Trial Outcomes & Findings for A Randomized Study to Evaluate the Safety, Tolerability and Antiviral Activity of ABT-450, ABT-333 and ABT-072 (NCT NCT01074008)

NCT ID: NCT01074008

Last Updated: 2015-01-08

Results Overview

Plasma HCV RNA levels (reported as log10 IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification of 25 IU/mL. The baseline value was the HCV RNA level before the first dose of study drug on Day 1. The maximal change during monotherapy was the difference from baseline to the lowest log10 HCV RNA level anytime after the first dose of study drug on Day 1 through the last log10 HCV RNA level before the first dose of study drug on Day 4. Data are reported as the mean ± standard deviation.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

74 participants

Primary outcome timeframe

Prior to dosing on Day 1 to before the morning dose on Day 4

Results posted on

2015-01-08

Participant Flow

Participant milestones

Participant milestones
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Overall Study
STARTED
8
8
8
8
8
7
8
8
11
Overall Study
Completed Direct-acting Antiviral Agent
8
7
7
8
8
5
8
7
5
Overall Study
COMPLETED
7
5
6
7
6
7
7
8
7
Overall Study
NOT COMPLETED
1
3
2
1
2
0
1
0
4

Reasons for withdrawal

Reasons for withdrawal
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Overall Study
Adverse Event
0
1
0
0
0
0
0
0
0
Overall Study
Withdrawal by Subject
1
1
1
0
1
0
0
0
0
Overall Study
Lost to Follow-up
0
1
1
1
1
0
1
0
4

Baseline Characteristics

A Randomized Study to Evaluate the Safety, Tolerability and Antiviral Activity of ABT-450, ABT-333 and ABT-072

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
n=7 Participants
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
n=8 Participants
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
n=8 Participants
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV
n=11 Participants
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Total
n=74 Participants
Total of all reporting groups
Age, Continuous
48.4 years
STANDARD_DEVIATION 9.36 • n=5 Participants
50.9 years
STANDARD_DEVIATION 2.59 • n=7 Participants
50.6 years
STANDARD_DEVIATION 9.26 • n=5 Participants
53.5 years
STANDARD_DEVIATION 5.40 • n=4 Participants
51.3 years
STANDARD_DEVIATION 7.76 • n=21 Participants
40.9 years
STANDARD_DEVIATION 11.25 • n=10 Participants
49.6 years
STANDARD_DEVIATION 8.37 • n=115 Participants
53.5 years
STANDARD_DEVIATION 6.46 • n=6 Participants
51.5 years
STANDARD_DEVIATION 6.36 • n=6 Participants
50.2 years
STANDARD_DEVIATION 8.01 • n=64 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
3 Participants
n=7 Participants
4 Participants
n=5 Participants
3 Participants
n=4 Participants
1 Participants
n=21 Participants
0 Participants
n=10 Participants
2 Participants
n=115 Participants
0 Participants
n=6 Participants
2 Participants
n=6 Participants
16 Participants
n=64 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
5 Participants
n=7 Participants
4 Participants
n=5 Participants
5 Participants
n=4 Participants
7 Participants
n=21 Participants
7 Participants
n=10 Participants
6 Participants
n=115 Participants
8 Participants
n=6 Participants
9 Participants
n=6 Participants
58 Participants
n=64 Participants

PRIMARY outcome

Timeframe: Prior to dosing on Day 1 to before the morning dose on Day 4

Population: Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.

Plasma HCV RNA levels (reported as log10 IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification of 25 IU/mL. The baseline value was the HCV RNA level before the first dose of study drug on Day 1. The maximal change during monotherapy was the difference from baseline to the lowest log10 HCV RNA level anytime after the first dose of study drug on Day 1 through the last log10 HCV RNA level before the first dose of study drug on Day 4. Data are reported as the mean ± standard deviation.

Outcome measures

Outcome measures
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
n=7 Participants
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
n=8 Participants
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
n=8 Participants
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV
n=11 Participants
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-450/r, ABT-333, or ABT-072 Monotherapy Treatment
-4.07 log10 IU/mL
Standard Deviation 0.53
-3.91 log10 IU/mL
Standard Deviation 0.42
-4.11 log10 IU/mL
Standard Deviation 0.32
-1.14 log10 IU/mL
Standard Deviation 0.99
-1.07 log10 IU/mL
Standard Deviation 0.41
-1.57 log10 IU/mL
Standard Deviation 0.94
-1.08 log10 IU/mL
Standard Deviation 0.68
-0.95 log10 IU/mL
Standard Deviation 0.68
-0.36 log10 IU/mL
Standard Deviation 0.13

PRIMARY outcome

Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

Population: All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-450 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-450 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.

