Trial Outcomes & Findings for A Study of Peginterferon Alfa-2a With or Without Ribavirin in Participants With Chronic Hepatitis D (CHD) (NCT NCT02731131)

Last Updated: 2016-07-15

Results Overview

Normalized ALT was defined as ALT value above the upper limit of normal (ULN) at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). Negative HDV RNA was defined as HDV RNA not detected by polymerase chain reaction (PCR). The number of participants with ALT normalization and negative HDV RNA at Week 96 was reported.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Week 96

Results posted on

2016-07-15

Participant Flow

Participant milestones

Participant milestones
Measure	Group A: Monotherapy With Peginterferon Alfa-2a Participants received peginterferon alfa-2a for 48 weeks as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection.	Group B: Combination With Peginterferon Alfa-2a + Ribavirin Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 milligrams (mg) per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
Overall Study STARTED	6	6
Overall Study COMPLETED	6	4
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A: Monotherapy With Peginterferon Alfa-2a Participants received peginterferon alfa-2a for 48 weeks as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection.	Group B: Combination With Peginterferon Alfa-2a + Ribavirin Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 milligrams (mg) per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
Overall Study Psychiatric Disorder	0	1
Overall Study Refused Therapy	0	1

Baseline Characteristics

A Study of Peginterferon Alfa-2a With or Without Ribavirin in Participants With Chronic Hepatitis D (CHD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A: Monotherapy With Peginterferon Alfa-2a n=6 Participants Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.	Group B: Combination With Peginterferon Alfa-2a + Ribavirin n=6 Participants Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.	Total n=12 Participants Total of all reporting groups
Age, Continuous	47.2 years STANDARD_DEVIATION 9.2 • n=5 Participants	49.2 years STANDARD_DEVIATION 7.4 • n=7 Participants	48.2 years STANDARD_DEVIATION 8.0 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 96

Population: ITT Population.

Outcome measures

Outcome measures
Measure	Group A: Monotherapy With Peginterferon Alfa-2a n=6 Participants Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.	Group B: Combination With Peginterferon Alfa-2a + Ribavirin n=6 Participants Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment	0 participants	1 participants

SECONDARY outcome

Timeframe: Week 48

Population: ITT Population.

Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with ALT normalization and negative HDV RNA at Week 48 was reported.

Outcome measures

Outcome measures
Measure	Group A: Monotherapy With Peginterferon Alfa-2a n=6 Participants Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.	Group B: Combination With Peginterferon Alfa-2a + Ribavirin n=6 Participants Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment	0 participants	0 participants

SECONDARY outcome

Timeframe: Week 96

Population: ITT Population.

Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). The number of participants with ALT normalization at Week 96 was reported.

Outcome measures

Outcome measures
Measure	Group A: Monotherapy With Peginterferon Alfa-2a n=6 Participants Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.	Group B: Combination With Peginterferon Alfa-2a + Ribavirin n=6 Participants Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
Number of Participants With ALT Normalization at 48 Weeks After End of Treatment	3 participants	1 participants

SECONDARY outcome

Timeframe: Week 48

Population: ITT Population.

Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). The number of participants with ALT normalization at Week 48 was reported.

Outcome measures

Outcome measures
Measure	Group A: Monotherapy With Peginterferon Alfa-2a n=6 Participants Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.	Group B: Combination With Peginterferon Alfa-2a + Ribavirin n=6 Participants Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
Number of Participants With ALT Normalization at End of Treatment	1 participants	0 participants

SECONDARY outcome

Timeframe: Week 96

Population: ITT Population.

Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at 48 weeks after end of treatment (Week 96) was reported.

Outcome measures

Outcome measures
Measure	Group A: Monotherapy With Peginterferon Alfa-2a n=6 Participants Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.	Group B: Combination With Peginterferon Alfa-2a + Ribavirin n=6 Participants Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment	0 participants	1 participants

SECONDARY outcome

Timeframe: Week 48

Population: ITT Population.

Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at the end of treatment (Week 48) was reported.

Outcome measures

Outcome measures
Measure	Group A: Monotherapy With Peginterferon Alfa-2a n=6 Participants Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.	Group B: Combination With Peginterferon Alfa-2a + Ribavirin n=6 Participants Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
Number of Participants With Negative HDV RNA at End of Treatment	1 participants	2 participants

Adverse Events

Group A: Monotherapy With Peginterferon Alfa-2a

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Group B: Combination With Peginterferon Alfa-2a + Ribavirin

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	Group A: Monotherapy With Peginterferon Alfa-2a n=6 participants at risk Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.	Group B: Combination With Peginterferon Alfa-2a + Ribavirin n=6 participants at risk Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
General disorders Asthenia	83.3% 5/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	50.0% 3/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
General disorders Pyrexia	83.3% 5/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	50.0% 3/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
General disorders Influenza like illness	33.3% 2/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
General disorders Malaise	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	0.00% 0/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
General disorders Fatigue	0.00% 0/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Arthralgia	83.3% 5/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	33.3% 2/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Myalgia	66.7% 4/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	33.3% 2/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Back pain	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	0.00% 0/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Neck pain	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	0.00% 0/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Nervous system disorders Headache	50.0% 3/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	33.3% 2/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Nervous system disorders Dizziness	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	0.00% 0/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Nervous system disorders Disturbance in attention	0.00% 0/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Nervous system disorders Dysgeusia	0.00% 0/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Nervous system disorders Neuropathy peripheral	0.00% 0/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Nervous system disorders Tremor	0.00% 0/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Psychiatric disorders Insomnia	66.7% 4/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	50.0% 3/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Psychiatric disorders Depression	33.3% 2/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	50.0% 3/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Psychiatric disorders Irritability	33.3% 2/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	50.0% 3/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Psychiatric disorders Emotional disorder	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	0.00% 0/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Psychiatric disorders Nervousness	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Psychiatric disorders Anxiety	0.00% 0/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	66.7% 4/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Cough	50.0% 3/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	33.3% 2/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Epistaxis	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	0.00% 0/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Gastrointestinal disorders Diarrhoea	33.3% 2/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	0.00% 0/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Gastrointestinal disorders Nausea	33.3% 2/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Gastrointestinal disorders Abdominal pain	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	33.3% 2/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Gastrointestinal disorders Dyspepsia	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	0.00% 0/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Gastrointestinal disorders Dry mouth	0.00% 0/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Gastrointestinal disorders Flatulence	0.00% 0/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Gastrointestinal disorders Stomatitis	0.00% 0/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Anorexia	33.3% 2/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	33.3% 2/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Skin and subcutaneous tissue disorders Pruritus	33.3% 2/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Skin and subcutaneous tissue disorders Dermatitis	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	0.00% 0/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Blood and lymphatic system disorders Neutropenia	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Blood and lymphatic system disorders Thrombocytopenia	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Renal and urinary disorders Renal colic	16.7% 1/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	0.00% 0/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.	33.3% 2/6 • Baseline through 24 weeks after end of treatment (up to 72 weeks) Safety Population: All randomized participants who received at least one dose of study medication and had at least one post-baseline safety assessment.