Trial Outcomes & Findings for Safety and Efficacy of Boceprevir in Asia Pacific Participants With Chronic Hepatitis C Genotype 1 (P07063) (NCT NCT01390844)
NCT ID: NCT01390844
Last Updated: 2018-09-11
Results Overview
SVR is defined as undetectable plasma HCV-RNA at Follow-up Week (FW) 24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The last observation carried forward (LOCF) method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
282 participants
Primary outcome timeframe
Follow-up Week 24
Results posted on
2018-09-11
Participant Flow
Adult participants in an Asia Pacific population with chronic Hepatitis C (CHC) genotype 1 who have failed prior treatment with pegylated interferon and ribavirin (PR) were selected to participate in this study.
Of 282 participants randomized and treated, 269 participants followed Good Clinical Practice (GCP); 13 participants did not follow GCP.
Participant milestones
| Measure |
Boceprevir - Korea+Taiwan
PegIntron (pegylated interferon alfa-2b) (PEG) + ribavirin (RBV) for 4 weeks followed by boceprevir (BOC) + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
|
Control - Korea+Taiwan
PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
|
Boceprevir - India
PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
|
Control - India
PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
|
|---|---|---|---|---|
|
Treatment Phase
STARTED
|
133
|
65
|
57
|
27
|
|
Treatment Phase
Followed Good Clinical Practice (GCP)
|
133
|
65
|
47
|
24
|
|
Treatment Phase
COMPLETED
|
93
|
37
|
26
|
8
|
|
Treatment Phase
NOT COMPLETED
|
40
|
28
|
31
|
19
|
|
Follow-Up Phase
STARTED
|
93
|
37
|
26
|
8
|
|
Follow-Up Phase
COMPLETED
|
92
|
36
|
25
|
8
|
|
Follow-Up Phase
NOT COMPLETED
|
1
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Boceprevir - Korea+Taiwan
PegIntron (pegylated interferon alfa-2b) (PEG) + ribavirin (RBV) for 4 weeks followed by boceprevir (BOC) + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
|
Control - Korea+Taiwan
PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
|
Boceprevir - India
PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
|
Control - India
PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
|
|---|---|---|---|---|
|
Treatment Phase
Adverse Event
|
12
|
2
|
3
|
2
|
|
Treatment Phase
Treatment Failure
|
23
|
25
|
10
|
13
|
|
Treatment Phase
Non-Medical Reasons
|
5
|
1
|
8
|
1
|
|
Treatment Phase
Non-GCP Compliant
|
0
|
0
|
10
|
3
|
|
Follow-Up Phase
Non-Medical Reasons
|
1
|
1
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of Boceprevir in Asia Pacific Participants With Chronic Hepatitis C Genotype 1 (P07063)
Baseline characteristics by cohort
| Measure |
Boceprevir - Korea+Taiwan
n=133 Participants
PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
|
Control - Korea+Taiwan
n=65 Participants
PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
|
Boceprevir - India
n=57 Participants
PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
|
Control - India
n=27 Participants
PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
|
Total
n=282 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.0 Years
STANDARD_DEVIATION 10.15 • n=5 Participants
|
52.4 Years
STANDARD_DEVIATION 9.80 • n=7 Participants
|
47.9 Years
STANDARD_DEVIATION 9.83 • n=5 Participants
|
45.2 Years
STANDARD_DEVIATION 12.27 • n=4 Participants
|
51.6 Years
STANDARD_DEVIATION 10.63 • n=21 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
99 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
183 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Follow-up Week 24Population: FAS - population includes all randomized participants who received at least one (1) dose of any study medication (i.e., PEG, RBV, or BOC).
SVR is defined as undetectable plasma HCV-RNA at Follow-up Week (FW) 24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The last observation carried forward (LOCF) method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.
