Trial Outcomes & Findings for Combination Therapy for Chronic Hepatitis C Infection (NCT NCT01805882)
NCT ID: NCT01805882
Last Updated: 2017-06-08
Results Overview
The primary outcome was the proportion of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than 43 IU/mL - the lower limit of quantification.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
229 participants
Primary outcome timeframe
12 weeks after stop of treatment
Results posted on
2017-06-08
Participant Flow
Participant milestones
| Measure |
A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients
|
B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669
Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
|
C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451
Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
|
D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H
|
D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin
|
E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects
|
F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease
|
G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451
Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
|
H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669
Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
34
|
14
|
21
|
50
|
25
|
25
|
|
Overall Study
COMPLETED
|
20
|
20
|
19
|
32
|
14
|
20
|
48
|
25
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
2
|
0
|
1
|
2
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination Therapy for Chronic Hepatitis C Infection
Baseline characteristics by cohort
| Measure |
A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir
n=20 Participants
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients
|
B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669
n=20 Participants
Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
|
C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451
n=20 Participants
Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
|
D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir
n=34 Participants
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H
|
D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir
n=14 Participants
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin
|
E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir
n=21 Participants
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects
|
F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451
n=50 Participants
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease
|
G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451
n=25 Participants
Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
|
H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669
n=25 Participants
Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
|
Total
n=229 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
48 Participants
n=8 Participants
|
24 Participants
n=24 Participants
|
19 Participants
n=42 Participants
|
205 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
24 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
63 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
17 Participants
n=24 Participants
|
19 Participants
n=42 Participants
|
166 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
46 Participants
n=8 Participants
|
24 Participants
n=24 Participants
|
25 Participants
n=42 Participants
|
223 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
19 Participants
n=24 Participants
|
19 Participants
n=42 Participants
|
169 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
49 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after stop of treatmentPopulation: Subjects who received treatment drugs per arm as listed in the Outcome Measure Description
The primary outcome was the proportion of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than 43 IU/mL - the lower limit of quantification.
Outcome measures
| Measure |
A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir
n=20 Participants
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients
|
B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669
n=20 Participants
Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
|
C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451
n=20 Participants
Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
|
D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir
n=34 Participants
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H
|
D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir
n=14 Participants
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin
|
E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir
n=21 Participants
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects
|
F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451
n=50 Participants
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease
|
G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451
n=25 Participants
Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
|
H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669
n=25 Participants
Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
|
|---|---|---|---|---|---|---|---|---|---|
|
The Proportion of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs
|
100 percentage of subjects
Interval 83.0 to 100.0
|
95 percentage of subjects
Interval 75.0 to 100.0
|
95 percentage of subjects
