Trial Outcomes & Findings for ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected Patients (NCT NCT01464827)
NCT ID: NCT01464827
Last Updated: 2015-04-22
Results Overview
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each AE to the use of direct-acting antiviral agents (DAAs) and to ribavirin, and rated the severity of each event as either: Mild: The AE was transient and easily tolerated by the participant; Moderate: The AE caused the participant discomfort and interrupted usual activities; Severe: The AE caused considerable interference with the participant's usual activities and could have been incapacitating or life-threatening. A serious adverse event was any event that resulted in death, was life-threatening, resulted in or prolonged hospitalization, resulted in a congenital anomaly or persistent or significant disability or was any other important medical event requiring medical or surgical intervention.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
580 participants
Primary outcome timeframe
From the time of study drug administration until 30 days following discontinuation of study drug administration (up to 28 weeks).
Results posted on
2015-04-22
Participant Flow
This was a Phase 2, open-label, randomized, combination treatment study of multiple doses of ABT-450/ritonavir, and ABT-267 and/or ABT-333 with or without ribavirin in hepatitis C virus (HCV) genotype 1-infected treatment-naïve patients and previous null responders to pegylated interferon (pegIFN) and ribavirin treatment.
Participant milestones
| Measure |
Group A
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 8 weeks.
|
Group B
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
|
Group C
Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
|
Group D
Treatment-naïve participants received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
|
Group E
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
|
Group F
Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
|
Group G
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group H
Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group I
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group J
Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group K
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group L
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group M
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group N
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
80
|
43
|
39
|
40
|
80
|
39
|
41
|
40
|
40
|
47
|
23
|
23
|
23
|
22
|
|
Overall Study
Treated
|
80
|
41
|
39
|
40
|
79
|
39
|
40
|
40
|
40
|
45
|
23
|
22
|
23
|
20
|
|
Overall Study
COMPLETED
|
77
|
36
|
39
|
36
|
72
|
38
|
37
|
37
|
37
|
44
|
21
|
21
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
0
|
4
|
8
|
1
|
4
|
3
|
3
|
3
|
2
|
2
|
2
|
3
|
Reasons for withdrawal
| Measure |
Group A
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 8 weeks.
|
Group B
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
|
Group C
Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
|
Group D
Treatment-naïve participants received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
|
Group E
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
|
Group F
Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
|
Group G
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group H
Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group I
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group J
Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group K
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group L
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group M
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group N
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
0
|
2
|
3
|
1
|
2
|
2
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Other
|
2
|
3
|
0
|
2
|
3
|
0
|
1
|
0
|
3
|
1
|
2
|
0
|
1
|
0
|
|
Overall Study
Not Treated
|
0
|
2
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
2
|
0
|
1
|
0
|
2
|
Baseline Characteristics
ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected Patients
Baseline characteristics by cohort
| Measure |
Group A
n=80 Participants
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 8 weeks.
|
Group B
n=41 Participants
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
|
Group C
n=39 Participants
Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
|
Group D
n=40 Participants
Treatment-naïve participants received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
|
Group E
n=79 Participants
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
|
Group F
n=39 Participants
Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
|
Group G
n=40 Participants
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group H
n=40 Participants
Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group I
n=40 Participants
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group J
n=45 Participants
Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group K
n=23 Participants
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group L
n=22 Participants
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group M
n=23 Participants
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group N
n=20 Participants
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Total
n=571 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
50.1 years
STANDARD_DEVIATION 9.99 • n=39 Participants
|
50.8 years
STANDARD_DEVIATION 9.84 • n=41 Participants
|
51.1 years
STANDARD_DEVIATION 8.07 • n=35 Participants
|
49.0 years
STANDARD_DEVIATION 10.59 • n=31 Participants
|
48.3 years
STANDARD_DEVIATION 10.53 • n=146 Participants
|
49.4 years
STANDARD_DEVIATION 9.72 • n=19 Participants
|
51.0 years
STANDARD_DEVIATION 11.08 • n=147 Participants
|
51.5 years
STANDARD_DEVIATION 11.95 • n=193 Participants
|
51.5 years
STANDARD_DEVIATION 9.78
|
50.6 years
STANDARD_DEVIATION 11.19
|
48.5 years
STANDARD_DEVIATION 12.91 • n=19 Participants
|
51.2 years
STANDARD_DEVIATION 12.07 • n=4 Participants
|
51.5 years
STANDARD_DEVIATION 9.06 • n=7 Participants
|
54.6 years
STANDARD_DEVIATION 11.78 • n=7 Participants
|
50.3 years
STANDARD_DEVIATION 10.49 • n=3 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
20 Participants
n=31 Participants
|
34 Participants
n=146 Participants
|
19 Participants
n=19 Participants
|
16 Participants
n=147 Participants
|
22 Participants
n=193 Participants
|
24 Participants
|
18 Participants
|
7 Participants
n=19 Participants
|
10 Participants
n=4 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=7 Participants
|
257 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
