Trial Outcomes & Findings for A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With HCV Genotype 1, 4, 5, and 6 Infection (NCT NCT02243280)

Last Updated: 2021-07-13

Results Overview

The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

174 participants

Primary outcome timeframe

12 weeks after the last actual dose of study drug

Results posted on

2021-07-13

Participant Flow

Safety population: all participants who received at least 1 dose of study drug. Two participants assigned to Arm I received the incorrect dose of study drug throughout their participation in the study (ABT-493 200 mg QD instead of 300 mg) and are therefore included in Arm A instead of Arm I in the safety population.

Participant milestones

Participant milestones
Measure	Arm A ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis	Arm B ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis	Arm F ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis	Arm I ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis	Arm K ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
Enrolled STARTED	40	39	27	34	34
Enrolled COMPLETED	40	39	27	34	34
Enrolled NOT COMPLETED	0	0	0	0	0
Treated STARTED	42	39	27	32	34
Treated Completed Treatment	42	38	27	32	33
Treated COMPLETED	41	39	27	31	31
Treated NOT COMPLETED	1	0	0	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis	Arm B ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis	Arm C ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)	Arm D ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)	Arm E ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	Arm F ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis	Arm G ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	Arm H ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	Arm I ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis	Arm J ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)	Arm K ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
Treated Adverse Event	1	0	0	0	0	0	0	0	0	0	1
Treated Lost to Follow-up	0	0	0	0	0	0	0	0	1	0	2

Baseline Characteristics

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With HCV Genotype 1, 4, 5, and 6 Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A n=42 Participants ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis	Arm B n=39 Participants ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis	Arm C ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)	Arm D ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)	Arm E ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	Arm F n=27 Participants ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis	Arm G ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	Arm H ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	Arm I n=32 Participants ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis	Arm J ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)	Arm K n=34 Participants ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis	Total n=174 Participants Total of all reporting groups
Age, Continuous	52.4 years STANDARD_DEVIATION 10.01 • n=5 Participants	52.5 years STANDARD_DEVIATION 10.41 • n=7 Participants	—	—	—	58.9 years STANDARD_DEVIATION 5.47 • n=8 Participants	—	—	55.0 years STANDARD_DEVIATION 11.13 • n=42 Participants	—	53.5 years STANDARD_DEVIATION 10.34 • n=42 Participants	54.1 years STANDARD_DEVIATION 9.98 • n=42 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	21 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	7 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	16 Participants n=42 Participants	0 Participants n=42 Participants	15 Participants n=42 Participants	76 Participants n=42 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	18 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	20 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	16 Participants n=42 Participants	0 Participants n=42 Participants	19 Participants n=42 Participants	98 Participants n=42 Participants

PRIMARY outcome

Timeframe: 12 weeks after the last actual dose of study drug

Population: Intention-to-treat population: all participants who received at least 1 dose of study drug

Outcome measures

Outcome measures
Measure	Arm A n=40 Participants ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis	Arm B n=39 Participants ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis	Arm C ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)	Arm D ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)	Arm E ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	Arm F n=27 Participants ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis	Arm G ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	Arm H ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	Arm I n=34 Participants ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis	Arm J ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)	Arm K n=34 Participants ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks Post-treatment	100 percentage of participants Interval 91.2 to 100.0	97.4 percentage of participants Interval 86.8 to 99.5	—	—	—	96.3 percentage of participants Interval 81.7 to 99.3	—	—	100 percentage of participants Interval 89.8 to 100.0	—	97.1 percentage of participants Interval 85.1 to 99.5

SECONDARY outcome

Timeframe: 4 weeks after the last actual dose of study drug

Population: Intention-to-treat population: all participants who received at least 1 dose of study drug

The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid \[HCV RNA\] less than the lower limit of quantification \[\<LLOQ\]) 4 weeks after the last dose of study drug.

Outcome measures

Outcome measures
Measure	Arm A n=40 Participants ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis	Arm B n=39 Participants ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis	Arm C ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)	Arm D ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)	Arm E ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	Arm F n=27 Participants ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis	Arm G ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	Arm H ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	Arm I n=34 Participants ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis	Arm J ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)	Arm K n=34 Participants ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
Percentage of Participants With Sustained Virologic Response (SVR) 4 Weeks Post-treatment	100 percentage of participants Interval 91.2 to 100.0	97.4 percentage of participants Interval 86.8 to 99.5	—	—	—	96.3 percentage of participants Interval 81.7 to 99.3	—	—	100 percentage of participants Interval 89.8 to 100.0	—	100 percentage of participants Interval 89.8 to 100.0

SECONDARY outcome

Timeframe: Screening, Day 1, Day 3, treatment weeks 1, 2, 4, 6, 8, 10, and 12 or premature discontinuation from treatment

Population: Intention-to-treat population: all participants who received at least 1 dose of study drug

