Trial Outcomes & Findings for A Study of Olaratumab (LY3012207) Plus Pembrolizumab in Participants With Advanced or Metastatic Soft Tissue Sarcoma (NCT NCT03126591)

NCT ID: NCT03126591

Last Updated: 2024-10-23

Results Overview

A DLT was defined as an adverse event (AE) during Cycle 1 that is possibly related to the study drug and fulfills any 1 of the following criteria using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0: * Grade ≥3 nonhematologic toxicity, with exceptions * Grade 4 anemia * Grade 4 neutropenia or leukopenia of \>5 days duration * Febrile neutropenia * Grade 3 thrombocytopenia with clinically significant bleeding or Grade 4 thrombocytopenia * Any other significant toxicity deemed to be dose limiting

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 41 participants
• Primary outcome timeframe: Cycle 1 (21 Days)
• Results posted on: 2024-10-23

Participant Flow

Participants who completed the study were considered a completer.

Participant milestones

Measure	15 Milligrams/Kilogram (mg/kg) Olaratumab + 200 Milligrams (mg) Pembrolizumab - Dose Escalation Participants received15 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Expansion Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.
Overall Study STARTED	7	6	28
Overall Study Received at Least 1 Dose of Study Drug	7	6	28
Overall Study COMPLETED	0	0	1
Overall Study NOT COMPLETED	7	6	27

Reasons for withdrawal

Measure	15 Milligrams/Kilogram (mg/kg) Olaratumab + 200 Milligrams (mg) Pembrolizumab - Dose Escalation Participants received15 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Expansion Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.
Overall Study Death	6	3	17
Overall Study Progressive Disease	0	1	2
Overall Study Terminated by Sponsor	0	1	4
Overall Study Withdrawal by Subject	1	1	4

Baseline Characteristics

A Study of Olaratumab (LY3012207) Plus Pembrolizumab in Participants With Advanced or Metastatic Soft Tissue Sarcoma

Baseline characteristics by cohort

Measure	15 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation n=7 Participants Participants received15 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation n=6 Participants Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	15 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Expansion n=28 Participants Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	Total n=41 Participants Total of all reporting groups
Age, Continuous	53.57 years STANDARD_DEVIATION 14.97 • n=5 Participants	56.00 years STANDARD_DEVIATION 14.31 • n=7 Participants	57.82 years STANDARD_DEVIATION 12.71 • n=5 Participants	56.83 years STANDARD_DEVIATION 13.07 • n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	17 Participants n=5 Participants	26 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	11 Participants n=5 Participants	15 Participants n=4 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
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	3 Participants n=7 Participants	21 Participants n=5 Participants	31 Participants n=4 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
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	8 Participants n=4 Participants
Region of Enrollment Belgium	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	10 Participants n=4 Participants
Region of Enrollment United States	4 Participants n=5 Participants	2 Participants n=7 Participants	14 Participants n=5 Participants	20 Participants n=4 Participants
Region of Enrollment Denmark	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants
Region of Enrollment France	0 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants

PRIMARY outcome

Timeframe: Cycle 1 (21 Days)

Population: All enrolled participants who received at least one dose of study drug.

A DLT was defined as an adverse event (AE) during Cycle 1 that is possibly related to the study drug and fulfills any 1 of the following criteria using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0:

• Grade ≥3 nonhematologic toxicity, with exceptions
• Grade 4 anemia
• Grade 4 neutropenia or leukopenia of >5 days duration
• Febrile neutropenia
• Grade 3 thrombocytopenia with clinically significant bleeding or Grade 4 thrombocytopenia
• Any other significant toxicity deemed to be dose limiting

Outcome measures

Measure	15 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation n=7 Participants Participants received15 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation n=6 Participants Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Expansion n=28 Participants Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.
Number of Participants With Olaratumab Dose Limiting Toxicities (DLTs)	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 3 Day (D) 1: Predose, 1, 2, 5, 24, 96, 168 hours Postdose; Cycle 1 and Cycle 3 Day 8: Predose, 1, 2, 5, 48, 168, 336 hours Postdose

Population: All enrolled participants who received at least 1 dose of study drug and have at least 1 post-baseline evaluable PK sample.

