Trial Outcomes & Findings for A Study of Galunisertib (LY2157299) in Combination With Nivolumab in Advanced Refractory Solid Tumors and in Recurrent or Refractory NSCLC, or Hepatocellular Carcinoma (NCT NCT02423343)

Last Updated: 2021-09-09

Results Overview

The MTD is defined as the highest tested dose that has less than 33% probability of causing a dose limiting toxicity (DLT).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

41 participants

Primary outcome timeframe

Cycle 1 through Cycle 2 (Up to 2 Months)

Results posted on

2021-09-09

Participant Flow

Due low enrollment, the Hepatocellular Carcinoma (HCC) cohort was terminated early.

Participants who had at least one post baseline tumor assessment were considered to have completed the study.

Participant milestones

Participant milestones
Measure	Galunisertib + Nivolumab (Cohort 1) Phase 1b 50 milligram (mg) Galunisertib administered orally daily (QD) on Day 1 through Day 14 of each 4-week cycle in combination with 3 milligrams per kilogram (3 mg/kg) nivolumab given intravenously (IV), every 2 weeks (Q2W), on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab (Cohort 2) Phase 1b 50 mg Galunisertib administered orally twice daily (BID) on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, Q2W, on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab (Cohort 3) Phase 1b 80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, Q2W, on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab (Cohort 4) Phase 1b 150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, Q2W, on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab - Non-Small Cell Lung Cancer (NSCLC) Phase 2 150 mg Galunisertib administered orally BID for the first 14 days of each 4 week cycle in combination with 3 mg/kg nivolumab given IV, Q2W, (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab - Hepatocellular Carcinoma (HCC) Phase 2 150 mg Galunisertib administered orally BID for the first 14 days of each 4 week cycle in combination with 3 mg/kg nivolumab given IV, Q2W, (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Overall Study STARTED	3	5	3	4	25	1
Overall Study Received at Least One Dose of Study Drug	3	5	3	4	25	1
Overall Study COMPLETED	3	4	3	4	20	1
Overall Study NOT COMPLETED	0	1	0	0	5	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Galunisertib + Nivolumab (Cohort 2) Phase 1b 50 mg Galunisertib administered orally twice daily (BID) on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, Q2W, on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab - Non-Small Cell Lung Cancer (NSCLC) Phase 2 150 mg Galunisertib administered orally BID for the first 14 days of each 4 week cycle in combination with 3 mg/kg nivolumab given IV, Q2W, (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Overall Study Withdrawal by Subject	1	0
Overall Study Progressive Disease	0	2
Overall Study Adverse Event	0	2
Overall Study Death	0	1

Baseline Characteristics

A Study of Galunisertib (LY2157299) in Combination With Nivolumab in Advanced Refractory Solid Tumors and in Recurrent or Refractory NSCLC, or Hepatocellular Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Galunisertib + Nivolumab (Cohort 1) Phase 1b n=3 Participants 50 mg Galunisertib administered orally daily on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given intravenously (IV) every 2 weeks (Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab (Cohort 2) Phase 1b n=5 Participants 50 mg Galunisertib administered orally twice daily on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV every 2 weeks (Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab (Cohort 3) Phase 1b n=3 Participants 80 mg Galunisertib administered orally twice daily on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV every 2 weeks(Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab (Cohort 4) Phase 1b n=4 Participants 150 mg Galunisertib administered orally twice daily on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV every 2 weeks (Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab - Non Small Cell Lung Cancer (NSCLC) Phase 2 n=25 Participants 150 mg Galunisertib given orally twice daily for the first 14 days of each 4 week cycle in combination with 3 mg/kg nivolumab given IV every 2 weeks (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab - Hepatocellular Carcinoma(HCC) Phase 2 n=1 Participants 150 mg Galunisertib given orally twice daily for the first 14 days of each 4 week cycle in combination with 3 mg/kg nivolumab given IV every 2 weeks (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.	Total n=41 Participants Total of all reporting groups
Age, Continuous	60.7 years STANDARD_DEVIATION 15.6 • n=5 Participants	47.2 years STANDARD_DEVIATION 15.8 • n=7 Participants	36.0 years STANDARD_DEVIATION 5.3 • n=5 Participants	61.5 years STANDARD_DEVIATION 9.0 • n=4 Participants	61.0 years STANDARD_DEVIATION 8.4 • n=21 Participants	64.0 years STANDARD_DEVIATION NA • n=10 Participants	57.6 years STANDARD_DEVIATION 12.1 • n=115 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	9 Participants n=21 Participants	1 Participants n=10 Participants	16 Participants n=115 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	16 Participants n=21 Participants	0 Participants n=10 Participants	25 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	25 Participants n=21 Participants	1 Participants n=10 Participants	39 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Region of Enrollment United States	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	13 Participants n=115 Participants
Region of Enrollment Spain	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	24 Participants n=21 Participants	1 Participants n=10 Participants	28 Participants n=115 Participants

