Trial Outcomes & Findings for Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Cirrhotic Subjects With Chronic Hepatitis C Virus (HCV) Genotype 3 (GT3) Infection (MK-5172-083) (NCT NCT02601573)
NCT ID: NCT02601573
Last Updated: 2019-08-13
Results Overview
The percentage of participants achieving SVR12 (i.e., HCV ribnonucleic acid \[RNA\] \< Lower Limit of Quantification \[LLOQ\] 12 weeks after completing study treatment) was determined. Plasma HCV RNA levels were determined with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
101 participants
Primary outcome timeframe
Up to Week 28
Results posted on
2019-08-13
Participant Flow
Adult participants infected with HCV GT3 were enrolled at 14 study centers in the United Kingdom.
A total of 101 participants were randomized, including 1 participant who did not meet inclusion criteria and who should have been considered a screen failure; this participant was not treated with study drug. A total of 100 participants were treated.
Participant milestones
| Measure |
Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks
Treatment-naïve (TN) Hepatitis C virus (HCV) genotype 3 (GT3) participants took 1 fixed-dose combination (FDC) tablet containing elbasvir (EBR) 50 mg + grazoprevir (GZR) 100 mg and 1 tablet containing sofosbuvir (SOF) 400 mg once daily (q.d.) with ribavirin (RBV) (200 mg capsules; weight-based dosing) twice daily (b.i.d.) for 8 weeks.
|
Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks
TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
|
Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks
Treatment-experienced (TE) HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
|
Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
|
Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
24
|
17
|
18
|
18
|
|
Overall Study
COMPLETED
|
23
|
20
|
16
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks
Treatment-naïve (TN) Hepatitis C virus (HCV) genotype 3 (GT3) participants took 1 fixed-dose combination (FDC) tablet containing elbasvir (EBR) 50 mg + grazoprevir (GZR) 100 mg and 1 tablet containing sofosbuvir (SOF) 400 mg once daily (q.d.) with ribavirin (RBV) (200 mg capsules; weight-based dosing) twice daily (b.i.d.) for 8 weeks.
|
Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks
TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
|
Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks
Treatment-experienced (TE) HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
|
Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
|
Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
1
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Cirrhotic Subjects With Chronic Hepatitis C Virus (HCV) Genotype 3 (GT3) Infection (MK-5172-083)
Baseline characteristics by cohort
| Measure |
Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks
n=23 Participants
TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 8 weeks.
|
Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks
n=24 Participants
TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
|
Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks
n=17 Participants
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
|
Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks
n=18 Participants
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
|
Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
n=18 Participants
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
52.5 Years
STANDARD_DEVIATION 9.0 • n=93 Participants
|
48.1 Years
STANDARD_DEVIATION 9.3 • n=4 Participants
|
58.6 Years
STANDARD_DEVIATION 6.1 • n=27 Participants
|
56.1 Years
STANDARD_DEVIATION 8.4 • n=483 Participants
|
53.8 Years
STANDARD_DEVIATION 6.4 • n=36 Participants
|
53.4 Years
STANDARD_DEVIATION 8.7 • n=10 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
32 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
15 Participants
n=36 Participants
|
68 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Up to Week 28Population: All randomized participants who received at least 1 dose of study drug, were not lost to follow-up for reasons unrelated to study treatment, and had SVR12 data available are included.
The percentage of participants achieving SVR12 (i.e., HCV ribnonucleic acid \[RNA\] \< Lower Limit of Quantification \[LLOQ\] 12 weeks after completing study treatment) was determined. Plasma HCV RNA levels were determined with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL.