Outcome measures

Outcome measures
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Maximum Plasma Concentration (Cmax) of ABT-450
34.4 ng/mL
Standard Deviation 31.7
165 ng/mL
Standard Deviation 221
2923 ng/mL
Standard Deviation 2026

PRIMARY outcome

Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

Population: All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-450 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-450 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.

Outcome measures

Outcome measures
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Time to Maximum Plasma Concentration (Tmax) of ABT-450
2.5 Hours
Standard Deviation 0.9
4.8 Hours
Standard Deviation 3.5
3.0 Hours
Standard Deviation 1.1

PRIMARY outcome

Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

Population: All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-450 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng\*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABT-450 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.

Outcome measures

Outcome measures
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-450
250 ng*hr/mL
Standard Deviation 245
1122 ng*hr/mL
Standard Deviation 992
17351 ng*hr/mL
Standard Deviation 15841

PRIMARY outcome

Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

Population: All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ritonavir using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ritonavir was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.

Outcome measures

Outcome measures
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Maximum Plasma Concentration (Cmax) of Ritonavir
563 ng/mL
Standard Deviation 674
851 ng/mL
Standard Deviation 638
1098 ng/mL
Standard Deviation 619

PRIMARY outcome

Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

Population: All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ritonavir using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ritonavir was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.

Outcome measures

Outcome measures
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Time to Maximum Plasma Concentration (Tmax) of Ritonavir
4.8 Hours
Standard Deviation 2.8
5.3 Hours
Standard Deviation 3.2
4.5 Hours
Standard Deviation 1.4

PRIMARY outcome

Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

Population: All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ritonavir using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng\*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ritonavir was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.

Outcome measures

Outcome measures
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of Ritonavir
4518 ng*hr/mL
Standard Deviation 5063
7638 ng*hr/mL
Standard Deviation 6284
8663 ng*hr/mL
Standard Deviation 5006

PRIMARY outcome

Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

Population: All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-072 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-072 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.

Outcome measures

Outcome measures
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
n=7 Participants
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Maximum Plasma Concentration (Cmax) of ABT-072
390 ng/mL
Standard Deviation 153
1218 ng/mL
Standard Deviation 382
1748 ng/mL
Standard Deviation 707

PRIMARY outcome

Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

Population: All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-072 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-072 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.

Outcome measures

Outcome measures
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
n=7 Participants
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Time to Maximum Plasma Concentration (Tmax) of ABT-072
4.5 Hours
Standard Deviation 1.4
2.8 Hours
Standard Deviation 1.0
3.1 Hours
Standard Deviation 1.1

PRIMARY outcome

Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

Population: All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-072 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng\*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABT-072 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.

Outcome measures

Outcome measures
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
n=7 Participants
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-072
3678 ng*hr/mL
Standard Deviation 1742
9413 ng*hr/mL
Standard Deviation 3125
14126 ng*hr/mL
Standard Deviation 6102

PRIMARY outcome

Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

Population: All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.

Outcome measures

Outcome measures
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
n=6 Participants
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Maximum Plasma Concentration (Cmax) of ABT-333
800 ng/mL
Standard Deviation 382
1201 ng/mL
Standard Deviation 419

PRIMARY outcome

Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

Population: All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.

Outcome measures

Outcome measures
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
n=6 Participants
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Time to Maximum Plasma Concentration (Tmax) of ABT-333
4.5 Hours
Standard Deviation 5.2
7.0 Hours
Standard Deviation 8.4

PRIMARY outcome

Timeframe: Immediately prior to morning dose (time 0 hours) and at 2, 4, 8, and 12 hours after the morning dose on Day 1

Population: All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.

Blood samples were collected immediately prior to morning dose (time 0 hours) and at 2, 4, 8, and 12 hours after the morning dose on Day 1. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng\*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC12 of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.

Outcome measures

Outcome measures
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
n=6 Participants
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Area Under the Plasma Concentration-time Curve From 0 to 12 Hours (AUC12) Post-dose of ABT-333
4315 ng*hr/mL
Standard Deviation 2176
6431 ng*hr/mL
Standard Deviation 1914

SECONDARY outcome

Timeframe: Week 4

Population: All participants who received at least one dose of study drug and had at least one post-baseline HCV RNA value were included in this efficacy analysis.

Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification (LLOQ) of 25 IU/mL. Rapid virologic response was defined as HCV RNA level \< LLOQ (\< 25 IU/mL) at Week 4. Data are reported as the percentage of participants with RVR.

Outcome measures

Outcome measures
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
n=7 Participants
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
n=8 Participants
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
n=8 Participants
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV
n=11 Participants
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
87.5 percentage of participants
75.0 percentage of participants
100.0 percentage of participants
37.5 percentage of participants
12.5 percentage of participants
42.9 percentage of participants
50.0 percentage of participants
50.0 percentage of participants
9.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: To be included in the efficacy analysis, participants received at least one dose of study drug (direct-acting antiviral agent) and at least one post-baseline measurement of HCV RNA levels.

Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification of 25 IU/mL. Partial early virologic response (EVR) was defined as HCV RNA levels that decreased \> 2 log10 IU/mL at Week 12 as compared to baseline. The baseline value was the last measurement before the first dose on Day 1. Data are reported as the percentage of participants with partial EVR.

Outcome measures

Outcome measures
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
n=7 Participants
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
n=8 Participants
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
n=8 Participants
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV
n=11 Participants
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Percentage of Participants With Partial Early Virologic Response (EVR) at Week 12
100.0 percentage of participants
87.5 percentage of participants
100.0 percentage of participants
100.0 percentage of participants
62.5 percentage of participants
100.0 percentage of participants
100.0 percentage of participants
100.0 percentage of participants
36.4 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: To be included in the efficacy analysis, participants received at least one dose of study drug (direct-acting antiviral agent) and have at least one post-baseline measurement of HCV RNA levels.

Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification (LLOQ) of 25 IU/mL. Complete EVR was defined as HCV RNA levels \< LLOQ (\< 25 IU/mL) at Week 12. Data are reported as the percentage of participants with cEVR.

Outcome measures

Outcome measures
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
n=7 Participants
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
n=8 Participants
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
n=8 Participants
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV
n=11 Participants
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Percentage of Participants With Complete Early Virologic Response (cEVR) at Week 12
87.5 percentage of participants
87.5 percentage of participants
100.0 percentage of participants
75.0 percentage of participants
50.0 percentage of participants
85.7 percentage of participants
87.5 percentage of participants
62.5 percentage of participants
18.2 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Day 4

Population: All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the analysis. When the number of participants used to analyze the data at a specific time point differs from the Number of Participants Analyzed, the n (number of participants) is denoted in the Category Title.

Baseline samples were analyzed for resistance-associated amino acid variants using population and clonal sequencing and were compared with the appropriate reference sequence (1a-H77 or 1b-Con1). Phenotypic resistance to ABT-450 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Available samples at Day 4 with HCV RNA ≥ 1000 IU/mL were analyzed for resistance-associated variants using population and clonal sequencing and were compared with the baseline sequences to assess amino acid changes. Phenotypic resistance to ABT-450 at Day 4 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance are presented.

Outcome measures

Outcome measures
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-450 in Non-structural Viral Protein 3 (NS3)
Baseline Variants in NS3
0 participants
0 participants
0 participants
Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-450 in Non-structural Viral Protein 3 (NS3)
Baseline Resistance to ABT-450 >10-fold
0 participants
0 participants
0 participants
Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-450 in Non-structural Viral Protein 3 (NS3)
Day 4 Variants in NS3 (n=3, 2, 3)
2 participants
2 participants
1 participants
Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-450 in Non-structural Viral Protein 3 (NS3)
Day 4: Resistance to ABT-450 >10-fold (n=3, 2, 3)
1 participants
1 participants
0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Day 4

Population: All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the analysis. When the number of participants used to analyze the data at a specific time point differs from the Number of Participants Analyzed, the n (number of participants) is denoted in the Category Title.

Baseline samples were analyzed for resistance-associated amino acid variants using population and clonal sequencing and were compared with the appropriate reference sequence (1a-H77 or 1b-Con1). Phenotypic resistance to ABT-072 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Available samples at Day 4 with HCV RNA ≥ 1000 IU/mL were analyzed for the presence of resistance-associated variants using population and clonal sequencing and were compared with the baseline sequences to assess amino acid changes. Phenotypic resistance to ABT-072 at Day 4 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance are presented.

