Trial Outcomes & Findings for Study of Pegilodecakin (LY3500518) With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer (NCT NCT03382899)

NCT ID: NCT03382899

Last Updated: 2021-01-20

Results Overview

ORR defined as the percentage of participants who achieve a CR or PR as assessed by RECIST v.1.1. The ORR is the number of participants with a complete response (CR) or partial response (PR) divided by the number of randomized participants recorded between the date of randomization and the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever comes first. Complete response (CR) is defined as disappearance of all target (and non-target) lesions, and normalization of tumor marker level. Partial response (PR) is defined as at least a 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum of longest diameters.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 101 participants
• Primary outcome timeframe: From Date of Randomization to Progressive Disease, Death from Any cause (Up to 24 Months)
• Results posted on: 2021-01-20

Participant Flow

Participants that had a recorded death on study or are alive and being followed at the end of the trial but off treatment are considered as completed group

Participant milestones

Measure	Pegilodecakin + Pembrolizumab Participants received pegilodecakin subcutaneously (SQ) at 0.8 milligrams (mg) (≤80 kilograms (kg) body weight) or 1.6 mg (\>80 kg body weight) once daily (QD) in the abdomen, thigh or back of upper arm. Pembrolizumab administered as an intravenous (IV) infusion at 200 mg on Day 1 of a 21-day cycle.	Pembrolizumab Participants received pembrolizumab as an IV infusion at 200 mg on Day 1 of a 21-day cycle.
Overall Study STARTED	51	50
Overall Study Received at Least 1 Dose of Study Drug	50	48
Overall Study COMPLETED	20	15
Overall Study NOT COMPLETED	31	35

Reasons for withdrawal

Measure	Pegilodecakin + Pembrolizumab Participants received pegilodecakin subcutaneously (SQ) at 0.8 milligrams (mg) (≤80 kilograms (kg) body weight) or 1.6 mg (\>80 kg body weight) once daily (QD) in the abdomen, thigh or back of upper arm. Pembrolizumab administered as an intravenous (IV) infusion at 200 mg on Day 1 of a 21-day cycle.	Pembrolizumab Participants received pembrolizumab as an IV infusion at 200 mg on Day 1 of a 21-day cycle.
Overall Study Ineligibility Determined	0	1
Overall Study Lost to Follow-up	0	1
Overall Study Sponsor's decision	31	28
Overall Study Withdrawal by Subject	0	5

Baseline Characteristics

Study of Pegilodecakin (LY3500518) With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Pegilodecakin + Pembrolizumab n=51 Participants Participants received pegilodecakin SQ at 0.8 mg (≤80 kg body weight) or 1.6 mg (\>80 kg body weight) QD in the abdomen, thigh or back of upper arm. Pembrolizumab administered as an IV infusion at 200 mg on Day 1 of a 21-day cycle.	Pebrolizumab n=50 Participants Participants received pembrolizumab as an IV infusion at 200 mg on Day 1 of a 21-day cycle.	Total n=101 Participants Total of all reporting groups
Age, Continuous	67.5 Years STANDARD_DEVIATION 7.7 • n=5 Participants	67.1 Years STANDARD_DEVIATION 9.0 • n=7 Participants	67.3 Years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	18 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	32 Participants n=7 Participants	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=5 Participants	47 Participants n=7 Participants	87 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	1 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 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
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants	38 Participants n=7 Participants	77 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	51 Participants n=5 Participants	50 Participants n=7 Participants	101 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Date of Randomization to Progressive Disease, Death from Any cause (Up to 24 Months)

Population: All randomized participants who had adequate baseline and at least 1 post-baseline tumor assessments.

ORR defined as the percentage of participants who achieve a CR or PR as assessed by RECIST v.1.1. The ORR is the number of participants with a complete response (CR) or partial response (PR) divided by the number of randomized participants recorded between the date of randomization and the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever comes first. Complete response (CR) is defined as disappearance of all target (and non-target) lesions, and normalization of tumor marker level. Partial response (PR) is defined as at least a 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum of longest diameters.