Interval 75.0 to 100.0
|
91.2 percentage of subjects
Interval 76.0 to 98.0
|
100 percentage of subjects
Interval 83.0 to 100.0
|
95 percentage of subjects
Interval 76.0 to 100.0
|
76 percentage of subjects
Interval 60.0 to 85.0
|
40 percentage of subjects
Interval 21.0 to 61.0
|
20 percentage of subjects
Interval 7.0 to 41.0
|
Adverse Events
A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451
Serious events: 2 serious events
Other events: 48 other events
Deaths: 0 deaths
G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir
n=20 participants at risk
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients
|
B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669
n=20 participants at risk
Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
|
C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451
n=20 participants at risk
Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
|
D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir
n=34 participants at risk
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H
|
D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir
n=14 participants at risk
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin
|
E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir
n=21 participants at risk
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects
|
F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451
n=50 participants at risk
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease
|
G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451
n=25 participants at risk
Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
|
H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669
n=25 participants at risk
Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.9%
1/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
4.0%
1/25
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
General disorders
Pain
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Infections and infestations
Influenza
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
7.1%
1/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
Other adverse events
| Measure |
A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir
n=20 participants at risk
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients
|
B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669
n=20 participants at risk
Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
|
C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451
n=20 participants at risk
Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
|
D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir
n=34 participants at risk
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H
|
D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir
n=14 participants at risk
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin
|
E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir
n=21 participants at risk
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects
|
F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451
n=50 participants at risk
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease
|
G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451
n=25 participants at risk
Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
|
H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669
n=25 participants at risk
Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.9%
1/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Ear and labyrinth disorders
Ear pain
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
8.0%
2/25
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
16.0%
4/25
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
4.0%
1/25
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20
|
10.0%
2/20
|
5.0%
1/20
|
5.9%
2/34
|
7.1%
1/14
|
0.00%
0/21
|
6.0%
3/50
|
12.0%
3/25
|
12.0%
3/25
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20
|
30.0%
6/20
|
15.0%
3/20
|
0.00%
0/34
|
7.1%
1/14
|
14.3%
3/21
|
8.0%
4/50
|
4.0%
1/25
|
20.0%
5/25
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/34
|
0.00%
0/14
|
4.8%
1/21
|
2.0%
1/50
|
16.0%
4/25
|
12.0%
3/25
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/34
|
0.00%
0/14
|
4.8%
1/21
|
0.00%
0/50
|
0.00%
0/25
|
4.0%
1/25
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/34
|
7.1%
1/14
|
0.00%
0/21
|
4.0%
2/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Gastrointestinal disorders
Gastritis
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20
|
10.0%
2/20
|
10.0%
2/20
|
2.9%
1/34
|
0.00%
0/14
|
9.5%
2/21
|
10.0%
5/50
|
0.00%
0/25
|
32.0%
8/25
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
4.0%
1/25
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20
|
10.0%
2/20
|
0.00%
0/20
|
2.9%
1/34
|
0.00%
0/14
|
0.00%
0/21
|
6.0%
3/50
|
0.00%
0/25
|
0.00%
0/25
|
|
General disorders
Face oedema
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
General disorders
Fatigue
|
5.0%
1/20
|
10.0%
2/20
|
20.0%
4/20
|
5.9%
2/34
|
0.00%
0/14
|
14.3%
3/21
|
12.0%
6/50
|
16.0%
4/25
|
16.0%
4/25
|
|
General disorders
Influenza like illness
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
General disorders
Localised oedema
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
9.5%
2/21
|
0.00%
0/50
|
4.0%
1/25
|
4.0%
1/25
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.9%
1/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