Maximum observed serum concentration of Olaratumab

Outcome measures

Measure	15 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation n=6 Participants Participants received15 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation n=5 Participants Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Expansion n=28 Participants Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab C1D1	385 μg/mL Geometric Coefficient of Variation 19	548 μg/mL Geometric Coefficient of Variation 16	529 μg/mL Geometric Coefficient of Variation 19
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab C1D8	NA μg/mL Geometric Coefficient of Variation NA Individual values reported: 710 μg/mL and 472 μg/mL	682 μg/mL Geometric Coefficient of Variation 17	693 μg/mL Geometric Coefficient of Variation 24
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab C3D1	NA μg/mL Geometric Coefficient of Variation NA Individual value reported: 694 μg/mL	703 μg/mL Geometric Coefficient of Variation 14	761 μg/mL Geometric Coefficient of Variation 34
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab C3D8	NA μg/mL Geometric Coefficient of Variation NA Individual value reported: 819 μg/mL	855 μg/mL Geometric Coefficient of Variation 8	845 μg/mL Geometric Coefficient of Variation 34

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 3 Day 1: Predose, 1, 2, 5, 24, 96, 168 hours Postdose; Cycle 1 and Cycle 3 Day 8: Predose, 1, 2, 5, 48, 168, 336 hours Postdose

Population: All enrolled participants who received at least 1 dose of study drug and have at least 1 post-baseline evaluable PK sample.

Cmin was the concentration of olaratumab in the sample taken just prior to the following dose.

Outcome measures

Measure	15 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation n=7 Participants Participants received15 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation n=6 Participants Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Expansion n=24 Participants Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.
PK: Minimum Serum Concentration (Cmin) of Olaratumab C1D1	129 μg/mL Geometric Coefficient of Variation 20	141 μg/mL Geometric Coefficient of Variation 13	135 μg/mL Geometric Coefficient of Variation 35
PK: Minimum Serum Concentration (Cmin) of Olaratumab C1D8	132 μg/mL Geometric Coefficient of Variation 38	144 μg/mL Geometric Coefficient of Variation 35	134 μg/mL Geometric Coefficient of Variation 59
PK: Minimum Serum Concentration (Cmin) of Olaratumab C3D1	272 μg/mL Geometric Coefficient of Variation 38	320 μg/mL Geometric Coefficient of Variation 17	263 μg/mL Geometric Coefficient of Variation 62
PK: Minimum Serum Concentration (Cmin) of Olaratumab C3D8	NA μg/mL Geometric Coefficient of Variation NA Individual values reported: 212 μg/mL and 350 μg/mL	207 μg/mL Geometric Coefficient of Variation 45	190 μg/mL Geometric Coefficient of Variation 79

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 3 Day 1: Predose, 1, 2, 5, 24, 96, 168 hours Postdose; Cycle 1 and Cycle 3 Day 8: Predose, 1, 2, 5, 48, 168, 336 hours Postdose

Population: All enrolled participants who received at least 1 dose of study drug and have at least 1 post-baseline evaluable PK sample.

Terminal elimination half-life of Olaratumab

Outcome measures

Measure	15 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation n=6 Participants Participants received15 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation n=5 Participants Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Expansion n=27 Participants Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.
PK: Elimination Half-Life (t½) of Olaratumab C1D1	5.20 days Geometric Coefficient of Variation 40	4.47 days Geometric Coefficient of Variation 15	4.12 days Geometric Coefficient of Variation 22
PK: Elimination Half-Life (t½) of Olaratumab C1D8	NA days Geometric Coefficient of Variation NA Individual values reported: 9.70 days and 8.94 days	7.82 days Geometric Coefficient of Variation 13	7.53 days Geometric Coefficient of Variation 34
PK: Elimination Half-Life (t½) of Olaratumab C3D1	NA days Geometric Coefficient of Variation NA Individual value reported: 9.71 days	6.40 days Geometric Coefficient of Variation 24	6.39 days Geometric Coefficient of Variation 73
PK: Elimination Half-Life (t½) of Olaratumab C3D8	NA days Geometric Coefficient of Variation NA Individual value reported: 15.2 days	9.42 days Geometric Coefficient of Variation 29	8.84 days Geometric Coefficient of Variation 51

SECONDARY outcome

Timeframe: Predose Cycle 1 Day 1 through Follow Up (up to 6 months)

Population: All enrolled participants who received at least one dose of study drug and had at least one anti-olaratumab antibody positive result.

Detection of ADA in the presence of Olaratumab

Outcome measures

Measure	15 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation n=7 Participants Participants received15 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation n=6 Participants Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Expansion n=28 Participants Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.
Number of Participants With Anti-Olaratumab Antibodies (ADA) When Administered in Combination With Pembrolizumab	1 participants	1 participants	2 participants

SECONDARY outcome

Timeframe: Baseline to Measured Progressive Disease (PD) or Start of New Anti-Cancer Therapy (up to 28 months)

Population: All enrolled participants who received at least one dose of study drug.