Outcome measures
| Measure |
Boceprevir - Korea+Taiwan
n=133 Participants
PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
|
Control - Korea+Taiwan
n=65 Participants
PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
|
|---|---|---|
|
Percentage of Participants in Korea and Taiwan With Sustained Virologic Response (SVR) at Follow-Up Week 24 - Full Analysis Set (FAS) Population
|
60.90 Percentage of Participants
|
26.15 Percentage of Participants
|
PRIMARY outcome
Timeframe: Follow-up Week 24Population: FAS - population includes all randomized participants who received at least one (1) dose of any study medication (i.e., PEG, RBV, or BOC); participants who did not demonstrate GCP compliance were excluded from analysis.
SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.
Outcome measures
| Measure |
Boceprevir - Korea+Taiwan
n=47 Participants
PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
|
Control - Korea+Taiwan
n=24 Participants
PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
|
|---|---|---|
|
Percentage of Participants in India With SVR at Follow-Up Week 24 - FAS Population
|
53.19 Percentage of Participants
|
20.83 Percentage of Participants
|
SECONDARY outcome
Timeframe: Follow-up Week 24Population: mITT - population includes all randomized participants who received at least one (1) dose of experimental study drug (i.e., BOC for the Experimental Arm or placebo for the Control Arm).
SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.
Outcome measures
| Measure |
Boceprevir - Korea+Taiwan
n=131 Participants
PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
|
Control - Korea+Taiwan
n=64 Participants
PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
|
|---|---|---|
|
Percentage of Participants in Korea and Taiwan With SVR at Follow-Up Week 24 - Modified Intent-to-Treat (mITT) Population
|
61.83 Percentage of Participants
|
26.56 Percentage of Participants
|
SECONDARY outcome
Timeframe: Follow-up Week 24Population: mITT - population includes all randomized participants who received at least one (1) dose of experimental study drug (i.e., BOC for the Experimental Arm or placebo for the Control Arm); participants who did not demonstrate GCP compliance were excluded from analysis.
SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.
Outcome measures
| Measure |
Boceprevir - Korea+Taiwan
n=47 Participants
PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
|
Control - Korea+Taiwan
n=23 Participants
PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
|
|---|---|---|
|
Percentage of Participants in India With SVR at Follow-Up Week 24 - mITT Population
|
53.19 Percentage of Participants
|
21.74 Percentage of Participants
|
SECONDARY outcome
Timeframe: Treatment Week 8Population: FAS - population includes all randomized participants who received at least one (1) dose of any study medication (i.e., PEG, RBV, or BOC).
Percentage of participants achieving early virologic response (undetectable HCV-RNA at Treatment Week 8)
Outcome measures
| Measure |
Boceprevir - Korea+Taiwan
n=133 Participants
PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
|
Control - Korea+Taiwan
n=65 Participants
PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
|
|---|---|---|
|
Percentage of Participants in Korea and Taiwan Achieving Early Virologic Response (EVR) at Treatment Week 8
|
73.68 Percentage of Participants
|
44.62 Percentage of Participants
|
SECONDARY outcome
Timeframe: Treatment Week 8Population: FAS - population includes all randomized participants who received at least one (1) dose of any study medication (i.e., PEG, RBV, or BOC); participants who did not demonstrate GCP compliance were excluded from analysis.
Percentage of participants achieving early virologic response (undetectable HCV-RNA at Treatment Week 8)
Outcome measures
| Measure |
Boceprevir - Korea+Taiwan
n=47 Participants
PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
|
Control - Korea+Taiwan
n=24 Participants
PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
|
|---|---|---|
|
Percentage of Participants in India Achieving EVR at Treatment Week 8
|
59.57 Percentage of Participants
|
25.00 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 96 weeksPopulation: All Participants as Treated (APaT) - population consists of all randomized participants in Korea and Taiwan who received at least one dose of study treatment, corresponding to the study treatment they actually received. Only participants with at least one treatment value for a given laboratory test are included.
