMG 910 6.5 µg n=4 Participants For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Cohort 2b: AMG 910 15 µg n=5 Participants For Cycle 1 Week 1, participants received AMG 910 as an eIV infusion (approximately 96 hours) at a dose of 15 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 15 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Total n=15 Participants Total of all reporting groups
Age, Continuous	55.5 years STANDARD_DEVIATION 14.9 • n=5 Participants	54.3 years STANDARD_DEVIATION 22.9 • n=7 Participants	63.6 years STANDARD_DEVIATION 10.7 • n=5 Participants	57.9 years STANDARD_DEVIATION 15.6 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	13 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized White	4 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 28

Population: Safety Analysis Set: All participants that were enrolled and received at least 1 dose of AMG 910. Only participants who received study treatment (at least 80% of the planned dose for Cycle 1) and remained on study through the DLT assessment window were considered DLT-evaluable.

Outcome measures

Outcome measures
Measure	Cohort 1: AMG 910 6.5 µg n=4 Participants For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Cohort 1b: AMG 910 6.5 µg n=3 Participants For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Cohort 2b: AMG 910 15 µg n=5 Participants For Cycle 1 Week 1, participants received AMG 910 as an eIV infusion (approximately 96 hours) at a dose of 15 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 15 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT)	2 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 1 to 30 days post-last dose; maximum duration was 10.97 months

Population: Safety Analysis Set: All participants that were enrolled and received at least 1 dose of AMG 910.

A TEAE was defined as any adverse event starting on or after the first administration of investigational product, as determined by the flag indicating if the adverse event started prior to the first dose on the Events case report form, and up to and including 30 days after the last investigational product dose date. Evaluation of TEAEs included the number of participants with at least 1 TEAE or treatment-related TEAE. Clinically significant changes in vital signs, electrocardiogram (ECG) and clinical laboratory tests were recorded as TEAEs.

Outcome measures

Outcome measures
Measure	Cohort 1: AMG 910 6.5 µg n=6 Participants For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Cohort 1b: AMG 910 6.5 µg n=4 Participants For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Cohort 2b: AMG 910 15 µg n=5 Participants For Cycle 1 Week 1, participants received AMG 910 as an eIV infusion (approximately 96 hours) at a dose of 15 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 15 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
Number of Participants Who Experienced a Treatment-emergent AE (TEAE) TEAEs	6 Participants	4 Participants	5 Participants
Number of Participants Who Experienced a Treatment-emergent AE (TEAE) Treatment-related TEAEs	4 Participants	4 Participants	5 Participants

SECONDARY outcome

Timeframe: Cycle 1: Days 1-7 at pre-infusion, 1, 2, 4, 24, 48, 72, 96, 120 and 144 hr; Days 8 and 10* at pre-infusion, EOI, 4 and 24 hr post-EOI; Days 15, 17* and 22* at pre-infusion and EOI; Day 24* at pre-infusion, EOI, 2, 4 and 24 hr post-EOI (*=Cohort 1 only)

Population: PK Analysis Set: Includes all participants who have received at least 1 dose of the AMG 910 and have at least 1 PK sample collected. Participants with data available at each time point are included.

Mean Cmax values for the dosing intervals following short-term IV infusion (Cohort 1) and following extended IV infusions (Cohorts 1b and 2b) for Cycle 1 Week 1, and for short-term IV infusions in subsequent dosing intervals in Cycle 1. The timing of the pharmacokinetic (PK) sampling for Week 1 (Days 1 - 7) was based on hours after the start of the infusion and from Day 8 onwards was based on hours after the end of infusion (EOI). Due to the limited number of samples obtained and early termination of the study, PK data are summarized for Cycle 1 only.