25 Participants
n=35 Participants
|
20 Participants
n=31 Participants
|
45 Participants
n=146 Participants
|
20 Participants
n=19 Participants
|
24 Participants
n=147 Participants
|
18 Participants
n=193 Participants
|
16 Participants
|
27 Participants
|
16 Participants
n=19 Participants
|
12 Participants
n=4 Participants
|
15 Participants
n=7 Participants
|
12 Participants
n=7 Participants
|
314 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: From the time of study drug administration until 30 days following discontinuation of study drug administration (up to 28 weeks).Population: Safety population. Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each AE to the use of direct-acting antiviral agents (DAAs) and to ribavirin, and rated the severity of each event as either: Mild: The AE was transient and easily tolerated by the participant; Moderate: The AE caused the participant discomfort and interrupted usual activities; Severe: The AE caused considerable interference with the participant's usual activities and could have been incapacitating or life-threatening. A serious adverse event was any event that resulted in death, was life-threatening, resulted in or prolonged hospitalization, resulted in a congenital anomaly or persistent or significant disability or was any other important medical event requiring medical or surgical intervention.
Outcome measures
| Measure |
Group A
n=80 Participants
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 8 weeks.
|
Group B
n=41 Participants
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
|
Group C + D
n=79 Participants
Treatment-naïve participants received ABT-450 (100 mg or 200 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group E
n=79 Participants
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
|
Group F + G
n=79 Participants
Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group H + I
n=80 Participants
Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group J
n=45 Participants
Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group K + L
n=45 Participants
Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group M + N
n=45 Participants
Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group J
Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group K
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group L
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group M
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group N
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Any adverse event
|
67 participants
|
36 participants
|
71 participants
|
68 participants
|
71 participants
|
77 participants
|
42 participants
|
39 participants
|
37 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Any adverse event at least possibly DAA-related
|
58 participants
|
29 participants
|
53 participants
|
51 participants
|
57 participants
|
68 participants
|
35 participants
|
30 participants
|
28 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Any severe adverse event
|
3 participants
|
0 participants
|
3 participants
|
5 participants
|
3 participants
|
3 participants
|
1 participants
|
1 participants
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Any serious adverse event
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Any AE leading to discontinuation of study drug
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
3 participants
|
3 participants
|
1 participants
|
0 participants
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Any AE leading to interruption of study drug
|
0 participants
|
1 participants
|
2 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Any AE leading to ribavirin dose modification
|
2 participants
|
2 participants
|
4 participants
|
0 participants
|
9 participants
|
10 participants
|
3 participants
|
1 participants
|
3 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Any fatal adverse events
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Post Treatment Week 24Population: Intent-to-treat population (all participants who received at least 1 dose of direct-acting antiviral agent); participants with missing data were counted as non-responders.
The percentage of participants achieving sustained virologic response 24 weeks after the last dose of study drug (SVR24), defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantitation (LLOQ), without any confirmed quantifiable (≥ LLOQ) post-treatment value before that time point. HCV RNA levels were measured from plasma by a central laboratory. The LLOQ for the assay was 25 IU/mL. The primary efficacy endpoint was the comparison between treatment-naïve participants following 8 weeks of treatment with 3 DAAs and ribavirin and those with 12 weeks of treatment with 3 DAAs and ribavirin (Group A versus Group G).
Outcome measures
| Measure |
Group A
n=80 Participants
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 8 weeks.
|
Group B
n=41 Participants
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
|
Group C + D
n=39 Participants
Treatment-naïve participants received ABT-450 (100 mg or 200 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group E
n=40 Participants
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
|
Group F + G
n=79 Participants
Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group H + I
n=39 Participants
Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group J
n=40 Participants
Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group K + L
n=40 Participants
Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group M + N
n=40 Participants
Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group J
n=45 Participants
Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group K
n=23 Participants
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group L
n=22 Participants
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group M
n=23 Participants
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group N
n=20 Participants
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose for 8 Weeks Versus 12 Weeks of Treatment With 3 DAAs and Ribavirin
|
87.5 percentage of participants
|
82.9 percentage of participants
|
84.6 percentage of participants
|
92.5 percentage of participants
|
88.6 percentage of participants
|
97.4 percentage of participants
|
95.0 percentage of participants
|
92.5 percentage of participants
|
90.0 percentage of participants
|
88.9 percentage of participants
|
91.3 percentage of participants
|
95.5 percentage of participants
|
91.3 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Post-Treatment Week 24Population: Intent-to-treat population; participants with missing data were counted as non-responders.