Anemia is a condition in which the number of red blood cells or hemoglobin concentration is insufficient to meet the body's physiologic needs. This measure gives the percentage of participants who experienced an occurrence of modified World Health Organization (WHO) grade 1-4 anemia during the treatment period. A higher grade indicates a higher degree of anemia. This table summarizes the worst category observed within the period per participant per laboratory test (i.e., the lowest value for the hemotologic parameters).
Outcome measures
| Measure |
Boceprevir - Korea+Taiwan
n=133 Participants
PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
|
Control - Korea+Taiwan
n=65 Participants
PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
|
|---|---|---|
|
Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan
Grade 1 (9.5 to <11 g/dL of hemoglobin)
|
34.6 Percentage of Participants
|
43.1 Percentage of Participants
|
|
Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan
Grade 2 (8.0 to <9.5 g/dL of hemoglobin)
|
29.3 Percentage of Participants
|
7.7 Percentage of Participants
|
|
Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan
Grade 3 (6.5 to <8.0 g/dL of hemoglobin)
|
4.5 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan
Grade 4 (<6.5 g/dL of hemoglobin)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 96 weeksPopulation: APaT - population consists of all randomized participants in India who received ≥ 1 dose of study treatment, corresponding to the study treatment they actually received. Only participants with at least one treatment value for a given laboratory test are included; participants who did not demonstrate GCP compliance were excluded from analysis.
Anemia is a condition in which the number of red blood cells (hemoglobin) is insufficient to meet the body's physiologic needs. This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 anemia during the treatment period. A higher grade indicates a higher degree of anemia. This table summarizes the worst category observed within the period per participant per laboratory test (i.e., the lowest value for the hemotologic parameters).
Outcome measures
| Measure |
Boceprevir - Korea+Taiwan
n=47 Participants
PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
|
Control - Korea+Taiwan
n=24 Participants
PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
|
|---|---|---|
|
Percentage of Participants With an AE of Anemia in India
Grade 1 (9.5 to <11 g/dL of hemoglobin)
|
25.5 Percentage of Participants
|
33.3 Percentage of Participants
|
|
Percentage of Participants With an AE of Anemia in India
Grade 2 (8.0 to <9.5 g/dL of hemoglobin)
|
46.8 Percentage of Participants
|
8.3 Percentage of Participants
|
|
Percentage of Participants With an AE of Anemia in India
Grade 3 (6.5 to <8.0 g/dL of hemoglobin)
|
10.6 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With an AE of Anemia in India
Grade 4 (<6.5 g/dL of hemoglobin)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 96 weeksPopulation: APaT - population consists of all randomized participants in Korea and Taiwan who received at least one dose of study treatment, corresponding to the study treatment they actually received. Only participants with at least one treatment value for a given laboratory test are included.
Neutropenia is an abnormally low level of white blood cells (neutrophils). This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 neutropenia during the treatment phase. A higher grade indicates a higher degree of neutropenia. This table summarizes the worst category observed within the period for each participant.
Outcome measures
| Measure |
Boceprevir - Korea+Taiwan
n=133 Participants
PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
|
Control - Korea+Taiwan
n=65 Participants
PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
|
|---|---|---|
|
Percentage of Participants With an AE of Neutropenia in Korea and Taiwan
Grade 1 (1.0 to 1.5x10^9/L of neutrophils)
|
30.1 Percentage of Participants
|
41.5 Percentage of Participants
|
|
Percentage of Participants With an AE of Neutropenia in Korea and Taiwan
Grade 2 (0.75 to <1.0x10^9/L of neutrophils)
|
24.8 Percentage of Participants
|
20.0 Percentage of Participants
|
|
Percentage of Participants With an AE of Neutropenia in Korea and Taiwan
Grade 3 (0.5 to <0.75x10^9/L of neutrophils)
|
22.6 Percentage of Participants
|
12.3 Percentage of Participants
|
|
Percentage of Participants With an AE of Neutropenia in Korea and Taiwan
Grade 4 (<0.5x10^9/L of neutrophils)
|
3.8 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 96 weeksPopulation: APaT - population consists of all randomized participants in India who received ≥ 1 dose of study treatment, corresponding to the study treatment they actually received. Only participants with at least one treatment value for a given laboratory test are included; participants who did not demonstrate GCP compliance were excluded from analysis.
