Trial Outcomes & Findings for A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment (NCT NCT00703118)
NCT ID: NCT00703118
Last Updated: 2014-01-22
Results Overview
SVR24 planned is defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after the last planned dose of study medication.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
663 participants
Primary outcome timeframe
Week 72
Results posted on
2014-01-22
Participant Flow
The study was conducted at 105 sites in 17 countries: Argentina, Australia, Austria, Belgium, Brazil, Canada, Switzerland, Germany, Spain, France, United Kingdom, Israel, Italy, Netherlands, Poland, Sweden, and the United States.
662 participants were treated (266 participants in the T12/PR48 group, 264 participants in the T12(DS)/PR48 group, and 132 participants in the Pbo/PR48 group) in this study.
Participant milestones
| Measure |
T12/PR48
12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
T12(DS)/PR48
4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
Pbo/PR48
48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
|---|---|---|---|
|
Overall Study
STARTED
|
266
|
264
|
132
|
|
Overall Study
COMPLETED
|
245
|
248
|
110
|
|
Overall Study
NOT COMPLETED
|
21
|
16
|
22
|
Reasons for withdrawal
| Measure |
T12/PR48
12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
T12(DS)/PR48
4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
Pbo/PR48
48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
2
|
|
Overall Study
Subject Ineligible To Continue The Trial
|
6
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
6
|
4
|
4
|
|
Overall Study
Withdrawal by Subject
|
8
|
7
|
13
|
|
Overall Study
Other
|
0
|
0
|
1
|
Baseline Characteristics
A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment
Baseline characteristics by cohort
| Measure |
T12/PR48
n=266 Participants
12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
T12(DS)/PR48
n=264 Participants
4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
Pbo/PR48
n=132 Participants
48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
Total
n=662 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.7 years
STANDARD_DEVIATION 8.51 • n=5 Participants
|
51 years
STANDARD_DEVIATION 8.24 • n=7 Participants
|
49.9 years
STANDARD_DEVIATION 9.74 • n=5 Participants
|
50.6 years
STANDARD_DEVIATION 8.66 • n=4 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
202 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
183 Participants
n=5 Participants
|
189 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
460 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
246 Participants
n=5 Participants
|
252 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
615 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
AgeCategoricalOther
>= 45 years
|
64 participants
n=5 Participants
|
55 participants
n=7 Participants
|
40 participants
n=5 Participants
|
159 participants
n=4 Participants
|
|
AgeCategoricalOther
Between 45 and 65 years
|
197 participants
n=5 Participants
|
201 participants
n=7 Participants
|
85 participants
n=5 Participants
|
483 participants
n=4 Participants
|
|
AgeCategoricalOther
>= 65 years
|
5 participants
n=5 Participants
|
8 participants
n=7 Participants
|
7 participants
n=5 Participants
|
20 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 72Population: Full Analysis Set: All randomized participants who received at least one dose of study medication.
SVR24 planned is defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after the last planned dose of study medication.
Outcome measures
| Measure |
T12/PR48
n=266 Participants
12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
T12(DS)/PR48
n=264 Participants
4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
Pbo/PR48
n=132 Participants
48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
|---|---|---|---|
|
Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned
|
171 Participants
|
175 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Week 4Population: All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.
RVR was defined as having undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 4.
Outcome measures
| Measure |
T12/PR48
n=266 Participants
12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
T12(DS)/PR48
n=264 Participants
4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
Pbo/PR48
n=132 Participants
48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
|---|---|---|---|
|
Number of Participants Acheiving Rapid Virologic Response (RVR) at Week 4
|
152 Participants
|
188 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 48Population: All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.
Outcome measures
| Measure |
T12/PR48
n=266 Participants
12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
T12(DS)/PR48
n=264 Participants
4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
Pbo/PR48
n=132 Participants
48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
|---|---|---|---|
|
Number of Participants Acheiving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 48 (End of Treatment)
|
184 Participants
|
191 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: Week 60Population: All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.
SVR12 planned was defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 12 weeks after the last planned dose of study medication (SVR12 planned).
Outcome measures
| Measure |
T12/PR48
n=266 Participants
12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
T12(DS)/PR48
n=264 Participants
4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
Pbo/PR48
n=132 Participants
48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
|---|---|---|---|
|
Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Medication - SVR12 Planned
|
175 Participants
|
178 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Week 4, Week 6, or Week 8Population: All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.
