Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis (NCT NCT01704755)

NCT ID: NCT01704755

Last Updated: 2021-07-12

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 quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 381 participants
• Primary outcome timeframe: 12 weeks after the last actual dose of study drug
• Results posted on: 2021-07-12

Participant Flow

In the 12-week treatment group, one participant withdrew from the study before receiving study drug.

Participant milestones

Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
Overall Study STARTED	208	172
Overall Study Completed Study Drug	204	163
Overall Study COMPLETED	196	165
Overall Study NOT COMPLETED	12	7

Reasons for withdrawal

Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
Overall Study Adverse Event	4	1
Overall Study Lost to Follow-up	3	4
Overall Study Withdrew consent	1	1
Overall Study Other (not specified)	3	1
Overall Study Withdrew consent and personal issues	1	0

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis

Baseline characteristics by cohort

Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks n=208 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks n=172 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks	Total n=380 Participants Total of all reporting groups
Age, Continuous	57.1 years STANDARD_DEVIATION 7.01 • n=5 Participants	56.5 years STANDARD_DEVIATION 7.87 • n=7 Participants	56.8 years STANDARD_DEVIATION 7.41 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	51 Participants n=7 Participants	113 Participants n=5 Participants
Sex: Female, Male Male	146 Participants n=5 Participants	121 Participants n=7 Participants	267 Participants n=5 Participants

PRIMARY outcome

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

Population: All randomized 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] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.

Outcome measures

Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks n=208 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks n=172 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment	91.8 Percentage of participants	96.5 Percentage of participants

SECONDARY outcome

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

Population: All randomized participants who received at least 1 dose of study drug.

A sustained virologic response is defined as plasma Hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug.

Outcome measures

Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks n=208 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks n=172 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 24-week Arm Compared to the 12-week Arm	91.8 Percentage of participants	96.5 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24

Population: All randomized participants who received at least 1 dose of study drug.

Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).

Outcome measures

Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks n=208 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks n=172 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
Percentage of Participants in Each Arm With On-treatment Virologic Failure During the Treatment Period	0.5 Percentage of participants Interval 0.0 to 1.4	1.7 Percentage of participants Interval 0.0 to 3.7

SECONDARY outcome

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

Population: All randomized participants who received at least 1 dose of study drug with HCV RNA \< LLOQ at the final treatment visit who completed treatment.

Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.

Outcome measures

Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks n=203 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks n=164 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
Percentage of Participants With Virologic Relapse After Treatment	5.9 Percentage of participants Interval 2.7 to 9.2	0.6 Percentage of participants Interval 0.0 to 1.8

Adverse Events

ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks

Serious events: 13 serious events

Other events: 175 other events

Deaths: 0 deaths

ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks

Serious events: 7 serious events

Other events: 146 other events

Deaths: 0 deaths

Serious adverse events

Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks n=208 participants at risk ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks n=172 participants at risk ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
Blood and lymphatic system disorders ANAEMIA	0.48% 1/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.58% 1/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Cardiac disorders ATRIAL FIBRILLATION	0.48% 1/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.00% 0/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Gastrointestinal disorders HAEMATEMESIS	0.00% 0/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.58% 1/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Gastrointestinal disorders MELAENA	0.00% 0/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.58% 1/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Gastrointestinal disorders NAUSEA	0.48% 1/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.00% 0/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Gastrointestinal disorders OESOPHAGEAL VARICES HAEMORRHAGE	0.00% 0/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.58% 1/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Gastrointestinal disorders VOMITING	0.48% 1/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.00% 0/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
General disorders MULTI-ORGAN FAILURE	0.48% 1/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.00% 0/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
General disorders OEDEMA PERIPHERAL	0.48% 1/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.00% 0/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Hepatobiliary disorders CHOLECYSTITIS ACUTE	0.48% 1/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.00% 0/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Hepatobiliary disorders HEPATITIS ACUTE	0.48% 1/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.00% 0/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Infections and infestations CANDIDIASIS	0.48% 1/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.00% 0/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Infections and infestations CELLULITIS	0.00% 0/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.58% 1/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Infections and infestations ENTEROCOCCAL BACTERAEMIA	0.48% 1/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.00% 0/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Infections and infestations ESCHERICHIA SEPSIS	0.48% 1/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.00% 0/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Infections and infestations PHARYNGITIS	0.48% 1/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.00% 0/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Infections and infestations PNEUMONIA	0.48% 1/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.00% 0/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.48% 1/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.00% 0/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Injury, poisoning and procedural complications CLAVICLE FRACTURE	0.48% 1/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.00% 0/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Injury, poisoning and procedural complications EXTRADURAL HAEMATOMA	0.48% 1/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.00% 0/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Injury, poisoning and procedural complications FALL	0.00% 0/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.58% 1/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Injury, poisoning and procedural complications FEMORAL NECK FRACTURE	0.48% 1/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.00% 0/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Injury, poisoning and procedural complications HEAD INJURY	0.00% 0/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.58% 1/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Injury, poisoning and procedural complications TOXICITY TO VARIOUS AGENTS	0.48% 1/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.00% 0/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Injury, poisoning and procedural complications WOUND	0.48% 1/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.00% 0/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Investigations BLOOD GLUCOSE INCREASED	0.00% 0/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.58% 1/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Metabolism and nutrition disorders LACTIC ACIDOSIS	0.48% 1/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.00% 0/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.00% 0/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.58% 1/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Musculoskeletal and connective tissue disorders RHABDOMYOLYSIS	0.48% 1/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.00% 0/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HEPATOCELLULAR CARCINOMA	0.48% 1/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.58% 1/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Nervous system disorders INTRACRANIAL ANEURYSM	0.00% 0/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.58% 1/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Psychiatric disorders MAJOR DEPRESSION	0.48% 1/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.00% 0/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.00% 0/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	0.58% 1/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).