This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks after the last dose of study drug (HCV RNA \< LLOQ at post-treatment Week 24) following treatment with 3 DAAs (ABT-450/ritonavir, ABT-267, and ABT-333) and ribavirin in both treatment naïve and null-responder participants for 8 weeks (Group A) versus 12 weeks (Groups F + G + K + L) versus 24 weeks (Groups H + I + M + N).
Outcome measures
| Measure |
Group A
n=80 Participants
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 8 weeks.
|
Group B
n=124 Participants
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
|
Group C + D
n=123 Participants
Treatment-naïve participants received ABT-450 (100 mg or 200 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group E
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
|
Group F + G
Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group H + I
Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group J
Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group K + L
Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group M + N
Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group J
Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group K
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group L
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group M
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group N
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment of Different Durations With 3 Direct-acting Antiviral Agents (DAAs) and Ribavirin
|
87.5 percentage of participants
|
95.2 percentage of participants
|
92.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Post-Treatment Week 24Population: Intent-to-treat population; participants with missing data were counted as non-responders.
This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA \< LLOQ at post-treatment Week 24) following treatment with 2 DAAs (ABT-450/ritonavir plus ABT-333 \[Group B\] or ABT-450/ritonavir plus ABT-267 \[Groups C + D + J\]) and ribavirin versus 3 DAAs (ABT-450/ritonavir plus ABT-333 and ABT-267) and ribavirin (Groups F + G + K + L).
Outcome measures
| Measure |
Group A
n=41 Participants
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 8 weeks.
|
Group B
n=124 Participants
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
|
Group C + D
n=124 Participants
Treatment-naïve participants received ABT-450 (100 mg or 200 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group E
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
|
Group F + G
Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group H + I
Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group J
Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group K + L
Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group M + N
Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group J
Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group K
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group L
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group M
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group N
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 2 DAAs and Ribavirin Versus 3 DAAs and Ribavirin
|
82.9 percentage of participants
|
88.7 percentage of participants
|
95.2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Post-Treatment Week 24Population: Intent-to-treat population; participants with missing data were counted as non-responders.
This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA \< LLOQ at post-treatment Week 24) following treatment with 3 DAAs with or without ribavirin (Group E versus Groups F + G + K + L).
Outcome measures
| Measure |
Group A
n=79 Participants
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 8 weeks.
|
Group B
n=124 Participants
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
|
Group C + D
Treatment-naïve participants received ABT-450 (100 mg or 200 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group E
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
|
Group F + G
Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group H + I
Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group J
Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group K + L
Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group M + N
Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group J
Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group K
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group L
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group M
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group N
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 3 DAAs With Versus Without Ribavirin
|
88.6 percentage of participants
|
95.2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Post-Treatment Week 24Population: Intent-to-treat population; participants with missing data were counted as non-responders.
This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA \< LLOQ at post-treatment Week 24) following treatment with 3 DAAs and ribavirin in participants who were treatment-naïve versus those who were null-responders to previous HCV therapy (Groups F + G + H + I versus Groups K + L + M + N).
Outcome measures
| Measure |
Group A
n=159 Participants
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 8 weeks.
|
Group B
n=88 Participants
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
|
Group C + D
Treatment-naïve participants received ABT-450 (100 mg or 200 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group E
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
|
Group F + G
Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group H + I
Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group J
Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group K + L
Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group M + N
Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group J
Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group K
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group L
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group M
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group N
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose in Treatment-naïve Versus Null-responders
|
93.7 percentage of participants
|
94.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 64 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Group C + D
Serious events: 2 serious events
Other events: 66 other events
Deaths: 0 deaths
Group E
Serious events: 2 serious events
Other events: 59 other events
Deaths: 0 deaths
Group F + G
Serious events: 1 serious events
Other events: 66 other events
Deaths: 0 deaths
Group H + I
Serious events: 1 serious events
Other events: 74 other events
Deaths: 0 deaths
Group J
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Group K + L
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Group M + N
Serious events: 2 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A
n=80 participants at risk
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 8 weeks.
|
Group B
n=41 participants at risk
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
|
Group C + D
n=79 participants at risk
Treatment-naïve participants received ABT-450 (100 mg or 200 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group E
n=79 participants at risk
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
|
Group F + G
n=79 participants at risk
Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group H + I
n=80 participants at risk
Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group J
n=45 participants at risk
Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group K + L
n=45 participants at risk
Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group M + N
n=43 participants at risk
Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.3%
1/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Injury, poisoning and procedural complications
ANIMAL BITE
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.2%
1/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.3%
1/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.3%
1/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Nervous system disorders
CERVICOBRACHIAL SYNDROME
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.3%
1/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Nervous system disorders
FACIAL PARESIS
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Psychiatric disorders
AFFECTIVE DISORDER
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
Other adverse events
| Measure |
Group A
n=80 participants at risk
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 8 weeks.