General disorders
Oedema peripheral
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
General disorders
Pain
|
10.0%
2/20
|
10.0%
2/20
|
5.0%
1/20
|
0.00%
0/34
|
0.00%
0/14
|
4.8%
1/21
|
2.0%
1/50
|
4.0%
1/25
|
0.00%
0/25
|
|
General disorders
Pyrexia
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.9%
1/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
4.0%
1/25
|
0.00%
0/25
|
|
Infections and infestations
Bronchitis
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Infections and infestations
Cellulitis
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
4.0%
2/50
|
4.0%
1/25
|
0.00%
0/25
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
4.8%
1/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
4.0%
1/25
|
0.00%
0/25
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
7.1%
1/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Infections and infestations
Hordeolum
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
2.9%
1/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
4/20
|
5.0%
1/20
|
5.0%
1/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
6.0%
3/50
|
4.0%
1/25
|
0.00%
0/25
|
|
Infections and infestations
Sinusitis
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Infections and infestations
Staphylococcal infection
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Infections and infestations
Tooth infection
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.9%
1/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
9.5%
2/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Infections and infestations
Urethritis trichomonal
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.9%
1/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
5.9%
2/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Infections and infestations
Vaginitis bacterial
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Infections and infestations
Wound infection
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.9%
1/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
2.9%
1/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Injury, poisoning and procedural complications
Muscle strain
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
4.0%
1/25
|
4.0%
1/25
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
4.0%
2/50
|
4.0%
1/25
|
4.0%
1/25
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
1/20
|
10.0%
2/20
|
0.00%
0/20
|
5.9%
2/34
|
0.00%
0/14
|
0.00%
0/21
|
16.0%
8/50
|
4.0%
1/25
|
4.0%
1/25
|
|
Investigations
Amylase increased
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
14.7%
5/34
|
0.00%
0/14
|
4.8%
1/21
|
22.0%
11/50
|
12.0%
3/25
|
4.0%
1/25
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
2/20
|
10.0%
2/20
|
10.0%
2/20
|
8.8%
3/34
|
0.00%
0/14
|
0.00%
0/21
|
18.0%
9/50
|
8.0%
2/25
|
8.0%
2/25
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/20
|
10.0%
2/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
9.5%
2/21
|
2.0%
1/50
|
0.00%
0/25
|
4.0%
1/25
|
|
Investigations
Blood bicarbonate abnormal
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
5.9%
2/34
|
7.1%
1/14
|
0.00%
0/21
|
8.0%
4/50
|
0.00%
0/25
|
4.0%
1/25
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/20
|
5.0%
1/20
|
25.0%
5/20
|
0.00%
0/34
|
7.1%
1/14
|
9.5%
2/21
|
4.0%
2/50
|
0.00%
0/25
|
12.0%
3/25
|
|
Investigations
Blood cholesterol increased
|
20.0%
4/20
|
15.0%
3/20
|
15.0%
3/20
|
50.0%
17/34
|
21.4%
3/14
|
23.8%
5/21
|
8.0%
4/50
|
28.0%
7/25
|
20.0%
5/25
|
|
Investigations
Blood creatine phosphokinase increased
|
10.0%
2/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Investigations
Blood creatinine increased
|
0.00%
0/20
|
5.0%
1/20
|
20.0%
4/20
|
17.6%
6/34
|
14.3%
2/14
|
14.3%
3/21
|
2.0%
1/50
|
4.0%
1/25
|
0.00%
0/25
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/20
|
5.0%
1/20
|
15.0%
3/20
|
0.00%
0/34
|
0.00%
0/14
|
4.8%
1/21
|
12.0%
6/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Investigations
Lipase increased
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
7.1%
1/14
|
9.5%
2/21
|
8.0%
4/50
|
0.00%
0/25
|
4.0%
1/25
|
|
Investigations
Low density lipoprotein increased
|
10.0%
2/20
|
10.0%
2/20
|
0.00%
0/20
|
29.4%
10/34
|
21.4%
3/14
|
23.8%
5/21
|
6.0%
3/50
|
20.0%
5/25
|
16.0%
4/25
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
4.8%
1/21
|
4.0%
2/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Investigations
Neutrophil count decreased
|
20.0%
4/20
|
5.0%
1/20
|
5.0%
1/20
|
8.8%
3/34
|
7.1%
1/14
|
9.5%
2/21
|
6.0%
3/50
|
8.0%
2/25
|
12.0%
3/25
|
|
Investigations
Platelet count decreased
|
15.0%
3/20
|
5.0%
1/20
|
10.0%
2/20
|
2.9%
1/34
|
0.00%
0/14
|
9.5%
2/21
|
10.0%
5/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Investigations
Tuberculin test positive
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
7.1%
1/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Investigations
White blood cell count decreased
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
4.8%
1/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
4.0%
1/25
|
0.00%
0/25
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.9%
1/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
11.8%
4/34
|
0.00%
0/14
|
4.8%
1/21
|
6.0%
3/50
|
8.0%
2/25
|
8.0%
2/25
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
30.0%
6/20
|
45.0%
9/20
|
45.0%
9/20
|
35.3%
12/34
|
42.9%
