Trial Outcomes & Findings for A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3) (NCT NCT00420784)
NCT ID: NCT00420784
Last Updated: 2014-08-05
Results Overview
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
465 participants
Primary outcome timeframe
24 weeks after the completion of study drug dosing (up to Week 72)
Results posted on
2014-08-05
Participant Flow
A total of 465 subjects were enrolled, of which 12 subjects discontinued the study prior to study drug administration. A total of 453 subjects started treatment.
Participant milestones
| Measure |
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week
Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks.
|
Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
|
PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
115
|
113
|
111
|
114
|
|
Overall Study
COMPLETED
|
86
|
55
|
58
|
36
|
|
Overall Study
NOT COMPLETED
|
29
|
58
|
53
|
78
|
Reasons for withdrawal
| Measure |
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week
Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks.
|
Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
|
PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
11
|
29
|
10
|
5
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
1
|
|
Overall Study
Virologic Stopping Rule
|
17
|
26
|
41
|
67
|
|
Overall Study
Other
|
1
|
2
|
0
|
5
|
Baseline Characteristics
A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3)
Baseline characteristics by cohort
| Measure |
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week
n=115 Participants
Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks.
|
Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week
n=113 Participants
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week
n=111 Participants
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
|
PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=114 Participants
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
Total
n=453 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
114 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
446 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Age, Continuous
|
49.7 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
52.0 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
51.9 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
49.8 years
STANDARD_DEVIATION 7.2 • n=4 Participants
|
50.8 years
STANDARD_DEVIATION 7.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
147 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
306 Participants
n=21 Participants
|
|
Region of Enrollment
North America
|
101 participants
n=5 Participants
|
103 participants
n=7 Participants
|
101 participants
n=5 Participants
|
101 participants
n=4 Participants
|
406 participants
n=21 Participants
|
|
Region of Enrollment
Europe
|
14 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
13 participants
n=4 Participants
|
47 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 24 weeks after the completion of study drug dosing (up to Week 72)Population: Full Analysis Set = subjects who received at least 1 dose of study drug
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Outcome measures
| Measure |
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week
n=115 Participants
Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks.
|
Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week
n=113 Participants
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week
n=111 Participants
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
|
PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=114 Participants
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
|---|---|---|---|---|
|
Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing
|
51.3 percentage of participants
|
53.1 percentage of participants
|
24.3 percentage of participants
|
14.0 percentage of participants
|
SECONDARY outcome
Timeframe: Completion of study drug dosing (up to Week 48)Population: Full Analysis Set = subjects who received at least 1 dose of study drug.
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Outcome measures
| Measure |
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week
n=115 Participants
Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks.
|
Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week
n=113 Participants
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week
n=111 Participants
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
|
PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=114 Participants
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
|---|---|---|---|---|
|
Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing
|
75.7 percentage of participants
|
67.3 percentage of participants
|
54.1 percentage of participants
|
29.8 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 96 (24 weeks after last dose of study drug for PBO group; 48 weeks after last dose of study drug for telaprevir groups)Population: Full Analysis Set = subjects who received at least 1 dose of study drug.
Percentage of subjects with undetectable HCV RNA at 24 weeks after last dose of study drug for treatment group "PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week" and at 48 weeks after last dose of study drug for treatment groups "Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week", "Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week" and "Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week" were presented. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Outcome measures
| Measure |
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week
n=115 Participants
Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks.
|
Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week
n=113 Participants
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week
n=111 Participants
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
|
PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=114 Participants
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
|---|---|---|---|---|
|
Percentage of Subjects With Undetectable Plasma HCV RNA
|
48.7 percentage of participants
|
44.2 percentage of participants
|
22.5 percentage of participants
|
14.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to 2 weeks after last dose of study drug (up to Week 50)Population: Full Analysis Set = subjects who received at least 1 dose of study drug.
AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study.