Telaprevir stopping rule is defined as having Hepatitis C virus (HCV) ribonucleic acid (RNA) levels \>100 IU/mL at Week 4, Week 6, or Week 8 after start of telaprevir.
Outcome measures
| Measure |
T12/PR48
n=266 Participants
12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
T12(DS)/PR48
n=264 Participants
4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
Pbo/PR48
48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
|---|---|---|---|
|
Number of Participants Who Meet the Telaprevir Stopping Rule at Week 4, Week 6, or Week 8
Week 4
|
16 Participants
|
14 Participants
|
—
|
|
Number of Participants Who Meet the Telaprevir Stopping Rule at Week 4, Week 6, or Week 8
Week 6
|
5 Participants
|
2 Participants
|
—
|
|
Number of Participants Who Meet the Telaprevir Stopping Rule at Week 4, Week 6, or Week 8
Week 8
|
2 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 72Population: All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.
Viral relapse was defined as having confirmed detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels during entire follow-up period (up to Week 72).
Outcome measures
| Measure |
T12/PR48
n=266 Participants
12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
T12(DS)/PR48
n=264 Participants
4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
Pbo/PR48
n=132 Participants
48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
|---|---|---|---|
|
Number of Participants Who Have Viral Relapse During Entire Follow-up Period (up to Week 72)
|
26 Participants
|
27 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 4Population: All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.
Outcome measures
| Measure |
T12/PR48
n=245 Participants
12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
T12(DS)/PR48
n=240 Participants
4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
Pbo/PR48
n=121 Participants
48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
|---|---|---|---|
|
Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4
|
-5.5 log10 IU/mL
Standard Deviation 1.06
|
-2.0 log10 IU/mL
Standard Deviation 1.42
|
-1.9 log10 IU/mL
Standard Deviation 1.40
|
SECONDARY outcome
Timeframe: Week 4 and Week 12Population: All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.
Extended rapid virologic response was defined as undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels.
Outcome measures
| Measure |
T12/PR48
n=266 Participants
12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
T12(DS)/PR48
n=264 Participants
4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
Pbo/PR48
n=132 Participants
48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
|
|---|---|---|---|
|
Number of Participants Acheiving Extended Rapid Virologic Response at Week 4 and Week 12
|
141 Participants
|
180 Participants
|
3 Participants
|
Adverse Events
T12/PR48 - TVR/PBO TREATMENT
Serious events: 18 serious events
Other events: 253 other events
Deaths: 0 deaths
T12(DS)/PR48 - TVR/PBO TREATMENT
Serious events: 17 serious events
Other events: 255 other events
Deaths: 0 deaths
Pbo/PR48 - TVR/PBO TREATMENT
Serious events: 4 serious events
Other events: 126 other events
Deaths: 0 deaths
T12/PR48 - OVERALL TREATMENT
Serious events: 33 serious events
Other events: 257 other events
Deaths: 0 deaths
T12(DS)/PR48 - OVERALL TREATMENT
Serious events: 32 serious events
Other events: 260 other events
Deaths: 0 deaths
Pbo/PR48 - OVERALL TREATMENT
Serious events: 7 serious events
Other events: 126 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
T12/PR48 - TVR/PBO TREATMENT
n=266 participants at risk
12 weeks of 750 mg telaprevir q8hr followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase
|
T12(DS)/PR48 - TVR/PBO TREATMENT
n=264 participants at risk
