Trial Outcomes & Findings for Azacitidine Combined With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors (ECHO-206) (NCT NCT02959437)

NCT ID: NCT02959437

Last Updated: 2025-10-21

Results Overview

A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug. A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 70 participants
• Primary outcome timeframe: Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period).
• Results posted on: 2025-10-21

Participant Flow

The study was conducted at 8 study sites in United States, 2 sites in UK and 1 site in Spain.

A total of 70 participants were enrolled in the study. Study enrollment was permanently discontinued on 15-Feb-2019 as a strategic decision. No patients were enrolled in Treatment Group B and Treatment Group C.

Participant milestones

Measure	Treatment Group A :100mg of INCB24360 In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. Due to early termination of study subjects from dose escalation and dose expansion are combined.	Treatment Group A :300mg of INCB24360 In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 300mg.	Treatment Group B :INCB057643+Pembrolizumab+Epacadostat In Treatment Group B, subjects will receive INCB057643 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.	Treatment Group C :INCB059872+Pembrolizumab+Epacadostat In Treatment Group C, subjects will receive INCB059872 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.
Overall Study STARTED	62	8	0	0
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	62	8	0	0

Reasons for withdrawal

Measure	Treatment Group A :100mg of INCB24360 In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. Due to early termination of study subjects from dose escalation and dose expansion are combined.	Treatment Group A :300mg of INCB24360 In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 300mg.	Treatment Group B :INCB057643+Pembrolizumab+Epacadostat In Treatment Group B, subjects will receive INCB057643 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.	Treatment Group C :INCB059872+Pembrolizumab+Epacadostat In Treatment Group C, subjects will receive INCB059872 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.
Overall Study Death	33	3	0	0
Overall Study Lost to Follow-up	3	1	0	0
Overall Study Withdrawal by Subject	11	3	0	0
Overall Study Progressive Disease	9	1	0	0
Overall Study Study Terminated by Sponsor	4	0	0	0
Overall Study Other Unspecified	2	0	0	0

Baseline Characteristics

Azacitidine Combined With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors (ECHO-206)

Baseline characteristics by cohort

Measure	Treatment Group A :100mg of INCB24360 n=62 Participants In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. Due to early termination of study subjects from dose escalation and dose expansion are combined.	Treatment Group A :300mg of INCB24360 n=8 Participants In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 300mg.	Treatment Group B :INCB057643+Pembrolizumab+Epacadostat In Treatment Group B, subjects will receive INCB057643 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.	Treatment Group C :INCB059872+Pembrolizumab+Epacadostat In Treatment Group C, subjects will receive INCB059872 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.	Total n=70 Participants Total of all reporting groups
Age, Continuous	57.0 years STANDARD_DEVIATION 11.92 • n=5 Participants	53.0 years STANDARD_DEVIATION 11.31 • n=7 Participants	—	—	56.5 years STANDARD_DEVIATION 11.84 • n=21 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	4 Participants n=7 Participants	—	—	23 Participants n=21 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	4 Participants n=7 Participants	—	—	47 Participants n=21 Participants
Race/Ethnicity, Customized White/Caucasian	56 Participants n=5 Participants	5 Participants n=7 Participants	—	—	61 Participants n=21 Participants
Race/Ethnicity, Customized Black/African-American	3 Participants n=5 Participants	0 Participants n=7 Participants	—	—	3 Participants n=21 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	—	—	2 Participants n=21 Participants
Race/Ethnicity, Customized American-Indian/Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian/Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	3 Participants n=7 Participants	—	—	4 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic or Latino · Hispanic or Latino	4 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic or Latino · Not Hispanic or Latino	54 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	60 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic or Latino · Unknown	4 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period).

Population: The safety population includes all subjects enrolled in the study who received at least 1 dose of study drug.

A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug. A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).

Outcome measures

Measure	Treatment Group A :100mg of INCB24360 n=62 Participants In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. Due to early termination of study subjects from dose escalation and dose expansion are combined.	Treatment Group A :300mg of INCB24360 n=8 Participants In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 300mg.	Treatment Group B :INCB057643+Pembrolizumab+Epacadostat In Treatment Group B, subjects will receive INCB057643 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.	Treatment Group C :INCB059872+Pembrolizumab+Epacadostat In Treatment Group C, subjects will receive INCB059872 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.
Part 1 and 2 : Number of Participants With Treatment Emergent Adverse Events	62 Participants	8 Participants	—	—

PRIMARY outcome

Timeframe: Every 9 weeks for the duration of study participation; estimated minimum of 6 months.

