Trial Outcomes & Findings for Short Duration Versus Standard Response-Guided Therapy With Boceprevir Combined With PegIntron and Ribavirin in Previously Untreated Non-Cirrhotic Asian Participants With Chronic HCV Genotype 1 (MK-3034-107) (NCT NCT01945294)
NCT ID: NCT01945294
Last Updated: 2018-07-12
Results Overview
SVR12 was declared when participants who had undetectable HCV RNA (HCV RNA \< Lower Limit of Quantification \[LLoQ\]) after the 12-week lead-in also had undetectable HCV RNA 12 weeks after completing their assigned BOC treatment regimen. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
257 participants
Primary outcome timeframe
Follow-up Week (FW) 12 (up to 40 weeks)
Results posted on
2018-07-12
Participant Flow
Treatment-naïve adult male and female participants with chronic hepatitis C virus (HCV) genotype 1 (GT1) infection were recruited in the Asia-Pacific region.
Participant milestones
| Measure |
All Treated Participants
All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable hepatitis C virus \[HCV\] ribonucleic acid \[RNA\]) or allocation to Arm 3 (participants with detectable HCV RNA).
|
Arm 1: 16-week Treatment Arm
After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
|
Arm 2: 28-week Treatment Arm
After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
|
Arm 3: 48-week Treatment Arm
After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
|
|---|---|---|---|---|
|
Period 1: 12-Week PR + BOC Lead-In
STARTED
|
257
|
0
|
0
|
0
|
|
Period 1: 12-Week PR + BOC Lead-In
COMPLETED
|
236
|
0
|
0
|
0
|
|
Period 1: 12-Week PR + BOC Lead-In
NOT COMPLETED
|
21
|
0
|
0
|
0
|
|
Period 2: BOC+ PR Treatment & Follow-up
STARTED
|
0
|
102
|
105
|
29
|
|
Period 2: BOC+ PR Treatment & Follow-up
COMPLETED
|
0
|
97
|
97
|
23
|
|
Period 2: BOC+ PR Treatment & Follow-up
NOT COMPLETED
|
0
|
5
|
8
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Short Duration Versus Standard Response-Guided Therapy With Boceprevir Combined With PegIntron and Ribavirin in Previously Untreated Non-Cirrhotic Asian Participants With Chronic HCV Genotype 1 (MK-3034-107)
Baseline characteristics by cohort
| Measure |
Arm 1: 16-week Treatment Arm
n=102 Participants
After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
|
Arm 2: 28-week Treatment Arm
n=105 Participants
After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
|
Arm 3: 48-week Treatment Arm
n=50 Participants
After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
|
Total
n=257 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.1 Years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
44.6 Years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
46.5 Years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
44.8 Years
STANDARD_DEVIATION 11.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
108 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
149 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Follow-up Week (FW) 12 (up to 40 weeks)Population: Participants of the Full Analysis Set (FAS) who were treated with any study medication, had undetectable HCV RNA at TW8, and were randomized to Arm 1 or Arm 2. Participants in Arm 3 were not included in the primary efficacy analysis as pre-specified by the protocol.
SVR12 was declared when participants who had undetectable HCV RNA (HCV RNA \< Lower Limit of Quantification \[LLoQ\]) after the 12-week lead-in also had undetectable HCV RNA 12 weeks after completing their assigned BOC treatment regimen. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.
Outcome measures
| Measure |
Arm 2: 28-week Treatment Arm
n=105 Participants
After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
|
Arm 3: 48-week Treatment Arm
After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
|
Arm 1: 16-week Treatment Arm
n=102 Participants
After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
|
|---|---|---|---|
|
Percentage of Participants With Undetectable HCV RNA Who Achieve Sustained Viral Response at Follow-up Week 12 (SVR12) [16-Week Arm vs. 28-Week Arm]
|
81.9 Percentage of Participants
|
—
|
70.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: TW4, TW8, and TW12Population: Participants in the FAS population (consisting of all participants treated with any study medication who had undetectable HCV RNA at TW8 and were randomized to Arm 1 or Arm 2, and participants with detectable HCV RNA at TW8 in Arm 3) with available data.
The percentage of participants with undetectable HCV RNA (HCV RNA \<LLoQ) at TW4, TW8, and TW12 is summarized for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.