PRIMARY outcome

Timeframe: Cycle 1 through Cycle 2 (Up to 2 Months)

Population: All participants who received at least one dose of study drug in Phase 1b per protocol.

The MTD is defined as the highest tested dose that has less than 33% probability of causing a dose limiting toxicity (DLT).

Outcome measures

Outcome measures
Measure	Phase 1b Participants n=15 Participants Cohort 1: 50 mg Galunisertib administered QD on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, every Q2W, on Day 1 and Day 15 for 2 cycles. Cohort 2: 50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Cohort 3: 80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Cohort 4: 150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (Cohort 2) Phase 1b 50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (Cohort 3) Phase 1b 80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (Cohort 4) Phase 1b 150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (NSCLC) Phase 2 150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab ( HCC) Phase 2 150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Phase 1b: Maximum Tolerated Dose (MTD) of Galunisertib in Combination With Nivolumab	300 milligrams (mg)	—	—	—	—	—

SECONDARY outcome

Timeframe: PK: Cycle 1 Day 15 Predose; Cycle 2: Day 1: Pre-dose; Day 15: Predose: Cycle 4: Day 1: Predose

Population: All participants who received at least one dose of study drug and had evaluable PK data.

Minimum Concentration (Cmin) of Nivolumab

Outcome measures

Outcome measures
Measure	Phase 1b Participants n=2 Participants Cohort 1: 50 mg Galunisertib administered QD on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, every Q2W, on Day 1 and Day 15 for 2 cycles. Cohort 2: 50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Cohort 3: 80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Cohort 4: 150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (Cohort 2) Phase 1b n=5 Participants 50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (Cohort 3) Phase 1b n=3 Participants 80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (Cohort 4) Phase 1b n=4 Participants 150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (NSCLC) Phase 2 n=11 Participants 150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab ( HCC) Phase 2 150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Nivolumab	33.5 micrograms per milliliter (µg/mL) Interval 19.9 to 53.6	36.2 micrograms per milliliter (µg/mL) Interval 11.8 to 58.1	43.2 micrograms per milliliter (µg/mL) Interval 5.45 to 76.0	29.2 micrograms per milliliter (µg/mL) Interval 9.39 to 63.7	37.6 micrograms per milliliter (µg/mL) Interval 1.08 to 105.0	—

SECONDARY outcome

Timeframe: PK: Cycle 1 and Cycle 2 Day 1: Predose, 0.5 - 3 hours postdose, Cycle 1 and Cycle 2 Day 14: Predose, 0.5 - 2, 3.5 - 5, and 24 hours postdose through Cycle 4 Day 1 predose

Population: All participants who received at least one dose of study drug and had evaluable PK data.

Area under the plasma concentration curve from time zero to 24 hours of galunisertib for Cycle 1 and Cycle 2.

