Trial Outcomes & Findings for Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) With or Without Ribavirin for Participants With Hepatitis C Genotype 1, 4, or 6 Infections Who Have Failed Prior Treatment With Pegylated Interferon + Ribavirin (MK-5172-068) (NCT NCT02105701)
NCT ID: NCT02105701
Last Updated: 2021-02-05
Results Overview
HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
420 participants
Primary outcome timeframe
12 weeks after the end of all study treatment (up to 28 weeks)
Results posted on
2021-02-05
Participant Flow
Participant milestones
| Measure |
Grazoprevir + Elbasvir 12 Weeks
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
|
Grazoprevir + Elbasvir + RBV 12 Weeks
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
|
Grazoprevir + Elbasvir 16 Weeks
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
|
Grazoprevir + Elbasvir + RBV 16 Weeks
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
105
|
104
|
105
|
106
|
|
Overall Study
COMPLETED
|
101
|
103
|
102
|
104
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
3
|
2
|
Reasons for withdrawal
| Measure |
Grazoprevir + Elbasvir 12 Weeks
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
|
Grazoprevir + Elbasvir + RBV 12 Weeks
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
|
Grazoprevir + Elbasvir 16 Weeks
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
|
Grazoprevir + Elbasvir + RBV 16 Weeks
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
2
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
1
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) With or Without Ribavirin for Participants With Hepatitis C Genotype 1, 4, or 6 Infections Who Have Failed Prior Treatment With Pegylated Interferon + Ribavirin (MK-5172-068)
Baseline characteristics by cohort
| Measure |
Grazoprevir + Elbasvir 12 Weeks
n=105 Participants
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
|
Grazoprevir + Elbasvir + RBV 12 Weeks
n=104 Participants
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
|
Grazoprevir + Elbasvir 16 Weeks
n=105 Participants
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
|
Grazoprevir + Elbasvir + RBV 16 Weeks
n=106 Participants
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
|
Total
n=420 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55.71 Years
STANDARD_DEVIATION 9.81 • n=5 Participants
|
55.46 Years
STANDARD_DEVIATION 8.26 • n=7 Participants
|
54.91 Years
STANDARD_DEVIATION 9.79 • n=5 Participants
|
54.98 Years
STANDARD_DEVIATION 9.61 • n=4 Participants
|
55.27 Years
STANDARD_DEVIATION 9.37 • n=21 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
149 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
271 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after the end of all study treatment (up to 28 weeks)Population: The Full Analysis Set (FAS) population consists of all randomized subjects who receive at least one dose of study treatment.
HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
Outcome measures
| Measure |
Grazoprevir + Elbasvir 12 Weeks
n=105 Participants
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
|
Grazoprevir + Elbasvir + RBV 12 Weeks
n=104 Participants
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
|
Grazoprevir + Elbasvir 16 Weeks
n=105 Participants
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
|
Grazoprevir + Elbasvir + RBV 16 Weeks
n=106 Participants
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Undetectable HCV RNA 12 Weeks After Completing Study Therapy (SVR12)
|
92.4 Percentage of participants
Interval 85.5 to 96.7
|
94.2 Percentage of participants
Interval 87.9 to 97.9
|
92.4 Percentage of participants
Interval 85.5 to 96.7
|
98.1 Percentage of participants
Interval 93.4 to 99.8
|
PRIMARY outcome
Timeframe: Up to 18 weeksPopulation: The All Participants as Treated (APaT) population consists of all participants who received at least one dose of study treatment.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Grazoprevir + Elbasvir 12 Weeks
n=105 Participants
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
|
Grazoprevir + Elbasvir + RBV 12 Weeks
n=104 Participants
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
|
Grazoprevir + Elbasvir 16 Weeks
n=105 Participants
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
|
Grazoprevir + Elbasvir + RBV 16 Weeks
n=106 Participants
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Adverse Events (AE)
|
74 Number of participants
|
85 Number of participants
|
77 Number of participants
|
95 Number of participants
|
PRIMARY outcome
Timeframe: Up to 16 weeksPopulation: The All Participants as Treated (APaT) population consists of all participants who received at least one dose of study treatment.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Grazoprevir + Elbasvir 12 Weeks
n=105 Participants
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
|
Grazoprevir + Elbasvir + RBV 12 Weeks
n=104 Participants
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
|
Grazoprevir + Elbasvir 16 Weeks
n=105 Participants
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
|
Grazoprevir + Elbasvir + RBV 16 Weeks
n=106 Participants
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
|
|---|---|---|---|---|
|
Number of Participants Discontinuing Study Treatment Due to an AE
|
1 Number of participants
|
1 Number of participants
|
0 Number of participants
|
5 Number of participants
|
SECONDARY outcome
Timeframe: 24 weeks after the end of all study treatment (up to 40 weeks)Population: The Full Analysis Set (FAS) population consists of all randomized subjects who receive at least one dose of study treatment.
HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
Outcome measures
| Measure |
Grazoprevir + Elbasvir 12 Weeks
n=105 Participants
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
|
Grazoprevir + Elbasvir + RBV 12 Weeks
n=104 Participants
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
|
Grazoprevir + Elbasvir 16 Weeks
n=105 Participants
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
|
Grazoprevir + Elbasvir + RBV 16 Weeks
n=106 Participants
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Undetectable HCV RNA 24 Weeks After the End of All Treatment (SVR24)
|
91.4 Percentage of participants
Interval 84.4 to 96.0
|
94.2 Percentage of participants
Interval 87.9 to 97.9
|
89.5 Percentage of participants
Interval 82.0 to 94.7
|
95.3 Percentage of participants
Interval 89.3 to 98.5
|
Adverse Events
GZR/EBR 12 Weeks
Serious events: 6 serious events
Other events: 55 other events
Deaths: 0 deaths
GZR/EBR + RBV 12 Weeks
Serious events: 8 serious events
Other events: 72 other events
Deaths: 0 deaths
GZR/EBR 16 Weeks
Serious events: 4 serious events
Other events: 58 other events
Deaths: 0 deaths
GZR/EBR + RBV for 16 Weeks
Serious events: 6 serious events
Other events: 84 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GZR/EBR 12 Weeks
n=105 participants at risk
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
|
GZR/EBR + RBV 12 Weeks
n=104 participants at risk
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
|
GZR/EBR 16 Weeks
n=105 participants at risk
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
|
GZR/EBR + RBV for 16 Weeks
n=106 participants at risk
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/104 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.94%
1/106 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Cardiac disorders
Angina unstable
|
0.95%
1/105 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/104 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/106 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Cardiac disorders
Coronary artery disease
|
0.95%
1/105 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/104 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/106 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.95%
1/105 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/104 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/106 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.96%
1/104 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/106 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.95%
1/105 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/104 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/106 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/104 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.94%
1/106 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.96%
1/104 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/106 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Intestinal angioedema
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/104 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.94%
1/106 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.96%
1/104 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/106 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.96%
1/104 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/106 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Infections and infestations
Herpes simplex oesophagitis
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/104 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.94%
1/106 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.96%
1/104 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/106 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Infections and infestations
Parotitis
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.96%
1/104 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/106 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Infections and infestations
Pneumonia
|
0.95%
1/105 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/104 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/106 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/104 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject 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 Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/106 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.95%
1/105 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/104 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/106 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/104 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject 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 Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/106 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/104 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.94%
1/106 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/104 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.94%
1/106 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject 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)
Hepatocellular carcinoma
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.96%
1/104 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/106 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject 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)
Splenic marginal zone lymphoma
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/104 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject 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 Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/106 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/104 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject 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 Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/106 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.96%
1/104 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/106 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.96%
1/104 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/106 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/104 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.94%
1/106 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.96%
1/104 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/106 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Vascular disorders
Femoral artery occlusion
|
0.95%
1/105 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/104 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/106 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
Other adverse events
| Measure |
GZR/EBR 12 Weeks
n=105 participants at risk
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
|
GZR/EBR + RBV 12 Weeks
n=104 participants at risk
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
|
GZR/EBR 16 Weeks
n=105 participants at risk
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
|
GZR/EBR + RBV for 16 Weeks
n=106 participants at risk
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
11.5%
12/104 • Number of events 13 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
16.0%
17/106 • Number of events 19 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.7%
6/105 • Number of events 6 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
2.9%
3/104 • Number of events 3 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject 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 Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
2.8%
3/106 • Number of events 3 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.95%
1/105 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
2.9%