ORR was defined as the percentage of participants who achieved a CR or PR out of all participants treated, measured and recorded by Response Evaluation Criteria in Solid Tumors (RECIST v1.1). CR was defined as the disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 mm; tumor marker results must have normalized. PR was defined as at least a 30% decrease in the sum diameter of target lesions (taking as reference the baseline sum diameters). Long term follow up began the day after the safety follow up period was completed.

Outcome measures

Measure	15 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation n=7 Participants Participants received15 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation n=6 Participants Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Expansion n=28 Participants Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.
Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)	0 percentage of participants 95% Confidence Interval could not be calculated as zero participants attained the event.	0 percentage of participants 95% Confidence Interval could not be calculated as zero participants attained the event.	21.4 percentage of participants Interval 6.2 to 36.6

SECONDARY outcome

Timeframe: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (up to 28 months)

Population: All enrolled participants who received at least one dose of study drug.

DCR was defined according to RECIST v1.1 as the percentage of participants who have achieved CR, PR or stable disease (SD). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Long term follow up began the day after the safety follow up period was completed.

Outcome measures

Measure	15 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation n=7 Participants Participants received15 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation n=6 Participants Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Expansion n=28 Participants Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.
Disease Control Rate (DCR): Percentage of Participants With a Best Response of CR, PR or Stable Disease (SD)	14.3 percentage of participants Interval 0.0 to 40.2	66.7 percentage of participants Interval 28.9 to 100.0	53.6 percentage of participants Interval 35.1 to 72.0

SECONDARY outcome

Timeframe: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (up to 24 months)

Population: All enrolled participants who received at least one dose of study drug and who had a PR or CR. Number of participants censored in 20 mg/kg Dose Expansion arm = 2.

DoR was defined according to RECIST v1.1 as the time from the date of the first CR or PR to the first date of PD or death from any cause, whichever is earlier. For each participant who was not known to have died or to have had a progression of disease as of the data inclusion cut-off date, DOR was censored at the date of last objective response assessment prior to the date of any subsequent systemic anticancer therapy. Long term follow up began the day after the safety follow up period was completed.

Outcome measures

Measure	15 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation Participants received15 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Expansion n=6 Participants Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.
Duration of Response (DoR)	—	—	16.16 months Interval 1.68 to There were not enough events to estimate the upper confidence limit.

SECONDARY outcome

Timeframe: Baseline to Measured Progressive Disease or Death Due to Any Cause (up to 28 months)

Population: All enrolled participants who received at least one dose of study drug. Number of participants censored per arm: 15 mg/kg Olaratumab - Dose Escalation = 2 participants; 20 mg/kg Olaratumab - Dose Escalation = 0 participants; 20 mg/kg Olaratumab - Dose Expansion = 5 participants.

Progression-free survival (PFS) time was defined as the time from the date of start of study treatment to the first date of PD (symptomatic or objective) or death due to any cause, whichever occurs first. For participants who were not known to have died or progressed as of the data-inclusion cut-off date, PFS time was censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy. Long term follow up began the day after the safety follow up period was completed.

Outcome measures

Measure	15 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation n=7 Participants Participants received15 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation n=6 Participants Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Expansion n=28 Participants Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.
Progression Free Survival (PFS)	1.38 months Interval 1.28 to There were not enough events to estimate the upper confidence limit.	2.71 months Interval 1.38 to There were not enough events to estimate the upper confidence limit.	2.69 months Interval 1.31 to 4.07

SECONDARY outcome

Timeframe: Baseline to Death from Any Cause (up to 35 months)

Population: All enrolled participants who received at least one dose of study drug. Number of participants censored per arm: 15 mg/kg Olaratumab - Dose Escalation = 1 participant; 20 mg/kg Olaratumab - Dose Escalation = 3 participants; 20 mg/kg Olaratumab - Dose Expansion = 12 participants.

OS was defined as the time from the date of randomization to the date of death from any cause. Data was censored for any participant who was not known to have died or was lost to follow up. Long term follow up began the day after the safety follow up period was completed.

Outcome measures

Measure	15 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation n=7 Participants Participants received15 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation n=6 Participants Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Expansion n=28 Participants Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.
Overall Survival (OS)	11.37 months Interval 5.62 to There were not enough events to estimate the upper confidence limit.	16.39 months Interval 6.01 to There were not enough events to estimate the upper confidence limit.	14.78 months Interval 12.58 to There were not enough events to estimate the upper confidence limit.

