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Trial record 96 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3

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ClinicalTrials.gov Identifier: NCT01260350
Recruitment Status : Completed
First Posted : December 15, 2010
Results First Posted : November 17, 2014
Last Update Posted : November 17, 2014
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Hepatitis C Infection
Interventions Drug: SOF
Drug: RBV
Drug: PEG
Drug: LDV
Drug: GS-9669
Drug: LDV/SOF
Enrollment 292
Recruitment Details Participants were enrolled in a total of 2 study sites in New Zealand. The first participant was screened on 18 November 2010. The last participant observation was on 23 December 2013.
Pre-assignment Details  
Arm/Group Title Group 1: SOF+RBV 12 wk: GT 2 or 3, TN Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN Group 5: SOF 12 wk: GT 2 or 3, TN Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN Group 7: SOF+RBV 12 wk: GT 1, TE Group 8: SOF+RBV 12 wk: GT 1, TN Group 9: SOF+RBV 12 wk: GT 2 or 3, TE Group 10: SOF+RBV 8 wk: GT 2 or 3, TN Group 11: SOF+RBV 12 wk: GT 2 or 3, TN Group 12: SOF+RBV+LDV 12 wk: GT 1, TE Group 13: SOF+RBV+LDV 12 wk: GT 1, TN Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN Group 19: LDV/SOF FDC 12 wk: GT 2 or 3, TE Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN Group 22: LDV/SOF FDC 6 wk: GT 1, TN
Hide Arm/Group Description Sofosbuvir (SOF) 400 mg once daily plus weight-based ribavirin (RBV) (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus ledipasvir (LDV) 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection LDV 90 mg/SOF 400 mg fixed-dose combination (FDC) once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection Treatment-naive participants with genotype 1 HCV infection were randomized to receive LDV 90 mg/SOF 400 mg FDC once daily for 6 weeks.
Period Title: Overall Study
Started 10 9 10 11 10 10 10 25 25 25 10 9 25 10 25 10 9 10 0 14 25 0
Completed 10 9 10 11 10 10 10 25 24 25 10 9 25 10 25 10 9 9 0 14 22 0
Not Completed 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 1 0 0 3 0
Reason Not Completed
Lack of Efficacy             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0             3             0
Did Not Complete Follow-up 12 Visit             0             0             0             0             0             0             0             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0
Arm/Group Title Group 1: SOF+RBV 12 wk: GT 2 or 3, TN Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN Group 5: SOF 12 wk: GT 2 or 3, TN Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN Group 7: SOF+RBV 12 wk: GT 1, TE Group 8: SOF+RBV 12 wk: GT 1, TN Group 9: SOF+RBV 12 wk: GT 2 or 3, TE Group 10: SOF+RBV 8 wk: GT 2 or 3, TN Group 11: SOF+RBV 12 wk: GT 2 or 3, TN Group 12: SOF+RBV+LDV 12 wk: GT 1, TE Group 13: SOF+RBV+LDV 12 wk: GT 1, TN Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN Total
Hide Arm/Group Description SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection Total of all reporting groups
Overall Number of Baseline Participants 10 9 10 11 10 10 10 25 25 25 10 9 25 10 25 10 9 10 14 25 292
Hide Baseline Analysis Population Description
Safety Analysis Set: participants were randomized and received at least one dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 9 participants 10 participants 11 participants 10 participants 10 participants 10 participants 25 participants 25 participants 25 participants 10 participants 9 participants 25 participants 10 participants 25 participants 10 participants 9 participants 10 participants 14 participants 25 participants 292 participants
47  (6.0) 47  (10.2) 49  (9.9) 46  (6.3) 43  (13.5) 39  (12.2) 48  (10.4) 48  (11.4) 53  (7.9) 48  (9.4) 39  (8.9) 50  (13.0) 45  (9.2) 55  (6.0) 46  (9.3) 61  (4.9) 57  (5.2) 39  (10.8) 54  (13.0) 51  (9.0) 48  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 10 participants 11 participants 10 participants 10 participants 10 participants 25 participants 25 participants 25 participants 10 participants 9 participants 25 participants 10 participants 25 participants 10 participants 9 participants 10 participants 14 participants 25 participants 292 participants