4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir q8hr in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase
|
Pbo/PR48 - TVR/PBO TREATMENT
n=132 participants at risk
48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase
|
T12/PR48 - OVERALL TREATMENT
n=266 participants at risk
12 weeks of 750 mg telaprevir q8hr followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AES during the overall treatment phase
|
T12(DS)/PR48 - OVERALL TREATMENT
n=264 participants at risk
4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir q8hr in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AES during the overall treatment phase
|
Pbo/PR48 - OVERALL TREATMENT
n=132 participants at risk
48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the overall treatment phase
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
4/266 • 72 weeks
|
1.9%
5/264 • 72 weeks
|
0.76%
1/132 • 72 weeks
|
2.3%
6/266 • 72 weeks
|
2.7%
7/264 • 72 weeks
|
0.76%
1/132 • 72 weeks
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
1.1%
3/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.76%
2/264 • 72 weeks
|
0.76%
1/132 • 72 weeks
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Endocrine disorders
Basedow's disease
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Eye disorders
Retinal detachment
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.76%
1/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.76%
1/132 • 72 weeks
|
|
Gastrointestinal disorders
Anal fissure
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Gastrointestinal disorders
Caecitis
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.76%
1/132 • 72 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Gastrointestinal disorders
Pancreatitis
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
General disorders
General physical health deterioration
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Injury, poisoning and procedural complications
Injection site reaction
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
General disorders
Pyrexia
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Infections and infestations
Appendicitis
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.75%
2/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Infections and infestations
Erysipelas
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Infections and infestations
Folliculitis
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Infections and infestations
Pneumonia
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.76%
1/132 • 72 weeks
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.76%
1/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.76%
1/132 • 72 weeks
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.76%
2/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Injury, poisoning and procedural complications
Multiple drug overdose
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Investigations
Blood corticotrophin decreased
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Investigations
Weight decreased
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/266 • 72 weeks
|
0.76%
2/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.76%
2/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.75%
2/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Histiocytosis haematophagic
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Nervous system disorders
Cerebral thrombosis
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.76%
1/132 • 72 weeks
|
|
Nervous system disorders
Coma
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.76%
1/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.76%
1/132 • 72 weeks
|
|
Nervous system disorders
Lethargy
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Psychiatric disorders
Delirium
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Psychiatric disorders