Outcome measures

Measure	Pegilodecakin + Pembrolizumab n=51 Participants Participants received pegilodecakin SQ at 0.8 mg (≤80 kg body weight) or 1.6 mg (\>80 kg body weight) QD in the abdomen, thigh or back of upper arm. Pembrolizumab administered as an IV infusion at 200 mg on Day 1 of a 21-day cycle.	Pembrolizumab n=50 Participants Participants received pembrolizumab as an IV infusion at 200 mg on Day 1 of a 21-day cycle.
Percentage of Participants Who Achieved an Objective Response Rate (ORR)	47.1 percentage of participants Interval 32.9 to 61.5	44.0 percentage of participants Interval 30.0 to 58.8

SECONDARY outcome

Timeframe: From Date of Randomization to Death Due to Any Cause (Up to 24 Months)

Population: All randomized participants. Censored participants in the Pegilodecakin + Pembrolizumab arm is 32 and the Pembrolizumab arm is 39.

OS is defined as the time from date of randomization to death due to any cause. Participants who were alive at the end of the follow-up period or lost to follow-up were censored on the last date the participant was known to be alive.

Outcome measures

Measure	Pegilodecakin + Pembrolizumab n=51 Participants Participants received pegilodecakin SQ at 0.8 mg (≤80 kg body weight) or 1.6 mg (\>80 kg body weight) QD in the abdomen, thigh or back of upper arm. Pembrolizumab administered as an IV infusion at 200 mg on Day 1 of a 21-day cycle.	Pembrolizumab n=50 Participants Participants received pembrolizumab as an IV infusion at 200 mg on Day 1 of a 21-day cycle.
Overall Survival (OS)	16.33 Months Interval 10.51 to The upper 95% confidence interval was not achieved due to high censoring rate.	NA Months Median and the upper 95% confidence interval was not achieved due to high censoring rate.

SECONDARY outcome

Timeframe: From Date of Randomization to Progressive Disease (PD) or Death Due to Any Cause (Up to 24 Months)

Population: All randomized participants. Censored participants in the Pegilodecakin + Pembrolizumab arm is 24 and Pembrolizumab arm is 22.

PFS is defined as the time from date of randomization to the earlier of first documentation of disease progression or death due to any cause. Progressive disease (PD) is defined by at least a 20% increase in the sum of longest diameters of target lesions, taking as reference the baseline sum of longest diameters or the presence of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression determined by scans. Participants who did not progress, who discontinued treatment for toxicity or a reason other than documented progression, or who were lost to follow up before documented progression and death or were censored at the date of last adequate tumor assessment, participants or new anticancer therapy started and not tumor progression or death were censored at the last adequate tumor assessment before the start of new anticancer therapy.

Outcome measures

Measure	Pegilodecakin + Pembrolizumab n=51 Participants Participants received pegilodecakin SQ at 0.8 mg (≤80 kg body weight) or 1.6 mg (\>80 kg body weight) QD in the abdomen, thigh or back of upper arm. Pembrolizumab administered as an IV infusion at 200 mg on Day 1 of a 21-day cycle.	Pembrolizumab n=50 Participants Participants received pembrolizumab as an IV infusion at 200 mg on Day 1 of a 21-day cycle.
Progression Free Survival (PFS)	6.28 Months Interval 2.86 to Upper limit of confidence interval was not reached.	6.08 Months Interval 2.23 to Upper limit of confidence interval was not reached.

SECONDARY outcome

Timeframe: From Date of Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up to 24 Months)

Population: All randomized participants.

DCR is defined as the percentage of participants in the analysis population who have achieved a complete response (CR), partial response (PR) or stable disease (SD) response prior to disease progression. CR is defined as disappearance of all target (and non-target) lesions, and normalization of tumor marker level. PR is defined as at least a 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum of longest diameters. SD is defined as neither sufficient shrinkage of target lesions to qualify for partial response, nor sufficient increase to qualify for progressive disease, taking as reference the baseline sum of longest diameters.