Neutropenia is an abnormally low level of white blood cells (neutrophils). This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 neutropenia during the treatment phase. A higher grade indicates a higher degree of neutropenia. This table summarizes the worst category observed within the period for each participant.
Outcome measures
| Measure |
Boceprevir - Korea+Taiwan
n=47 Participants
PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
|
Control - Korea+Taiwan
n=24 Participants
PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
|
|---|---|---|
|
Percentage of Participants With an AE of Neutropenia in India
Grade 2 (0.75 to <1.0x10^9/L of neutrophils)
|
12.8 Percentage of Participants
|
4.2 Percentage of Participants
|
|
Percentage of Participants With an AE of Neutropenia in India
Grade 1 (1.0 to 1.5x10^9/L of neutrophils)
|
51.1 Percentage of Participants
|
29.2 Percentage of Participants
|
|
Percentage of Participants With an AE of Neutropenia in India
Grade 3 (0.5 to <0.75x10^9/L of neutrophils)
|
6.4 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With an AE of Neutropenia in India
Grade 4 (<0.5x10^9/L of neutrophils)
|
2.1 Percentage of Participants
|
0 Percentage of Participants
|
Adverse Events
Boceprevir - Korea + Taiwan
Serious events: 16 serious events
Other events: 131 other events
Deaths: 0 deaths
Control - Korea + Taiwan
Serious events: 3 serious events
Other events: 62 other events
Deaths: 0 deaths
Boceprevir - India
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
Control - India
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Boceprevir - Korea + Taiwan
n=133 participants at risk
PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
|
Control - Korea + Taiwan
n=65 participants at risk
PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
|
Boceprevir - India
n=47 participants at risk
PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
|
Control - India
n=24 participants at risk
PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
2/133 • Number of events 2 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/65 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
4.2%
1/24 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/133 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/65 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
4.2%
1/24 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/133 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
1.5%
1/65 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.75%
1/133 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/65 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/133 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
1.5%
1/65 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
General disorders
Asthenia
|
0.75%
1/133 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
1.5%
1/65 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/133 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
1.5%
1/65 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Infections and infestations
Infectious colitis
|
0.75%
1/133 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/65 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Infections and infestations
Pneumonia
|
0.75%
1/133 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/65 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Infections and infestations
Pyelonephritis acute
|
0.75%
1/133 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/65 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Infections and infestations
Sepsis
|
0.75%
1/133 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/65 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.75%
1/133 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/65 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.75%
1/133 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/65 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.75%
1/133 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/65 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.75%
1/133 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/65 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Nervous system disorders
Cerebral infarction
|
0.75%
1/133 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/65 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Nervous system disorders
Headache
|
0.75%
1/133 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
1.5%
1/65 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Psychiatric disorders
Major depression
|
0.75%
1/133 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/65 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Renal and urinary disorders
Calculus bladder
|
0.75%
1/133 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/65 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.75%
1/133 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/65 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.75%
1/133 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/65 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
Other adverse events
| Measure |
Boceprevir - Korea + Taiwan
n=133 participants at risk
PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
|
Control - Korea + Taiwan
n=65 participants at risk
PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
|
Boceprevir - India
n=47 participants at risk
PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
|
Control - India
n=24 participants at risk
PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
|
|---|---|---|---|---|
|
Investigations
Blood uric acid increased
|
0.00%
0/133 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/65 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
6.4%
3/47 • Number of events 3 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Investigations
Haemoglobin decreased
|
17.3%
23/133 • Number of events 27 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
10.8%
7/65 • Number of events 9 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
44.7%
21/47 • Number of events 24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
16.7%
4/24 • Number of events 6 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Investigations
Neutrophil count decreased
|
11.3%
15/133 • Number of events 25 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
12.3%
8/65 • Number of events 15 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
19.1%
9/47 • Number of events 9 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Investigations
Platelet count decreased