Outcome measures

Outcome measures
Measure	Cohort 1: AMG 910 6.5 µg n=6 Participants For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Cohort 1b: AMG 910 6.5 µg n=4 Participants For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Cohort 2b: AMG 910 15 µg n=5 Participants For Cycle 1 Week 1, participants received AMG 910 as an eIV infusion (approximately 96 hours) at a dose of 15 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 15 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
Maximum Serum Concentration (Cmax) of AMG 910 Cycle 1 Day 8	2.92 ng/mL Interval 2.16 to 3.52	13.6 ng/mL Interval 1.63 to 47.6	22.3 ng/mL Interval 9.02 to 28.1
Maximum Serum Concentration (Cmax) of AMG 910 Cycle 1 Day 1	3.78 ng/mL Interval 1.19 to 10.1	—	—
Maximum Serum Concentration (Cmax) of AMG 910 Cycle 1 Day 3	5.89 ng/mL Interval 2.02 to 17.2	—	—
Maximum Serum Concentration (Cmax) of AMG 910 Cycle 1 Day 7	—	2.91 ng/mL Interval 1.12 to 4.99	15.8 ng/mL Interval 1.47 to 30.2
Maximum Serum Concentration (Cmax) of AMG 910 Cycle 1 Day 10	3.62 ng/mL Interval 2.45 to 4.27	—	—
Maximum Serum Concentration (Cmax) of AMG 910 Cycle 1 Day 15	1.82 ng/mL Interval 1.82 to 1.82	4.99 ng/mL Interval 1.35 to 8.62	10.5 ng/mL Interval 5.79 to 17.3
Maximum Serum Concentration (Cmax) of AMG 910 Cycle 1 Day 17	2.17 ng/mL Interval 2.17 to 2.17	—	—
Maximum Serum Concentration (Cmax) of AMG 910 Cycle 1 Day 22	2.22 ng/mL Interval 2.22 to 2.22	—	—
Maximum Serum Concentration (Cmax) of AMG 910 Cycle 1 Day 24	2.38 ng/mL Interval 2.38 to 2.38	—	—

SECONDARY outcome

Mean Ctrough values for the dosing intervals following short-term IV infusion (Cohort 1) and following extended IV infusions (Cohorts 1b and 2b) for Cycle 1 Week 1, and for short-term IV infusions in subsequent dosing intervals in Cycle 1 are presented. The timing of the PK sampling for Week 1 (Days 1-7) was based on hours after the start of infusion and from Day 8 onwards was based on hours after EOI. Due to the limited number of samples obtained and early termination of the study, PK data are summarized for Cycle 1 only.

Outcome measures

Outcome measures
Measure	Cohort 1: AMG 910 6.5 µg n=6 Participants For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Cohort 1b: AMG 910 6.5 µg n=4 Participants For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Cohort 2b: AMG 910 15 µg n=5 Participants For Cycle 1 Week 1, participants received AMG 910 as an eIV infusion (approximately 96 hours) at a dose of 15 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 15 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
Minimum Serum Concentration (Ctrough) of AMG 910 Cycle 1 Day 1	0.952 ng/mL Interval 0.416 to 1.97	—	—
Minimum Serum Concentration (Ctrough) of AMG 910 Cycle 1 Day 3	0.698 ng/mL Interval 0.45 to 1.21	—	—
Minimum Serum Concentration (Ctrough) of AMG 910 Cycle 1 Day 7	—	0.813 ng/mL Interval 0.438 to 1.59	7.27 ng/mL Interval 2.24 to 11.0
Minimum Serum Concentration (Ctrough) of AMG 910 Cycle 1 Day 8	1.48 ng/mL Interval 1.04 to 1.92	1.54 ng/mL Interval 0.316 to 3.4	3.70 ng/mL Interval 1.06 to 5.55
Minimum Serum Concentration (Ctrough) of AMG 910 Cycle 1 Day 10	0.979 ng/mL Interval 0.582 to 1.68	—	—
Minimum Serum Concentration (Ctrough) of AMG 910 Cycle 1 Day 15	0.836 ng/mL Interval 0.836 to 0.836	1.02 ng/mL Interval 0.0 to 2.03	2.54 ng/mL Interval 0.809 to 4.37
Minimum Serum Concentration (Ctrough) of AMG 910 Cycle 1 Day 17	0.664 ng/mL Interval 0.664 to 0.664	—	—
Minimum Serum Concentration (Ctrough) of AMG 910 Cycle 1 Day 22	1.05 ng/mL Interval 1.05 to 1.05	—	—
Minimum Serum Concentration (Ctrough) of AMG 910 Cycle 1 Day 24	0.540 ng/mL Interval 0.54 to 0.54	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 at pre-infusion, 1, 2, 4, 24, 48, 72, 96, 120 and 144 hr after infusion start and Cycle 1 Day 8 pre-infusion through 168 hr post-EOI

Population: PK Analysis Set: Includes all participants who have received at least 1 dose of the AMG 910 and have at least 1 PK sample collected. Participants with data available are included.

The timing of the PK sampling for Week 1 (Days 1-7) was based on hours after the start of infusion, and for Day 8 after EOI.

Outcome measures

Outcome measures
Measure	Cohort 1: AMG 910 6.5 µg n=5 Participants For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Cohort 1b: AMG 910 6.5 µg n=4 Participants For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Cohort 2b: AMG 910 15 µg n=3 Participants For Cycle 1 Week 1, participants received AMG 910 as an eIV infusion (approximately 96 hours) at a dose of 15 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 15 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval (AUC0_168hr)	359 hr•ng/mL Standard Deviation 262	251 hr•ng/mL Standard Deviation 98.6	1710 hr•ng/mL Standard Deviation 1160

SECONDARY outcome

Timeframe: Cycle 1 Day 8 pre-infusion and Cycle 1 Day 22 pre-infusion

Calculated as AR = Cycle 1 Day 22 pre-infusion concentration/Cycle 1 Day 8 pre-infusion concentration.