Female
2
  20.0%
4
  44.4%
5
  50.0%
2
  18.2%
6
  60.0%
5
  50.0%
3
  30.0%
10
  40.0%
6
  24.0%
8
  32.0%
3
  30.0%
2
  22.2%
17
  68.0%
3
  30.0%
12
  48.0%
0
   0.0%
1
  11.1%
7
  70.0%
2
  14.3%
12
  48.0%
110
  37.7%
Male
8
  80.0%
5
  55.6%
5
  50.0%
9
  81.8%
4
  40.0%
5
  50.0%
7
  70.0%
15
  60.0%
19
  76.0%
17
  68.0%
7
  70.0%
7
  77.8%
8
  32.0%
7
  70.0%
13
  52.0%
10
 100.0%
8
  88.9%
3
  30.0%
12
  85.7%
13
  52.0%
182
  62.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 10 participants 11 participants 10 participants 10 participants 10 participants 25 participants 25 participants 25 participants 10 participants 9 participants 25 participants 10 participants 25 participants 10 participants 9 participants 10 participants 14 participants 25 participants 292 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
   1.0%
Not Hispanic or Latino
10
 100.0%
9
 100.0%
10
 100.0%
11
 100.0%
10
 100.0%
9
  90.0%
10
 100.0%
25
 100.0%
25
 100.0%
25
 100.0%
10
 100.0%
9
 100.0%
25
 100.0%
10
 100.0%
25
 100.0%
8
  80.0%
9
 100.0%
10
 100.0%
14
 100.0%
25
 100.0%
289
  99.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 10 participants 11 participants 10 participants 10 participants 10 participants 25 participants 25 participants 25 participants 10 participants 9 participants 25 participants 10 participants 25 participants 10 participants 9 participants 10 participants 14 participants 25 participants 292 participants
White 7 4 8 9 10 7 9 20 17 20 9 9 23 9 20 8 9 7 12 22 239
Asian 0 0 2 0 0 0 0 2 0 1 1 0 0 0 1 0 0 3 1 0 11
Native Hawaiian of Other Pacific Islander 0 0 0 0 0 0 0 0 2 1 0 0 1 0 0 0 0 0 0 1 5
American Indian or Alaska Native 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
Other 3 4 0 2 0 3 1 3 6 3 0 0 1 1 4 2 0 0 1 2 36
Hepatitis C Virus (HCV) RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 10 participants 9 participants 10 participants 11 participants 10 participants 10 participants 10 participants 25 participants 25 participants 25 participants 10 participants 9 participants 25 participants 10 participants 25 participants 10 participants 9 participants 10 participants 14 participants 25 participants 292 participants
6.7  (0.42) 6.6  (0.52) 6.4  (0.57) 6.3  (0.76) 5.7  (0.89) 6.1  (0.88) 6.8  (0.55) 6.1  (0.75) 6.5  (0.66) 6.1  (0.80) 6.2  (0.96) 6.9  (0.20) 5.9  (0.85) 7.0  (0.38) 6.3  (0.54) 6.5  (0.57) 6.3  (0.78) 6.1  (0.94) 6.5  (0.51) 6.5  (0.56) 6.3  (0.73)
HCV RNA Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 10 participants 11 participants 10 participants 10 participants 10 participants 25 participants 25 participants 25 participants 10 participants 9 participants 25 participants 10 participants 25 participants 10 participants 9 participants 10 participants 14 participants 25 participants 292 participants
< 6 log10 IU/mL 1 1 3 3 5 5 1 10 5 12 4 0 11 0 8 2 3 5 2 6 87
≥ 6 log10 IU/mL 9 8 7 8 5 5 9 15 20 13 6 9 14 10 17 8 6 5 12 19 205
HCV Genotype   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 10 participants 11 participants 10 participants 10 participants 10 participants 25 participants 25 participants 25 participants 10 participants 9 participants 25 participants 10 participants 25 participants 10 participants 9 participants 10 participants 14 participants 25 participants 292 participants
Genotype 1 0 0 0 0 0 0 10 25 0 0 0 9 25 10 25 10 9 0 14 25 162
Genotype 2 4 3 4 4 3 0 0 0 6 5 0 0 0 0 0 0 0 2 0 0 31
Genotype 3 6 6 6 7 7 10 0 0 19 20 10 0 0 0 0 0 0 8 0 0 99
[1]
Measure Description: There are variations of HCV which are all similar enough to be called HCV, but are distinct enough to be referred to as HCV genotypes.
IL28b Genotype   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 10 participants 11 participants 10 participants 10 participants 10 participants 25 participants 25 participants 25 participants 10 participants 9 participants 25 participants 10 participants 25 participants 10 participants 9 participants 10 participants 14 participants 25 participants 292 participants
CC 5 4 4 4 2 3 10 25 0 13 4 0 9 1 7 4 2 3 4 5 109
CT 4 4 4 5 6 6 0 0 6 12 5 7 14 8 14 4 5 6 7 15 132
TT 1 1 2 2 2 1 0 0 19 0 1 2 2 1 4 2 2 1 3 5 51
[1]
Measure Description: CC, CT, and TT alleles are different forms of the IL28b gene.