The percentage of participants with on-treatment virologic failure (defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation \[≥ LLOQ\] 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	Arm A n=40 Participants ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis	Arm B n=39 Participants ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis	Arm C ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)	Arm D ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)	Arm E ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	Arm F n=27 Participants ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis	Arm G ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	Arm H ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	Arm I n=34 Participants ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis	Arm J ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)	Arm K n=34 Participants ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
Percentage of Participants With On-treatment Virologic Failure	0 percentage of participants Interval 0.0 to 8.8	0 percentage of participants Interval 0.0 to 9.0	—	—	—	0 percentage of participants Interval 0.0 to 12.5	—	—	0 percentage of participants Interval 0.0 to 10.2	—	0 percentage of participants Interval 0.0 to 10.2

SECONDARY outcome

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

Population: All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA \<LLOQ at the final treatment visit

Post-treatment relapse was defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation (≥ 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	Arm A n=40 Participants ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis	Arm B n=38 Participants ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis	Arm C ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)	Arm D ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)	Arm E ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	Arm F n=27 Participants ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis	Arm G ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	Arm H ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	Arm I n=34 Participants ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis	Arm J ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)	Arm K n=33 Participants ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
Percentage of Participants With Post-treatment Relapse	0 percentage of participants Interval 0.0 to 8.8	2.6 percentage of participants Interval 0.5 to 13.5	—	—	—	3.7 percentage of participants Interval 0.7 to 18.3	—	—	0 percentage of participants Interval 0.0 to 10.2	—	0 percentage of participants Interval 0.0 to 10.4

Adverse Events

Arm A

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Arm B

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Arm F

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Arm I

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Arm K

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A n=42 participants at risk ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis	Arm B n=39 participants at risk ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis	Arm F n=27 participants at risk ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis	Arm I n=32 participants at risk ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6- infected participants without cirrhosis	Arm K n=34 participants at risk ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	2.9% 1/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER METASTATIC	2.4% 1/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	3.7% 1/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.

Other adverse events

Other adverse events
Measure	Arm A n=42 participants at risk ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis	Arm B n=39 participants at risk ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis	Arm F n=27 participants at risk ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis	Arm I n=32 participants at risk ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6- infected participants without cirrhosis	Arm K n=34 participants at risk ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	3.7% 1/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	3.1% 1/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	5.9% 2/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	2.6% 1/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	9.4% 3/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	2.9% 1/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
Nervous system disorders MEMORY IMPAIRMENT	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	5.1% 2/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
Musculoskeletal and connective tissue disorders BACK PAIN	2.4% 1/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	2.6% 1/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	3.7% 1/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	5.9% 2/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
Nervous system disorders DIZZINESS	4.8% 2/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	5.1% 2/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	6.2% 2/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	2.9% 1/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
Nervous system disorders HEADACHE	11.9% 5/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	20.5% 8/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	11.1% 3/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	25.0% 8/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	2.9% 1/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
Eye disorders VISION BLURRED	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	2.6% 1/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	6.2% 2/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
Gastrointestinal disorders CONSTIPATION	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	3.1% 1/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	5.9% 2/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
Gastrointestinal disorders DIARRHOEA	7.1% 3/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	7.7% 3/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	3.7% 1/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	15.6% 5/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	8.8% 3/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
Gastrointestinal disorders DRY MOUTH	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	6.2% 2/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
Gastrointestinal disorders FLATULENCE	7.1% 3/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	6.2% 2/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
Gastrointestinal disorders NAUSEA	11.9% 5/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	20.5% 8/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	9.4% 3/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	8.8% 3/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
General disorders FATIGUE	23.8% 10/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	12.8% 5/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	11.1% 3/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	9.4% 3/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	17.6% 6/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
General disorders PAIN	2.4% 1/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	2.6% 1/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	3.1% 1/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	5.9% 2/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
General disorders PYREXIA	7.1% 3/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	2.6% 1/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	4.8% 2/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	2.6% 1/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	7.4% 2/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	3.1% 1/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	2.9% 1/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
Infections and infestations URINARY TRACT INFECTION	2.4% 1/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	2.6% 1/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	8.8% 3/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
Injury, poisoning and procedural complications MUSCLE STRAIN	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	7.4% 2/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	3.1% 1/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	5.9% 2/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
Skin and subcutaneous tissue disorders PRURITUS	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	2.6% 1/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	7.4% 2/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	3.1% 1/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	2.9% 1/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
Nervous system disorders PARAESTHESIA	2.4% 1/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	5.1% 2/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
Psychiatric disorders ANXIETY	4.8% 2/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	7.7% 3/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	2.9% 1/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
Psychiatric disorders DEPRESSION	4.8% 2/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	3.7% 1/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	6.2% 2/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
Psychiatric disorders INSOMNIA	2.4% 1/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	7.7% 3/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	3.1% 1/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	5.9% 2/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
Respiratory, thoracic and mediastinal disorders COUGH	4.8% 2/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	3.1% 1/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	8.8% 3/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
Respiratory, thoracic and mediastinal disorders PARANASAL SINUS DISCOMFORT	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	5.9% 2/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
Skin and subcutaneous tissue disorders HYPERHIDROSIS	2.4% 1/42 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/27 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	0.00% 0/32 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.	5.9% 2/34 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.

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