Outcome measures

Outcome measures
Measure	Phase 1b Participants n=3 Participants Cohort 1: 50 mg Galunisertib administered QD on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, every Q2W, on Day 1 and Day 15 for 2 cycles. Cohort 2: 50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Cohort 3: 80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Cohort 4: 150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (Cohort 2) Phase 1b n=4 Participants 50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (Cohort 3) Phase 1b n=3 Participants 80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (Cohort 4) Phase 1b n=4 Participants 150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (NSCLC) Phase 2 n=12 Participants 150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab ( HCC) Phase 2 n=1 Participants 150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
PK: Area Under the Plasma Concentration -Time Curve of Galunisertib From Time Zero to 24 Hours (AUC [0-24h]) at Steady State	3060 microgramshour per liter (μgh/L) Geometric Coefficient of Variation 41	2350 microgramshour per liter (μgh/L) Geometric Coefficient of Variation 46	2220 microgramshour per liter (μgh/L) Geometric Coefficient of Variation 164	5580 microgramshour per liter (μgh/L) Geometric Coefficient of Variation 61	7322 microgramshour per liter (μgh/L) Geometric Coefficient of Variation 67	NA microgramshour per liter (μgh/L) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as there was only one participant. Individual value reported: 6005 μg\*h/L

SECONDARY outcome

Timeframe: Cycle 1: Days 1, 14, 15 Predose and Day 100 Follow-up; Cycles 2 and 4: Day 1 Predose and Day 100 Follow-up

Population: All participants who received at least one dose of study drug and were evaluable for TE ADA.

Participants with treatment-emergent anti-nivolumab antibodies when administered with galunisertib were participants with a 4-fold or greater increase in titer from baseline measurement (treatment-boosted). If baseline result is ADA not present, then the subject is TE ADA+, if there is at least 1 postbaseline result of ADA present with titer ≥ 40 (treatment-induced).

Outcome measures

Outcome measures
Measure	Phase 1b Participants n=3 Participants Cohort 1: 50 mg Galunisertib administered QD on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, every Q2W, on Day 1 and Day 15 for 2 cycles. Cohort 2: 50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Cohort 3: 80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Cohort 4: 150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (Cohort 2) Phase 1b n=5 Participants 50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (Cohort 3) Phase 1b n=2 Participants 80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (Cohort 4) Phase 1b n=3 Participants 150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (NSCLC) Phase 2 n=13 Participants 150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab ( HCC) Phase 2 n=1 Participants 150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Number of Participants With Anti-Nivolumab Antibodies When Administered in Combination With Galunisertib	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Date of First Study Treatment to Measured Progressive Disease or Death (Up to 35 Months)

Population: All participants who received at least one dose of study drug in the Phase 2 cohorts. Censored participants Galunisertib + Nivolumab (NSCLC) Phase 2 = 6.

PFS was defined as the time from the date of first study treatment to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.

Outcome measures

Outcome measures
Measure	Phase 1b Participants n=25 Participants Cohort 1: 50 mg Galunisertib administered QD on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, every Q2W, on Day 1 and Day 15 for 2 cycles. Cohort 2: 50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Cohort 3: 80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Cohort 4: 150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (Cohort 2) Phase 1b n=1 Participants 50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (Cohort 3) Phase 1b 80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (Cohort 4) Phase 1b 150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (NSCLC) Phase 2 150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab ( HCC) Phase 2 150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Phase 2: Progression Free Survival (PFS)	5.26 months Interval 1.77 to 9.2	5.39 months	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to Measured Progressive Disease (Up to 35 Months)

Population: All participants who received at least one dose of study drug in Phase 2 cohorts.

Objective Response Rate was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.