Population: The response evaluable population includes all subjects enrolled in the study who received at least 1 dose of study drug, completed a baseline scan and have at least 1 post baseline scan, or has been on study for a minimum of 70 days of follow-up or who discontinued treatment. No participants enrolled in part 2 of the study due to early termination of study

ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. A participant was considered as an objective responder if the participant had a best overall response of CR or PR.

Outcome measures

Measure	Treatment Group A :100mg of INCB24360 n=62 Participants In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. Due to early termination of study subjects from dose escalation and dose expansion are combined.	Treatment Group A :300mg of INCB24360 n=8 Participants In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 300mg.	Treatment Group B :INCB057643+Pembrolizumab+Epacadostat In Treatment Group B, subjects will receive INCB057643 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.	Treatment Group C :INCB059872+Pembrolizumab+Epacadostat In Treatment Group C, subjects will receive INCB059872 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.
Part 1 and 2: Objective Response Rate Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	3 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to Week 5/6 or week 8/9

Population: All subjects enrolled in the study who received at least 1 dose of study drug, who had evaluable baseline and on treatment biopsies. No participants enrolled in part 2 of the study due to early termination of study.

Responder is defined as an increase in the number of tumor-infiltrating lymphocytes or the ratio of CD8+ lymphocytes to T regulatory cells infiltrating tumor post-treatment versus pretreatment with pembrolizumab and epacadostat in combination with azacitidine.

Outcome measures

Measure	Treatment Group A :100mg of INCB24360 n=19 Participants In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. Due to early termination of study subjects from dose escalation and dose expansion are combined.	Treatment Group A :300mg of INCB24360 In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 300mg.	Treatment Group B :INCB057643+Pembrolizumab+Epacadostat In Treatment Group B, subjects will receive INCB057643 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.	Treatment Group C :INCB059872+Pembrolizumab+Epacadostat In Treatment Group C, subjects will receive INCB059872 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.
Parts 1 and 2: Percentage of Responders Determined by Immunohistochemistry CD8+:FoxP3+ ratios	10 Participants	—	—	—
Parts 1 and 2: Percentage of Responders Determined by Immunohistochemistry Intratumoral CD8+ T cells	14 Participants	—	—	—

SECONDARY outcome

Timeframe: Every 9 weeks from date of randomization until the date of first documented progression or date of death from any cause whichever came first, assessed up to 24 months

Population: All subjects enrolled in the study who received at least 1 dose of study drug, completed a baseline scan and have at least 1 post baseline scan, or has been on study for a minimum of 70 days of follow-up or who discontinued treatment. No participants enrolled in part 2 of the study due to early termination of study

Defined as the time from date of first dose of study drug until the earliest date of disease progression per RECIST v1.1, or death due to any cause, if occurring sooner than progression.

Outcome measures

Measure	Treatment Group A :100mg of INCB24360 n=62 Participants In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. Due to early termination of study subjects from dose escalation and dose expansion are combined.	Treatment Group A :300mg of INCB24360 n=8 Participants In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 300mg.	Treatment Group B :INCB057643+Pembrolizumab+Epacadostat In Treatment Group B, subjects will receive INCB057643 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.	Treatment Group C :INCB059872+Pembrolizumab+Epacadostat In Treatment Group C, subjects will receive INCB059872 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.
Parts 1 and 2: Progression-free Survival Based on RECIST v1.1.	2.07 Months Interval 1.97 to 2.17	2.64 Months Interval 1.31 to 6.11	—	—

SECONDARY outcome

Timeframe: Every 9 weeks from date of randomization until the date of first documented progression or date of death from any cause whichever came first, assessed up to 24 months

Population: All subjects enrolled in the study who received at least 1 dose of study drug, completed a baseline scan and have at least 1 post baseline scan, or has been on study for a minimum of 70 days of follow-up or who discontinued treatment. No participants enrolled in part 2 of the study due to early termination of study.