Outcome measures
| Measure |
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week
n=115 Participants
Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks.
|
Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week
n=113 Participants
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week
n=111 Participants
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
|
PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=114 Participants
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
|---|---|---|---|---|
|
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
112 participants
|
113 participants
|
105 participants
|
111 participants
|
|
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
6 participants
|
16 participants
|
6 participants
|
9 participants
|
SECONDARY outcome
Timeframe: After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)Population: Analysis population included subjects who completed their assigned study drug treatment and had undetectable HCV RNA at the completion of treatment (up to Week 48).
Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Outcome measures
| Measure |
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week
n=87 Participants
Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks.
|
Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week
n=76 Participants
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week
n=60 Participants
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
|
PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=34 Participants
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
|---|---|---|---|---|
|
Number of Subjects With Viral Relapse
|
26 participants
|
10 participants
|
32 participants
|
18 participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16, 24Population: Pharmacokinetic population included all subjects who provided pharmacokinetic assessments and had evaluable and interpretable data.
Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.
Outcome measures
| Measure |
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week
n=339 Participants
Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks.
|
Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
|
PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
|---|---|---|---|---|
|
Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir
Cmax
|
2755 nanogram per milliliter (ng/mL)
Standard Deviation 811
|
—
|
—
|
—
|
|
Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir
Cmin
|
2335 nanogram per milliliter (ng/mL)
Standard Deviation 733
|
—
|
—
|
—
|
|
Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir
Cavg
|
2610 nanogram per milliliter (ng/mL)
Standard Deviation 780
|
—
|
—
|
—
|
Adverse Events
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week
Serious events: 6 serious events
Other events: 112 other events
Deaths: 0 deaths
Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week
Serious events: 16 serious events
Other events: 112 other events
Deaths: 0 deaths
Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week
Serious events: 6 serious events
Other events: 105 other events
Deaths: 0 deaths
PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
Serious events: 9 serious events
Other events: 111 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week
n=115 participants at risk
Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks.
|
Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week
n=113 participants at risk
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week
n=111 participants at risk
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
|
PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=114 participants at risk
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
6/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.7%
3/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.8%
2/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Infected insect bite
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.90%
1/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.90%
1/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.90%
1/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.90%
1/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
6/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.90%
1/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.87%
1/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.90%
1/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.90%
1/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.87%
1/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.90%
1/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.7%
2/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.90%
1/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.87%
1/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.90%
1/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.90%
1/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.90%
1/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.8%
2/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Psychiatric disorders
Depression
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
Headache
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.90%
1/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.87%
1/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
Syncope
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Renal and urinary disorders
Renal tubular acidosis
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.8%
2/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell unclassifiable lymphoma low grade
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Vascular disorders
Haematoma
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Vascular disorders
Hypotension
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.90%
1/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
Other adverse events
| Measure |
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week
n=115 participants at risk
Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks.
|
Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week
n=113 participants at risk
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week
n=111 participants at risk
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
|
PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=114 participants at risk
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
67.0%
77/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
61.1%
69/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
45.9%
51/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
56.1%
64/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Influenza like illness
|
25.2%
29/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
31.9%
36/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
25.2%
28/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
31.6%
36/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Irritability
|
17.4%
20/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
23.9%
27/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
14.4%
16/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
21.9%
25/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Pyrexia
|
13.9%
16/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
23.9%
27/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
14.4%
16/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
12.3%
14/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Chills
|
14.8%
17/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
20.4%
23/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
15.3%
17/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
13.2%
15/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Injection site erythema
|
12.2%
14/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
8.8%
10/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
8.1%
9/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
4.4%
5/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Pain
|
7.0%
8/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
3.5%
4/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.4%
6/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
3.5%
4/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Oedema peripheral
|
2.6%
3/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
6/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
4.5%
5/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Nausea
|
35.7%
41/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
47.8%
54/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
24.3%
27/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
34.2%
39/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Diarrhoea
|
32.2%
37/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
43.4%
49/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
26.1%
29/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
19.3%
22/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Haemorrhoids
|
13.0%
15/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
16.8%
19/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
12.6%
14/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.6%
3/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Vomiting
|
13.0%
15/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
11.5%
13/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
8.1%
9/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
11.4%
13/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Dry mouth
|
7.0%
8/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
11.5%
13/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
8.1%
9/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
6/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.2%
6/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