Adverse Events

15 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation

Serious events: 0 serious events

Other events: 7 other events

Deaths: 6 deaths

20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation

Serious events: 2 serious events

Other events: 5 other events

Deaths: 3 deaths

20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Expansion

Serious events: 15 serious events

Other events: 27 other events

Deaths: 17 deaths

Serious adverse events

Measure	15 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation n=7 participants at risk Participants received15 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation n=6 participants at risk Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Expansion n=28 participants at risk Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.
Blood and lymphatic system disorders Anaemia	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Gastrointestinal disorders Abdominal pain	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Gastrointestinal disorders Colitis	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Gastrointestinal disorders Constipation	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Gastrointestinal disorders Diarrhoea	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	7.1% 2/28 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Gastrointestinal disorders Gastritis	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Gastrointestinal disorders Intestinal perforation	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
General disorders Pyrexia	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Infections and infestations Covid-19	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Infections and infestations Infection	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Infections and infestations Paraspinal abscess	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Infections and infestations Pseudomonal sepsis	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Infections and infestations Staphylococcal skin infection	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Investigations Alanine aminotransferase increased	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Nervous system disorders Brain oedema	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/28 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Nervous system disorders Depressed level of consciousness	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/28 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Nervous system disorders Headache	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/28 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Psychiatric disorders Confusional state	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Psychiatric disorders Mental disorder	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Renal and urinary disorders Acute kidney injury	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.