Outcome measures

Outcome measures
Measure	Phase 1b Participants n=25 Participants Cohort 1: 50 mg Galunisertib administered QD on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, every Q2W, on Day 1 and Day 15 for 2 cycles. Cohort 2: 50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Cohort 3: 80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Cohort 4: 150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (Cohort 2) Phase 1b n=1 Participants 50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (Cohort 3) Phase 1b 80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (Cohort 4) Phase 1b 150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (NSCLC) Phase 2 150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab ( HCC) Phase 2 150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Phase 2: Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response or Partial Response: Objective Response Rate (ORR)	24.0 Percentage of Participants	0 Percentage of Participants	—	—	—	—

SECONDARY outcome

Timeframe: Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up to 35 Months)

Population: All participants who received at least one dose of study drug in Phase 2 cohorts and had a response of complete response or partial response. Censored participants Galunisertib + Nivolumab (NSCLC) Phase 2 = 1.

Duration of response was measured from the date of documented response to the date of first progression of disease or the date of death due to any cause, whichever is earlier.

Outcome measures

Outcome measures
Measure	Phase 1b Participants n=6 Participants Cohort 1: 50 mg Galunisertib administered QD on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, every Q2W, on Day 1 and Day 15 for 2 cycles. Cohort 2: 50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Cohort 3: 80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Cohort 4: 150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (Cohort 2) Phase 1b 50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (Cohort 3) Phase 1b 80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (Cohort 4) Phase 1b 150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (NSCLC) Phase 2 150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab ( HCC) Phase 2 150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Phase 2: Duration of Response (DoR)	9.03 months Interval 1.97 to 35.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Date of First Study Treatment to Date of Complete Response or Partial Response (Up to 35 Months)

Population: All participants who received at least one dose of study drug in Phase 2 cohorts and had a documented response of CR or PR.

Time to response was measured from the date of first study treatment to the first documented response of Complete Response (CR) or Partial Response (PR).

Outcome measures

Outcome measures
Measure	Phase 1b Participants n=6 Participants Cohort 1: 50 mg Galunisertib administered QD on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, every Q2W, on Day 1 and Day 15 for 2 cycles. Cohort 2: 50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Cohort 3: 80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Cohort 4: 150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (Cohort 2) Phase 1b 50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (Cohort 3) Phase 1b 80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (Cohort 4) Phase 1b 150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (NSCLC) Phase 2 150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab ( HCC) Phase 2 150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Phase 2: Time to Response	4.2 months Interval 0.5 to 35.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Date of First Study Treatment to Death from Any Cause (Up to 35 Months)

Population: All participants who received at least one dose of study drug in Phase 2 cohorts. Censored participants Galunisertib + Nivolumab (NSCLC) Phase 2 = 8.

Overall Survival was determined from the date of first study treatment until death due to any cause.

Outcome measures

Outcome measures
Measure	Phase 1b Participants n=25 Participants Cohort 1: 50 mg Galunisertib administered QD on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, every Q2W, on Day 1 and Day 15 for 2 cycles. Cohort 2: 50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Cohort 3: 80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Cohort 4: 150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (Cohort 2) Phase 1b n=1 Participants 50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (Cohort 3) Phase 1b 80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (Cohort 4) Phase 1b 150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.	Galunisertib + Nivolumab (NSCLC) Phase 2 150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab ( HCC) Phase 2 150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Phase 2: Overall Survival (OS)	11.99 months Interval 8.15 to 16.23	14.52 months	—	—	—	—

Adverse Events

Galunisertib + Nivolumab (Cohort 1) Phase 1b

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Galunisertib + Nivolumab (Cohort 2) Phase 1b

Serious events: 2 serious events

Other events: 4 other events

Deaths: 4 deaths

Galunisertib + Nivolumab (Cohort 3) Phase 1b

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Galunisertib + Nivolumab (Cohort 4) Phase 1b