Outcome measures

Measure	Pegilodecakin + Pembrolizumab n=51 Participants Participants received pegilodecakin SQ at 0.8 mg (≤80 kg body weight) or 1.6 mg (\>80 kg body weight) QD in the abdomen, thigh or back of upper arm. Pembrolizumab administered as an IV infusion at 200 mg on Day 1 of a 21-day cycle.	Pembrolizumab n=50 Participants Participants received pembrolizumab as an IV infusion at 200 mg on Day 1 of a 21-day cycle.
Percentage of Participants Who Achieved a Disease Control Rate (DCR)	62.7 percentage of participants Interval 48.1 to 75.9	62.0 percentage of participants Interval 47.2 to 75.4

SECONDARY outcome

Timeframe: From Date of Response to Death Due to Any Cause (Up to 24 Months)

Population: All randomized participants.

DOR is defined as the time from the earliest date of qualifying response until earliest date of disease progression per RECIST v1.1 or death from any cause, whichever comes first. Duration of response was analyzed in participants who had CR or PR. Duration of response was censored on the date of the last tumor assessment on trial for participants who did not have objective tumor progression and who did not die due to any cause while on trial. For participants who discontinued participation in the trial or discontinued from tumor scan assessments before disease progression, the duration of response was censored at the date of the last tumor assessment.

Outcome measures

Measure	Pegilodecakin + Pembrolizumab n=51 Participants Participants received pegilodecakin SQ at 0.8 mg (≤80 kg body weight) or 1.6 mg (\>80 kg body weight) QD in the abdomen, thigh or back of upper arm. Pembrolizumab administered as an IV infusion at 200 mg on Day 1 of a 21-day cycle.	Pembrolizumab n=50 Participants Participants received pembrolizumab as an IV infusion at 200 mg on Day 1 of a 21-day cycle.
Duration of Response (DOR)	14.23 Months Interval 2.5 to 14.23	NA Months Interval 4.14 to Median was not calculated and upper limit confidence interval was not reached.

Adverse Events

Pegilodecakin + Pembrolizumab

Serious events: 28 serious events

Other events: 48 other events

Deaths: 19 deaths

Pembrolizumab

Serious events: 25 serious events

Other events: 48 other events

Deaths: 13 deaths

Serious adverse events

Measure	Pegilodecakin + Pembrolizumab n=50 participants at risk Participants received pegilodecakin SQ at 0.8 mg (≤80 kg body weight) or 1.6 mg (\>80 kg body weight) QD in the abdomen, thigh or back of upper arm. Pembrolizumab administered as an IV infusion at 200 mg on Day 1 of a 21-day cycle.	Pembrolizumab n=48 participants at risk Participants received pembrolizumab as an IV infusion at 200 mg on Day 1 of a 21-day cycle.
Blood and lymphatic system disorders Anaemia	8.0% 4/50 • Number of events 4 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Cardiac arrest	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Cardiac failure congestive	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Cardio-respiratory arrest	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Pericardial effusion	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Pericarditis	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Tachycardia	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Adrenal insufficiency	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Hyperthyroidism	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal distension	2.0% 1/50 • Number of events 2 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain upper	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Colitis microscopic	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 2/48 • Number of events 2 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Diverticular perforation	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastric haemorrhage	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastritis	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Vomiting	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Fatigue	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 2/48 • Number of events 2 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Localised oedema	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Non-cardiac chest pain	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Pyrexia	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Systemic inflammatory response syndrome	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Drug-induced liver injury	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pneumonia	18.0% 9/50 • Number of events 10 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 6/48 • Number of events 6 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Sepsis	10.0% 5/50 • Number of events 6 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Septic shock	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Streptococcal bacteraemia	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Overdose	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Spinal compression fracture	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Spinal fracture	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Alanine aminotransferase increased	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Aspartate aminotransferase increased	2.0% 1/50 • Number of events 2 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood bilirubin increased	4.0% 2/50 • Number of events 2 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Dehydration	10.0% 5/50 • Number of events 7 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Failure to thrive	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hyperglycaemia	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypokalaemia	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hyponatraemia	6.0% 3/50 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Brain oedema	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cerebrovascular accident	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dizziness	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 2/48 • Number of events 2 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Ischaemic cerebral infarction	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Loss of consciousness	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Myelopathy	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Confusional state	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Acute kidney injury	4.0% 2/50 • Number of events 2 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.0% 3/50 • Number of events 5 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 4/48 • Number of events 5 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 3/48 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 3/48 • Number of events 4 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.0% 2/50 • Number of events 2 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 2/48 • Number of events 2 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	4.0% 2/50 • Number of events 2 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Respiratory failure	4.0% 2/50 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 2/48 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Capillary leak syndrome	2.0% 1/50 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Deep vein thrombosis	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Hypotension	6.0% 3/50 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.