|
12.0%
16/133 • Number of events 21 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
10.8%
7/65 • Number of events 10 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
10.6%
5/47 • Number of events 5 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Blood and lymphatic system disorders
Anaemia
|
39.8%
53/133 • Number of events 78 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
24.6%
16/65 • Number of events 23 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
29.8%
14/47 • Number of events 15 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
8.3%
2/24 • Number of events 2 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.0%
8/133 • Number of events 12 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
12.3%
8/65 • Number of events 15 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
4.3%
2/47 • Number of events 3 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
4.2%
1/24 • Number of events 4 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.6%
34/133 • Number of events 58 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
26.2%
17/65 • Number of events 36 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
6.4%
3/47 • Number of events 3 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
8.3%
2/24 • Number of events 3 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.3%
7/133 • Number of events 7 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
1.5%
1/65 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
2.1%
1/47 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
4.2%
1/24 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Eye disorders
Dry eye
|
2.3%
3/133 • Number of events 3 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
6.2%
4/65 • Number of events 4 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.5%
10/133 • Number of events 24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
6.2%
4/65 • Number of events 4 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.5%
10/133 • Number of events 10 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
1.5%
1/65 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
4.3%
2/47 • Number of events 2 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.3%
19/133 • Number of events 23 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
13.8%
9/65 • Number of events 10 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
2.1%
1/47 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.75%
1/133 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/65 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
2.1%
1/47 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
8.3%
2/24 • Number of events 2 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.3%
23/133 • Number of events 33 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
7.7%
5/65 • Number of events 9 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
12.8%
6/47 • Number of events 6 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Gastrointestinal disorders
Dry mouth
|
6.8%
9/133 • Number of events 9 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
7.7%
5/65 • Number of events 6 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
2.1%
1/47 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.8%
13/133 • Number of events 13 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
3.1%
2/65 • Number of events 2 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
4.3%
2/47 • Number of events 2 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Gastrointestinal disorders
Gastritis
|
0.75%
1/133 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
1.5%
1/65 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
6.4%
3/47 • Number of events 3 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.8%
9/133 • Number of events 12 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
9.2%
6/65 • Number of events 7 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Gastrointestinal disorders
Nausea
|
20.3%
27/133 • Number of events 30 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
18.5%
12/65 • Number of events 13 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
6.4%
3/47 • Number of events 3 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
11/133 • Number of events 11 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
4.6%
3/65 • Number of events 4 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
4.3%
2/47 • Number of events 2 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
4.2%
1/24 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
General disorders
Asthenia
|
10.5%
14/133 • Number of events 27 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
7.7%
5/65 • Number of events 9 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
38.3%
18/47 • Number of events 21 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
25.0%
6/24 • Number of events 6 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
General disorders
Chest discomfort
|
3.8%
5/133 • Number of events 5 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
6.2%
4/65 • Number of events 4 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
4.2%
1/24 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
General disorders
Chills
|
3.0%
4/133 • Number of events 4 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
6.2%
4/65 • Number of events 5 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
General disorders
Fatigue
|
27.1%
36/133 • Number of events 37 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
21.5%
14/65 • Number of events 18 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
2.1%
1/47 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
4.2%
1/24 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
General disorders
Influenza like illness
|
12.0%
16/133 • Number of events 23 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
9.2%
6/65 • Number of events 18 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
4.3%
2/47 • Number of events 2 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
General disorders
Injection site pruritus
|
0.00%
0/133 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
6.2%
4/65 • Number of events 4 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
General disorders
Malaise
|
7.5%
10/133 • Number of events 12 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
9.2%
6/65 • Number of events 10 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
4.3%
2/47 • Number of events 2 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
General disorders
Pain
|