Cirrhosis Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 10 participants 11 participants 10 participants 10 participants 10 participants 25 participants 25 participants 25 participants 10 participants 9 participants 25 participants 10 participants 25 participants 10 participants 9 participants 10 participants 14 participants 25 participants 292 participants
Yes 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 10 9 0 1 0 20
No 10 9 10 11 10 10 10 25 25 25 10 9 25 10 25 0 0 10 13 25 272
1.Primary Outcome
Title Percentage of Participants Who Experienced Adverse Events
Hide Description Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.
Time Frame Up to 12 weeks plus 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: participants were randomized and received at least one dose of study medication.
Arm/Group Title Group 1: SOF+RBV 12 wk: GT 2 or 3, TN Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN Group 5: SOF 12 wk: GT 2 or 3, TN Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN Group 7: SOF+RBV 12 wk: GT 1, TE Group 8: SOF+RBV 12 wk: GT 1, TN Group 9: SOF+RBV 12 wk: GT 2 or 3, TE Group 10: SOF+RBV 8 wk: GT 2 or 3, TN Group 11: SOF+RBV 12 wk: GT 2 or 3, TN Group 12: SOF+RBV+LDV 12 wk: GT 1, TE Group 13: SOF+RBV+LDV 12 wk: GT 1, TN Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
Hide Arm/Group Description:
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
Overall Number of Participants Analyzed 10 9 10 11 10 10 10 25 25 25 10 9 25 10 25 10 9 10 14 25
Measure Type: Number
Unit of Measure: Percentage of participants
Any AE 10 9 10 11 10 10 10 25 24 25 10 9 24 10 25 7 8 7 13 22
Drug-related AE 8 9 10 11 7 10 10 25 20 21 7 9 24 10 21 5 8 6 12 19
Grade 3 or higher AE 0 2 0 1 0 3 0 1 0 1 0 0 3 0 2 0 1 0 1 0
AE leading to drug discontinuation 0 0 0 1 0 0 0 0 0 0 0 0 1 0 0 0 0 0 3 2
Serious AE 1 0 0 0 0 1 0 1 0 2 0 0 2 0 0 0 0 0 2 0
2.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)
Hide Description SVR12 was defined as HCV RNA < the limit of detection (LOD; < 15 IU/mL) 12 weeks after the last dose of study drug.
Time Frame Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Group 1: SOF+RBV 12 wk: GT 2 or 3, TN Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN Group 5: SOF 12 wk: GT 2 or 3, TN Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN Group 7: SOF+RBV 12 wk: GT 1, TE Group 8: SOF+RBV 12 wk: GT 1, TN Group 9: SOF+RBV 12 wk: GT 2 or 3, TE Group 10: SOF+RBV 8 wk: GT 2 or 3, TN Group 11: SOF+RBV 12 wk: GT 2 or 3, TN Group 12: SOF+RBV+LDV 12 wk: GT 1, TE Group 13: SOF+RBV+LDV 12 wk: GT 1, TN Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
Hide Arm/Group Description:
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
Overall Number of Participants Analyzed 10 9 10 11 10 10 10 25 25 25 10 9 25 10 25 10 9 10 14 25
Measure Type: Number
Unit of Measure: percentage of participants
100.0 100.0 100.0 100.0 60.0 100.0 10.0 84.0 68.0 64.0 60.0 100.0 100.0 100.0 92.0 70.0 100.0 80.0 100.0 68.0
3.Secondary Outcome
Title Percentage of Participants With HCV RNA < LOD at Week 6
Hide Description [Not Specified]
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Group 1: SOF+RBV 12 wk: GT 2 or 3, TN Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN Group 5: SOF 12 wk: GT 2 or 3, TN Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN Group 7: SOF+RBV 12 wk: GT 1, TE Group 8: SOF+RBV 12 wk: GT 1, TN Group 9: SOF+RBV 12 wk: GT 2 or 3, TE Group 10: SOF+RBV 8 wk: GT 2 or 3, TN Group 11: SOF+RBV 12 wk: GT 2 or 3, TN Group 12: SOF+RBV+LDV 12 wk: GT 1, TE Group 13: SOF+RBV+LDV 12 wk: GT 1, TN Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
Hide Arm/Group Description:
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
Overall Number of Participants Analyzed 10 9 10 11 10 10 10 25 25 25 10 9 25 10 25 10 9 10 14 25
Measure Type: Number
Unit of Measure: percentage of participants
100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
4.Secondary Outcome
Title Percentage of Participants With HCV RNA < LOD at Week 8
Hide Description Data are not presented for Group 21 which ended treatment after Week 6.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title Group 1: SOF+RBV 12 wk: GT 2 or 3, TN Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN Group 5: SOF 12 wk: GT 2 or 3, TN Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN Group 7: SOF+RBV 12 wk: GT 1, TE Group 8: SOF+RBV 12 wk: GT 1, TN Group 9: SOF+RBV 12 wk: GT 2 or 3, TE Group 10: SOF+RBV 8 wk: GT 2 or 3, TN Group 11: SOF+RBV 12 wk: GT 2 or 3, TN Group 12: SOF+RBV+LDV 12 wk: GT 1, TE Group 13: SOF+RBV+LDV 12 wk: GT 1, TN Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
Hide Arm/Group Description:
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
Overall Number of Participants Analyzed 10 9 10 11 10 10 10 25 25 25 10 9 25 10 25 10 9 10 14