Substance abuse
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Renal and urinary disorders
Renal cyst
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Renal and urinary disorders
Renal failure
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/266 • 72 weeks
|
0.76%
2/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.76%
2/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.00%
0/266 • 72 weeks
|
0.38%
1/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
0.38%
1/266 • 72 weeks
|
0.00%
0/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
Other adverse events
| Measure |
T12/PR48 - TVR/PBO TREATMENT
n=266 participants at risk
12 weeks of 750 mg telaprevir q8hr followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase
|
T12(DS)/PR48 - TVR/PBO TREATMENT
n=264 participants at risk
4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir q8hr in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase
|
Pbo/PR48 - TVR/PBO TREATMENT
n=132 participants at risk
48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase
|
T12/PR48 - OVERALL TREATMENT
n=266 participants at risk
12 weeks of 750 mg telaprevir q8hr followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AES during the overall treatment phase
|
T12(DS)/PR48 - OVERALL TREATMENT
n=264 participants at risk
4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir q8hr in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AES during the overall treatment phase
|
Pbo/PR48 - OVERALL TREATMENT
n=132 participants at risk
48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the overall treatment phase
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
26.3%
70/266 • 72 weeks
|
31.1%
82/264 • 72 weeks
|
12.9%
17/132 • 72 weeks
|
29.3%
78/266 • 72 weeks
|
35.2%
93/264 • 72 weeks
|
14.4%
19/132 • 72 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.6%
23/266 • 72 weeks
|
4.9%
13/264 • 72 weeks
|
6.8%
9/132 • 72 weeks
|
10.2%
27/266 • 72 weeks
|
7.6%
20/264 • 72 weeks
|
8.3%
11/132 • 72 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.4%
17/266 • 72 weeks
|
9.1%
24/264 • 72 weeks
|
9.1%
12/132 • 72 weeks
|
14.3%
38/266 • 72 weeks
|
13.3%
35/264 • 72 weeks
|
10.6%
14/132 • 72 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.6%
7/266 • 72 weeks
|
5.3%
14/264 • 72 weeks
|
4.5%
6/132 • 72 weeks
|
3.4%
9/266 • 72 weeks
|
6.1%
16/264 • 72 weeks
|
5.3%
7/132 • 72 weeks
|
|
Eye disorders
Vision blurred
|
3.8%
10/266 • 72 weeks
|
2.7%
7/264 • 72 weeks
|
1.5%
2/132 • 72 weeks
|
6.0%
16/266 • 72 weeks
|
3.8%
10/264 • 72 weeks
|
2.3%
3/132 • 72 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
12.0%
32/266 • 72 weeks
|
11.0%
29/264 • 72 weeks
|
12.1%
16/132 • 72 weeks
|
16.2%
43/266 • 72 weeks
|
13.6%
36/264 • 72 weeks
|
15.9%
21/132 • 72 weeks
|
|
Gastrointestinal disorders
Anal pruritus
|
5.3%
14/266 • 72 weeks
|
5.7%
15/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
5.3%
14/266 • 72 weeks
|
5.7%
15/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Gastrointestinal disorders
Anorectal discomfort
|
7.5%
20/266 • 72 weeks
|
4.2%
11/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
7.9%
21/266 • 72 weeks
|
4.2%
11/264 • 72 weeks
|
0.00%
0/132 • 72 weeks
|
|
Gastrointestinal disorders
Constipation
|
4.1%
11/266 • 72 weeks
|
4.2%
11/264 • 72 weeks
|
3.8%
5/132 • 72 weeks
|
7.5%
20/266 • 72 weeks
|
6.4%
17/264 • 72 weeks
|
3.8%
5/132 • 72 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
22.6%
60/266 • 72 weeks
|
24.2%
64/264 • 72 weeks
|
12.1%
16/132 • 72 weeks
|
24.8%
66/266 • 72 weeks
|
26.1%
69/264 • 72 weeks
|
13.6%
18/132 • 72 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
8.6%
23/266 • 72 weeks
|
7.6%
20/264 • 72 weeks
|
9.1%
12/132 • 72 weeks
|
9.4%
25/266 • 72 weeks
|
8.0%
21/264 • 72 weeks
|
9.1%