Other adverse events

Measure	15 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation n=7 participants at risk Participants received15 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation n=6 participants at risk Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.	20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Expansion n=28 participants at risk Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.
Blood and lymphatic system disorders Anaemia	14.3% 1/7 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	25.0% 7/28 • Number of events 16 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Blood and lymphatic system disorders Neutropenia	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	7.1% 2/28 • Number of events 3 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Cardiac disorders Sinus bradycardia	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	7.1% 2/28 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Cardiac disorders Sinus tachycardia	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	10.7% 3/28 • Number of events 5 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Endocrine disorders Hyperthyroidism	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	7.1% 2/28 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Endocrine disorders Hypothyroidism	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/28 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Eye disorders Diplopia	14.3% 1/7 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/28 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Gastrointestinal disorders Abdominal pain	14.3% 1/7 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	17.9% 5/28 • Number of events 7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Gastrointestinal disorders Constipation	14.3% 1/7 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	17.9% 5/28 • Number of events 7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Gastrointestinal disorders Diarrhoea	14.3% 1/7 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	32.1% 9/28 • Number of events 11 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Gastrointestinal disorders Dysphagia	14.3% 1/7 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	7.1% 2/28 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Gastrointestinal disorders Hypoaesthesia oral	14.3% 1/7 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/28 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Gastrointestinal disorders Nausea	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	50.0% 3/6 • Number of events 3 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	10.7% 3/28 • Number of events 5 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Gastrointestinal disorders Stomatitis	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	10.7% 3/28 • Number of events 4 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Gastrointestinal disorders Vomiting	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/28 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
General disorders Asthenia	14.3% 1/7 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/28 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
General disorders Chest pain	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	7.1% 2/28 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
General disorders Chills	14.3% 1/7 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/28 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
General disorders Fatigue	28.6% 2/7 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	33.3% 2/6 • Number of events 3 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	39.3% 11/28 • Number of events 15 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
General disorders Pain	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	7.1% 2/28 • Number of events 3 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
General disorders Pyrexia	14.3% 1/7 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	7.1% 2/28 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/28 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Infections and infestations Upper respiratory tract infection	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	7.1% 2/28 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Infections and infestations Urinary tract infection	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 3 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Infections and infestations Varicella zoster virus infection	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/28 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	10.7% 3/28 • Number of events 4 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Investigations Alanine aminotransferase increased	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	14.3% 4/28 • Number of events 6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Investigations Aspartate aminotransferase increased	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	33.3% 2/6 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	7.1% 2/28 • Number of events 3 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Investigations Blood alkaline phosphatase increased	14.3% 1/7 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	10.7% 3/28 • Number of events 3 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Investigations Blood bilirubin increased	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/28 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Investigations Blood creatinine increased	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	7.1% 2/28 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Investigations Blood lactate dehydrogenase increased	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	14.3% 4/28 • Number of events 5 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Investigations Blood uric acid decreased	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	7.1% 2/28 • Number of events 3 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Investigations Cystoscopy	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/28 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Investigations Haemoglobin increased	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Investigations Lipase increased	28.6% 2/7 • Number of events 4 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	10.7% 3/28 • Number of events 4 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Investigations Lymphocyte count decreased	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 3 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	14.3% 4/28 • Number of events 8 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Investigations Neutrophil count decreased	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	17.9% 5/28 • Number of events 17 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Investigations Platelet count decreased	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	10.7% 3/28 • Number of events 6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Investigations Protein total decreased	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	7.1% 2/28 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Investigations Weight decreased	14.3% 1/7 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	7.1% 2/28 • Number of events 3 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Investigations Weight increased	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/28 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Investigations White blood cell count decreased	14.3% 1/7 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	10.7% 3/28 • Number of events 10 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	33.3% 2/6 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	14.3% 4/28 • Number of events 5 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	10.7% 3/28 • Number of events 3 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	21.4% 6/28 • Number of events 15 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	10.7% 3/28 • Number of events 11 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	33.3% 2/6 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	10.7% 3/28 • Number of events 5 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	10.7% 3/28 • Number of events 6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	14.3% 4/28 • Number of events 4 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Metabolism and nutrition disorders Hypophosphataemia	28.6% 2/7 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	33.3% 2/6 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	14.3% 4/28 • Number of events 10 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Musculoskeletal and connective tissue disorders Arthralgia	14.3% 1/7 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	33.3% 2/6 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	10.7% 3/28 • Number of events 5 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Musculoskeletal and connective tissue disorders Muscle spasms	14.3% 1/7 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/28 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Musculoskeletal and connective tissue disorders Muscular weakness	14.3% 1/7 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Musculoskeletal and connective tissue disorders Myalgia	14.3% 1/7 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	33.3% 2/6 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	7.1% 2/28 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	7.1% 2/28 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	7.1% 2/28 • Number of events 3 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Nervous system disorders Dizziness	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	10.7% 3/28 • Number of events 4 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Nervous system disorders Dysgeusia	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	7.1% 2/28 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Nervous system disorders Headache	14.3% 1/7 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	33.3% 2/6 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	21.4% 6/28 • Number of events 7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Nervous system disorders Neuropathy peripheral	14.3% 1/7 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/28 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Nervous system disorders Tremor	14.3% 1/7 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/28 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Psychiatric disorders Anxiety	14.3% 1/7 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/28 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Psychiatric disorders Depression	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/28 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Psychiatric disorders Insomnia	28.6% 2/7 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Psychiatric disorders Panic attack	14.3% 1/7 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/28 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Psychiatric disorders Restlessness	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/28 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Renal and urinary disorders Haematuria	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	7.1% 2/28 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Renal and urinary disorders Proteinuria	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	7.1% 2/28 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Renal and urinary disorders Urinary tract pain	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/28 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Reproductive system and breast disorders Gynaecomastia	0.00% 0/2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	9.1% 1/11 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Respiratory, thoracic and mediastinal disorders Cough	28.6% 2/7 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	21.4% 6/28 • Number of events 7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Respiratory, thoracic and mediastinal disorders Dyspnoea	28.6% 2/7 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	25.0% 7/28 • Number of events 11 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Respiratory, thoracic and mediastinal disorders Hypoxia	14.3% 1/7 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/28 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Respiratory, thoracic and mediastinal disorders Nasal congestion	28.6% 2/7 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Respiratory, thoracic and mediastinal disorders Pleural effusion	14.3% 1/7 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/28 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	7.1% 2/28 • Number of events 3 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	10.7% 3/28 • Number of events 4 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Skin and subcutaneous tissue disorders Nail ridging	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/28 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	17.9% 5/28 • Number of events 5 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Skin and subcutaneous tissue disorders Rash	14.3% 1/7 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/28 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	16.7% 1/6 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	7.1% 2/28 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Skin and subcutaneous tissue disorders Rosacea	0.00% 0/7 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	7.1% 2/28 • Number of events 2 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.
Vascular disorders Hypertension	14.3% 1/7 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	0.00% 0/6 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.	3.6% 1/28 • Number of events 1 • Baseline through completion of safety follow up period (up to 35 months) All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. The safety follow-up period began one day after the participant was no longer continuing treatment and lasted up to 90 days.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: ClinicalTrials.gov@lilly.com

Results disclosure agreements

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

Restriction type: GT60