Outcome measures
| Measure |
Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks
n=23 Participants
TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 8 weeks.
|
Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks
n=23 Participants
TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
|
Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks
n=17 Participants
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
|
Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks
n=17 Participants
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
|
Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
n=18 Participants
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving SVR12 (Sustained Virologic Response 12 Weeks After the End of All Study Therapy)
|
91.3 Percentage of Participants
Interval 72.0 to 98.9
|
100.0 Percentage of Participants
Interval 85.2 to 100.0
|
100.0 Percentage of Participants
Interval 80.5 to 100.0
|
100.0 Percentage of Participants
Interval 80.5 to 100.0
|
94.4 Percentage of Participants
Interval 72.7 to 99.9
|
PRIMARY outcome
Timeframe: Up to 18 weeks (up to 2 weeks after completion of study treatment)Population: All participants who received at least 1 dose of study drug are included.
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.
Outcome measures
| Measure |
Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks
n=23 Participants
TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 8 weeks.
|
Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks
n=24 Participants
TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
|
Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks
n=17 Participants
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
|
Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks
n=18 Participants
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
|
Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
n=18 Participants
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Experiencing an Adverse Event (AE)
|
87.0 Percentage of Participants
|
87.5 Percentage of Participants
|
82.4 Percentage of Participants
|
94.4 Percentage of Participants
|
94.4 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 16 weeksPopulation: All participants who received at least 1 dose of study drug are included.
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.
Outcome measures
| Measure |
Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks
n=23 Participants
TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 8 weeks.
|
Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks
n=24 Participants
TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
|
Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks
n=17 Participants
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
|
Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks
n=18 Participants
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
|
Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
n=18 Participants
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Discontinuing From Study Therapy Due to an AE
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
5.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to Week 40Population: All randomized participants who received at least 1 dose of study drug, were not lost to follow-up for reasons unrelated to study treatment, and had SVR24 data available are included.
The percentage of participants achieving SVR24 (i.e., HCV RNA \< LLOQ 24 weeks after completing study treatment) was determined. Plasma HCV RNA levels were determined with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL.
Outcome measures
| Measure |
Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks
n=23 Participants
TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 8 weeks.
|
Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks
n=21 Participants
TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
|
Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks
n=16 Participants
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
|
Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks
n=17 Participants
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
|
Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
n=16 Participants
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving SVR24 (Sustained Virologic Response 24 Weeks After the End of All Study Therapy)
|
91.3 Percentage of Participants
Interval 72.0 to 98.9
|
100.0 Percentage of Participants
Interval 83.9 to 100.0
|
100.0 Percentage of Participants
Interval 79.4 to 100.0
|
100.0 Percentage of Participants
Interval 80.5 to 100.0
|
93.8 Percentage of Participants
Interval 69.8 to 99.8
|
Adverse Events
Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks
n=23 participants at risk
TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 8 weeks.
|
Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks
n=24 participants at risk
TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
|
Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks
n=17 participants at risk
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
|
Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks
n=18 participants at risk
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
|
Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
n=18 participants at risk
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
|
|---|---|---|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Infections and infestations
Lung infection
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
Other adverse events
| Measure |
Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks
n=23 participants at risk
TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 8 weeks.