Defined as the time from earliest date of disease response until the earliest date of disease progression per RECIST v1.1, or death due to any cause, if occurring sooner than progression.

Outcome measures

Measure	Treatment Group A :100mg of INCB24360 n=3 Participants In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. Due to early termination of study subjects from dose escalation and dose expansion are combined.	Treatment Group A :300mg of INCB24360 n=1 Participants In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 300mg.	Treatment Group B :INCB057643+Pembrolizumab+Epacadostat In Treatment Group B, subjects will receive INCB057643 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.	Treatment Group C :INCB059872+Pembrolizumab+Epacadostat In Treatment Group C, subjects will receive INCB059872 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.
Parts 1 and 2: Duration of Response Based on RECIST v1.1	2.63 Months Interval 2.2 to 21.85	1.22 Months Upper and Lower bound not estimable due to 1 responder in the treatment arm.	—	—

Adverse Events

Treatment Group A :100mg of INCB24360

Serious events: 28 serious events

Other events: 59 other events

Deaths: 41 deaths

Treatment Group A :300mg of INCB24360

Serious events: 3 serious events

Other events: 8 other events

Deaths: 4 deaths

Serious adverse events

Measure	Treatment Group A :100mg of INCB24360 n=62 participants at risk In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. Due to early termination of study subjects from dose escalation and dose expansion are combined.	Treatment Group A :300mg of INCB24360 n=8 participants at risk In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 300mg.
Blood and lymphatic system disorders Anemia	3.2% 2/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Cardiac disorders Atrial fibrillation	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Cardiac disorders Sinua tachycardia	0.00% 0/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Endocrine disorders Hyperthyroidism	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Gastrointestinal disorders Abdominal Pain	3.2% 2/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Gastrointestinal disorders Ascites	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Gastrointestinal disorders Diarrhoea	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Gastrointestinal disorders Intra-abdominal haemorrhage	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Gastrointestinal disorders Intussusception	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Gastrointestinal disorders Nausea	6.5% 4/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Gastrointestinal disorders Small Intestinal Obstruction	4.8% 3/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Gastrointestinal disorders Vomiting	3.2% 2/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
General disorders Asthenia	0.00% 0/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
General disorders Disease Progression	12.9% 8/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
General disorders Fatigue	3.2% 2/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
General disorders Non-cardiac Chest Pain	0.00% 0/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
General disorders Pain	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
General disorders Pyrexia	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Infections and infestations Infection	0.00% 0/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Infections and infestations Urinary tract Infection	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Injury, poisoning and procedural complications Head Injury	0.00% 0/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Injury, poisoning and procedural complications Wound Haemorrhage	0.00% 0/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Metabolism and nutrition disorders Dehydration	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Musculoskeletal and connective tissue disorders Back Pain	4.8% 3/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Musculoskeletal and connective tissue disorders Bone Pain	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Musculoskeletal and connective tissue disorders Muscular Weakness	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Musculoskeletal and connective tissue disorders Pain in Extremity	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Neoplasm Progression	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Cancer Metastatic	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Nervous system disorders Brain Injury	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Nervous system disorders Brain Oedema	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Nervous system disorders Dizziness	0.00% 0/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Nervous system disorders Dysmetria	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Nervous system disorders Headache	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Nervous system disorders Hemiparesis	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Nervous system disorders Hypoaesthesia	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Nervous system disorders Loss of Consciousness	0.00% 0/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Nervous system disorders Peroneal Nerve Palsy	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Nervous system disorders Seizure	3.2% 2/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Psychiatric disorders Confusional State	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Psychiatric disorders Mental Status Changes	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Renal and urinary disorders Urinary Retention	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Respiratory, thoracic and mediastinal disorders Cough	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Respiratory, thoracic and mediastinal disorders Haemoptysis	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphangiosis Carcinomatosa	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.