Outcome measures

Outcome measures
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
n=7 Participants
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-072 in Non-structural Viral Protein 5B (NS5B)
Baseline Variants in NS5B
0 participants
1 participants
0 participants
Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-072 in Non-structural Viral Protein 5B (NS5B)
Baseline Resistance to ABT-072 >10-fold
0 participants
1 participants
0 participants
Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-072 in Non-structural Viral Protein 5B (NS5B)
Day 4: Variants in NS5B (n=6, 7, 6)
1 participants
2 participants
1 participants
Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-072 in Non-structural Viral Protein 5B (NS5B)
Day 4: Resistance to ABT-072 >10-fold (n=6, 7, 6)
0 participants
0 participants
1 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Day 4

Population: All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the analysis. When the number of participants used to analyze the data at a specific time point differs from the Number of Participants Analyzed, the n (number of participants) is denoted in the Category Title.

Baseline samples were analyzed for resistance-associated amino acid variants using population and clonal sequencing and were compared with the appropriate reference sequence (1a-H77 or 1b-Con1). Phenotypic resistance to ABT-333 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Available samples at Day 4 with HCV RNA ≥ 1000 IU/mL were analyzed for the presence of resistance-associated variants using population and clonal sequencing and were compared with the baseline sequences to assess amino acid changes. Phenotypic resistance to ABT-333 at Day 4 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance are presented.

Outcome measures

Outcome measures
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
n=8 Participants
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-333 in Non-structural Viral Protein 5B (NS5B)
Baseline Variants in NS5B
1 participants
2 participants
Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-333 in Non-structural Viral Protein 5B (NS5B)
Baseline Resistance to ABT-333 >10-fold NS5B
0 participants
1 participants
Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-333 in Non-structural Viral Protein 5B (NS5B)
Day 4: Variants in NS5B (n=7, 8)
3 participants
3 participants
Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-333 in Non-structural Viral Protein 5B (NS5B)
Day 4: Resistance to ABT-333 >10-fold (n=7, 8)
0 participants
0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to Post-treatment Week 24

Population: Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.

The Hepatitis C Virus Patient-report Outcomes (HCV-PRO, formerly known as HCV Quality of Life) survey was used to assess disease-specific function and well-being on a scale from 0 to 100; a higher score indicated relatively good function and well-being of treated participants. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are reported as the group mean change from baseline ± standard deviation.

Outcome measures

Outcome measures
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
n=12 Participants
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
n=13 Participants
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
n=10 Participants
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
n=4 Participants
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Change From Baseline in Hepatitis C Virus Patient-reported Outcomes (HCV-PRO) Total Score
-0.78 units on a scale
Standard Deviation 15.53
-0.37 units on a scale
Standard Deviation 13.97
-3.25 units on a scale
Standard Deviation 14.72
-9.04 units on a scale
Standard Deviation 12.41

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Post-treatment Week 24

Population: Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.

The ED-5D VAS was a self-rating survey used to capture the current health status of a participant and ranged from 0 (the worst imaginable health state) to 100 (best imaginable health state). Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.

Outcome measures

Outcome measures
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
n=11 Participants
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
n=13 Participants
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
n=11 Participants
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
n=4 Participants
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Change From Baseline in ED-5D Visual Analog Scale (ED-5D VAS) Score
-5.91 units on a scale
Standard Deviation 31.92
-2.38 units on a scale
Standard Deviation 29.86
11.18 units on a scale
Standard Deviation 27.19
-9.00 units on a scale
Standard Deviation 22.23

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Post-treatment Week 24

Population: Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.

The EQ-5D was a health state questionnaire used to measure five health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The combination of responses from all five dimensions were derived into an index score ranging from 0 to 1; a higher score indicated a more preferable health utility value from the societal perspectives. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.

Outcome measures

Outcome measures
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
n=12 Participants
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
n=13 Participants
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
n=11 Participants
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
n=4 Participants
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Change From Baseline in EQ-5D (3 Level) Health Index Score
-0.06 units on a scale
Standard Deviation 0.22
-0.06 units on a scale
Standard Deviation 0.15
-0.02 units on a scale
Standard Deviation 0.17
-0.09 units on a scale
Standard Deviation 0.09

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Post-treatment Week 24

Population: Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.

