Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) in People With Hepatitis C Virus Infection Who Have Not Had Treatment Before (NCT NCT01854697)

Last Updated: 2018-06-06

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

311 participants

Primary outcome timeframe

12 weeks after the last actual dose of active study drug

Results posted on

2018-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A: 3-DAA + RBV in GT1a ABT-450/ritonavir (r)/ABT-267 150 mg/100 mg/25 mg once daily (QD) and ABT-333 250 mg twice daily (BID) and weight-based ribavirin (RBV) for 12 weeks (3 Direct-Acting Antivirals (DAAs) with RBV in genotype \[GT\] 1a)	Arm B: TPV/PR in GT1a Telaprevir (TPV) 750 mg every 8 hours (q8h) and pegylated interferon (pegIFN) 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)	Arm C: 3-DAA + RBV in GT1b ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)	Arm D: 3-DAA in GT1b ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)	Arm E: TPV/PR in GT1b Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
Overall Study STARTED	69	34	84	83	41
Overall Study COMPLETED	63	31	82	80	39
Overall Study NOT COMPLETED	6	3	2	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: 3-DAA + RBV in GT1a ABT-450/ritonavir (r)/ABT-267 150 mg/100 mg/25 mg once daily (QD) and ABT-333 250 mg twice daily (BID) and weight-based ribavirin (RBV) for 12 weeks (3 Direct-Acting Antivirals (DAAs) with RBV in genotype \[GT\] 1a)	Arm B: TPV/PR in GT1a Telaprevir (TPV) 750 mg every 8 hours (q8h) and pegylated interferon (pegIFN) 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)	Arm C: 3-DAA + RBV in GT1b ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)	Arm D: 3-DAA in GT1b ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)	Arm E: TPV/PR in GT1b Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
Overall Study Adverse Event	1	0	0	0	1
Overall Study Lost to Follow-up	4	1	1	2	0
Overall Study To enter another AbbVie study	1	0	0	0	1
Overall Study Withdrew Consent	0	1	0	1	0
Overall Study Other	0	1	1	0	0

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) in People With Hepatitis C Virus Infection Who Have Not Had Treatment Before

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: 3-DAA + RBV in GT1a n=69 Participants ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)	Arm B: TPV/PR in GT1a n=34 Participants TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)	Arm C: 3-DAA + RBV in GT1b n=84 Participants ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)	Arm D: 3-DAA in GT1b n=83 Participants ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)	Arm E: TPV/PR in GT1b n=41 Participants Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)	Total n=311 Participants Total of all reporting groups
Age, Continuous	46.1 years STANDARD_DEVIATION 12.25 • n=5 Participants	44.5 years STANDARD_DEVIATION 14.10 • n=7 Participants	46.2 years STANDARD_DEVIATION 11.34 • n=5 Participants	47.1 years STANDARD_DEVIATION 11.33 • n=4 Participants	45.9 years STANDARD_DEVIATION 10.78 • n=21 Participants	46.2 years STANDARD_DEVIATION 11.75 • n=10 Participants
Age, Customized < 55 years	46 participants n=5 Participants	23 participants n=7 Participants	59 participants n=5 Participants	60 participants n=4 Participants	31 participants n=21 Participants	219 participants n=10 Participants
Age, Customized >= 55 years	23 participants n=5 Participants	11 participants n=7 Participants	25 participants n=5 Participants	23 participants n=4 Participants	10 participants n=21 Participants	92 participants n=10 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	17 Participants n=7 Participants	46 Participants n=5 Participants	43 Participants n=4 Participants	24 Participants n=21 Participants	151 Participants n=10 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	17 Participants n=7 Participants	38 Participants n=5 Participants	40 Participants n=4 Participants	17 Participants n=21 Participants	160 Participants n=10 Participants

PRIMARY outcome

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

Population: Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Arm A: 3-DAA + RBV in GT1a n=69 Participants ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)	Arm B: TPV/PR in GT1a n=34 Participants TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)	Arm C: 3-DAA + RBV in GT1b n=84 Participants ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)	Arm D: 3-DAA in GT1b n=83 Participants ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)	Arm E: TPV/PR in GT1b n=41 Participants Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12) - Primary Efficacy Analyses	97.1 percentage of participants	82.4 percentage of participants	98.8 percentage of participants	97.6 percentage of participants	78.0 percentage of participants

SECONDARY outcome

Timeframe: From Day 1 of treatment up to 12 weeks for Arms A, C and D and up to 24 or 48 weeks for Arms B and E

Population: Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug and a baseline and post-baseline value.