Other adverse events

Measure	Treatment Group A :100mg of INCB24360 n=62 participants at risk In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. Due to early termination of study subjects from dose escalation and dose expansion are combined.	Treatment Group A :300mg of INCB24360 n=8 participants at risk In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 300mg.
Blood and lymphatic system disorders Anaemia	17.7% 11/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	25.0% 2/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Cardiac disorders Sinus Tachycardia	0.00% 0/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Gastrointestinal disorders Abdominal Distension	3.2% 2/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	25.0% 2/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Gastrointestinal disorders Abdominal pain	19.4% 12/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Gastrointestinal disorders Abdominal pain lower	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Gastrointestinal disorders Constipation	25.8% 16/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	37.5% 3/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Gastrointestinal disorders Dyspepsia	4.8% 3/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Gastrointestinal disorders Gastrooesophageal reflux disease	6.5% 4/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Gastrointestinal disorders Nausea	54.8% 34/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	37.5% 3/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Gastrointestinal disorders Vomiting	33.9% 21/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	25.0% 2/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
General disorders Chills	6.5% 4/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
General disorders Fatigue	45.2% 28/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	75.0% 6/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
General disorders Injection site erythema	8.1% 5/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
General disorders Injection site pain	6.5% 4/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
General disorders Injection site reaction	21.0% 13/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
General disorders Local swelling	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
General disorders Oedema peripheral	9.7% 6/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
General disorders Pyrexia	9.7% 6/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Infections and infestations Herpes zoster	0.00% 0/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Infections and infestations Mastoiditis	0.00% 0/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Infections and infestations Upper respiratory tract infection	4.8% 3/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Investigations Alanine aminotransferase increased	6.5% 4/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	25.0% 2/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Investigations Aspartate aminotransferase increased	8.1% 5/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	37.5% 3/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Investigations Blood alkaline phosphatase increased	11.3% 7/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	25.0% 2/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Investigations Blood creatinine increased	6.5% 4/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Investigations Blood phosphorus decreased	0.00% 0/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Investigations Electrocardiogram QT prolonged	0.00% 0/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Investigations Platelet count decreased	3.2% 2/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Investigations White blood cell count decreased	4.8% 3/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Metabolism and nutrition disorders Decreased appetite	19.4% 12/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	62.5% 5/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Metabolism and nutrition disorders Hyperkalaemia	6.5% 4/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Metabolism and nutrition disorders Hypoalbuminaemia	6.5% 4/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Metabolism and nutrition disorders Hypokalaemia	6.5% 4/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Metabolism and nutrition disorders Hyponatraemia	4.8% 3/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Musculoskeletal and connective tissue disorders Arthralgia	11.3% 7/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Musculoskeletal and connective tissue disorders Back pain	9.7% 6/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	25.0% 2/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Musculoskeletal and connective tissue disorders Flank pain	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Musculoskeletal and connective tissue disorders Muscle spasms	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	3.2% 2/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	25.0% 2/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Musculoskeletal and connective tissue disorders Myalgia	6.5% 4/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	25.0% 2/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Musculoskeletal and connective tissue disorders Neck pain	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	1.6% 1/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Nervous system disorders Headache	6.5% 4/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	50.0% 4/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Nervous system disorders Neuropathy peripheral	3.2% 2/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Nervous system disorders Peroneal nerve palsy	0.00% 0/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Psychiatric disorders Anxiety	4.8% 3/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Psychiatric disorders Insomnia	8.1% 5/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Renal and urinary disorders Haematuria	0.00% 0/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Renal and urinary disorders Pneumaturia	0.00% 0/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Renal and urinary disorders Terminal dribbling	0.00% 0/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Respiratory, thoracic and mediastinal disorders Cough	14.5% 9/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	25.0% 2/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.9% 8/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	6.5% 4/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	0.00% 0/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Respiratory, thoracic and mediastinal disorders Productive cough	3.2% 2/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	25.0% 2/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Skin and subcutaneous tissue disorders Acne	0.00% 0/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Skin and subcutaneous tissue disorders Pruritus	9.7% 6/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Skin and subcutaneous tissue disorders Rash	14.5% 9/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	25.0% 2/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Vascular disorders Hypotension	3.2% 2/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	12.5% 1/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
Gastrointestinal disorders Diarrhoea	19.4% 12/62 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.	37.5% 3/8 • Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period). The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.

Additional Information

Study Director

Incyte Corporation

Phone: 1-855-463-3463

Email: medinfo@incyte.com

Results disclosure agreements

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

Restriction type: OTHER