Measure Type: Number
Unit of Measure: percentage of participants
100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
5.Secondary Outcome
Title Percentage of Participants With HCV RNA < LOD at Week 12
Hide Description Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title Group 1: SOF+RBV 12 wk: GT 2 or 3, TN Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN Group 5: SOF 12 wk: GT 2 or 3, TN Group 7: SOF+RBV 12 wk: GT 1, TE Group 8: SOF+RBV 12 wk: GT 1, TN Group 9: SOF+RBV 12 wk: GT 2 or 3, TE Group 11: SOF+RBV 12 wk: GT 2 or 3, TN Group 12: SOF+RBV+LDV 12 wk: GT 1, TE Group 13: SOF+RBV+LDV 12 wk: GT 1, TN Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
Hide Arm/Group Description:
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
Overall Number of Participants Analyzed 10 9 10 11 10 10 25 25 10 9 24 10 25 10 9 10 14
Measure Type: Number
Unit of Measure: percentage of participants
100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
6.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 6
Hide Description [Not Specified]
Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Group 1: SOF+RBV 12 wk: GT 2 or 3, TN Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN Group 5: SOF 12 wk: GT 2 or 3, TN Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN Group 7: SOF+RBV 12 wk: GT 1, TE Group 8: SOF+RBV 12 wk: GT 1, TN Group 9: SOF+RBV 12 wk: GT 2 or 3, TE Group 10: SOF+RBV 8 wk: GT 2 or 3, TN Group 11: SOF+RBV 12 wk: GT 2 or 3, TN Group 12: SOF+RBV+LDV 12 wk: GT 1, TE Group 13: SOF+RBV+LDV 12 wk: GT 1, TN Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
Hide Arm/Group Description:
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
Overall Number of Participants Analyzed 10 9 10 11 10 10 10 25 25 25 10 9 25 10 25 10 9 10 14 25
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-5.52  (0.418) -5.44  (0.519) -5.23  (0.571) -5.20  (0.756) -6.23  (0.892) -4.94  (0.885) -5.70  (0.550) -4.95  (0.746) -5.38  (0.660) -4.92  (0.803) -5.01  (0.962) -5.74  (0.203) -4.80  (0.851) -5.84  (0.383) -5.19  (0.536) -5.36  (0.575) -5.18  (0.781) -4.93  (0.942) -5.35  (0.510) -5.39  (0.559)
7.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 8
Hide Description Data are not presented for Group 21 which ended treatment after Week 6.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title Group 1: SOF+RBV 12 wk: GT 2 or 3, TN Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN Group 5: SOF 12 wk: GT 2 or 3, TN Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN Group 7: SOF+RBV 12 wk: GT 1, TE Group 8: SOF+RBV 12 wk: GT 1, TN Group 9: SOF+RBV 12 wk: GT 2 or 3, TE Group 10: SOF+RBV 8 wk: GT 2 or 3, TN Group 11: SOF+RBV 12 wk: GT 2 or 3, TN Group 12: SOF+RBV+LDV 12 wk: GT 1, TE Group 13: SOF+RBV+LDV 12 wk: GT 1, TN Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
Hide Arm/Group Description:
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
Overall Number of Participants Analyzed 10 9 10 11 10 10 10 25 25 25 10 9 25 10 25 10 9 10 14
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-5.52  (0.418) -5.44  (0.519) -5.23  (0.571) -5.20  (0.756) -4.59  (0.892) -4.94  (0.885) -5.70  (0.550) -4.95  (0.746) -5.38  (0.660) -4.92  (0.803) -5.01  (0.962) -5.74  (0.203) -4.80  (0.851) -5.84  (0.383) -5.19  (0.536) -5.36  (0.575) -5.18  (0.781) -4.93  (0.942) -5.35  (0.510)
8.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 12
Hide Description Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6. Data are not presented for Groups 16, 17, 18, and 20 because participants with detectable HCV RNA discontinued due to protocol-specified stopping rules.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title Group 1: SOF+RBV 12 wk: GT 2 or 3, TN Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN Group 5: SOF 12 wk: GT 2 or 3, TN Group 7: SOF+RBV 12 wk: GT 1, TE Group 8: SOF+RBV 12 wk: GT 1, TN Group 9: SOF+RBV 12 wk: GT 2 or 3, TE Group 11: SOF+RBV 12 wk: GT 2 or 3, TN Group 12: SOF+RBV+LDV 12 wk: GT 1, TE Group 13: SOF+RBV+LDV 12 wk: GT 1, TN Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
Hide Arm/Group Description:
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
Overall Number of Participants Analyzed 10 9 10 11 10 10 25 25 10 9 24 10 25
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-5.52  (0.418) -5.44  (0.519) -5.23  (0.571) -5.20  (0.756) -4.59  (0.892) -5.70  (0.550) -4.95  (0.746) -5.39  (0.660) -2.01  (0.962) -5.74  (0.203) -4.85  (0.823) -5.84  (0.383) -5.19  (0.536)
9.Secondary Outcome
Title Percentage of Participants With Virologic Failure
Hide Description

The percentage of participants with on-treatment virologic failure (viral breakthrough, rebound, or nonresponse) or following treatment (viral relapse) was summarized.

