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

Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT01260350
Collaborator
(none)
292
Enrollment
2
Locations
22
Arms
36
Duration (Months)
146
Patients Per Site
4.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to assess the safety and tolerability of sofosbuvir (SOF) 400 mg with and without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG) in subjects with genotype 1, 2 or 3 hepatitis C (HCV) infection.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Part 1: HCV genotype 2 or 3: participants will receive SOF 400 mg once daily with weight-based RBV for 12 weeks. Participants will be randomized in equal proportions to: no PEG (Arm 1), PEG for 4 weeks (Arm 2), PEG for 8 weeks (Arm 3), or PEG for 12 weeks (Arm 4).

Part 2: HCV genotype 2 or 3: participants will receive SOF 400 mg once daily (monotherapy) for 12 weeks (Arm 5), or SOF 400 mg once daily with PEG and weight-based RBV for 8 weeks (Arm 6); HCV genotype 1: null responders (did not respond to their prior treatment) will receive SOF 400 mg once daily with weight-based RBV for 12 weeks (Arm 7).

Part 3: HCV genotype 1 treatment-naive (Arm 8) or HCV genotype 2 or 3 treatment-experienced participants (Arm 9) will receive SOF 400 mg once daily in combination with weight-based RBV for 12 weeks.

Part 4: HCV genotype 2 or 3 treatment naive participants will receive SOF 400 mg once daily with weight-based RBV for 8 weeks (Arm 10) or SOF 400 mg once daily and 800 mg RBV for 12 weeks (Arm 11). HCV genotype 1 null responders will receive SOF 400 mg once daily, ledipasvir (LDV), and weight based RBV for 12 weeks (Arm 12). HCV genotype-1 treatment naive participants will receive SOF 400 mg once daily with weight-based RBV and LDV for 12 weeks (Arm 13).

Part 5: HCV genotype 1 null responders will receive SOF 400 mg once daily with GS-9669 500 mg once daily and weight-based RBV for 12 weeks (Arm 14). HCV genotype-1 treatment naive participants receive SOF 400 mg once daily with GS-9669 500 mg once daily and weight-based RBV for 12 weeks (Arm 15).

Part 6: HCV genotype 1 null responders with Stage F4 fibrosis will receive LDV/SOF FDC for 12 weeks (Arm 16) or LDV/SOF FDC with weight-based RBV for 12 weeks (Arm 17). HCV genotype 2 or 3 treatment-naive participants will receive LDV/SOF FDC for 12 weeks (Arm 18). HCV genotype 2 or 3 treatment-experienced participants will receive LDV/SOF FDC for 12 weeks (Arm 19). HCV genotype 1 hemophiliacs will receive LDV/SOF FDC with weight-based RBV for 12 weeks (Arm 20). HCV genotype 1 treatment-naive participants will receive LDV/SOF FDC with weight-based RBV for 6 weeks (Arm 21). HCV genotype 1 treatment-naive participants will receive LDV/SOF FDC for 6 weeks (Arm 22).

Study Design

Study Type:
Interventional
Actual Enrollment :
292 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multi-center, Open-Labeled Exploratory Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 400 mg and Ribavirin for 12 Weeks With and Without Pegylated Interferon in Treatment-Naïve Patients With Chronic HCV Infection Genotype 2 or Genotype 3
Study Start Date :
Dec 1, 2010
Actual Primary Completion Date :
Oct 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1: SOF+RBV 12 wk: GT 2 or 3, TN

Treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.

Drug: SOF
Sofosbuvir (SOF) tablets administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

    • Drug: RBV
    Ribavirin (RBV) capsules administered orally in a divided daily dose
    Other Names:
  • Copegus®

    		•
    Experimental: Group 2: SOF+RBV 12 wk+PEG 4 wk: GT 2 or 3, TN

    Treatment-naive participants with genotype 2 or 3 HCV infection will receive 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.

    Drug: SOF
    Sofosbuvir (SOF) tablets administered orally once daily
    Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

    • Drug: RBV
    Ribavirin (RBV) capsules administered orally in a divided daily dose
    Other Names:
  • Copegus®

    • Drug: PEG
    Peginterferon alfa-2a (PEG) administered via subcutaneous injection once weekly
    Other Names:
  • Pegasys®

    		•
    Experimental: Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN

    Treatment-naive participants with genotype 2 or 3 HCV infection will receive 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.