|
Group B
n=41 participants at risk
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
|
Group C + D
n=79 participants at risk
Treatment-naïve participants received ABT-450 (100 mg or 200 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group E
n=79 participants at risk
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
|
Group F + G
n=79 participants at risk
Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group H + I
n=80 participants at risk
Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
Group J
n=45 participants at risk
Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group K + L
n=45 participants at risk
Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
|
Group M + N
n=43 participants at risk
Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
15.0%
12/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
12.2%
5/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
13.9%
11/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
10.1%
8/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
15.0%
12/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
15.6%
7/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.7%
3/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
20.9%
9/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
6.2%
5/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.4%
1/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
8.9%
7/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.5%
6/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.7%
3/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.7%
3/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.7%
2/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Ear and labyrinth disorders
TINNITUS
|
1.2%
1/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.3%
3/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.4%
1/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.2%
5/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.4%
2/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.2%
1/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.3%
3/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
5.1%
4/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
8.8%
7/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.2%
1/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
13.3%
6/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.9%
2/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.3%
5/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
5.1%
4/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
5.0%
4/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.2%
1/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.7%
2/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Gastrointestinal disorders
CONSTIPATION
|
3.8%
3/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.4%
1/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.3%
5/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.3%
5/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
11.2%
9/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.4%
2/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.2%
1/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
9.3%
4/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Gastrointestinal disorders
DIARRHOEA
|
10.0%
8/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
24.4%
10/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
10.1%
8/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
16.5%
13/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
12.7%
10/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
13.8%
11/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
15.6%
7/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
17.8%
8/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
18.6%
8/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Gastrointestinal disorders
DRY MOUTH
|
5.0%
4/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.2%
1/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.4%
2/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.7%
2/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
8.8%
7/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.4%
1/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
11.4%
9/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
5.1%
4/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.5%
6/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.4%
2/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.4%
2/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.7%
2/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.4%
1/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
5.1%
4/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
5.1%
4/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.2%
1/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.2%
1/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.3%
1/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
1.2%
1/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.2%
1/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.2%
1/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
9.3%
4/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Gastrointestinal disorders
NAUSEA
|
15.0%
12/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
17.1%
7/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
20.3%
16/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
13.9%
11/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
24.1%
19/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
25.0%
20/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
13.3%
6/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
20.0%
9/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
18.6%
8/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Gastrointestinal disorders
VOMITING
|
8.8%
7/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
9.8%
4/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
5.1%
4/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
5.1%
4/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
5.1%
4/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
5.0%
4/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
8.9%
4/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
8.9%
4/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.0%
3/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
General disorders
ASTHENIA
|
8.8%
7/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.4%
1/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
10.1%
8/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.3%
5/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
15.0%
12/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
22.2%
10/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
8.9%
4/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
9.3%
4/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
General disorders
CHEST PAIN
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.4%
1/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
5.0%
4/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.2%
1/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.7%
3/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
General disorders
CHILLS
|
5.0%
4/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.4%
1/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.2%
1/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.7%
2/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
General disorders
FATIGUE
|
36.2%
29/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
31.7%
13/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
27.8%
22/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
20.3%
16/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
27.8%
22/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
37.5%
30/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
26.7%
12/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
26.7%
12/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
20.9%
9/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
General disorders
IRRITABILITY
|
1.2%
1/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
9.8%
4/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.3%
5/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.3%
5/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
12.5%
10/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
15.6%
7/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.4%
2/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.0%
3/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Hepatobiliary disorders
JAUNDICE
|
3.8%
3/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.2%
1/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.7%
3/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.3%
1/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Infections and infestations
INFLUENZA
|
1.2%
1/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.2%
1/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.2%
1/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.7%
3/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Infections and infestations
NASOPHARYNGITIS
|
5.0%
4/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.3%
3/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
5.1%
4/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
10.1%
8/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
8.9%
7/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
8.8%
7/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.4%
2/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
8.9%
4/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.0%
3/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Infections and infestations
ORAL HERPES
|
2.5%
2/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.7%
3/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.7%
3/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.7%
2/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Infections and infestations
RHINITIS
|
1.2%
1/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.3%
5/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.2%
1/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Infections and infestations
SINUSITIS
|
5.0%
4/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
8.9%
7/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.3%
5/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.2%
1/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.4%
2/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.0%
3/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Infections and infestations
TOOTH INFECTION
|
2.5%
2/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
5.1%
4/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
5.0%
4/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.2%
1/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.2%
1/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
6.2%
5/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.4%
1/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.3%
5/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.3%