On-treatment virologic failure was defined as:

  • Viral breakthrough (confirmed HCV RNA ≥ LOD after having previously had HCV RNA < LOD while on treatment),
  • Viral rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, or
  • Nonresponse (HCV RNA persistently ≥ LOD through 6 weeks of treatment)

Viral relapse was defined as confirmed HCV RNA ≥ LOD during the posttreatment period having achieved HCV RNA < LOD at the last on-treatment visit.

Time Frame Up to Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Group 1: SOF+RBV 12 wk: GT 2 or 3, TN Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN Group 5: SOF 12 wk: GT 2 or 3, TN Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN Group 7: SOF+RBV 12 wk: GT 1, TE Group 8: SOF+RBV 12 wk: GT 1, TN Group 9: SOF+RBV 12 wk: GT 2 or 3, TE Group 10: SOF+RBV 8 wk: GT 2 or 3, TN Group 11: SOF+RBV 12 wk: GT 2 or 3, TN Group 12: SOF+RBV+LDV 12 wk: GT 1, TE Group 13: SOF+RBV+LDV 12 wk: GT 1, TN Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
Hide Arm/Group Description:
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
Overall Number of Participants Analyzed 10 9 10 11 10 10 10 25 25 25 10 9 25 10 25 10 9 10 14 25
Measure Type: Number
Unit of Measure: percentage of participants
On-treatment virologic failure 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Viral relapse 0.0 0.0 0.0 0.0 40.0 0.0 90.0 16.0 32.0 36.0 40.0 0.0 0.0 0.0 8.0 30.0 0.0 20.0 0.0 32.0
Time Frame Up to 12 weeks plus 30 days.
Adverse Event Reporting Description Adverse events are included up to the last dose date of any study drug + 30 days.
 
Arm/Group Title Group 1: SOF+RBV 12 wk: GT 2 or 3, TN Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN Group 5: SOF 12 wk: GT 2 or 3, TN Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN Group 7: SOF+RBV 12 wk: GT 1, TE Group 8: SOF+RBV 12 wk: GT 1, TN Group 9: SOF+RBV 12 wk: GT 2 or 3, TE Group 10: SOF+RBV 8 wk: GT 2 or 3, TN Group 11: SOF+RBV 12 wk: GT 2 or 3, TN Group 12: SOF+RBV+LDV 12 wk: GT 1, TE Group 13: SOF+RBV+LDV 12 wk: GT 1, TN Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
Hide Arm/Group Description SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
All-Cause Mortality
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN Group 5: SOF 12 wk: GT 2 or 3, TN Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN Group 7: SOF+RBV 12 wk: GT 1, TE Group 8: SOF+RBV 12 wk: GT 1, TN Group 9: SOF+RBV 12 wk: GT 2 or 3, TE Group 10: SOF+RBV 8 wk: GT 2 or 3, TN Group 11: SOF+RBV 12 wk: GT 2 or 3, TN Group 12: SOF+RBV+LDV 12 wk: GT 1, TE Group 13: SOF+RBV+LDV 12 wk: GT 1, TN Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN Group 5: SOF 12 wk: GT 2 or 3, TN Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN Group 7: SOF+RBV 12 wk: GT 1, TE Group 8: SOF+RBV 12 wk: GT 1, TN Group 9: SOF+RBV 12 wk: GT 2 or 3, TE Group 10: SOF+RBV 8 wk: GT 2 or 3, TN Group 11: SOF+RBV 12 wk: GT 2 or 3, TN Group 12: SOF+RBV+LDV 12 wk: GT 1, TE Group 13: SOF+RBV+LDV 12 wk: GT 1, TN Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/10 (10.00%)   0/9 (0.00%)   0/10 (0.00%)   0/11 (0.00%)   0/10 (0.00%)   1/10 (10.00%)   0/10 (0.00%)   1/25 (4.00%)   0/25 (0.00%)   2/25 (8.00%)   0/10 (0.00%)   0/9 (0.00%)   2/25 (8.00%)   0/10 (0.00%)   0/25 (0.00%)   0/10 (0.00%)   0/9 (0.00%)   0/10 (0.00%)   2/14 (14.29%)   0/25 (0.00%) 
Cardiac disorders                                         
Angina Pectoris  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Gastrointestinal disorders                                         
Diverticulitis Perforation  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/25 (4.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Emterovesical Fistula  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/25 (4.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Hepatobiliary disorders                                         
Cholelithiasis  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/25 (0.00%) 
Infections and infestations                                         
Breast Abscess  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Diverticulitis  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/25 (4.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Furuncle  1  1/10 (10.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Pyelonephritis  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/25 (4.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Injury, poisoning and procedural complications                                         
Urethral injury  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                                         
Syncope  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/25 (0.00%) 
Respiratory, thoracic and mediastinal disorders                                         