    Drug: SOF
    Sofosbuvir (SOF) tablets administered orally once daily
    Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

    • Drug: RBV
    Ribavirin (RBV) capsules administered orally in a divided daily dose
    Other Names:
  • Copegus®

    • Drug: PEG
    Peginterferon alfa-2a (PEG) administered via subcutaneous injection once weekly
    Other Names:
  • Pegasys®

    		•
    Experimental: Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN

    Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily+weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks.

    Drug: SOF
    Sofosbuvir (SOF) tablets administered orally once daily
    Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

    • Drug: RBV
    Ribavirin (RBV) capsules administered orally in a divided daily dose
    Other Names:
  • Copegus®

    • Drug: PEG
    Peginterferon alfa-2a (PEG) administered via subcutaneous injection once weekly
    Other Names:
  • Pegasys®

    		•
    Experimental: Group 5: SOF 12 wk: GT 2 or 3, TN

    Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily for 12 weeks.

    Drug: SOF
    Sofosbuvir (SOF) tablets administered orally once daily
    Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

    		•
    Experimental: Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN

    Treatment-naive participants with genotype 2 or 3 HCV infection will receive 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.

    Drug: SOF
    Sofosbuvir (SOF) tablets administered orally once daily
    Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

    • Drug: RBV
    Ribavirin (RBV) capsules administered orally in a divided daily dose
    Other Names:
  • Copegus®

    • Drug: PEG
    Peginterferon alfa-2a (PEG) administered via subcutaneous injection once weekly
    Other Names:
  • Pegasys®

    		•
    Experimental: Group 7: SOF+RBV 12 wk: GT 1, TE

    Treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.

    Drug: SOF
    Sofosbuvir (SOF) tablets administered orally once daily
    Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

    • Drug: RBV
    Ribavirin (RBV) capsules administered orally in a divided daily dose
    Other Names:
  • Copegus®

    		•
    Experimental: Group 8: SOF+RBV 12 wk: GT 1, TN

    Treatment-naive participants with genotype 1 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.

    Drug: SOF
    Sofosbuvir (SOF) tablets administered orally once daily
    Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

    • Drug: RBV
    Ribavirin (RBV) capsules administered orally in a divided daily dose
    Other Names:
  • Copegus®

    		•
    Experimental: Group 9: SOF+RBV 12 wk: GT 2 or 3, TE

    Treatment-experienced participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.

    Drug: SOF
    Sofosbuvir (SOF) tablets administered orally once daily
    Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

    • Drug: RBV
    Ribavirin (RBV) capsules administered orally in a divided daily dose
    Other Names:
  • Copegus®

    		•
    Experimental: Group 10: SOF+RBV 8 wk: GT 2 or 3, TN

    Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks.

    Drug: SOF
    Sofosbuvir (SOF) tablets administered orally once daily
    Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

    • Drug: RBV
    Ribavirin (RBV) capsules administered orally in a divided daily dose
    Other Names:
  • Copegus®

    		•
    Experimental: Group 11: SOF+RBV 12 wk: GT 2 or 3, TN

    Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks.

    Drug: SOF
    Sofosbuvir (SOF) tablets administered orally once daily
    Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

    • Drug: RBV
    Ribavirin (RBV) capsules administered orally in a divided daily dose
    Other Names:
  • Copegus®

    		•
    Experimental: Group 12: SOF+RBV+LDV 12 wk: GT 1, TE

    Treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment will receive 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.

    Drug: SOF
    Sofosbuvir (SOF) tablets administered orally once daily
    Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

    • Drug: RBV
    Ribavirin (RBV) capsules administered orally in a divided daily dose
    Other Names:
  • Copegus®

    • Drug: LDV
    Ledipasvir (LDV) tablets administered orally once daily
    Other Names:
  • GS-5885

    		•
    Experimental: Group 13: SOF+RBV+LDV 12 wk: GT 1, TN

    Treatment-naive participants with genotype 1 HCV infection will receive 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.

    Drug: SOF
    Sofosbuvir (SOF) tablets administered orally once daily
    Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

    • Drug: RBV
    Ribavirin (RBV) capsules administered orally in a divided daily dose
    Other Names:
  • Copegus®

    • Drug: LDV
    Ledipasvir (LDV) tablets administered orally once daily
    Other Names:
  • GS-5885

    		•
    Experimental: Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE

    Treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment will receive 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.

    Drug: SOF
    Sofosbuvir (SOF) tablets administered orally once daily
    Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

    • Drug: RBV
    Ribavirin (RBV) capsules administered orally in a divided daily dose
    Other Names:
  • Copegus®

    • Drug: GS-9669
    GS-9669 tablets administered orally once daily
    Experimental: Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN

    Treatment-naive participants with genotype 1 HCV infection will receive 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.