6/14
|
38.1%
8/21
|
40.0%
20/50
|
24.0%
6/25
|
36.0%
9/25
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
4.0%
1/25
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
5.0%
1/20
|
0.00%
0/20
|
5.0%
1/20
|
11.8%
4/34
|
0.00%
0/14
|
0.00%
0/21
|
4.0%
2/50
|
8.0%
2/25
|
24.0%
6/25
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
20.0%
4/20
|
40.0%
8/20
|
40.0%
8/20
|
0.00%
0/34
|
14.3%
2/14
|
9.5%
2/21
|
6.0%
3/50
|
0.00%
0/25
|
4.0%
1/25
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/20
|
0.00%
0/20
|
10.0%
2/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
10.0%
2/20
|
5.0%
1/20
|
0.00%
0/20
|
11.8%
4/34
|
7.1%
1/14
|
9.5%
2/21
|
8.0%
4/50
|
12.0%
3/25
|
4.0%
1/25
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.0%
1/20
|
5.0%
1/20
|
0.00%
0/20
|
11.8%
4/34
|
0.00%
0/14
|
4.8%
1/21
|
4.0%
2/50
|
4.0%
1/25
|
12.0%
3/25
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.0%
1/20
|
5.0%
1/20
|
15.0%
3/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/20
|
5.0%
1/20
|
5.0%
1/20
|
0.00%
0/34
|
7.1%
1/14
|
0.00%
0/21
|
6.0%
3/50
|
8.0%
2/25
|
0.00%
0/25
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
35.0%
7/20
|
30.0%
6/20
|
20.0%
4/20
|
23.5%
8/34
|
14.3%
2/14
|
28.6%
6/21
|
10.0%
5/50
|
16.0%
4/25
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
2/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
4.0%
1/25
|
4.0%
1/25
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/34
|
7.1%
1/14
|
0.00%
0/21
|
0.00%
0/50
|
4.0%
1/25
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
4.0%
1/25
|
4.0%
1/25
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
7.1%
1/14
|
4.8%
1/21
|
6.0%
3/50
|
0.00%
0/25
|
4.0%
1/25
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
4.0%
1/25
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20
|
10.0%
2/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
6.0%
3/50
|
4.0%
1/25
|
24.0%
6/25
|
|
Nervous system disorders
Headache
|
25.0%
5/20
|
25.0%
5/20
|
0.00%
0/20
|
2.9%
1/34
|
14.3%
2/14
|
9.5%
2/21
|
8.0%
4/50
|
4.0%
1/25
|
28.0%
7/25
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Nervous system disorders
Somnolence
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
4.0%
1/25
|
|
Nervous system disorders
Tension headache
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Nervous system disorders
Tremor
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
4.8%
1/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
4.0%
1/25
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.9%
1/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Psychiatric disorders
Depression
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.9%
1/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20
|
5.0%
1/20
|
5.0%
1/20
|
0.00%
0/34
|
0.00%
0/14
|
4.8%
1/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Psychiatric disorders
Irritability
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.9%
1/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Renal and urinary disorders
Micturition urgency
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
4.0%
1/25
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.9%
1/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.9%
1/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Reproductive system and breast disorders
Spermatocele
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
4.0%
1/25
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.9%
1/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
4.0%
1/25
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.9%
1/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
7.1%
1/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/20
|
5.0%
1/20
|
5.0%
1/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.9%
1/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
4.8%
1/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Acute generalised exanthematous pustulosis
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/20
|
10.0%
2/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.9%
1/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
2/20
|
0.00%
0/20
|
0.00%
0/20
|
2.9%
1/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.0%
1/20
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
7.1%
1/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
4.8%
1/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Social circumstances
Ex-tobacco user
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.9%
1/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Surgical and medical procedures
Supplementation therapy
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.9%
1/34
|
0.00%
0/14
|
0.00%
0/21
|
0.00%
0/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.9%
1/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Surgical and medical procedures
Transfusion
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Vascular disorders
Hot flush
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/34
|
0.00%
0/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
|
Vascular disorders
Hypertension
|
5.0%
1/20
|
0.00%
0/20
|
5.0%
1/20
|
5.9%
2/34
|
7.1%
1/14
|
0.00%
0/21
|
2.0%
1/50
|
0.00%
0/25
|
0.00%
0/25
|
Additional Information
Shyam Kottilil MD
National Institute of Allergy and Infectious Diseases
Phone: +1 410 706 4872
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place