Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Experimental Drugs ABT- 493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1-6 Infection and Human Immunodeficiency Virus -1 Coinfection (EXPEDITION-2) (NCT NCT02738138)

Last Updated: 2021-07-13

Results Overview

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of active study drug.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

153 participants

Primary outcome timeframe

12 weeks after last dose of study drug

Results posted on

2021-07-13

Participant Flow

The study included a 35-day screening period.

Participant milestones

Participant milestones
Measure	ABT-493/ABT-530 for 8 Weeks HCV GT1-6/HIV-1 co-infected non-cirrhotic subjects treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeks	ABT-493/ABT-530 for 12 Weeks HCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks
Overall Study STARTED	137	16
Overall Study COMPLETED	134	15
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	ABT-493/ABT-530 for 8 Weeks HCV GT1-6/HIV-1 co-infected non-cirrhotic subjects treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeks	ABT-493/ABT-530 for 12 Weeks HCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks
Overall Study Adverse Event	0	1
Overall Study Lost to Follow-up	2	0
Overall Study Other - not further specified	1	0

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of Experimental Drugs ABT- 493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1-6 Infection and Human Immunodeficiency Virus -1 Coinfection (EXPEDITION-2)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ABT-493/ABT-530 for 8 Weeks n=137 Participants HCV GT1-6/HIV-1 co-infected non-cirrhotic subjects treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeks	ABT-493/ABT-530 for 12 Weeks n=16 Participants HCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks	Total n=153 Participants Total of all reporting groups
Age, Continuous	45.00 years STANDARD_DEVIATION 10.22 • n=5 Participants	50.00 years STANDARD_DEVIATION 8.36 • n=7 Participants	45.00 years STANDARD_DEVIATION 10.16 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	1 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	113 Participants n=5 Participants	15 Participants n=7 Participants	128 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	24 Participants n=5 Participants	1 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) White	106 Participants n=5 Participants	15 Participants n=7 Participants	121 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks after last dose of study drug

Population: Per protocol, all efficacy analyses were performed using the intention-to-treat (ITT) population (all enrolled participants who received at least 1 dose of study drug); in addition, efficacy analyses were performed overall, combining Treatment Arms A and B.

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of active study drug.

Outcome measures

Outcome measures
Measure	ABT-493/ABT-530 n=153 Participants HCV GT1-6/HIV-1 co-infected participants treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD)
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)	98.0 percentage of participants Interval 95.8 to 100.0

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Per protocol, all efficacy analyses were performed using the ITT population; in addition, efficacy analyses were performed overall, combining Treatment Arms A and B.

On-treatment virologic failure was defined as confirmed HCV RNA ≥ 100 IU/mL after HCV RNA \< LLOQ during treatment; confirmed increase of \> 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.

Outcome measures

Outcome measures
Measure	ABT-493/ABT-530 n=153 Participants HCV GT1-6/HIV-1 co-infected participants treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD)
Percentage of Participants With On-treatment Virologic Failure	0.7 percentage of participants Interval 0.1 to 3.6

SECONDARY outcome

Timeframe: From the end of treatment through 12 weeks after the last dose of study drug

Population: Per protocol, all efficacy analyses were performed using the ITT population including only those participants who had post-treatment data available, excluding reinfection (N = 151). In addition, efficacy analyses were performed overall, combining Treatment Arms A and B.

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels \< LLOQ at the end of treatment.

Outcome measures

Outcome measures
Measure	ABT-493/ABT-530 n=151 Participants HCV GT1-6/HIV-1 co-infected participants treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD)
Percentage of Participants With Post-treatment Relapse	0 percentage of participants Interval 0.0 to 2.5

Adverse Events

ABT-493/ABT-530 for 8 Weeks

Serious events: 3 serious events

Other events: 50 other events

Deaths: 0 deaths

ABT-493/ABT-530 for 12 Weeks

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ABT-493/ABT-530 for 8 Weeks n=137 participants at risk HCV GT1-6/HIV-1 co-infected non-cirrhotic subjects will be treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeks	ABT-493/ABT-530 for 12 Weeks n=16 participants at risk HCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis will be treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks
Gastrointestinal disorders UPPER GASTROINTESTINAL HAEMORRHAGE	0.73% 1/137 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).	0.00% 0/16 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).
Nervous system disorders CEREBRAL HAEMORRHAGE	0.00% 0/137 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).	6.2% 1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.00% 0/137 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).	6.2% 1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).
Renal and urinary disorders CALCULUS URINARY	0.73% 1/137 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).	0.00% 0/16 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).
Vascular disorders PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	0.73% 1/137 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).	0.00% 0/16 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).

Other adverse events

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER

Measure	ABT-493/ABT-530 for 8 Weeks n=137 participants at risk HCV GT1-6/HIV-1 co-infected non-cirrhotic subjects will be treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeks	ABT-493/ABT-530 for 12 Weeks n=16 participants at risk HCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis will be treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks
Gastrointestinal disorders ABDOMINAL PAIN	1.5% 2/137 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).	6.2% 1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).
Gastrointestinal disorders CONSTIPATION	0.73% 1/137 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).	6.2% 1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).
Gastrointestinal disorders DENTAL CARIES	0.73% 1/137 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).	6.2% 1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).
Gastrointestinal disorders GASTROINTESTINAL SOUNDS ABNORMAL	0.00% 0/137 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).	6.2% 1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).
Gastrointestinal disorders NAUSEA	8.8% 12/137 • Number of events 12 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).	6.2% 1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).
General disorders FATIGUE	13.1% 18/137 • Number of events 18 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).	0.00% 0/16 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).
Immune system disorders SEASONAL ALLERGY	0.00% 0/137 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).	6.2% 1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).
Infections and infestations CANDIDA INFECTION	0.00% 0/137 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).	6.2% 1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).
Infections and infestations SINUSITIS BACTERIAL	0.00% 0/137 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).	6.2% 1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).
Infections and infestations VIRAL UPPER RESPIRATORY TRACT INFECTION	8.8% 12/137 • Number of events 12 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).	0.00% 0/16 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).
Nervous system disorders DIZZINESS	2.2% 3/137 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).	6.2% 1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).
Nervous system disorders HEADACHE	8.8% 12/137 • Number of events 12 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).	0.00% 0/16 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).
Psychiatric disorders ANXIETY	1.5% 2/137 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).	6.2% 1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).
Respiratory, thoracic and mediastinal disorders COUGH	1.5% 2/137 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).	6.2% 1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).
Respiratory, thoracic and mediastinal disorders SINUS CONGESTION	0.73% 1/137 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).	6.2% 1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).
Respiratory, thoracic and mediastinal disorders UPPER-AIRWAY COUGH SYNDROME	0.00% 0/137 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).	6.2% 1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).
Skin and subcutaneous tissue disorders PRURITUS	2.2% 3/137 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).	6.2% 1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).
Skin and subcutaneous tissue disorders RASH	3.6% 5/137 • Number of events 5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).	6.2% 1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).