SF-36V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQoL) covering 2 summary measures: physical component summary (PCS) and MCS; it consists of 8 subscales. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Scoring is done for both MCS subscale scores and summary scores; for each, the range is 0 (worst HRQoL) to 100 (best HRQoL).

Outcome measures

Outcome measures
Measure	Arm A: 3-DAA + RBV in GT1a n=69 Participants ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)	Arm B: TPV/PR in GT1a n=32 Participants TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)	Arm C: 3-DAA + RBV in GT1b n=84 Participants ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)	Arm D: 3-DAA in GT1b n=83 Participants ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)	Arm E: TPV/PR in GT1b n=40 Participants Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
Mean Change From Baseline to the Final Treatment Visit in Short-Form 36 Version 2 Health Status Survey (SF-36V2) Mental Component Summary (MCS)	-4.2 units on a scale Standard Deviation 10.59	-5.8 units on a scale Standard Deviation 12.18	-0.3 units on a scale Standard Deviation 8.89	-0.1 units on a scale Standard Deviation 7.73	-6.4 units on a scale Standard Deviation 11.78

SECONDARY outcome

Timeframe: From Day 1 of treatment up to 12 weeks for Arms A, C and D and up to 24 or 48 weeks for Arms B and E

Population: Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug and a baseline and post-baseline value.

SF-36V2 is a generic 36-item questionnaire measuring HRQoL covering 2 summary measures: PCS and MCS; it consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception. Participants self-report on items in a subscale that have choices per item. Scoring is done for both PCS subscale scores and summary scores; for each, the range is 0 (worst HRQoL) to 100 (best HRQoL).

Outcome measures

Outcome measures
Measure	Arm A: 3-DAA + RBV in GT1a n=69 Participants ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)	Arm B: TPV/PR in GT1a n=32 Participants TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)	Arm C: 3-DAA + RBV in GT1b n=84 Participants ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)	Arm D: 3-DAA in GT1b n=83 Participants ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)	Arm E: TPV/PR in GT1b n=40 Participants Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
Mean Change From Baseline to the Final Treatment Visit in SF-36V2 Physical Component Summary (PCS)	0.5 units on a scale Standard Deviation 8.63	-5.5 units on a scale Standard Deviation 8.26	0.4 units on a scale Standard Deviation 5.80	2.2 units on a scale Standard Deviation 4.34	-5.5 units on a scale Standard Deviation 11.46

SECONDARY outcome

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

Population: Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug.

The percentage of participants with sustained virologic response (plasma HCV RNA level \< LLOQ) 12 weeks after the last dose of study drug.

Outcome measures

Outcome measures
Measure	Arm A: 3-DAA + RBV in GT1a n=69 Participants ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)	Arm B: TPV/PR in GT1a n=34 Participants TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)	Arm C: 3-DAA + RBV in GT1b n=84 Participants ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)	Arm D: 3-DAA in GT1b n=83 Participants ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)	Arm E: TPV/PR in GT1b n=41 Participants Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
Percentage of Participants With SVR12 - Secondary Efficacy Analyses	97.1 percentage of participants	82.4 percentage of participants	98.8 percentage of participants	97.6 percentage of participants	78.0 percentage of participants

SECONDARY outcome

Timeframe: 12 weeks for Arms A, C and D and 24 weeks or 48 weeks for Arms B and E

Population: Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug.

Participants in Arms A, C or D demonstrating any of the following were considered virologic failures and discontinued therapy: * Confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements of \>1 log10 IU/mL above nadir) at any time point during treatment * Failure to achieve HCV RNA \< LLOQ by Week 6 or * Confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) at any point after HCV RNA \< LLOQ during treatment after HCV RNA \< LLOQ. Participants in Arms B and E followed virologic stopping criteria described in the TPV Summary of Product Characteristics; they were considered virologic failures and discontinued therapy as follows: * HCV RNA \> 1000 IU/mL at Week 4 to Week 12, discontinue TPV and pegIFN and RBV * HCV RNA \> 1000 IU/mL at Week 12, discontinue pegIFN and RBV * Confirmed HCV RNA \> lower limit of detection (LLOD) at Week 24, discontinue pegIFN and RBV * Confirmed HCV RNA \> LLOD at Week 36, discontinue pegIFN and RBV.