Outcome measures
| Measure |
Arm 2: 28-week Treatment Arm
n=105 Participants
After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
|
Arm 3: 48-week Treatment Arm
n=29 Participants
After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
|
Arm 1: 16-week Treatment Arm
n=101 Participants
After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
|
|---|---|---|---|
|
Percentage of Participants With Undetectable HCV RNA Across Treatment
TW8
|
100.0 Percentage of Participants
|
0.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants With Undetectable HCV RNA Across Treatment
TW12
|
100.0 Percentage of Participants
|
69.0 Percentage of Participants
|
99.0 Percentage of Participants
|
|
Percentage of Participants With Undetectable HCV RNA Across Treatment
TW4
|
17.1 Percentage of Participants
|
0.0 Percentage of Participants
|
24.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: TW4, TW8, and TW12Population: The subset of the FAS population consisting of all participants treated with any study medication in Arms 1, 2, and 3 and who had undetectable HCV RNA at Week 4, Week 8, or Week 12.
The percentage of participants achieving SVR12 who had undetectable HCV RNA (HCV RNA \<LLoQ) at Week 4, Week 8, and Week 12 is summarized for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.
Outcome measures
| Measure |
Arm 2: 28-week Treatment Arm
n=105 Participants
After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
|
Arm 3: 48-week Treatment Arm
n=20 Participants
After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
|
Arm 1: 16-week Treatment Arm
n=102 Participants
After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
|
|---|---|---|---|
|
Percentage of Participants Achieving SVR12 Among Participants With Undetectable HCV RNA Across Treatment
% Undetectable HCV RNA at TW4 (n=25, 18, 0)
|
14.3 Percentage of Participants
|
0.0 Percentage of Participants
|
24.5 Percentage of Participants
|
|
Percentage of Participants Achieving SVR12 Among Participants With Undetectable HCV RNA Across Treatment
% Undetectable HCV RNA at TW8 (n=101, 104, 0)
|
81.0 Percentage of Participants
|
0.0 Percentage of Participants
|
69.6 Percentage of Participants
|
|
Percentage of Participants Achieving SVR12 Among Participants With Undetectable HCV RNA Across Treatment
% Undetectable HCV RNA at TW12 (n=100, 103, 20)
|
80.0 Percentage of Participants
|
41.4 Percentage of Participants
|
68.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: From EOT to FW12 (up to 12 weeks)Population: Participants in the FAS with undetectable HCV RNA at EOT and who have data available at FW12 were included.
The percentage of viral relapse (defined as confirmed HCV RNA \>15 IU/mL after End-of-Treatment \[EOT\]) among participants who had undetectable HCV RNA at EOT was determined for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.
Outcome measures
| Measure |
Arm 2: 28-week Treatment Arm
n=90 Participants
After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
|
Arm 3: 48-week Treatment Arm
n=18 Participants
After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
|
Arm 1: 16-week Treatment Arm
n=93 Participants
After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
|
|---|---|---|---|
|
Percentage of Participants With Relapse
|
1.1 Percentage of Participants
|
0.0 Percentage of Participants
|
20.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 60 weeksPopulation: The All Participants as Treated (APaT) includes all participants who received ≥1 dose of study drug.
The percentage of participants with neutropenia (neutrophil count \<0.75 x10\^9/L) is summarized for each arm.
Outcome measures
| Measure |
Arm 2: 28-week Treatment Arm
n=105 Participants
After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
|
Arm 3: 48-week Treatment Arm
n=50 Participants
After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
|
Arm 1: 16-week Treatment Arm
n=102 Participants
After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
|
|---|---|---|---|
|
Percentage of Participants With Neutropenia
|
12.4 Percentage of Participants
|
4.0 Percentage of Participants
|
10.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 60 weeksPopulation: The All Participants as Treated (APaT) includes all participants who received ≥1 dose of study drug.
The percentage of participants with anemia (hemoglobin \[Hgb\] \<10 g/dL) was determined in each arm.
Outcome measures
| Measure |
Arm 2: 28-week Treatment Arm
n=105 Participants
After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
|
Arm 3: 48-week Treatment Arm
n=50 Participants
After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
|
Arm 1: 16-week Treatment Arm
n=102 Participants
After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
|
|---|---|---|---|
|
Percentage of Participants With Anemia
|
43.8 Percentage of Participants
|
26.0 Percentage of Participants
|
33.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: From TW1 through TW48Population: The APaT includes all participants who received ≥1 dose of study drug.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The percentage of participants who discontinued from BOC, BOC + RBV, or all medications due to an AE are reported.