    Drug: SOF
    Sofosbuvir (SOF) tablets administered orally once daily
    Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

    • Drug: RBV
    Ribavirin (RBV) capsules administered orally in a divided daily dose
    Other Names:
  • Copegus®

    • Drug: GS-9669
    GS-9669 tablets administered orally once daily
    Experimental: Group 16: LDV/SOF FDC 12 wk: GT 1, fibrosis

    Treatment-experienced participants with genotype 1 HCV infection and Stage F4 fibrosis who did not respond to prior treatment will receive LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks.

    Drug: LDV/SOF
    LDV/SOF fixed-dose combination (FDC) tablet administered once daily
    Other Names:
  • Harvoni®

    		•
    Experimental: Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, fibrosis

    Treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment will receive LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.

    Drug: RBV
    Ribavirin (RBV) capsules administered orally in a divided daily dose
    Other Names:
  • Copegus®

    • Drug: LDV/SOF
    LDV/SOF fixed-dose combination (FDC) tablet administered once daily
    Other Names:
  • Harvoni®

    		•
    Experimental: Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN

    Treatment-naive participants with genotype 2 or 3 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks.

    Drug: LDV/SOF
    LDV/SOF fixed-dose combination (FDC) tablet administered once daily
    Other Names:
  • Harvoni®

    		•
    Experimental: Group 19: LDV/SOF FDC 12 wk: GT 2 or 3, TE

    Treatment-experienced participants with genotype 2 or 3 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks.

    Drug: LDV/SOF
    LDV/SOF fixed-dose combination (FDC) tablet administered once daily
    Other Names:
  • Harvoni®

    		•
    Experimental: Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, hemophiliac

    Hemophiliac participants with genotype 1 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.

    Drug: RBV
    Ribavirin (RBV) capsules administered orally in a divided daily dose
    Other Names:
  • Copegus®

    • Drug: LDV/SOF
    LDV/SOF fixed-dose combination (FDC) tablet administered once daily
    Other Names:
  • Harvoni®

    		•
    Experimental: Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN

    Treatment-naive participants with genotype 1 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks.

    Drug: RBV
    Ribavirin (RBV) capsules administered orally in a divided daily dose
    Other Names:
  • Copegus®

    • Drug: LDV/SOF
    LDV/SOF fixed-dose combination (FDC) tablet administered once daily
    Other Names:
  • Harvoni®

    		•
    Experimental: Group 22: LDV/SOF FDC 6 wk: GT 1, TN

    Treatment-naive participants with genotype 1 HCV infection were randomized to receive LDV 90 mg/SOF 400 mg FDC once daily for 6 weeks.

    Drug: LDV/SOF
    LDV/SOF fixed-dose combination (FDC) tablet administered once daily
    Other Names:
  • Harvoni®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Who Experienced Adverse Events [Up to 12 weeks plus 30 days]

      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.

    Secondary Outcome Measures

    1. Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12) [Posttreatment Week 12]

      SVR12 was defined as HCV RNA < the limit of detection (LOD; < 15 IU/mL) 12 weeks after the last dose of study drug.

    2. Percentage of Participants With HCV RNA < LOD at Week 6 [Week 6]

    3. Percentage of Participants With HCV RNA < LOD at Week 8 [Week 8]

      Data are not presented for Group 21 which ended treatment after Week 6.

    4. Percentage of Participants With HCV RNA < LOD at Week 12 [Week 12]

      Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6.

    5. Change From Baseline in HCV RNA at Week 6 [Baseline to Week 6]

    6. Change From Baseline in HCV RNA at Week 8 [Baseline to Week 8]

      Data are not presented for Group 21 which ended treatment after Week 6.

    7. Change From Baseline in HCV RNA at Week 12 [Baseline to Week 12]

      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.

    8. Percentage of Participants With Virologic Failure [Up to Posttreatment Week 24]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Chronic Genotype 2 or 3 HCV-infection or Genotype 1, serum HCV RNA ≥ 50,000 IU/mL

    • Not co-infected with HIV

    • Use of highly effective contraception methods if female of childbearing potential or sexually active male

    Exclusion Criteria:

    • History of any other clinically significant chronic liver disease

    • Pregnant or nursing female or male with pregnant female partner

    • History of significant drug allergy to nucleoside/nucleotide analogs.