Other adverse events

Measure	Pegilodecakin + Pembrolizumab n=50 participants at risk Participants received pegilodecakin SQ at 0.8 mg (≤80 kg body weight) or 1.6 mg (\>80 kg body weight) QD in the abdomen, thigh or back of upper arm. Pembrolizumab administered as an IV infusion at 200 mg on Day 1 of a 21-day cycle.	Pembrolizumab n=48 participants at risk Participants received pembrolizumab as an IV infusion at 200 mg on Day 1 of a 21-day cycle.
Blood and lymphatic system disorders Anaemia	60.0% 30/50 • Number of events 92 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.8% 10/48 • Number of events 18 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Thrombocytopenia	28.0% 14/50 • Number of events 28 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.4% 5/48 • Number of events 9 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Sinus tachycardia	8.0% 4/50 • Number of events 4 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Tachycardia	8.0% 4/50 • Number of events 4 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Hypothyroidism	2.0% 1/50 • Number of events 2 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 3/48 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain	6.0% 3/50 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 2/48 • Number of events 4 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Constipation	10.0% 5/50 • Number of events 6 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 16/48 • Number of events 19 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	24.0% 12/50 • Number of events 23 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	22.9% 11/48 • Number of events 16 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Dry mouth	10.0% 5/50 • Number of events 5 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 3/48 • Number of events 4 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Dyspepsia	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 4/48 • Number of events 4 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Dysphagia	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 3/48 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Nausea	28.0% 14/50 • Number of events 16 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.8% 10/48 • Number of events 12 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Stomatitis	6.0% 3/50 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 2/48 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Vomiting	6.0% 3/50 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.4% 5/48 • Number of events 7 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Asthenia	8.0% 4/50 • Number of events 4 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 3/48 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Chills	14.0% 7/50 • Number of events 8 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 2 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Fatigue	54.0% 27/50 • Number of events 41 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	47.9% 23/48 • Number of events 25 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Injection site reaction	8.0% 4/50 • Number of events 5 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 2/48 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Localised oedema	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 3/48 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Malaise	2.0% 1/50 • Number of events 6 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 3/48 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Non-cardiac chest pain	10.0% 5/50 • Number of events 6 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Oedema peripheral	18.0% 9/50 • Number of events 9 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.8% 10/48 • Number of events 12 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Pyrexia	26.0% 13/50 • Number of events 16 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 3/48 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Hyperbilirubinaemia	8.0% 4/50 • Number of events 6 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pneumonia	8.0% 4/50 • Number of events 5 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 2/48 • Number of events 2 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Sinusitis	4.0% 2/50 • Number of events 2 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 3/48 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Upper respiratory tract infection	4.0% 2/50 • Number of events 2 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 4/48 • Number of events 4 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Urinary tract infection	14.0% 7/50 • Number of events 9 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 4/48 • Number of events 4 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Fall	6.0% 3/50 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 6/48 • Number of events 7 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 3/48 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Alanine aminotransferase increased	8.0% 4/50 • Number of events 9 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 2/48 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Aspartate aminotransferase increased	10.0% 5/50 • Number of events 8 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 4/48 • Number of events 7 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood alkaline phosphatase increased	8.0% 4/50 • Number of events 5 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood bilirubin increased	6.0% 3/50 • Number of events 5 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 4 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood creatinine increased	12.0% 6/50 • Number of events 15 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 2/48 • Number of events 2 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood urea increased	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 3/48 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Platelet count decreased	12.0% 6/50 • Number of events 13 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 4/48 • Number of events 9 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Weight decreased	10.0% 5/50 • Number of events 6 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 