5/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
5.1%
4/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.2%
5/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.7%
3/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
8.9%
4/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
5.0%
4/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.3%
3/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.5%
6/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.4%
2/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.7%
3/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.7%
2/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.2%
1/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
9.3%
4/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
10.0%
8/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.4%
1/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.3%
5/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.5%
6/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.7%
3/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.2%
1/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.3%
1/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
2.5%
2/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.9%
2/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.6%
6/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
8.9%
7/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.3%
5/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
10.0%
8/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.7%
3/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
11.1%
5/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
16.3%
7/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
2.5%
2/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.4%
1/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
5.1%
4/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.2%
5/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.4%
2/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.4%
2/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
9.3%
4/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
2.5%
2/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.4%
1/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.3%
5/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.4%
2/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
5.0%
4/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.3%
3/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.3%
5/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
11.2%
9/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
11.1%
5/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
8.9%
4/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
14.0%
6/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
2.5%
2/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.4%
1/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.7%
3/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
2.5%
2/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.4%
1/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
11.2%
9/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.7%
3/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.7%
3/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.0%
3/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Nervous system disorders
DIZZINESS
|
6.2%
5/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
17.1%
7/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
5.1%
4/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
10.0%
8/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
8.9%
4/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.2%
1/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
9.3%
4/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Nervous system disorders
DYSGEUSIA
|
2.5%
2/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.4%
1/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
5.0%
4/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
8.9%
4/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
9.3%
4/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Nervous system disorders
HEADACHE
|
35.0%
28/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
31.7%
13/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
29.1%
23/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
19.0%
15/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
26.6%
21/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
35.0%
28/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
33.3%
15/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
28.9%
13/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
32.6%
14/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.2%
1/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.2%
1/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.7%
3/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.7%
2/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.2%
5/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.2%
1/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.7%
2/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.2%
1/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
11.6%
5/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Psychiatric disorders
ABNORMAL DREAMS
|
1.2%
1/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.9%
2/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.2%
5/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.2%
1/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.2%
1/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.3%
1/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Psychiatric disorders
ANXIETY
|
2.5%
2/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.9%
2/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
5.1%
4/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.5%
6/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
8.9%
4/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.2%
1/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.0%
3/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Psychiatric disorders
DEPRESSED MOOD
|
1.2%
1/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.3%
3/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.4%
2/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.3%
1/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Psychiatric disorders
DEPRESSION
|
3.8%
3/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.3%
3/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
15.0%
12/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.4%
2/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
11.1%
5/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.3%
1/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Psychiatric disorders
INSOMNIA
|
12.5%
10/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
19.5%
8/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
11.4%
9/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.6%
6/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
20.3%
16/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
25.0%
20/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
17.8%
8/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
13.3%
6/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
16.3%
7/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Psychiatric disorders
SLEEP DISORDER
|
1.2%
1/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
8.9%
4/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.7%
2/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
10.0%
8/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.3%
3/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
5.1%
4/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.3%
5/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
10.0%
8/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
8.9%
4/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
6.7%
3/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.0%
3/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
2.5%
2/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
5.1%
4/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
11.2%
9/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.7%
2/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
3.8%
3/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
5.1%
4/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
5.0%
4/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.4%
2/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
8.9%
4/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.7%
2/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
5.0%
4/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.2%
1/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.5%
2/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.5%
6/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
9.3%
4/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
5.0%
4/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.3%
3/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
5.1%
4/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.5%
6/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
13.3%
6/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
8.9%
4/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
9.3%
4/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
15.0%
12/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.3%
3/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
10.1%
8/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.6%
6/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
13.8%
11/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
13.3%
6/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
15.6%
7/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
14.0%
6/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Skin and subcutaneous tissue disorders
PRURITUS GENERALISED
|
2.5%
2/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
12.2%
5/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
1.3%
1/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
5.1%
4/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
3.8%
3/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
11.1%
5/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
0.00%
0/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
2.3%
1/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
|
Skin and subcutaneous tissue disorders
RASH
|
12.5%
10/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.9%
2/41 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.6%
6/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
7.6%
6/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
13.9%
11/79 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
18.8%
15/80 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
4.4%
2/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
8.9%
4/45 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
14.0%
6/43 • Up to 28 weeks
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
|
Additional Information
Global Medical Services
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