4.5%
6/133 • Number of events 6 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
4.6%
3/65 • Number of events 3 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
14.9%
7/47 • Number of events 39 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
16.7%
4/24 • Number of events 18 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
General disorders
Pyrexia
|
23.3%
31/133 • Number of events 54 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
21.5%
14/65 • Number of events 56 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
46.8%
22/47 • Number of events 372 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
41.7%
10/24 • Number of events 129 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.8%
9/133 • Number of events 10 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
6.2%
4/65 • Number of events 4 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Investigations
Alanine aminotransferase increased
|
0.75%
1/133 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
6.2%
4/65 • Number of events 6 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Investigations
Reticulocyte count increased
|
0.00%
0/133 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/65 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
8.5%
4/47 • Number of events 5 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Investigations
Weight decreased
|
4.5%
6/133 • Number of events 6 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
10.8%
7/65 • Number of events 8 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
12.8%
6/47 • Number of events 6 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
12.5%
3/24 • Number of events 3 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Investigations
White blood cell count decreased
|
12.0%
16/133 • Number of events 24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
7.7%
5/65 • Number of events 6 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
6.4%
3/47 • Number of events 3 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.6%
34/133 • Number of events 36 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
23.1%
15/65 • Number of events 17 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
8.5%
4/47 • Number of events 4 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
5/133 • Number of events 5 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
9.2%
6/65 • Number of events 6 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
24.8%
33/133 • Number of events 40 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
23.1%
15/65 • Number of events 17 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Nervous system disorders
Dizziness
|
32.3%
43/133 • Number of events 46 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
23.1%
15/65 • Number of events 20 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Nervous system disorders
Dysgeusia
|
28.6%
38/133 • Number of events 41 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
6.2%
4/65 • Number of events 4 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
19.1%
9/47 • Number of events 10 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
16.7%
4/24 • Number of events 4 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Nervous system disorders
Headache
|
30.1%
40/133 • Number of events 54 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
23.1%
15/65 • Number of events 23 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
4.2%
1/24 • Number of events 4 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Nervous system disorders
Hypoaesthesia
|
5.3%
7/133 • Number of events 7 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
1.5%
1/65 • Number of events 2 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
4.2%
1/24 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Psychiatric disorders
Depression
|
5.3%
7/133 • Number of events 7 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/65 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
4.3%
2/47 • Number of events 2 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Psychiatric disorders
Insomnia
|
18.8%
25/133 • Number of events 28 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
16.9%
11/65 • Number of events 14 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
2.1%
1/47 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
4.2%
1/24 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
19/133 • Number of events 23 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
21.5%
14/65 • Number of events 15 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
4.3%
2/47 • Number of events 3 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
4.2%
1/24 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.0%
16/133 • Number of events 18 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
13.8%
9/65 • Number of events 10 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.8%
9/133 • Number of events 9 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
13.8%
9/65 • Number of events 9 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.0%
8/133 • Number of events 9 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
1.5%
1/65 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
9.8%
13/133 • Number of events 14 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
13.8%
9/65 • Number of events 12 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
24.8%
33/133 • Number of events 33 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
35.4%
23/65 • Number of events 23 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
2.1%
1/47 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
8.3%
2/24 • Number of events 2 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
32.3%
43/133 • Number of events 49 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
35.4%
23/65 • Number of events 27 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/47 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.5%
22/133 • Number of events 33 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
12.3%
8/65 • Number of events 8 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
2.1%
1/47 • Number of events 1 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
0.00%
0/24 • Up to 96 weeks (including up to 38 weeks of follow-up)
All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment. Due to lack of GCP compliance, 13 Indian participants were not included in this population.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial.
- Publication restrictions are in place
Restriction type: OTHER