Pulmonary embolism  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN Group 5: SOF 12 wk: GT 2 or 3, TN Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN Group 7: SOF+RBV 12 wk: GT 1, TE Group 8: SOF+RBV 12 wk: GT 1, TN Group 9: SOF+RBV 12 wk: GT 2 or 3, TE Group 10: SOF+RBV 8 wk: GT 2 or 3, TN Group 11: SOF+RBV 12 wk: GT 2 or 3, TN Group 12: SOF+RBV+LDV 12 wk: GT 1, TE Group 13: SOF+RBV+LDV 12 wk: GT 1, TN Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/10 (100.00%)   9/9 (100.00%)   10/10 (100.00%)   11/11 (100.00%)   10/10 (100.00%)   10/10 (100.00%)   10/10 (100.00%)   25/25 (100.00%)   24/25 (96.00%)   25/25 (100.00%)   10/10 (100.00%)   9/9 (100.00%)   24/25 (96.00%)   10/10 (100.00%)   25/25 (100.00%)   7/10 (70.00%)   8/9 (88.89%)   7/10 (70.00%)   13/14 (92.86%)   22/25 (88.00%) 
Blood and lymphatic system disorders                                         
Anaemia  1  1/10 (10.00%)  3/9 (33.33%)  0/10 (0.00%)  2/11 (18.18%)  0/10 (0.00%)  3/10 (30.00%)  2/10 (20.00%)  0/25 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/10 (0.00%)  0/9 (0.00%)  3/25 (12.00%)  0/10 (0.00%)  1/25 (4.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  2/14 (14.29%)  0/25 (0.00%) 
Haemolytic anaemia  1  1/10 (10.00%)  1/9 (11.11%)  1/10 (10.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  5/25 (20.00%)  1/25 (4.00%)  2/25 (8.00%)  0/10 (0.00%)  0/9 (0.00%)  3/25 (12.00%)  0/10 (0.00%)  3/25 (12.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  2/25 (8.00%) 
Iron deficiency anaemia  1  0/10 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Lymphadenopathy  1  0/10 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  2/25 (8.00%)  0/10 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Neutropenia  1  0/10 (0.00%)  1/9 (11.11%)  1/10 (10.00%)  2/11 (18.18%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Cardiac disorders                                         
Palpitations  1  0/10 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  2/25 (8.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Ear and labyrinth disorders                                         
Ear discomfort  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/25 (0.00%) 
Eustachian tube obstruction  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Tinnitus  1  1/10 (10.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Eye disorders                                         
Blepharitis  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/25 (0.00%)  0/10 (0.00%)  1/25 (4.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  1/25 (4.00%) 
Blepharospasm  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/14 (0.00%)  0/25 (0.00%) 
Conjunctivitis  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  2/9 (22.22%)  0/10 (0.00%)  1/14 (7.14%)  0/25 (0.00%) 
Dry eye  1  0/10 (0.00%)  0/9 (0.00%)  2/10 (20.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  1/25 (4.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Eye inflammation  1  0/10 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Eye irritation  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Eye pain  1  0/10 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Lacrimation increased  1  0/10 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Ocular discomfort  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Photophobia  1  0/10 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/14 (0.00%)  0/25 (0.00%) 
Pterygium  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  1/10 (10.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Vision blurred  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  1/25 (4.00%)  1/25 (4.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Visual impairment  1  1/10 (10.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Gastrointestinal disorders                                         
Abdominal discomfort  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Abdominal distension  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  1/10 (10.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  1/10 (10.00%)  0/14 (0.00%)  0/25 (0.00%) 
Abdominal pain  1  0/10 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  2/10 (20.00%)  0/10 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  1/25 (4.00%)  1/10 (10.00%)  1/9 (11.11%)  2/25 (8.00%)  0/10 (0.00%)  2/25 (8.00%)  0/10 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/14 (0.00%)  1/25 (4.00%) 
Abdominal pain lower  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/11 (9.09%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  1/25 (4.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  1/10 (10.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/25 (0.00%) 
Abdominal pain upper  1  1/10 (10.00%)  1/9 (11.11%)  1/10 (10.00%)  0/11 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/10 (0.00%)  0/9 (0.00%)  2/25 (8.00%)  0/10 (0.00%)  1/25 (4.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Anal fissure  1  0/10 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Anal pruritus  1  0/10 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/25 (0.00%) 
Aphthous stomatitis  1  1/10 (10.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  1/10 (10.00%)  1/9 (11.11%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  2/25 (8.00%) 