6/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.3%
7/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.0%
8/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Constipation
|
3.5%
4/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
6/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.8%
2/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.9%
9/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
7.0%
8/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.2%
7/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
3.6%
4/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.5%
4/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.2%
7/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.8%
2/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
6/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Flatulence
|
5.2%
6/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.2%
7/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.8%
2/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.6%
3/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Proctalgia
|
5.2%
6/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
3.6%
4/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Stomach discomfort
|
6.1%
7/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.8%
2/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.8%
2/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.9%
39/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
44.2%
50/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
36.0%
40/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
14.9%
17/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Rash
|
37.4%
43/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
45.1%
51/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
28.8%
32/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
17.5%
20/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.9%
24/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
14.2%
16/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
12.6%
14/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
11.4%
13/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.4%
12/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.1%
8/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.8%
12/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.1%
7/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
4.3%
5/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
8.8%
10/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.4%
6/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
3.5%
4/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
5.2%
6/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
3.5%
4/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.3%
7/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.8%
2/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
1.7%
2/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.2%
7/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
3.6%
4/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
3.5%
4/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
6/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.8%
2/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
5.2%
6/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.8%
2/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.7%
3/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
Headache
|
44.3%
51/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
34.5%
39/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
36.0%
40/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
36.0%
41/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
Dizziness
|
8.7%
10/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
17.7%
20/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
15.3%
17/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
15.8%
18/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
Dysgeusia
|
4.3%
5/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
8.8%
10/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.2%
8/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.0%
8/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
Disturbance in attention
|
6.1%
7/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.2%
7/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.2%
8/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.1%
7/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
Memory impairment
|
1.7%
2/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.1%
8/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.90%
1/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.8%
2/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Psychiatric disorders
Insomnia
|
28.7%
33/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
26.5%
30/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
18.0%
20/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
16.7%
19/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Psychiatric disorders
Anxiety
|
8.7%
10/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
11.5%
13/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
3.6%
4/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
8.8%
10/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
21.7%
25/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
14.2%
16/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
17.1%
19/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
18.4%
21/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.2%
14/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
19.5%
22/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
13.5%
15/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
18.4%
21/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.0%
8/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
6/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
4.5%
5/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.9%
9/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.2%
6/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.7%
3/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
4.5%
5/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
6/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.6%
11/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
8.8%
10/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.4%
6/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.9%
9/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.3%
5/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
9.7%
11/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.8%
2/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.9%
9/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.1%
7/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
8.0%
9/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.7%
3/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
4.4%
5/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.2%
7/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.90%
1/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.8%
2/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.87%
1/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.1%
8/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
3.6%
4/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.6%
3/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Urinary tract infection
|
4.3%
5/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.2%
7/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
3.6%
4/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Blood and lymphatic system disorders
Anaemia
|
26.1%
30/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
26.5%
30/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
8.1%
9/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.9%
9/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.4%
12/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
9.7%
11/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.2%
8/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.1%
7/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.6%
3/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
4.4%
5/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
9.0%
10/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.1%
7/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.1%
8/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
4.5%
5/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.5%
12/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Eye disorders
Vision blurred
|
5.2%
6/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
8.8%
10/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.3%
7/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
6/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Vascular disorders
Hypertension
|
0.87%
1/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
6/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.88%
1/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.0%
15/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
19.5%
22/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
8.1%
9/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
17.5%
20/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Psychiatric disorders
Depression
|
11.3%
13/115 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
15.0%
17/113 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
11.7%
13/111 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
16.7%
19/114 • Baseline up to 2 weeks after last dose of study drug (up to Week 50)
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
Additional Information
Jeff Chodakewitz, M.D.
Vertex Pharmaceuticals Incorporated
Phone: 617-341-6777
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60