Outcome measures

Outcome measures
Measure	Cohort 1: AMG 910 6.5 µg n=1 Participants For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Cohort 1b: AMG 910 6.5 µg For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Cohort 2b: AMG 910 15 µg For Cycle 1 Week 1, participants received AMG 910 as an eIV infusion (approximately 96 hours) at a dose of 15 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 15 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
Cohort 1 Only: Accumulation Ratio (AR) of AMG 910	1.48 ratio	—	—

SECONDARY outcome

Timeframe: Cycle 1: Days 1-7 at pre-infusion, 1, 2, 4, 24, 48, 72, 96, 120 and 144 hr; Days 8 and 10* at pre-infusion, EOI, 4 and 24 hr post-EOI (*=Cohort 1 only)

Mean t1/2 values for the dosing intervals following short-term IV infusion (Cohort 1) and following extended IV infusions (Cohorts 1b and 2b) for Cycle 1 Week 1, and for short-term IV infusions in subsequent dosing intervals in Cycle 1 are presented. The timing of the PK sampling for Week 1 (Days 1-7) was based on hours after the start of infusion and from Day 8 onwards was based on hours after EOI. Due to the limited number of samples obtained and early termination of the study, PK data are summarized for Cycle 1 only.

Outcome measures

Outcome measures
Measure	Cohort 1: AMG 910 6.5 µg n=2 Participants For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Cohort 1b: AMG 910 6.5 µg n=4 Participants For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Cohort 2b: AMG 910 15 µg n=4 Participants For Cycle 1 Week 1, participants received AMG 910 as an eIV infusion (approximately 96 hours) at a dose of 15 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 15 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
Half-life (t1/2) of AMG 910 Cycle 1 Day 8	—	63.2 hr Interval 55.2 to 71.1	66.9 hr Interval 60.0 to 74.0
Half-life (t1/2) of AMG 910 Cycle 1 Day 10	45.6 hr Interval 45.6 to 45.6	—	—
Half-life (t1/2) of AMG 910 Cycle 1 Day 3	47.4 hr Interval 47.4 to 47.4	—	—
Half-life (t1/2) of AMG 910 Cycle 1 Day 7	—	39.3 hr Interval 33.5 to 45.1	—

SECONDARY outcome

Timeframe: Day 1 to end of study (EOS); maximum time on study was 18.76 months

Population: RECIST Evaluable Analysis Set: Included all participants that were enrolled and received at least 1 dose of AMG 910 with at least 1 tumor lesion that was measurable in contrast-enhanced computed tomography (CT) as defined by RECIST 1.1 at baseline.

OR was defined as a best overall response (BOR) of complete response (CR) or partial response (PR) per RECIST v1.1: * CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm. * PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Non target lesions must be non-progressive Disease (non-PD).

Outcome measures

Outcome measures
Measure	Cohort 1: AMG 910 6.5 µg n=5 Participants For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Cohort 1b: AMG 910 6.5 µg n=3 Participants For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Cohort 2b: AMG 910 15 µg n=5 Participants For Cycle 1 Week 1, participants received AMG 910 as an eIV infusion (approximately 96 hours) at a dose of 15 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 15 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
Number of Participants With an Objective Response (OR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 to EOS; maximum time on study was 18.76 months

Population: Data were not collected.

ORR was defined as the incidence of a BOR of immune complete response (iCR) or immune partial response (iPR) per iRECIST: * iCR: Disappearance of all non-nodal target and non-target lesions and normalization of pathological lymph nodes (whether target or non-target) to \<10 mm in short axis. * iPR: At least a 30% decrease in the sum of measures of target lesions, taking as reference the baseline target lesion sum. Data was not collected due to early termination of study, therefore data are not available.