Other adverse events

Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks n=208 participants at risk ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks n=172 participants at risk ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
Blood and lymphatic system disorders ANAEMIA	7.2% 15/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	9.9% 17/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Gastrointestinal disorders ABDOMINAL DISTENSION	2.9% 6/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	5.2% 9/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Gastrointestinal disorders ABDOMINAL PAIN UPPER	5.3% 11/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	9.3% 16/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Gastrointestinal disorders DIARRHOEA	14.4% 30/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	16.9% 29/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	3.4% 7/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	5.8% 10/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Gastrointestinal disorders NAUSEA	17.3% 36/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	20.3% 35/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Gastrointestinal disorders VOMITING	2.9% 6/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	8.1% 14/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
General disorders ASTHENIA	13.9% 29/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	12.8% 22/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
General disorders FATIGUE	32.7% 68/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	46.5% 80/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
General disorders IRRITABILITY	7.2% 15/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	12.2% 21/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
General disorders OEDEMA PERIPHERAL	5.8% 12/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	5.8% 10/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Hepatobiliary disorders HYPERBILIRUBINAEMIA	7.2% 15/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	1.2% 2/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Infections and infestations NASOPHARYNGITIS	6.2% 13/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	7.6% 13/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	1.9% 4/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	7.6% 13/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Investigations BLOOD BILIRUBIN INCREASED	5.8% 12/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	5.2% 9/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Metabolism and nutrition disorders DECREASED APPETITE	5.8% 12/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	8.1% 14/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Musculoskeletal and connective tissue disorders ARTHRALGIA	4.8% 10/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	8.1% 14/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Musculoskeletal and connective tissue disorders BACK PAIN	1.9% 4/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	7.6% 13/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	6.7% 14/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	8.1% 14/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Nervous system disorders DIZZINESS	8.7% 18/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	5.8% 10/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Nervous system disorders HEADACHE	27.9% 58/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	30.8% 53/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Nervous system disorders MEMORY IMPAIRMENT	2.4% 5/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	7.0% 12/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Psychiatric disorders ANXIETY	7.2% 15/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	8.1% 14/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Psychiatric disorders DEPRESSION	3.8% 8/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	7.0% 12/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Psychiatric disorders INSOMNIA	15.4% 32/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	18.0% 31/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Respiratory, thoracic and mediastinal disorders COUGH	11.5% 24/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	11.0% 19/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Respiratory, thoracic and mediastinal disorders DYSPNOEA	5.8% 12/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	12.2% 21/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	6.2% 13/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	6.4% 11/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Skin and subcutaneous tissue disorders DRY SKIN	8.7% 18/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	6.4% 11/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Skin and subcutaneous tissue disorders PRURITUS	18.3% 38/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	19.2% 33/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Skin and subcutaneous tissue disorders PRURITUS GENERALISED	4.8% 10/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	7.0% 12/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Skin and subcutaneous tissue disorders RASH	11.1% 23/208 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).	14.5% 25/172 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group. Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).

Additional Information

Global Medical Information

AbbVie (prior sponsor, Abbott)

Phone: 800 633-9110

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