|
Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks
n=24 participants at risk
TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
|
Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks
n=17 participants at risk
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
|
Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks
n=18 participants at risk
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
|
Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
n=18 participants at risk
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Investigations
Blood potassium increased
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
11.1%
2/18 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
16.7%
4/24 • Number of events 4 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
1/23 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
11.8%
2/17 • Number of events 3 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
16.7%
3/18 • Number of events 3 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
11.1%
2/18 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
1/23 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
8.3%
2/24 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
4.2%
1/24 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
23.5%
4/17 • Number of events 5 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
11.1%
2/18 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.7%
2/23 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
23.5%
4/17 • Number of events 4 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Nervous system disorders
Amnesia
|
4.3%
1/23 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Nervous system disorders
Disturbance in attention
|
4.3%
1/23 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Nervous system disorders
Dizziness
|
4.3%
1/23 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
12.5%
3/24 • Number of events 3 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
16.7%
3/18 • Number of events 3 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Nervous system disorders
Dysgeusia
|
4.3%
1/23 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Nervous system disorders
Headache
|
21.7%
5/23 • Number of events 6 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
29.2%
7/24 • Number of events 7 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
29.4%
5/17 • Number of events 7 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
61.1%
11/18 • Number of events 12 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
38.9%
7/18 • Number of events 7 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Nervous system disorders
Hypoaesthesia
|
4.3%
1/23 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
11.8%
2/17 • Number of events 3 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Nervous system disorders
Syncope
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Nervous system disorders
Tremor
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Psychiatric disorders
Anxiety
|
8.7%
2/23 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Psychiatric disorders
Depression
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Psychiatric disorders
Emotional disorder
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Psychiatric disorders
Insomnia
|
8.7%
2/23 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Psychiatric disorders
Irritability
|
8.7%
2/23 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Psychiatric disorders
Mood swings
|
4.3%
1/23 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
16.7%
3/18 • Number of events 3 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Psychiatric disorders
Sleep disorder
|
4.3%
1/23 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
11.8%
2/17 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
1/23 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
11.1%
2/18 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.3%
1/23 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
16.7%
3/18 • Number of events 3 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
13.0%
3/23 • Number of events 3 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
11.8%
2/17 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
11.1%
2/18 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.3%
1/23 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
11.1%
2/18 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
22.2%
4/18 • Number of events 4 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.7%
2/23 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
22.2%
4/18 • Number of events 4 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
27.8%
5/18 • Number of events 6 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.0%
3/23 • Number of events 3 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
16.7%
3/18 • Number of events 3 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Vascular disorders
Hypertension
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Cardiac disorders
Palpitations
|
8.7%
2/23 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Eye disorders
Dry eye
|
4.3%
1/23 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Eye disorders
Myopia
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Eye disorders
Vision blurred
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Eye disorders
Visual impairment
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
8.7%
2/23 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
17.6%
3/17 • Number of events 3 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
8.3%
2/24 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
22.2%
4/18 • Number of events 4 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.3%
1/23 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
8.3%
2/24 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Gastrointestinal disorders
Constipation
|
4.3%
1/23 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
12.5%
3/24 • Number of events 3 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
1/23 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
12.5%
3/24 • Number of events 4 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
17.6%
3/17 • Number of events 3 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
11.1%
2/18 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
16.7%
3/18 • Number of events 3 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Gastrointestinal disorders
Nausea
|
17.4%
4/23 • Number of events 4 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
12.5%
3/24 • Number of events 3 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
17.6%
3/17 • Number of events 3 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
33.3%
6/18 • Number of events 7 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
16.7%
3/18 • Number of events 3 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Gastrointestinal disorders
Toothache
|
4.3%
1/23 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
12.5%
3/24 • Number of events 3 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
General disorders
Chills
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
11.1%
2/18 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
General disorders
Fatigue
|
26.1%
6/23 • Number of events 6 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
33.3%
8/24 • Number of events 10 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
35.3%
6/17 • Number of events 6 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
55.6%
10/18 • Number of events 10 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
33.3%
6/18 • Number of events 6 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
General disorders
Feeling hot
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
General disorders
Influenza like illness
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
11.1%
2/18 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
General disorders
Oedema peripheral
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
General disorders
Pain
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
General disorders
Pyrexia
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
8.3%
2/24 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
11.1%
2/18 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Immune system disorders
Seasonal allergy
|
4.3%
1/23 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Infections and infestations
Lower respiratory tract infection
|
4.3%
1/23 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
8.3%
2/24 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
1/23 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
8.3%
2/24 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
11.1%
2/18 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
8.3%
2/24 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.9%
1/17 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/23 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
8.3%
2/24 • Number of events 2 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/17 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
5.6%
1/18 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
4.3%
1/23 • Number of events 1 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/24 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
11.8%
2/17 • Number of events 3 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
16.7%
3/18 • Number of events 4 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
0.00%
0/18 • Up to 40 weeks
All participants who received at least 1 dose of study drug are included.
|
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