Outcome measures

Outcome data not reported

Cohort 1: AMG 910 6.5 µg

Serious events: 4 serious events

Other events: 6 other events

Deaths: 4 deaths

Cohort 1b: AMG 910 6.5 µg

Serious events: 3 serious events

Other events: 4 other events

Deaths: 3 deaths

Cohort 2b: AMG 910 15 µg

Serious events: 2 serious events

Other events: 5 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Cohort 1: AMG 910 6.5 µg n=6 participants at risk For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Cohort 1b: AMG 910 6.5 µg n=4 participants at risk For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Cohort 2b: AMG 910 15 µg n=5 participants at risk For Cycle 1 Week 1, participants received AMG 910 as an eIV infusion (approximately 96 hours) at a dose of 15 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 15 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
Cardiac disorders Atrial fibrillation	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Gastrointestinal disorders Abdominal pain	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Gastrointestinal disorders Gastrointestinal haemorrhage	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Gastrointestinal disorders Oesophageal stent stenosis	0.00% 0/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	20.0% 1/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Gastrointestinal disorders Pancreatitis	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
General disorders Multiple organ dysfunction syndrome	0.00% 0/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	20.0% 1/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
General disorders Pyrexia	0.00% 0/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	25.0% 1/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Hepatobiliary disorders Hypertransaminasaemia	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Immune system disorders Cytokine release syndrome	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Infections and infestations Peritonitis	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Infections and infestations Staphylococcal infection	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	20.0% 1/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.00% 0/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	50.0% 2/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Nervous system disorders Paraparesis	0.00% 0/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	20.0% 1/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	25.0% 1/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Vascular disorders Hypotension	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.

Other adverse events
Measure	Cohort 1: AMG 910 6.5 µg n=6 participants at risk For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Cohort 1b: AMG 910 6.5 µg n=4 participants at risk For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Cohort 2b: AMG 910 15 µg n=5 participants at risk For Cycle 1 Week 1, participants received AMG 910 as an eIV infusion (approximately 96 hours) at a dose of 15 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 15 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
Gastrointestinal disorders Nausea	50.0% 3/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	50.0% 2/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	60.0% 3/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Blood and lymphatic system disorders Anaemia	50.0% 3/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	50.0% 2/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	40.0% 2/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Cardiac disorders Tachycardia	0.00% 0/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	25.0% 1/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Gastrointestinal disorders Abdominal pain	50.0% 3/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	25.0% 1/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	20.0% 1/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Gastrointestinal disorders Ascites	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	25.0% 1/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Gastrointestinal disorders Constipation	33.3% 2/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	50.0% 2/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	20.0% 1/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	60.0% 3/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Gastrointestinal disorders Dyspepsia	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Gastrointestinal disorders Dysphagia	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Gastrointestinal disorders Faecal vomiting	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Gastrointestinal disorders Gastrooesophageal reflux disease	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Gastrointestinal disorders Haemorrhoids	0.00% 0/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	25.0% 1/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Gastrointestinal disorders Obstruction gastric	0.00% 0/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	20.0% 1/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Gastrointestinal disorders Stomatitis	0.00% 0/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	20.0% 1/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Gastrointestinal disorders Vomiting	50.0% 3/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	25.0% 1/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	40.0% 2/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
General disorders Asthenia	0.00% 0/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	25.0% 1/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
General disorders Fatigue	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	75.0% 3/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	20.0% 1/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
General disorders Generalised oedema	0.00% 0/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	20.0% 1/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
General disorders Oedema peripheral	0.00% 0/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	25.0% 1/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
General disorders Pyrexia	0.00% 0/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	25.0% 1/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	20.0% 1/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Hepatobiliary disorders Bile duct stenosis	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Hepatobiliary disorders Cholestasis	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Hepatobiliary disorders Hypertransaminasaemia	33.3% 2/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Immune system disorders Cytokine release syndrome	33.3% 2/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	50.0% 2/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	40.0% 2/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Infections and infestations COVID-19	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Infections and infestations Oesophageal candidiasis	0.00% 0/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	20.0% 1/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Infections and infestations Oral candidiasis	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Infections and infestations Urinary tract infection	0.00% 0/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	25.0% 1/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Injury, poisoning and procedural complications Afferent loop syndrome	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	20.0% 1/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Injury, poisoning and procedural complications Procedural vomiting	0.00% 0/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	25.0% 1/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Investigations Alanine aminotransferase increased	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Investigations Amylase increased	0.00% 0/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	25.0% 1/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Investigations Aspartate aminotransferase increased	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Investigations Blood alkaline phosphatase increased	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Investigations C-reactive protein increased	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Investigations Gamma-glutamyltransferase increased	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Investigations International normalised ratio increased	0.00% 0/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	20.0% 1/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Investigations Lipase increased	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	25.0% 1/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.
Investigations Lymphocyte count decreased	16.7% 1/6 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/4 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.	0.00% 0/5 • For mortality reporting, "From enrollment until the end of study; median (min, max) time on study was 2.4 ( 0.43, 18.89) months". For AE reporting, "From first dose of study drug until 30 days after last dose; median (min, max) duration was 1.9 ( 0.43, 10.97) months". For all-cause mortality, time frame is from enrollment through end of study including long term follow-up. For SAE and non-serious AEs, time frame is treatment emergent.