    • Participation in a clinical study within 3 months prior to first dose

    • Positive result for significant drug use at Screening

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Auckland Clinical Studies Ltd. Auckland New Zealand
    2 Christchurch Clinical Studies Trust Christchurch New Zealand

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    • Study Director: Robert H. Hyland, DPhil, Gilead Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT01260350
    Other Study ID Numbers:
    • P7977-0523
    • Medsafe
    First Posted:
    Dec 15, 2010
    Last Update Posted:
    Nov 17, 2014
    Last Verified:
    Nov 1, 2014
    Keywords provided by Gilead Sciences
    PSI-7977
    Sofosbuvir
    GS-7977
    GS-5885
    GS-9669
    FDC
    ribavirin
    RBV
    Pegylated Interferon
    PEG-IFN
    Chronic Hepatitis C Infection
    HCV
    Hepatitis
    Genotype 1
    Genotype 2
    Genotype 3
    GT 1
    GT 2
    GT 3
    Hemophilia
    Additional relevant MeSH terms:
    Infections
    Hepatitis C
    Hepatitis C, Chronic
    Hepatitis
    Hepatitis, Chronic
    Sofosbuvir

    Study Results

    Participant Flow

    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 Detail
    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
    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

    Baseline Characteristics

    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
    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 Participants 10 9 10 11 10 10 10 25 25 25 10 9 25 10 25 10 9 10 14 25 292
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    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 (Count of Participants)
    Female
    2
    20%
    4
    44.4%
    5
    50%
    2
    18.2%
    6
    60%
    5
    50%
    3
    30%
    10
    40%
    6
    24%
    8
    32%
    3
    30%
    2
    22.2%
    17
    68%
    3
    30%
    12
    48%
    0
    0%
    1
    11.1%
    7
    70%
    2
    14.3%
    12
    48%
    110
    37.7%
    Male
    8
    80%
    5
    55.6%
    5
    50%
    9
    81.8%
    4
    40%
    5
    50%
    7
    70%
    15
    60%
    19
    76%
    17
    68%
    7
    70%
    7
    77.8%
    8
    32%
    7
    70%
    13
    52%
    10
    100%
    8
    88.9%
    3
    30%
    12
    85.7%
    13
    52%
    182
    62.3%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    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%
    2
    20%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    3
    1%
    Not Hispanic or Latino
    10
    100%
    9
    100%
    10
    100%
    11
    100%
    10
    100%
    9
    90%
    10
    100%
    25
    100%
    25
    100%
    25
    100%
    10
    100%
    9
    100%
    25
    100%
    10
    100%
    25
    100%
    8
    80%
    9
    100%
    10
    100%
    14
    100%
    25
    100%
    289
    99%
    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%
    Race/Ethnicity, Customized (participants) [Number]
    White
    7
    70%
    4
    44.4%
    8
    80%
    9
    81.8%
    10
    100%
    7
    70%
    9
    90%
    20
    80%
    17
    68%
    20
    80%
    9
    90%
    9
    100%
    23
    92%
    9
    90%
    20
    80%
    8
    80%
    9
    100%
    7
    70%
    12
    85.7%
    22
    88%
    239
    81.8%
    Asian
    0
    0%
    0
    0%
    2
    20%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    8%
    0
    0%
    1
    4%
    1
    10%
    0
    0%
    0
    0%
    0
    0%
    1
    4%
    0
    0%
    0
    0%
    3
    30%
    1
    7.1%
    0
    0%
    11
    3.8%
    Native Hawaiian of Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    8%
    1
    4%
    0
    0%
    0
    0%
    1
    4%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    4%
    5
    1.7%
    American Indian or Alaska Native
    0
    0%
    1
    11.1%
    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%
    1
    0.3%
    Other
    3
    30%
    4
    44.4%
    0
    0%
    2
    18.2%
    0
    0%
    3
    30%
    1
    10%
    3
    12%
    6
    24%
    3
    12%
    0
    0%
    0
    0%
    1
    4%
    1
    10%
    4
    16%
    2
    20%
    0
    0%
    0
    0%
    1
    7.1%
    2
    8%
    36
    12.3%
    Hepatitis C Virus (HCV) RNA (log10 IU/mL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [log10 IU/mL]
    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 (participants) [Number]
    < 6 log10 IU/mL
    1
    10%
    1
    11.1%
    3
    30%
    3
    27.3%
    5
    50%
    5
    50%
    1
    10%
    10
    40%
    5
    20%
    12
    48%
    4
    40%
    0
    0%
    11
    44%
    0
    0%
    8
    32%
    2
    20%
    3
    33.3%
    5
    50%
    2