Outcome measures
| Measure |
Arm 2: 28-week Treatment Arm
n=105 Participants
After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
|
Arm 3: 48-week Treatment Arm
n=50 Participants
After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
|
Arm 1: 16-week Treatment Arm
n=102 Participants
After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
|
|---|---|---|---|
|
Percentage of Participants With Dose Discontinuation Due to Adverse Events (AEs)
Discontinued from BOC
|
7.6 Percentage of Participants
|
16.0 Percentage of Participants
|
2.9 Percentage of Participants
|
|
Percentage of Participants With Dose Discontinuation Due to Adverse Events (AEs)
Discontinued from BOC + R
|
5.7 Percentage of Participants
|
8.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants With Dose Discontinuation Due to Adverse Events (AEs)
Discontinued from all Study Medication
|
5.7 Percentage of Participants
|
8.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 60 weeksPopulation: The APaT includes all participants who received ≥1 dose of study drug.
A SAE is any AE that results in death, is life threatening, results in persistent or significant disability, results in or prolongs an existing inpatient hospitalization, is a congenital birth defect, is a cancer, is associated with an overdose, or is another important medical event.
Outcome measures
| Measure |
Arm 2: 28-week Treatment Arm
n=105 Participants
After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
|
Arm 3: 48-week Treatment Arm
n=50 Participants
After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
|
Arm 1: 16-week Treatment Arm
n=102 Participants
After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
|
|---|---|---|---|
|
Percentage of Participants With Treatment-Related Serious AEs (SAEs)
|
3.8 Percentage of Participants
|
4.0 Percentage of Participants
|
2.9 Percentage of Participants
|
Adverse Events
Arm 1: 16-week Treatment Arm
Serious events: 9 serious events
Other events: 96 other events
Deaths: 0 deaths
Arm 2: 28-week Treatment Arm
Serious events: 6 serious events
Other events: 98 other events
Deaths: 0 deaths
Arm 3: 48-week Treatment Arm
Serious events: 4 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: 16-week Treatment Arm
n=102 participants at risk
After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
|
Arm 2: 28-week Treatment Arm
n=105 participants at risk
After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
|
Arm 3: 48-week Treatment Arm
n=50 participants at risk
After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.98%
1/102 • Number of events 1 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
1.9%
2/105 • Number of events 2 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.98%
1/102 • Number of events 1 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/50 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/102 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.95%
1/105 • Number of events 1 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/50 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.98%
1/102 • Number of events 1 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/50 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.98%
1/102 • Number of events 1 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/50 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
General disorders
Pyrexia
|
0.98%
1/102 • Number of events 1 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/50 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.98%
1/102 • Number of events 1 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/50 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Infections and infestations
Pneumonia
|
0.98%
1/102 • Number of events 1 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/50 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/102 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.95%
1/105 • Number of events 1 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/50 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.98%
1/102 • Number of events 1 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/50 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/102 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.95%
1/105 • Number of events 1 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/50 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/102 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.95%
1/105 • Number of events 1 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/50 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/102 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.98%
1/102 • Number of events 1 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/50 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/102 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/102 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Psychiatric disorders
Hallucinations, mixed
|
0.00%
0/102 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.95%
1/105 • Number of events 1 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/50 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
Other adverse events
| Measure |
Arm 1: 16-week Treatment Arm
n=102 participants at risk
After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
|
Arm 2: 28-week Treatment Arm
n=105 participants at risk
After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
|
Arm 3: 48-week Treatment Arm
n=50 participants at risk
After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
32.4%
33/102 • Number of events 35 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
41.9%
44/105 • Number of events 46 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
24.0%
12/50 • Number of events 13 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.8%
11/102 • Number of events 15 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
12.4%
13/105 • Number of events 15 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
4.0%
2/50 • Number of events 2 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
6/102 • Number of events 8 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
7.6%
8/105 • Number of events 10 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
14.0%
7/50 • Number of events 7 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.8%
8/102 • Number of events 8 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
12.4%
13/105 • Number of events 13 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
12.0%
6/50 • Number of events 6 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
5.9%
6/102 • Number of events 6 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
5.7%
6/105 • Number of events 8 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Nausea
|
15.7%
16/102 • Number of events 16 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
14.3%
15/105 • Number of events 15 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
22.0%
11/50 • Number of events 13 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Vomiting
|
9.8%
10/102 • Number of events 10 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
9.5%
10/105 • Number of events 11 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
12.0%
6/50 • Number of events 10 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
General disorders
Asthenia
|
6.9%
7/102 • Number of events 7 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
6.7%
7/105 • Number of events 7 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
14.0%
7/50 • Number of events 7 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
General disorders
Chills
|
4.9%
5/102 • Number of events 5 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
4.8%