8/48 • Number of events 11 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Decreased appetite	38.0% 19/50 • Number of events 21 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 16/48 • Number of events 16 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Dehydration	22.0% 11/50 • Number of events 12 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 3/48 • Number of events 4 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hyperglycaemia	6.0% 3/50 • Number of events 5 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.4% 5/48 • Number of events 9 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypoalbuminaemia	8.0% 4/50 • Number of events 4 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 2/48 • Number of events 2 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypokalaemia	8.0% 4/50 • Number of events 4 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypomagnesaemia	10.0% 5/50 • Number of events 6 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hyponatraemia	10.0% 5/50 • Number of events 6 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 4/48 • Number of events 7 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	18.0% 9/50 • Number of events 15 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	22.9% 11/48 • Number of events 12 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	6.0% 3/50 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.6% 7/48 • Number of events 7 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Muscle spasms	10.0% 5/50 • Number of events 5 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 3/48 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Muscular weakness	8.0% 4/50 • Number of events 6 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.4% 5/48 • Number of events 5 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	6.0% 3/50 • Number of events 4 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 3/48 • Number of events 4 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Myalgia	10.0% 5/50 • Number of events 12 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Pain in extremity	2.0% 1/50 • Number of events 2 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 3/48 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dizziness	14.0% 7/50 • Number of events 8 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 3/48 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dysgeusia	8.0% 4/50 • Number of events 4 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 2/48 • Number of events 2 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Headache	18.0% 9/50 • Number of events 10 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 6/48 • Number of events 10 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Anxiety	12.0% 6/50 • Number of events 6 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 2/48 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Depression	8.0% 4/50 • Number of events 4 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 4/48 • Number of events 4 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Insomnia	12.0% 6/50 • Number of events 9 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 6/48 • Number of events 6 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Acute kidney injury	6.0% 3/50 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/22 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 2 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Cough	22.0% 11/50 • Number of events 13 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	27.1% 13/48 • Number of events 16 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea	32.0% 16/50 • Number of events 28 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	27.1% 13/48 • Number of events 24 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Haemoptysis	4.0% 2/50 • Number of events 2 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 4/48 • Number of events 5 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.0% 2/50 • Number of events 2 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 4/48 • Number of events 5 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Productive cough	6.0% 3/50 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 4/48 • Number of events 4 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Wheezing	2.0% 1/50 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 3/48 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis	8.0% 4/50 • Number of events 5 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 1/48 • Number of events 1 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dry skin	6.0% 3/50 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 8/48 • Number of events 8 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Night sweats	12.0% 6/50 • Number of events 6 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/48 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Pruritus	16.0% 8/50 • Number of events 8 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 8/48 • Number of events 11 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash	26.0% 13/50 • Number of events 21 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.6% 7/48 • Number of events 7 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash maculo-papular	6.0% 3/50 • Number of events 4 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.6% 7/48 • Number of events 12 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Deep vein thrombosis	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 3/48 • Number of events 4 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Hypertension	0.00% 0/50 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 3/48 • Number of events 3 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Hypotension	26.0% 13/50 • Number of events 17 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 3/48 • Number of events 8 • Baseline Up To 24 Months All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: (800) 545-5979

Email: www.ClinicalTrials.gov@lilly.com

Results disclosure agreements

• Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 120 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
• Publication restrictions are in place

Restriction type: OTHER