    14.3%
    6
    24%
    87
    29.8%
    ≥ 6 log10 IU/mL
    9
    90%
    8
    88.9%
    7
    70%
    8
    72.7%
    5
    50%
    5
    50%
    9
    90%
    15
    60%
    20
    80%
    13
    52%
    6
    60%
    9
    100%
    14
    56%
    10
    100%
    17
    68%
    8
    80%
    6
    66.7%
    5
    50%
    12
    85.7%
    19
    76%
    205
    70.2%
    HCV Genotype (participants) [Number]
    Genotype 1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    10
    100%
    25
    100%
    0
    0%
    0
    0%
    0
    0%
    9
    100%
    25
    100%
    10
    100%
    25
    100%
    10
    100%
    9
    100%
    0
    0%
    14
    100%
    25
    100%
    162
    55.5%
    Genotype 2
    4
    40%
    3
    33.3%
    4
    40%
    4
    36.4%
    3
    30%
    0
    0%
    0
    0%
    0
    0%
    6
    24%
    5
    20%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    20%
    0
    0%
    0
    0%
    31
    10.6%
    Genotype 3
    6
    60%
    6
    66.7%
    6
    60%
    7
    63.6%
    7
    70%
    10
    100%
    0
    0%
    0
    0%
    19
    76%
    20
    80%
    10
    100%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    8
    80%
    0
    0%
    0
    0%
    99
    33.9%
    IL28b Genotype (participants) [Number]
    CC
    5
    50%
    4
    44.4%
    4
    40%
    4
    36.4%
    2
    20%
    3
    30%
    10
    100%
    25
    100%
    0
    0%
    13
    52%
    4
    40%
    0
    0%
    9
    36%
    1
    10%
    7
    28%
    4
    40%
    2
    22.2%
    3
    30%
    4
    28.6%
    5
    20%
    109
    37.3%
    CT
    4
    40%
    4
    44.4%
    4
    40%
    5
    45.5%
    6
    60%
    6
    60%
    0
    0%
    0
    0%
    6
    24%
    12
    48%
    5
    50%
    7
    77.8%
    14
    56%
    8
    80%
    14
    56%
    4
    40%
    5
    55.6%
    6
    60%
    7
    50%
    15
    60%
    132
    45.2%
    TT
    1
    10%
    1
    11.1%
    2
    20%
    2
    18.2%
    2
    20%
    1
    10%
    0
    0%
    0
    0%
    19
    76%
    0
    0%
    1
    10%
    2
    22.2%
    2
    8%
    1
    10%
    4
    16%
    2
    20%
    2
    22.2%
    1
    10%
    3
    21.4%
    5
    20%
    51
    17.5%
    Cirrhosis Status (participants) [Number]
    Yes
    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%
    10
    100%
    9
    100%
    0
    0%
    1
    7.1%
    0
    0%
    20
    6.8%
    No
    10
    100%
    9
    100%
    10
    100%
    11
    100%
    10
    100%
    10
    100%
    10
    100%
    25
    100%
    25
    100%
    25
    100%
    10
    100%
    9
    100%
    25
    100%
    10
    100%
    25
    100%
    0
    0%
    0
    0%
    10
    100%
    13
    92.9%
    25
    100%
    272
    93.2%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants Who Experienced Adverse Events
    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

    Outcome Measure Data

    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
    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
    Measure Participants 10 9 10 11 10 10 10 25 25 25 10 9 25 10 25 10 9 10 14 25
    Any AE
    10
    100%
    9
    100%
    10
    100%
    11
    100%
    10
    100%
    10
    100%
    10
    100%
    25
    100%
    24
    96%
    25
    100%
    10
    100%
    9
    100%
    24
    96%
    10
    100%
    25
    100%
    7
    70%
    8
    88.9%
    7
    70%
    13
    92.9%
    22
    88%
    Drug-related AE
    8
    80%
    9
    100%
    10
    100%
    11
    100%
    7
    70%
    10
    100%
    10
    100%
    25
    100%
    20
    80%
    21
    84%
    7
    70%
    9
    100%
    24
    96%
    10
    100%
    21
    84%
    5
    50%
    8
    88.9%
    6
    60%
    12
    85.7%
    19
    76%
    Grade 3 or higher AE
    0
    0%
    2
    22.2%
    0
    0%
    1
    9.1%
    0
    0%
    3
    30%
    0
    0%
    1
    4%
    0
    0%
    1
    4%
    0
    0%
    0
    0%
    3
    12%
    0
    0%
    2
    8%
    0
    0%
    1
    11.1%
    0
    0%
    1
    7.1%
    0
    0%
    AE leading to drug discontinuation
    0
    0%
    0
    0%
    0
    0%
    1
    9.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    4%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    3
    21.4%
    2
    8%
    Serious AE
    1
    10%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    10%
    0
    0%
    1
    4%
    0
    0%
    2
    8%
    0
    0%
    0
    0%
    2
    8%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    14.3%
    0
    0%
    2. Secondary Outcome
    Title Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)
    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