Outcome measures

Outcome measures
Measure	Arm A: 3-DAA + RBV in GT1a n=69 Participants ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)	Arm B: TPV/PR in GT1a n=34 Participants TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)	Arm C: 3-DAA + RBV in GT1b n=84 Participants ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)	Arm D: 3-DAA in GT1b n=83 Participants ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)	Arm E: TPV/PR in GT1b n=41 Participants Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
Percentage of Participants With Virologic Failure During Treatment	2.9 percentage of participants	5.9 percentage of participants	0 percentage of participants	1.2 percentage of participants	12.2 percentage of participants

SECONDARY outcome

Timeframe: Within 24 weeks post treatment

Population: Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug and had sustained virologic response at Week 24 (SVR24).

Hepatitis C virus (HCV) ribonucleic acid (RNA) confirmed greater than or equal to the lower limit of quantification (LLOQ) between the end of treatment and 24 weeks post treatment among participants completing treatment and with HCV RNA less than the LLOQ at the end of treatment.

Outcome measures

Outcome measures
Measure	Arm A: 3-DAA + RBV in GT1a n=66 Participants ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)	Arm B: TPV/PR in GT1a n=28 Participants TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)	Arm C: 3-DAA + RBV in GT1b n=84 Participants ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)	Arm D: 3-DAA in GT1b n=81 Participants ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)	Arm E: TPV/PR in GT1b n=32 Participants Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
Percentage of Participants With Post-treatment Relapse	0 percentage of participants	0 percentage of participants	1.2 percentage of participants	0 percentage of participants	6.3 percentage of participants

SECONDARY outcome

Timeframe: 24 weeks after the last actual dose of active study drug

Population: Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug.

The percentage of participants with sustained virologic response (plasma HCV RNA level \< LLOQ) 24 weeks after the last dose of study drug.

Outcome measures

Outcome measures
Measure	Arm A: 3-DAA + RBV in GT1a n=69 Participants ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)	Arm B: TPV/PR in GT1a n=34 Participants TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)	Arm C: 3-DAA + RBV in GT1b n=84 Participants ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)	Arm D: 3-DAA in GT1b n=83 Participants ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)	Arm E: TPV/PR in GT1b n=41 Participants Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24)	95.7 percentage of participants	82.4 percentage of participants	97.6 percentage of participants	97.6 percentage of participants	78.0 percentage of participants

Adverse Events

3 DAA + RBV

Serious events: 1 serious events

Other events: 100 other events

Deaths: 0 deaths

3 DAA

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

TPV + PEGIFN + RBV

Serious events: 9 serious events

Other events: 74 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	3 DAA + RBV n=153 participants at risk ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks	3 DAA n=83 participants at risk ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks	TPV + PEGIFN + RBV n=75 participants at risk TPV 750 mg q8h and pegIFN 180 μg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir
Blood and lymphatic system disorders ANAEMIA	0.00% 0/153 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.	0.00% 0/83 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.	2.7% 2/75 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.
Eye disorders RETINOPATHY	0.00% 0/153 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.	0.00% 0/83 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.	1.3% 1/75 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.
Gastrointestinal disorders HAEMATOCHEZIA	0.00% 0/153 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.	0.00% 0/83 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.	1.3% 1/75 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.
General disorders CHEST PAIN	0.00% 0/153 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.	0.00% 0/83 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.	1.3% 1/75 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.
Infections and infestations ABSCESS LIMB	0.00% 0/153 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.	0.00% 0/83 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.	1.3% 1/75 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.
Infections and infestations CELLULITIS	0.00% 0/153 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.	0.00% 0/83 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.	1.3% 1/75 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.
Injury, poisoning and procedural complications ACCIDENTAL OVERDOSE	0.00% 0/153 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.	0.00% 0/83 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.	1.3% 1/75 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.65% 1/153 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.	0.00% 0/83 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.	0.00% 0/75 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.
Respiratory, thoracic and mediastinal disorders COUGH	0.00% 0/153 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.	0.00% 0/83 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.	1.3% 1/75 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.
Skin and subcutaneous tissue disorders TOXIC SKIN ERUPTION	0.00% 0/153 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.	0.00% 0/83 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.	1.3% 1/75 • Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.

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