The Physical Component Summary (PCS) of the SF-36 was used to measure the overall physical health status of a participant. The aggregated score of the SF-36 PCS score was standardized using a linear T-score transformation with a mean of 50 and a standard deviation of 10; a higher score indicated better physical function and well-being. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.

Outcome measures

Outcome measures
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
n=11 Participants
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
n=13 Participants
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
n=11 Participants
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
n=4 Participants
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Change From Baseline in SF-36 Physical Component Summary (PCS)
3.01 units on a scale
Standard Deviation 6.15
-1.92 units on a scale
Standard Deviation 5.89
4.08 units on a scale
Standard Deviation 5.76
-2.84 units on a scale
Standard Deviation 7.92

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Post-treatment Week 24

Population: Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.

The Mental Component Summary (MCS) of the SF-36 was used to measure the overall mental health status of participants. The aggregated score of the SF-36 MPS was standardized using a linear T-score transformation with a mean of 50 and a standard deviation of 10; a higher score indicated better mental function and well-being. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.

Outcome measures

Outcome measures
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
n=11 Participants
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
n=13 Participants
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
n=11 Participants
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
n=4 Participants
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Change From Baseline in SF-36 Mental Component Summary (MCS)
-2.77 units on a scale
Standard Deviation 5.99
-0.41 units on a scale
Standard Deviation 10.64
-4.37 units on a scale
Standard Deviation 11.00
-10.29 units on a scale
Standard Deviation 11.35

Adverse Events

ABT-450/r (50/100 mg) Once Daily (QD) + (pegIFN/RBV)

Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths

ABT-450/r (100/100 mg) Once Daily (QD) + (pegIFN/RBV)

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

ABT-450/r (200/100 mg) Once Daily (QD) + (pegIFN/RBV)

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

ABT-072 (100 mg) Once Daily (QD) + (pegIFN/RBV)

Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths

ABT-072 (300 mg) Once Daily (QD) + (pegIFN/RBV)

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

ABT-072 (600 mg) Once Daily (QD) + (pegIFN/RBV

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

ABT-333 (400 mg) Twice a Day (BID) + (pegIFN/RBV)

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

ABT-333 (800 mg) Twice Daily (BID) + (pegIFN/RBV)

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Placebo + (pegIFN/RBV)

Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + (pegIFN/RBV)
n=8 participants at risk
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + (pegIFN/RBV)
n=8 participants at risk
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + (pegIFN/RBV)
n=8 participants at risk
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + (pegIFN/RBV)
n=8 participants at risk
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + (pegIFN/RBV)
n=8 participants at risk
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + (pegIFN/RBV
n=7 participants at risk
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + (pegIFN/RBV)
n=8 participants at risk
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + (pegIFN/RBV)
n=8 participants at risk
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + (pegIFN/RBV)
n=11 participants at risk
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Gastrointestinal disorders
HAEMORRHOIDS
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).