Serious events: 2 serious events

Other events: 4 other events

Deaths: 3 deaths

Galunisertib + Nivolumab (NSCLC) Phase 2

Serious events: 13 serious events

Other events: 23 other events

Deaths: 17 deaths

Galunisertib + Nivolumab (HCC) Phase 2

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Galunisertib + Nivolumab (Cohort 1) Phase 1b n=3 participants at risk 50 mg Galunisertib administered orally QD on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV every Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab (Cohort 2) Phase 1b n=5 participants at risk 50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab (Cohort 3) Phase 1b n=3 participants at risk 80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab (Cohort 4) Phase 1b n=4 participants at risk 150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab (NSCLC) Phase 2 n=25 participants at risk 150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab (HCC) Phase 2 n=1 participants at risk 150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Cardiac disorders Acute myocardial infarction	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Cardiac disorders Pericarditis	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
General disorders Chest pain	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Hepatobiliary disorders Cholestasis	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Infections and infestations Bronchitis	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Infections and infestations Lower respiratory tract infection	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Infections and infestations Pneumonia	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	12.0% 3/25 • Number of events 3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Infections and infestations Pyelonephritis	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Infections and infestations Respiratory tract infection	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	12.0% 3/25 • Number of events 3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Infections and infestations Septic shock	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Infections and infestations Urinary tract infection	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	33.3% 1/3 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Nervous system disorders Cerebrovascular accident	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Nervous system disorders Headache	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Nervous system disorders Noninfective encephalitis	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Renal and urinary disorders Hydronephrosis	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • Number of events 3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	8.0% 2/25 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Vascular disorders Angiopathy	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.