3/104 • Number of events 3 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject 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 8 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
4.7%
5/106 • Number of events 5 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
5/105 • Number of events 5 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
3.8%
4/104 • Number of events 4 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject 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 9 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
8.5%
9/106 • Number of events 9 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
3/105 • Number of events 3 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
3.8%
4/104 • Number of events 4 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
6.6%
7/106 • Number of events 9 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Nausea
|
8.6%
9/105 • Number of events 10 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
14.4%
15/104 • Number of events 19 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject 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 Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
17.0%
18/106 • Number of events 20 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
2/105 • Number of events 2 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
6.7%
7/104 • Number of events 8 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject 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 Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
8.5%
9/106 • Number of events 10 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
General disorders
Asthenia
|
7.6%
8/105 • Number of events 9 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
10.6%
11/104 • Number of events 13 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
8.6%
9/105 • Number of events 10 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
9.4%
10/106 • Number of events 10 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
General disorders
Fatigue
|
19.0%
20/105 • Number of events 21 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
26.9%
28/104 • Number of events 32 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject 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 18 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
30.2%
32/106 • Number of events 33 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.9%
3/105 • Number of events 3 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
1.9%
2/104 • Number of events 2 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject 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 9 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
4.7%
5/106 • Number of events 6 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
2.9%
3/105 • Number of events 3 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
14.4%
15/104 • Number of events 22 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject 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 Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
13.2%
14/106 • Number of events 23 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.96%
1/104 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
6.6%
7/106 • Number of events 7 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.9%
2/105 • Number of events 2 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
5.8%
6/104 • Number of events 6 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject 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 Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
5.7%
6/106 • Number of events 6 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
4/105 • Number of events 4 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
2.9%
3/104 • Number of events 4 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject 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 8 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
3.8%
4/106 • Number of events 5 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.9%
2/105 • Number of events 2 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
5.8%
6/104 • Number of events 7 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject 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 8 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
6.6%
7/106 • Number of events 7 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Nervous system disorders
Dizziness
|
6.7%
7/105 • Number of events 7 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
7.7%
8/104 • Number of events 8 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject 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 10 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
5.7%
6/106 • Number of events 8 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Nervous system disorders
Headache
|
20.0%
21/105 • Number of events 23 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
20.2%
21/104 • Number of events 23 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
20.0%
21/105 • Number of events 23 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
18.9%
20/106 • Number of events 22 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Psychiatric disorders
Insomnia
|
4.8%
5/105 • Number of events 5 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
10.6%
11/104 • Number of events 12 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject 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 Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
9.4%
10/106 • Number of events 10 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Psychiatric disorders
Irritability
|
3.8%
4/105 • Number of events 6 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
4.8%
5/104 • Number of events 5 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject 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 Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
7.5%
8/106 • Number of events 8 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
6/105 • Number of events 6 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
9.6%
10/104 • Number of events 10 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject 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 Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
9.4%
10/106 • Number of events 10 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.95%
1/105 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
8.7%
9/104 • Number of events 11 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject 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 Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
9.4%
10/106 • Number of events 10 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.95%
1/105 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
2.9%
3/104 • Number of events 4 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/105 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
7.5%
8/106 • Number of events 8 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.95%
1/105 • Number of events 1 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
10.6%
11/104 • Number of events 13 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject 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 Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
10.4%
11/106 • Number of events 11 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.9%
3/105 • Number of events 3 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
3.8%
4/104 • Number of events 4 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject 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 Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
7.5%
8/106 • Number of events 10 • Up to Week 40.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject 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