Other adverse events

Other adverse events
Measure
ABT-450/r (50/100 mg) Once Daily (QD) + (pegIFN/RBV)
n=8 participants at risk
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (100/100 mg) Once Daily (QD) + (pegIFN/RBV)
n=8 participants at risk
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-450/r (200/100 mg) Once Daily (QD) + (pegIFN/RBV)
n=8 participants at risk
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (100 mg) Once Daily (QD) + (pegIFN/RBV)
n=8 participants at risk
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (300 mg) Once Daily (QD) + (pegIFN/RBV)
n=8 participants at risk
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-072 (600 mg) Once Daily (QD) + (pegIFN/RBV
n=7 participants at risk
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (400 mg) Twice a Day (BID) + (pegIFN/RBV)
n=8 participants at risk
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
ABT-333 (800 mg) Twice Daily (BID) + (pegIFN/RBV)
n=8 participants at risk
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + (pegIFN/RBV)
n=11 participants at risk
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Infections and infestations
TOOTH ABSCESS
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
18.2%
2/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Infections and infestations
TOOTH INFECTION
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Infections and infestations
HERPES SIMPLEX
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Infections and infestations
INFLUENZA
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Infections and infestations
LOCALISED INFECTION
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Infections and infestations
SINUSITIS
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Infections and infestations
SKIN INFECTION
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Infections and infestations
NASOPHARYNGITIS
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Infections and infestations
ORAL CANDIDIASIS
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Infections and infestations
PERITONSILLAR ABSCESS
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Infections and infestations
PHARYNGITIS
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Blood and lymphatic system disorders
ANAEMIA
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Blood and lymphatic system disorders
LEUKOPENIA
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Blood and lymphatic system disorders
LYMPHADENOPATHY
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Blood and lymphatic system disorders
NEUTROPENIA
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
62.5%
5/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
18.2%
2/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Blood and lymphatic system disorders
THROMBOCYTOPENIA
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Ear and labyrinth disorders
CERUMEN IMPACTION
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Ear and labyrinth disorders
TINNITUS
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Eye disorders
CONJUNCTIVITIS
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Eye disorders
LACRIMATION INCREASED
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Eye disorders
MACULAR OEDEMA
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Eye disorders
RETINAL DETACHMENT
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Eye disorders
RETINAL EXUDATES
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Eye disorders
VISION BLURRED
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Eye disorders
VISUAL ACUITY REDUCED
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Gastrointestinal disorders
ABDOMINAL DISTENSION
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Gastrointestinal disorders
ABDOMINAL PAIN
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
18.2%
2/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Gastrointestinal disorders
APHTHOUS STOMATITIS
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Gastrointestinal disorders
CONSTIPATION
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
42.9%
3/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Gastrointestinal disorders
DIARRHOEA
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
37.5%
3/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
28.6%
2/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
37.5%
3/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
36.4%
4/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Gastrointestinal disorders
DRY MOUTH
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Gastrointestinal disorders
DYSPEPSIA
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Gastrointestinal disorders
FLATULENCE
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Gastrointestinal disorders
GINGIVITIS
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Gastrointestinal disorders
GLOSSODYNIA
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Gastrointestinal disorders
HAEMORRHOIDS
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Gastrointestinal disorders
LIP DRY
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Gastrointestinal disorders
LOOSE TOOTH
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Gastrointestinal disorders
MOUTH ULCERATION
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Gastrointestinal disorders
NAUSEA
37.5%
3/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
28.6%
2/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
37.5%
3/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
36.4%
4/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Gastrointestinal disorders
PROCTALGIA
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Gastrointestinal disorders
PROCTITIS
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Gastrointestinal disorders
RECTAL HAEMORRHAGE
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Gastrointestinal disorders
STOMATITIS
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Gastrointestinal disorders
VOMITING
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
28.6%
2/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
General disorders
APPLICATION SITE RASH
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
General disorders
ASTHENIA
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
General disorders
CHILLS
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
General disorders
FATIGUE
37.5%
3/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
50.0%
4/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
37.5%
3/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
75.0%
6/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
37.5%
3/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
42.9%
3/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
50.0%
4/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
37.5%
3/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
54.5%
6/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
General disorders
INFLUENZA LIKE ILLNESS
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
50.0%
4/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
General disorders
INFUSION SITE INFLAMMATION
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
General disorders
INJECTION SITE ERYTHEMA
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
General disorders
INJECTION SITE HAEMATOMA
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
General disorders
INJECTION SITE RASH
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
General disorders
INJECTION SITE REACTION
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
General disorders
IRRITABILITY
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
37.5%
3/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
General disorders
MALAISE
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
General disorders
NON-CARDIAC CHEST PAIN
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
General disorders
PAIN
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
37.5%
3/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
General disorders
PYREXIA
37.5%
3/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
General disorders
TEMPERATURE INTOLERANCE
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
General disorders
THIRST
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Hepatobiliary disorders
HEPATOMEGALY
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Infections and infestations
ANAL ABSCESS
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Infections and infestations
CANDIDIASIS
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Infections and infestations
CELLULITIS
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Infections and infestations
EAR INFECTION
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Infections and infestations
GASTROENTERITIS
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Injury, poisoning and procedural complications
BURNS THIRD DEGREE