5/105 • Number of events 5 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
16.0%
8/50 • Number of events 9 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
General disorders
Fatigue
|
12.7%
13/102 • Number of events 15 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
15.2%
16/105 • Number of events 34 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
12.0%
6/50 • Number of events 20 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
General disorders
Influenza like illness
|
4.9%
5/102 • Number of events 5 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
9.5%
10/105 • Number of events 26 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
10.0%
5/50 • Number of events 9 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
General disorders
Injection site pruritus
|
3.9%
4/102 • Number of events 4 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
10.5%
11/105 • Number of events 12 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/50 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
General disorders
Injection site rash
|
4.9%
5/102 • Number of events 5 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
5.7%
6/105 • Number of events 6 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
6.0%
3/50 • Number of events 3 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
General disorders
Pain
|
5.9%
6/102 • Number of events 7 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
3.8%
4/105 • Number of events 4 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
10.0%
5/50 • Number of events 5 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
General disorders
Pyrexia
|
22.5%
23/102 • Number of events 48 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
21.9%
23/105 • Number of events 74 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
34.0%
17/50 • Number of events 48 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Investigations
Haemoglobin decreased
|
3.9%
4/102 • Number of events 4 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
6.7%
7/105 • Number of events 7 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
4.0%
2/50 • Number of events 2 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Investigations
Weight decreased
|
0.00%
0/102 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
4.8%
5/105 • Number of events 5 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
10.0%
5/50 • Number of events 5 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.6%
18/102 • Number of events 18 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
22.9%
24/105 • Number of events 25 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
24.0%
12/50 • Number of events 13 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.98%
1/102 • Number of events 1 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
5.7%
6/105 • Number of events 11 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
22.5%
23/102 • Number of events 27 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
21.0%
22/105 • Number of events 31 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
14.0%
7/50 • Number of events 10 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Nervous system disorders
Dizziness
|
16.7%
17/102 • Number of events 18 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
23.8%
25/105 • Number of events 29 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
18.0%
9/50 • Number of events 12 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Nervous system disorders
Dysgeusia
|
14.7%
15/102 • Number of events 15 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
21.9%
23/105 • Number of events 24 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
16.0%
8/50 • Number of events 9 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Nervous system disorders
Headache
|
16.7%
17/102 • Number of events 18 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
17.1%
18/105 • Number of events 22 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
16.0%
8/50 • Number of events 21 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Nervous system disorders
Lethargy
|
0.98%
1/102 • Number of events 1 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
8.0%
4/50 • Number of events 4 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Psychiatric disorders
Anxiety
|
2.9%
3/102 • Number of events 3 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
11.4%
12/105 • Number of events 12 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/50 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Psychiatric disorders
Insomnia
|
15.7%
16/102 • Number of events 16 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
16.2%
17/105 • Number of events 19 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
8.0%
4/50 • Number of events 4 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Psychiatric disorders
Irritability
|
2.9%
3/102 • Number of events 3 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.95%
1/105 • Number of events 1 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
6.0%
3/50 • Number of events 3 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.8%
8/102 • Number of events 8 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
13.3%
14/105 • Number of events 15 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
16.0%
8/50 • Number of events 8 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.9%
6/102 • Number of events 6 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
5.7%
6/105 • Number of events 6 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
6.0%
3/50 • Number of events 3 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.98%
1/102 • Number of events 1 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
2.9%
3/105 • Number of events 3 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
6.0%
3/50 • Number of events 3 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
22.5%
23/102 • Number of events 23 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
32.4%
34/105 • Number of events 35 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
16.0%
8/50 • Number of events 8 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.9%
5/102 • Number of events 5 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
1.9%
2/105 • Number of events 2 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
8.0%
4/50 • Number of events 4 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
6/102 • Number of events 6 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
9.5%
10/105 • Number of events 11 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
12.0%
6/50 • Number of events 7 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
8.8%
9/102 • Number of events 9 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
1.9%
2/105 • Number of events 2 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
6.0%
3/50 • Number of events 3 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.8%
8/102 • Number of events 8 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
17.1%
18/105 • Number of events 19 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
8.0%
4/50 • Number of events 4 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/102 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.95%
1/105 • Number of events 1 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
6.0%
3/50 • Number of events 3 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.9%
6/102 • Number of events 7 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
2.9%
3/105 • Number of events 3 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Up to 60 weeks
A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
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 Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER