Trial Outcomes & Findings for A Study to Evaluate the Safety and Effect of the Experimental Drugs ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Subjects With Chronic Hepatitis C (NCT NCT01674725)

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. The LLOQ for the assay was 25 IU/mL. The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b infection treated with telaprevir and peginterferon (pegIFN)/RBV.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

187 participants

Primary outcome timeframe

12 weeks after last dose of study drug

Results posted on

2021-07-12

Participant Flow

Participant milestones

Participant milestones
Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks	ABT-450/r/ABT-267 and ABT-333 ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
Overall Study STARTED	92	95
Overall Study COMPLETED	89	94
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks	ABT-450/r/ABT-267 and ABT-333 ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
Overall Study Adverse Event	1	0
Overall Study Did not receive study drug	1	0
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

A Study to Evaluate the Safety and Effect of the Experimental Drugs ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Subjects With Chronic Hepatitis C

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV n=91 Participants ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks	ABT-450/r/ABT-267 and ABT-333 n=95 Participants ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks	Total n=186 Participants Total of all reporting groups
Age, Continuous	54.2 years STANDARD_DEVIATION 10.90 • n=5 Participants	54.2 years STANDARD_DEVIATION 10.51 • n=7 Participants	54.2 years STANDARD_DEVIATION 10.67 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	38 Participants n=7 Participants	84 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	57 Participants n=7 Participants	102 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks after last dose of study drug

Population: All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat \[ITT GT1b\] population); participants with missing data were counted as non-responders.

Outcome measures

Outcome measures
Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV n=88 Participants ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks	ABT-450/r/ABT-267 and ABT-333 n=91 Participants ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses	97.7 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 12 (End of Treatment)

Population: All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat \[ITT GT1b\]) and had hemoglobin ≥ LLN reference range at baseline.

The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to \< LLN at the end of treatment.

Outcome measures

Outcome measures
Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV n=88 Participants ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks	ABT-450/r/ABT-267 and ABT-333 n=91 Participants ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment	42.0 percentage of participants	5.5 percentage of participants

SECONDARY outcome

Timeframe: 12 weeks after last 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. The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b treated with telaprevir and pegIFN/RBV; and the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333 compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV.

Outcome measures

Outcome measures
Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV n=88 Participants ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks	ABT-450/r/ABT-267 and ABT-333 n=91 Participants ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses	97.7 percentage of participants	100 percentage of participants

SECONDARY outcome

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

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 \[2 consecutive HCV RNA measurements \> 1 log10 IU/mL above the lowest value post baseline\] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks \[≥ 36 days\] of treatment).

Outcome measures

Outcome measures
Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV n=88 Participants ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks	ABT-450/r/ABT-267 and ABT-333 n=91 Participants ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
Percentage of Participants With Virologic Failure During Treatment Rebound	0 percentage of participants	0 percentage of participants
Percentage of Participants With Virologic Failure During Treatment Failure to Suppress	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-Treatment)

Population: All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (ITT GT1b population) with HCV RNA \< LLOQ at the final treatment visit and completed treatment.

Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (\<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period. 95% CI was calculated using the Wilson score method for the single proportion because the point estimate was 0%.

Outcome measures

Outcome measures
Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV n=86 Participants ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks	ABT-450/r/ABT-267 and ABT-333 n=91 Participants ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
Percentage of Participants With Virologic Relapse After Treatment	0 percentage of participants Interval 0.0 to 4.3	0 percentage of participants Interval 0.0 to 4.1

Adverse Events

ABT-450/r/ABT-267 and ABT-333, Plus RBV

Serious events: 2 serious events

Other events: 71 other events

Deaths: 0 deaths

ABT-450/r/ABT-267 and ABT-333

Serious events: 2 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV n=91 participants at risk ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks	ABT-450/r/ABT-267 and ABT-333 n=95 participants at risk ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
Gastrointestinal disorders PANCREATITIS	1.1% 1/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	0.00% 0/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
Infections and infestations CELLULITIS	0.00% 0/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	1.1% 1/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	1.1% 1/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	0.00% 0/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
Renal and urinary disorders NEPHROLITHIASIS	0.00% 0/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	1.1% 1/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)

Other adverse events

Additional Information

Global Medical Information

AbbVie

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

Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV n=91 participants at risk ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks	ABT-450/r/ABT-267 and ABT-333 n=95 participants at risk ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
Blood and lymphatic system disorders ANAEMIA	11.0% 10/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	0.00% 0/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
Cardiac disorders PALPITATIONS	5.5% 5/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	2.1% 2/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
Gastrointestinal disorders CONSTIPATION	5.5% 5/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	1.1% 1/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
Gastrointestinal disorders DIARRHOEA	13.2% 12/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	12.6% 12/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
Gastrointestinal disorders NAUSEA	20.9% 19/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	6.3% 6/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
General disorders ASTHENIA	12.1% 11/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	7.4% 7/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
General disorders FATIGUE	31.9% 29/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	16.8% 16/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
General disorders IRRITABILITY	5.5% 5/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	1.1% 1/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
General disorders PYREXIA	6.6% 6/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	8.4% 8/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
Hepatobiliary disorders HYPERBILIRUBINAEMIA	5.5% 5/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	2.1% 2/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
Infections and infestations INFLUENZA	2.2% 2/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	6.3% 6/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
Infections and infestations NASOPHARYNGITIS	6.6% 6/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	6.3% 6/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
Investigations BLOOD BILIRUBIN INCREASED	8.8% 8/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	0.00% 0/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
Metabolism and nutrition disorders DECREASED APPETITE	9.9% 9/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	2.1% 2/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
Musculoskeletal and connective tissue disorders ARTHRALGIA	6.6% 6/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	6.3% 6/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
Musculoskeletal and connective tissue disorders MYALGIA	6.6% 6/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	4.2% 4/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
Nervous system disorders DIZZINESS	8.8% 8/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	3.2% 3/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
Nervous system disorders HEADACHE	24.2% 22/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	23.2% 22/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
Psychiatric disorders INSOMNIA	14.3% 13/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	3.2% 3/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
Respiratory, thoracic and mediastinal disorders COUGH	3.3% 3/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	7.4% 7/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
Respiratory, thoracic and mediastinal disorders DYSPNOEA	8.8% 8/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	2.1% 2/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	5.5% 5/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	1.1% 1/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
Skin and subcutaneous tissue disorders PRURITUS	14.3% 13/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	8.4% 8/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
Skin and subcutaneous tissue disorders RASH	8.8% 8/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	1.1% 1/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
Vascular disorders HYPERTENSION	5.5% 5/91 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)	4.2% 4/95 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)