    Outcome Measure Data

    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
    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
    Measure Participants 10 9 10 11 10 10 10 25 25 25 10 9 25 10 25 10 9 10 14 25
    Number [percentage of participants]
    100.0
    1000%
    100.0
    1111.1%
    100.0
    1000%
    100.0
    909.1%
    60.0
    600%
    100.0
    1000%
    10.0
    100%
    84.0
    336%
    68.0
    272%
    64.0
    256%
    60.0
    600%
    100.0
    1111.1%
    100.0
    400%
    100.0
    1000%
    92.0
    368%
    70.0
    700%
    100.0
    1111.1%
    80.0
    800%
    100.0
    714.3%
    68.0
    272%
    3. Secondary Outcome
    Title Percentage of Participants With HCV RNA < LOD at Week 6
    Description
    Time Frame Week 6

    Outcome Measure Data

    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
    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
    Measure Participants 10 9 10 11 10 10 10 25 25 25 10 9 25 10 25 10 9 10 14 25
    Number [percentage of participants]
    100.0
    1000%
    100.0
    1111.1%
    100.0
    1000%
    100.0
    909.1%
    100.0
    1000%
    100.0
    1000%
    100.0
    1000%
    100.0
    400%
    100.0
    400%
    100.0
    400%
    100.0
    1000%
    100.0
    1111.1%
    100.0
    400%
    100.0
    1000%
    100.0
    400%
    100.0
    1000%
    100.0
    1111.1%
    100.0
    1000%
    100.0
    714.3%
    100.0
    400%
    4. Secondary Outcome
    Title Percentage of Participants With HCV RNA < LOD at Week 8
    Description Data are not presented for Group 21 which ended treatment after Week 6.
    Time Frame Week 8

    Outcome Measure Data

    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
    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
    Measure Participants 10 9 10 11 10 10 10 25 25 25 10 9 25 10 25 10 9 10 14
    Number [percentage of participants]
    100.0
    1000%
    100.0
    1111.1%
    100.0
    1000%
    100.0
    909.1%
    100.0
    1000%
    100.0
    1000%
    100.0
    1000%
    100.0
    400%
    100.0
    400%
    100.0
    400%
    100.0
    1000%
    100.0
    1111.1%
    100.0
    400%
    100.0
    1000%
    100.0
    400%
    100.0
    1000%
    100.0
    1111.1%
    100.0
    1000%
    100.0
    714.3%
    5. Secondary Outcome
    Title Percentage of Participants With HCV RNA < LOD at Week 12
    Description Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6.
    Time Frame Week 12

    Outcome Measure Data

    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
    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
    Measure Participants 10 9 10 11 10 10 25 25 10 9 24 10 25 10 9 10 14
    Number [percentage of participants]
    100.0
    1000%
    100.0
    1111.1%
    100.0
    1000%
    100.0
    909.1%
    100.0
    1000%
    100.0
    1000%
    100.0
    1000%
    100.0
    400%
    100.0
    400%
    100.0
    400%
    100.0
    1000%
    100.0
    1111.1%
    100.0
    400%
    100.0
    1000%
    100.0
    400%
    100.0
    1000%
    100.0
    1111.1%
    6. Secondary Outcome
    Title Change From Baseline in HCV RNA at Week 6
    Description
    Time Frame Baseline to Week 6

    Outcome Measure Data

    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
    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
    Measure Participants 10 9 10 11 10 10 10 25 25 25 10 9 25 10 25 10 9 10 14 25
    Mean (Standard Deviation) [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
    Description Data are not presented for Group 21 which ended treatment after Week 6.
    Time Frame Baseline to Week 8