Other adverse events

Other adverse events
Measure	Galunisertib + Nivolumab (Cohort 1) Phase 1b n=3 participants at risk 50 mg Galunisertib administered orally QD on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV every Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab (Cohort 2) Phase 1b n=5 participants at risk 50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab (Cohort 3) Phase 1b n=3 participants at risk 80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab (Cohort 4) Phase 1b n=4 participants at risk 150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab (NSCLC) Phase 2 n=25 participants at risk 150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.	Galunisertib + Nivolumab (HCC) Phase 2 n=1 participants at risk 150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 3 • Up to 35 months All participants who received at least one dose of study drug.	12.0% 3/25 • Number of events 3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Cardiac disorders Cardiac failure	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Cardiac disorders Mitral valve incompetence	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Cardiac disorders Pericarditis	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Ear and labyrinth disorders Tinnitus	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Endocrine disorders Hyperthyroidism	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Endocrine disorders Hypothyroidism	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	16.0% 4/25 • Number of events 4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Eye disorders Cataract	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Eye disorders Dry eye	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	8.0% 2/25 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	12.0% 3/25 • Number of events 6 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Gastrointestinal disorders Cheilitis	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Gastrointestinal disorders Constipation	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	16.0% 4/25 • Number of events 5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	28.0% 7/25 • Number of events 10 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	16.0% 4/25 • Number of events 5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Gastrointestinal disorders Flatulence	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	8.0% 2/25 • Number of events 3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Gastrointestinal disorders Haematemesis	33.3% 1/3 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	50.0% 2/4 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	24.0% 6/25 • Number of events 6 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Gastrointestinal disorders Oesophageal spasm	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Gastrointestinal disorders Oral pain	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	12.0% 3/25 • Number of events 4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	66.7% 2/3 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	12.0% 3/25 • Number of events 3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
General disorders Asthenia	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	16.0% 4/25 • Number of events 5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
General disorders Chest pain	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
General disorders Chills	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
General disorders Fatigue	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	24.0% 6/25 • Number of events 10 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
General disorders Influenza like illness	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
General disorders Malaise	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
General disorders Multiple organ dysfunction syndrome	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
General disorders Non-cardiac chest pain	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	50.0% 2/4 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
General disorders Oedema peripheral	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
General disorders Pyrexia	33.3% 1/3 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	20.0% 5/25 • Number of events 8 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Hepatobiliary disorders Cholestasis	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	8.0% 2/25 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Infections and infestations Cellulitis	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Infections and infestations Escherichia infection	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Infections and infestations Gingivitis	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	100.0% 1/1 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.
Infections and infestations Influenza	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Infections and infestations Otitis externa	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Infections and infestations Otitis media	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Infections and infestations Pneumonia	33.3% 1/3 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Infections and infestations Respiratory tract infection	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	16.0% 4/25 • Number of events 4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Infections and infestations Rhinitis	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Infections and infestations Skin infection	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	8.0% 2/25 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	16.0% 4/25 • Number of events 4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Infections and infestations Urinary tract infection	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	8.0% 2/25 • Number of events 4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 3 • Up to 35 months All participants who received at least one dose of study drug.	8.0% 2/25 • Number of events 4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Investigations Amylase increased	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	75.0% 3/4 • Number of events 6 • Up to 35 months All participants who received at least one dose of study drug.	8.0% 2/25 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	50.0% 2/4 • Number of events 4 • Up to 35 months All participants who received at least one dose of study drug.	8.0% 2/25 • Number of events 4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	50.0% 2/4 • Number of events 4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Investigations Blood creatinine increased	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Investigations Cd4 lymphocytes decreased	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Investigations Cystatin c increased	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	50.0% 2/4 • Number of events 4 • Up to 35 months All participants who received at least one dose of study drug.	8.0% 2/25 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Investigations Lipase increased	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	50.0% 2/4 • Number of events 7 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Investigations Lymphocyte count decreased	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	50.0% 2/4 • Number of events 3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Investigations Neutrophil count decreased	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Investigations Platelet count decreased	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	50.0% 2/4 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	12.0% 3/25 • Number of events 3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Investigations Transaminases increased	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	8.0% 2/25 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Investigations Troponin t increased	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Investigations Weight decreased	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Investigations White blood cell count decreased	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Cachexia	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	28.0% 7/25 • Number of events 11 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Dehydration	33.3% 1/3 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	12.0% 3/25 • Number of events 3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	50.0% 2/4 • Number of events 3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	50.0% 2/4 • Number of events 5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	50.0% 2/4 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	8.0% 2/25 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	8.0% 2/25 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	8.0% 2/25 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	8.0% 2/25 • Number of events 3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 8 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	24.0% 6/25 • Number of events 6 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	8.0% 2/25 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	16.0% 4/25 • Number of events 4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Nervous system disorders Aura	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Nervous system disorders Dizziness	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	12.0% 3/25 • Number of events 4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Nervous system disorders Epilepsy	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Nervous system disorders Headache	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	20.0% 5/25 • Number of events 6 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Nervous system disorders Hypersomnia	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Nervous system disorders Neurological decompensation	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Nervous system disorders Neurological symptom	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Nervous system disorders Neuropathy peripheral	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Nervous system disorders Paraesthesia	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	8.0% 2/25 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Nervous system disorders Somnolence	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Psychiatric disorders Depression	33.3% 1/3 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Psychiatric disorders Disorientation	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Psychiatric disorders Insomnia	33.3% 1/3 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Renal and urinary disorders Dysuria	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Aphonia	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Bronchial fistula	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	12.0% 3/25 • Number of events 4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	8.0% 2/25 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	33.3% 1/3 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	8.0% 2/25 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	100.0% 1/1 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis acneiform	33.3% 1/3 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	12.0% 3/25 • Number of events 3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Livedo reticularis	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	33.3% 1/3 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	36.0% 9/25 • Number of events 14 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	8.0% 2/25 • Number of events 4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	50.0% 2/4 • Number of events 2 • Up to 35 months All participants who received at least one dose of study drug.	20.0% 5/25 • Number of events 10 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Vascular disorders Hot flush	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	8.0% 2/25 • Number of events 5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Vascular disorders Hypertension	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Vascular disorders Hypotension	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	12.0% 3/25 • Number of events 4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Vascular disorders Jugular vein thrombosis	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/5 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	4.0% 1/25 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.
Vascular disorders Phlebitis	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/3 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/4 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/25 • Up to 35 months All participants who received at least one dose of study drug.	0.00% 0/1 • Up to 35 months All participants who received at least one dose of study drug.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60