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Injury, poisoning and procedural complications
EXCORIATION
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Injury, poisoning and procedural complications
THERMAL BURN
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Investigations
BLOOD BILIRUBIN INCREASED
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Investigations
BLOOD CREATININE INCREASED
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Investigations
BLOOD GLUCOSE INCREASED
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Investigations
BLOOD PHOSPHORUS DECREASED
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Investigations
BLOOD POTASSIUM DECREASED
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Investigations
BLOOD TRIGLYCERIDES INCREASED
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Investigations
CREATININE RENAL CLEARANCE DECREASED
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Investigations
HAEMOGLOBIN DECREASED
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Investigations
LYMPHOCYTE COUNT DECREASED
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Investigations
NEUTROPHIL COUNT DECREASED
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Investigations
PLATELET COUNT DECREASED
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Investigations
WEIGHT DECREASED
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Investigations
WHITE BLOOD CELL COUNT DECREASED
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Metabolism and nutrition disorders
DECREASED APPETITE
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
28.6%
2/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
18.2%
2/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Metabolism and nutrition disorders
DEHYDRATION
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Metabolism and nutrition disorders
INCREASED APPETITE
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Musculoskeletal and connective tissue disorders
ARTHRALGIA
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
42.9%
3/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Musculoskeletal and connective tissue disorders
AXILLARY MASS
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Musculoskeletal and connective tissue disorders
BACK PAIN
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
36.4%
4/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Musculoskeletal and connective tissue disorders
COSTOCHONDRITIS
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Musculoskeletal and connective tissue disorders
FLANK PAIN
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Musculoskeletal and connective tissue disorders
JOINT STIFFNESS
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Musculoskeletal and connective tissue disorders
MUSCLE TIGHTNESS
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Musculoskeletal and connective tissue disorders
MYALGIA
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
37.5%
3/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
37.5%
3/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
42.9%
3/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
27.3%
3/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Musculoskeletal and connective tissue disorders
NECK PAIN
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
18.2%
2/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Nervous system disorders
DISTURBANCE IN ATTENTION
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Nervous system disorders
DIZZINESS
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
42.9%
3/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
36.4%
4/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Nervous system disorders
DYSGEUSIA
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
42.9%
3/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
18.2%
2/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Nervous system disorders
HEADACHE
75.0%
6/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
50.0%
4/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
62.5%
5/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
87.5%
7/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
62.5%
5/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
71.4%
5/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
50.0%
4/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
36.4%
4/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Nervous system disorders
HYPOAESTHESIA
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
18.2%
2/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Nervous system disorders
MEMORY IMPAIRMENT
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Nervous system disorders
RESTLESS LEGS SYNDROME
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Nervous system disorders
SINUS HEADACHE
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Nervous system disorders
SOMNOLENCE
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Psychiatric disorders
ABNORMAL DREAMS
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Psychiatric disorders
AFFECT LABILITY
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Psychiatric disorders
AGITATION
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Psychiatric disorders
ANGER
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Psychiatric disorders
ANXIETY
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
37.5%
3/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
18.2%
2/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Psychiatric disorders
CONFUSIONAL STATE
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Psychiatric disorders
DEPRESSED MOOD
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Psychiatric disorders
DEPRESSION
37.5%
3/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
50.0%
4/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Psychiatric disorders
IMPATIENCE
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Psychiatric disorders
INSOMNIA
37.5%
3/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
62.5%
5/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
18.2%
2/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Psychiatric disorders
MOOD SWINGS
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Psychiatric disorders
RESTLESSNESS
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Renal and urinary disorders
DYSURIA
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Renal and urinary disorders
POLLAKIURIA
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Renal and urinary disorders
URINE ODOUR ABNORMAL
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Reproductive system and breast disorders
VULVOVAGINAL PRURITUS
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Respiratory, thoracic and mediastinal disorders
COUGH
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
18.2%
2/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
18.2%
2/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Respiratory, thoracic and mediastinal disorders
UPPER-AIRWAY COUGH SYNDROME
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Skin and subcutaneous tissue disorders
ALOPECIA
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Skin and subcutaneous tissue disorders
DERMATITIS
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Skin and subcutaneous tissue disorders
DRY SKIN
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Skin and subcutaneous tissue disorders
ERYTHEMA
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Skin and subcutaneous tissue disorders
PRURITUS
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Skin and subcutaneous tissue disorders
PRURITUS GENERALISED
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Skin and subcutaneous tissue disorders
RASH
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
37.5%
3/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
25.0%
2/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
18.2%
2/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Skin and subcutaneous tissue disorders
RASH GENERALISED
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
28.6%
2/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Skin and subcutaneous tissue disorders
RASH PAPULAR
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Skin and subcutaneous tissue disorders
SKIN LESION
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Skin and subcutaneous tissue disorders
URTICARIA
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Vascular disorders
HOT FLUSH
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
14.3%
1/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
9.1%
1/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Vascular disorders
HYPERTENSION
12.5%
1/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/7 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/8 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
0.00%
0/11 • Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 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