12/132 • 72 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
4.9%
13/266 • 72 weeks
|
5.7%
15/264 • 72 weeks
|
7.6%
10/132 • 72 weeks
|
4.9%
13/266 • 72 weeks
|
6.8%
18/264 • 72 weeks
|
8.3%
11/132 • 72 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
14.3%
38/266 • 72 weeks
|
10.6%
28/264 • 72 weeks
|
5.3%
7/132 • 72 weeks
|
15.0%
40/266 • 72 weeks
|
12.1%
32/264 • 72 weeks
|
6.8%
9/132 • 72 weeks
|
|
Gastrointestinal disorders
Nausea
|
33.5%
89/266 • 72 weeks
|
30.3%
80/264 • 72 weeks
|
23.5%
31/132 • 72 weeks
|
35.3%
94/266 • 72 weeks
|
33.0%
87/264 • 72 weeks
|
23.5%
31/132 • 72 weeks
|
|
Gastrointestinal disorders
Vomiting
|
10.9%
29/266 • 72 weeks
|
10.6%
28/264 • 72 weeks
|
7.6%
10/132 • 72 weeks
|
13.9%
37/266 • 72 weeks
|
11.7%
31/264 • 72 weeks
|
8.3%
11/132 • 72 weeks
|
|
General disorders
Asthenia
|
18.4%
49/266 • 72 weeks
|
20.8%
55/264 • 72 weeks
|
26.5%
35/132 • 72 weeks
|
19.2%
51/266 • 72 weeks
|
22.7%
60/264 • 72 weeks
|
28.8%
38/132 • 72 weeks
|
|
General disorders
Chills
|
15.4%
41/266 • 72 weeks
|
11.7%
31/264 • 72 weeks
|
14.4%
19/132 • 72 weeks
|
15.8%
42/266 • 72 weeks
|
11.7%
31/264 • 72 weeks
|
14.4%
19/132 • 72 weeks
|
|
General disorders
Fatigue
|
51.9%
138/266 • 72 weeks
|
47.0%
124/264 • 72 weeks
|
38.6%
51/132 • 72 weeks
|
54.5%
145/266 • 72 weeks
|
49.6%
131/264 • 72 weeks
|
40.2%
53/132 • 72 weeks
|
|
General disorders
Influenza like illness
|
32.0%
85/266 • 72 weeks
|
34.1%
90/264 • 72 weeks
|
25.0%
33/132 • 72 weeks
|
32.0%
85/266 • 72 weeks
|
35.6%
94/264 • 72 weeks
|
25.0%
33/132 • 72 weeks
|
|
Injury, poisoning and procedural complications
Injection site erythema
|
5.3%
14/266 • 72 weeks
|
7.2%
19/264 • 72 weeks
|
3.8%
5/132 • 72 weeks
|
5.6%
15/266 • 72 weeks
|
7.6%
20/264 • 72 weeks
|
4.5%
6/132 • 72 weeks
|
|
General disorders
Irritability
|
11.7%
31/266 • 72 weeks
|
13.6%
36/264 • 72 weeks
|
14.4%
19/132 • 72 weeks
|
13.5%
36/266 • 72 weeks
|
14.4%
38/264 • 72 weeks
|
15.9%
21/132 • 72 weeks
|
|
General disorders
Pain
|
5.3%
14/266 • 72 weeks
|
1.9%
5/264 • 72 weeks
|
2.3%
3/132 • 72 weeks
|
6.0%
16/266 • 72 weeks
|
1.9%
5/264 • 72 weeks
|
3.0%
4/132 • 72 weeks
|
|
General disorders
Pyrexia
|
21.4%
57/266 • 72 weeks
|
23.9%
63/264 • 72 weeks
|
24.2%
32/132 • 72 weeks
|
22.2%
59/266 • 72 weeks
|
26.9%
71/264 • 72 weeks
|
27.3%
36/132 • 72 weeks
|
|
Infections and infestations
Nasopharyngitis
|
2.3%
6/266 • 72 weeks
|
3.8%
10/264 • 72 weeks
|
5.3%
7/132 • 72 weeks
|
3.0%
8/266 • 72 weeks
|
4.2%
11/264 • 72 weeks
|
6.1%
8/132 • 72 weeks
|
|
Investigations
Weight decreased
|
2.6%
7/266 • 72 weeks
|
1.9%
5/264 • 72 weeks
|
4.5%
6/132 • 72 weeks
|
4.5%
12/266 • 72 weeks
|
6.8%
18/264 • 72 weeks
|
5.3%
7/132 • 72 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
12.0%
32/266 • 72 weeks
|
12.5%
33/264 • 72 weeks
|
14.4%
19/132 • 72 weeks
|
12.4%
33/266 • 72 weeks
|
13.6%
36/264 • 72 weeks
|
14.4%
19/132 • 72 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.0%
16/266 • 72 weeks
|
7.2%
19/264 • 72 weeks
|
5.3%
7/132 • 72 weeks
|
6.4%
17/266 • 72 weeks
|
8.7%
23/264 • 72 weeks
|
6.8%
9/132 • 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.5%
28/266 • 72 weeks
|
10.2%
27/264 • 72 weeks
|
14.4%
19/132 • 72 weeks
|
13.5%
36/266 • 72 weeks
|
11.7%
31/264 • 72 weeks
|
15.2%
20/132 • 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
14/266 • 72 weeks
|
5.3%
14/264 • 72 weeks
|
6.1%
8/132 • 72 weeks
|
9.4%
25/266 • 72 weeks
|
8.0%
21/264 • 72 weeks
|
6.8%
9/132 • 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.8%
10/266 • 72 weeks
|
2.3%
6/264 • 72 weeks
|
3.0%
4/132 • 72 weeks
|
5.3%
14/266 • 72 weeks
|
3.8%
10/264 • 72 weeks
|
3.0%
4/132 • 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.2%
35/266 • 72 weeks
|
15.2%
40/264 • 72 weeks
|
18.2%
24/132 • 72 weeks
|
16.9%
45/266 • 72 weeks
|
15.9%