    Outcome Measure Data

    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
    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
    Measure Participants 10 9 10 11 10 10 10 25 25 25 10 9 25 10 25 10 9 10 14
    Mean (Standard Deviation) [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
    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

    Outcome Measure Data

    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
    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
    Measure Participants 10 9 10 11 10 10 25 25 10 9 24 10 25
    Mean (Standard Deviation) [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
    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

    Outcome Measure Data

    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
    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
    Measure Participants 10 9 10 11 10 10 10 25 25 25 10 9 25 10 25 10 9 10 14 25
    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%
    0.0
    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
    0%
    0.0
    0%
    40.0
    400%
    0.0
    0%
    90.0
    900%
    16.0
    64%
    32.0
    128%
    36.0
    144%
    40.0
    400%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    8.0
    32%
    30.0
    300%
    0.0
    0%
    20.0
    200%
    0.0
    0%
    32.0
    128%

    Adverse Events

    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
    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 (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    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 (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 1/25 (4%) 0/25 (0%) 2/25 (8%) 0/10 (0%) 0/9 (0%) 2/25 (8%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 2/14 (14.3%) 0/25 (0%)
    Cardiac disorders
    Angina Pectoris 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Gastrointestinal disorders
    Diverticulitis Perforation 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 1/25 (4%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Emterovesical Fistula 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 1/25 (4%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Hepatobiliary disorders
    Cholelithiasis 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 0/25 (0%)
    Infections and infestations
    Breast Abscess 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 1/25 (4%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Diverticulitis 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 1/25 (4%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Furuncle 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Pyelonephritis 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 1/25 (4%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Injury, poisoning and procedural complications
    Urethral injury 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/25 (4%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Syncope 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 0/25 (0%)
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 1/25 (4%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Other (Not Including 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 (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 10/10 (100%) 9/9 (100%) 10/10 (100%) 11/11 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 25/25 (100%) 24/25 (96%) 25/25 (100%) 10/10 (100%) 9/9 (100%) 24/25 (96%) 10/10 (100%) 25/25 (100%) 7/10 (70%) 8/9 (88.9%) 7/10 (70%) 13/14 (92.9%) 22/25 (88%)
    Blood and lymphatic system disorders
    Anaemia 1/10 (10%) 3/9 (33.3%) 0/10 (0%) 2/11 (18.2%) 0/10 (0%) 3/10 (30%) 2/10 (20%) 0/25 (0%) 0/25 (0%) 1/25 (4%) 0/10 (0%) 0/9 (0%) 3/25 (12%) 0/10 (0%) 1/25 (4%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 2/14 (14.3%) 0/25 (0%)
    Haemolytic anaemia 1/10 (10%) 1/9 (11.1%) 1/10 (10%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 5/25 (20%) 1/25 (4%) 2/25 (8%) 0/10 (0%) 0/9 (0%) 3/25 (12%) 0/10 (0%) 3/25 (12%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 2/25 (8%)
    Iron deficiency anaemia 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Lymphadenopathy 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 2/25 (8%) 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Neutropenia 0/10 (0%) 1/9 (11.1%) 1/10 (10%) 2/11 (18.2%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Cardiac disorders
    Palpitations 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 2/25 (8%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Ear and labyrinth disorders
    Ear discomfort 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 0/25 (0%)
    Eustachian tube obstruction 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Tinnitus 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Eye disorders
    Blepharitis 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/25 (0%) 0/10 (0%) 1/25 (4%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 1/25 (4%)
    Blepharospasm 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/14 (0%) 0/25 (0%)
    Conjunctivitis 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 2/9 (22.2%) 0/10 (0%) 1/14 (7.1%) 0/25 (0%)
    Dry eye 0/10 (0%) 0/9 (0%) 2/10 (20%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 1/25 (4%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Eye inflammation 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Eye irritation 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Eye pain 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Lacrimation increased 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Ocular discomfort 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Photophobia 0/10 (0%) 0/9 (0%) 1/10 (10%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 1/25 (4%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/14 (0%) 0/25 (0%)