Change of bowel habit  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Chapped lips  1  0/10 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Cheilitis  1  0/10 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Constipation  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  3/25 (12.00%)  0/10 (0.00%)  0/9 (0.00%)  3/25 (12.00%)  0/10 (0.00%)  1/25 (4.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  2/25 (8.00%) 
Dental caries  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Diarrhoea  1  2/10 (20.00%)  0/9 (0.00%)  2/10 (20.00%)  2/11 (18.18%)  0/10 (0.00%)  3/10 (30.00%)  1/10 (10.00%)  6/25 (24.00%)  1/25 (4.00%)  3/25 (12.00%)  1/10 (10.00%)  1/9 (11.11%)  2/25 (8.00%)  0/10 (0.00%)  4/25 (16.00%)  0/10 (0.00%)  0/9 (0.00%)  3/10 (30.00%)  0/14 (0.00%)  1/25 (4.00%) 
Dry mouth  1  0/10 (0.00%)  0/9 (0.00%)  2/10 (20.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/25 (0.00%) 
Dyspepsia  1  0/10 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/25 (0.00%)  1/25 (4.00%)  2/25 (8.00%)  0/10 (0.00%)  1/9 (11.11%)  3/25 (12.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  1/25 (4.00%) 
Flatulence  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  2/10 (20.00%)  0/10 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/25 (0.00%) 
Frequent bowel movements  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Gastrooesophageal reflux disease  1  1/10 (10.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  1/10 (10.00%)  3/25 (12.00%)  2/25 (8.00%)  1/25 (4.00%)  0/10 (0.00%)  2/9 (22.22%)  1/25 (4.00%)  0/10 (0.00%)  1/25 (4.00%)  0/10 (0.00%)  2/9 (22.22%)  0/10 (0.00%)  1/14 (7.14%)  0/25 (0.00%) 
Gingival bleeding  1  0/10 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Gingival disorder  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Gingival ulceration  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Glossodynia  1  0/10 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Haemorrhoids  1  0/10 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Mouth ulceration  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/11 (9.09%)  1/10 (10.00%)  0/10 (0.00%)  1/10 (10.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Nausea  1  0/10 (0.00%)  3/9 (33.33%)  4/10 (40.00%)  2/11 (18.18%)  3/10 (30.00%)  2/10 (20.00%)  2/10 (20.00%)  11/25 (44.00%)  5/25 (20.00%)  4/25 (16.00%)  3/10 (30.00%)  3/9 (33.33%)  6/25 (24.00%)  2/10 (20.00%)  9/25 (36.00%)  0/10 (0.00%)  4/9 (44.44%)  1/10 (10.00%)  4/14 (28.57%)  5/25 (20.00%) 
Oral pain  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Paraesthesia oral  1  0/10 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Stomatitis haemorrhagic  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/25 (0.00%) 
Toothache  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/11 (9.09%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  2/25 (8.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/14 (0.00%)  1/25 (4.00%) 
Umbilical hernia  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Vomiting  1  0/10 (0.00%)  2/9 (22.22%)  1/10 (10.00%)  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  2/25 (8.00%)  1/25 (4.00%)  2/25 (8.00%)  1/10 (10.00%)  1/9 (11.11%)  1/25 (4.00%)  1/10 (10.00%)  9/25 (36.00%)  0/10 (0.00%)  2/9 (22.22%)  1/10 (10.00%)  1/14 (7.14%)  3/25 (12.00%) 
General disorders                                         
Application site inflammation  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Asthenia  1  1/10 (10.00%)  0/9 (0.00%)  1/10 (10.00%)  0/11 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Axillary pain  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  2/10 (20.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Catheter site pain  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Chest discomfort  1  1/10 (10.00%)  0/9 (0.00%)  1/10 (10.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/25 (0.00%) 
Chest pain  1  1/10 (10.00%)  0/9 (0.00%)  1/10 (10.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Chills  1  0/10 (0.00%)  2/9 (22.22%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  2/10 (20.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Crying  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Drug withdrawal syndrome  1  1/10 (10.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Facial pain  1  1/10 (10.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Fatigue  1  1/10 (10.00%)  3/9 (33.33%)  3/10 (30.00%)  5/11 (45.45%)  3/10 (30.00%)  7/10 (70.00%)  4/10 (40.00%)  12/25 (48.00%)  10/25 (40.00%)  9/25 (36.00%)  1/10 (10.00%)  7/9 (77.78%)  6/25 (24.00%)  5/10 (50.00%)  4/25 (16.00%)  1/10 (10.00%)  1/9 (11.11%)  0/10 (0.00%)  7/14 (50.00%)  6/25 (24.00%) 