42/264 • 72 weeks
|
18.2%
24/132 • 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
9/266 • 72 weeks
|
2.7%
7/264 • 72 weeks
|
1.5%
2/132 • 72 weeks
|
5.6%
15/266 • 72 weeks
|
4.5%
12/264 • 72 weeks
|
1.5%
2/132 • 72 weeks
|
|
Nervous system disorders
Disturbance in attention
|
1.9%
5/266 • 72 weeks
|
4.9%
13/264 • 72 weeks
|
6.1%
8/132 • 72 weeks
|
2.6%
7/266 • 72 weeks
|
6.4%
17/264 • 72 weeks
|
6.8%
9/132 • 72 weeks
|
|
Nervous system disorders
Dizziness
|
6.8%
18/266 • 72 weeks
|
8.7%
23/264 • 72 weeks
|
3.8%
5/132 • 72 weeks
|
7.1%
19/266 • 72 weeks
|
10.2%
27/264 • 72 weeks
|
5.3%
7/132 • 72 weeks
|
|
Nervous system disorders
Dysgeusia
|
12.0%
32/266 • 72 weeks
|
10.2%
27/264 • 72 weeks
|
6.1%
8/132 • 72 weeks
|
12.4%
33/266 • 72 weeks
|
12.1%
32/264 • 72 weeks
|
6.1%
8/132 • 72 weeks
|
|
Nervous system disorders
Headache
|
39.8%
106/266 • 72 weeks
|
38.3%
101/264 • 72 weeks
|
34.8%
46/132 • 72 weeks
|
42.1%
112/266 • 72 weeks
|
41.3%
109/264 • 72 weeks
|
37.1%
49/132 • 72 weeks
|
|
Psychiatric disorders
Anxiety
|
2.3%
6/266 • 72 weeks
|
8.0%
21/264 • 72 weeks
|
8.3%
11/132 • 72 weeks
|
3.4%
9/266 • 72 weeks
|
9.8%
26/264 • 72 weeks
|
9.8%
13/132 • 72 weeks
|
|
Psychiatric disorders
Depression
|
7.5%
20/266 • 72 weeks
|
12.5%
33/264 • 72 weeks
|
10.6%
14/132 • 72 weeks
|
9.0%
24/266 • 72 weeks
|
13.3%
35/264 • 72 weeks
|
14.4%
19/132 • 72 weeks
|
|
Psychiatric disorders
Insomnia
|
20.7%
55/266 • 72 weeks
|
26.5%
70/264 • 72 weeks
|
22.0%
29/132 • 72 weeks
|
25.6%
68/266 • 72 weeks
|
31.8%
84/264 • 72 weeks
|
25.8%
34/132 • 72 weeks
|
|
Psychiatric disorders
Sleep disorder
|
3.8%
10/266 • 72 weeks
|
3.0%
8/264 • 72 weeks
|
5.3%
7/132 • 72 weeks
|
4.1%
11/266 • 72 weeks
|
4.2%
11/264 • 72 weeks
|
7.6%
10/132 • 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.5%
44/266 • 72 weeks
|
18.6%
49/264 • 72 weeks
|
17.4%
23/132 • 72 weeks
|
23.3%
62/266 • 72 weeks
|
25.0%
66/264 • 72 weeks
|
19.7%
26/132 • 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.2%
27/266 • 72 weeks
|
15.5%
41/264 • 72 weeks
|
12.1%
16/132 • 72 weeks
|
12.0%
32/266 • 72 weeks
|
18.9%
50/264 • 72 weeks
|
12.9%
17/132 • 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
4.1%
11/266 • 72 weeks
|
6.4%
17/264 • 72 weeks
|
3.8%
5/132 • 72 weeks
|
5.6%
15/266 • 72 weeks
|
7.6%
20/264 • 72 weeks
|
4.5%
6/132 • 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.5%
12/266 • 72 weeks
|
4.5%
12/264 • 72 weeks
|
3.8%
5/132 • 72 weeks
|
4.9%
13/266 • 72 weeks
|
6.8%
18/264 • 72 weeks
|
6.1%
8/132 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.3%
22/266 • 72 weeks
|
7.2%
19/264 • 72 weeks
|
9.1%
12/132 • 72 weeks
|
14.3%
38/266 • 72 weeks
|
15.2%
40/264 • 72 weeks
|
12.9%
17/132 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.5%
36/266 • 72 weeks
|
17.0%
45/264 • 72 weeks
|
15.9%
21/132 • 72 weeks
|
16.5%
44/266 • 72 weeks
|
20.1%
53/264 • 72 weeks
|
15.9%
21/132 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.1%
19/266 • 72 weeks
|
5.7%
15/264 • 72 weeks
|
3.8%
5/132 • 72 weeks
|
10.2%
27/266 • 72 weeks
|
6.1%
16/264 • 72 weeks
|
5.3%
7/132 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.1%
3/266 • 72 weeks
|
3.4%
9/264 • 72 weeks
|
4.5%
6/132 • 72 weeks
|
2.3%
6/266 • 72 weeks
|
3.4%
9/264 • 72 weeks
|
5.3%
7/132 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
49.6%
132/266 • 72 weeks
|
49.2%
130/264 • 72 weeks
|
26.5%
35/132 • 72 weeks
|
51.9%
138/266 • 72 weeks
|
50.0%
132/264 • 72 weeks
|
27.3%
36/132 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
34.2%
91/266 • 72 weeks
|
33.3%
88/264 • 72 weeks
|
18.2%
24/132 • 72 weeks
|
37.2%
99/266 • 72 weeks
|
36.0%
95/264 • 72 weeks
|
18.9%
25/132 • 72 weeks
|
Additional Information
Medical Leader
Tibotec
Phone: 1 609 730-3174
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60