Feeling abnormal  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Feeling cold  1  0/10 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  2/11 (18.18%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Feeling of body temperature change  1  0/10 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Influenza like illness  1  0/10 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Injection site discomfort  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Injection site erythema  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  2/10 (20.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Injection site inflammation  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Injection site pain  1  0/10 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Injection site reaction  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Irritability  1  2/10 (20.00%)  0/9 (0.00%)  1/10 (10.00%)  4/11 (36.36%)  1/10 (10.00%)  2/10 (20.00%)  1/10 (10.00%)  5/25 (20.00%)  0/25 (0.00%)  3/25 (12.00%)  0/10 (0.00%)  1/9 (11.11%)  4/25 (16.00%)  0/10 (0.00%)  1/25 (4.00%)  0/10 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  2/14 (14.29%)  3/25 (12.00%) 
Malaise  1  0/10 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  1/10 (10.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Oedema peripheral  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Pain  1  1/10 (10.00%)  0/9 (0.00%)  1/10 (10.00%)  1/11 (9.09%)  0/10 (0.00%)  2/10 (20.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Pyrexia  1  1/10 (10.00%)  1/9 (11.11%)  1/10 (10.00%)  2/11 (18.18%)  0/10 (0.00%)  5/10 (50.00%)  0/10 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Spinal pain  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Thirst  1  0/10 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Vessel puncture site bruise  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  2/25 (8.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Vessel puncture site pain  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Hepatobiliary disorders                                         
Biliary colic  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/25 (0.00%) 
Immune system disorders                                         
Drug hypersensitivity  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Hypersensitivity  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/25 (0.00%) 
Infections and infestations                                         
Cellulitis  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Conjunctivitis viral  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/14 (0.00%)  0/25 (0.00%) 
Folliculitis  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  2/25 (8.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Furuncle  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Gastroenteritis  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/25 (0.00%)  0/10 (0.00%)  1/25 (4.00%)  0/10 (0.00%)  2/9 (22.22%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Gingivitis  1  0/10 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Groin abscess  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Herpes simplex  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  1/25 (4.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Herpes zoster  1  1/10 (10.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Hordeolum  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/14 (0.00%)  0/25 (0.00%) 
Infective exacerbation of bronchiectasis  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Lower respiratory tract infection  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Oral herpes  1  0/10 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  1/10 (10.00%)  1/10 (10.00%)  2/25 (8.00%)  0/25 (0.00%)  1/25 (4.00%)  0/10 (0.00%)  0/9 (0.00%)  2/25 (8.00%)  1/10 (10.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Otitis externa  1  0/10 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/25 (0.00%) 
Otitis media  1  1/10 (10.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Pharyngitis  1  0/10 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/11 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  1/25 (4.00%)  1/10 (10.00%)  0/9 (0.00%)  2/25 (8.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Pilonidal cyst  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/25 (0.00%) 
Rash pustular  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/25 (4.00%)  1/25 (4.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Respiratory tract infection  1  2/10 (20.00%)  1/9 (11.11%)  0/10 (0.00%)  1/11 (9.09%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  4/25 (16.00%)  0/25 (0.00%)  0/25 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/25 (0.00%)  1/10 (10.00%)  1/25 (4.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Rhinitis  1  2/10 (20.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  2/10 (20.00%)  0/25 (0.00%)  2/25 (8.00%)  1/25 (4.00%)  0/10 (0.00%)  1/9 (11.11%)  2/25 (8.00%)  1/10 (10.00%)  3/25 (12.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Sinusitis  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Tinea pedis  1  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/14 (0.00%)  0/25 (0.00%) 
Upper respiratory tract infection  1  0/10 (0.00%)  1/9 (11.11%)  1/10 (10.00%)  1/11 (9.09%)  2/10 (20.00%)  1/10 (10.00%)  1/10 (10.00%)  4/25 (16.00%)  6/25 (24.00%)  3/25 (12.00%)