    Pterygium 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 1/10 (10%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Vision blurred 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 1/25 (4%) 1/25 (4%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Visual impairment 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Gastrointestinal disorders
    Abdominal discomfort 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/25 (0%) 1/25 (4%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Abdominal distension 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 1/25 (4%) 1/10 (10%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 1/10 (10%) 0/14 (0%) 0/25 (0%)
    Abdominal pain 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 2/10 (20%) 0/10 (0%) 1/25 (4%) 0/25 (0%) 1/25 (4%) 1/10 (10%) 1/9 (11.1%) 2/25 (8%) 0/10 (0%) 2/25 (8%) 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/14 (0%) 1/25 (4%)
    Abdominal pain lower 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 1/25 (4%) 0/25 (0%) 1/25 (4%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 1/10 (10%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 0/25 (0%)
    Abdominal pain upper 1/10 (10%) 1/9 (11.1%) 1/10 (10%) 0/11 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 1/25 (4%) 0/10 (0%) 0/9 (0%) 2/25 (8%) 0/10 (0%) 1/25 (4%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Anal fissure 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Anal pruritus 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 0/25 (0%)
    Aphthous stomatitis 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 1/25 (4%) 1/10 (10%) 1/9 (11.1%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 2/25 (8%)
    Change of bowel habit 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Chapped lips 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Cheilitis 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Constipation 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 1/25 (4%) 0/25 (0%) 3/25 (12%) 0/10 (0%) 0/9 (0%) 3/25 (12%) 0/10 (0%) 1/25 (4%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 2/25 (8%)
    Dental caries 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 1/25 (4%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Diarrhoea 2/10 (20%) 0/9 (0%) 2/10 (20%) 2/11 (18.2%) 0/10 (0%) 3/10 (30%) 1/10 (10%) 6/25 (24%) 1/25 (4%) 3/25 (12%) 1/10 (10%) 1/9 (11.1%) 2/25 (8%) 0/10 (0%) 4/25 (16%) 0/10 (0%) 0/9 (0%) 3/10 (30%) 0/14 (0%) 1/25 (4%)
    Dry mouth 0/10 (0%) 0/9 (0%) 2/10 (20%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 0/25 (0%)
    Dyspepsia 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/25 (0%) 1/25 (4%) 2/25 (8%) 0/10 (0%) 1/9 (11.1%) 3/25 (12%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 1/25 (4%)
    Flatulence 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 2/10 (20%) 0/10 (0%) 0/25 (0%) 1/25 (4%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 0/25 (0%)
    Frequent bowel movements 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/25 (4%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Gastrooesophageal reflux disease 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 1/10 (10%) 3/25 (12%) 2/25 (8%) 1/25 (4%) 0/10 (0%) 2/9 (22.2%) 1/25 (4%) 0/10 (0%) 1/25 (4%) 0/10 (0%) 2/9 (22.2%) 0/10 (0%) 1/14 (7.1%) 0/25 (0%)
    Gingival bleeding 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Gingival disorder 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Gingival ulceration 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Glossodynia 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Haemorrhoids 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Mouth ulceration 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 1/10 (10%) 0/10 (0%) 1/10 (10%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Nausea 0/10 (0%) 3/9 (33.3%) 4/10 (40%) 2/11 (18.2%) 3/10 (30%) 2/10 (20%) 2/10 (20%) 11/25 (44%) 5/25 (20%) 4/25 (16%) 3/10 (30%) 3/9 (33.3%) 6/25 (24%) 2/10 (20%) 9/25 (36%) 0/10 (0%) 4/9 (44.4%) 1/10 (10%) 4/14 (28.6%) 5/25 (20%)
    Oral pain 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Paraesthesia oral 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Stomatitis haemorrhagic 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 0/25 (0%)
    Toothache 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 2/25 (8%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/14 (0%) 1/25 (4%)
    Umbilical hernia 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Vomiting 0/10 (0%) 2/9 (22.2%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 2/25 (8%) 1/25 (4%) 2/25 (8%) 1/10 (10%) 1/9 (11.1%) 1/25 (4%) 1/10 (10%) 9/25 (36%) 0/10 (0%) 2/9 (22.2%) 1/10 (10%) 1/14 (7.1%) 3/25 (12%)
    General disorders
    Application site inflammation 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Asthenia 1/10 (10%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Axillary pain 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Catheter site pain 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Chest discomfort 1/10 (10%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 0/25 (0%)
    Chest pain 1/10 (10%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/25 (0%) 1/25 (4%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Chills 0/10 (0%) 2/9 (22.2%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 2/10 (20%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Crying 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Drug withdrawal syndrome 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Facial pain 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Fatigue 1/10 (10%) 3/9 (33.3%) 3/10 (30%) 5/11 (45.5%) 3/10 (30%) 7/10 (70%) 4/10 (40%) 12/25 (48%) 10/25 (40%) 9/25 (36%) 1/10 (10%) 7/9 (77.8%) 6/25 (24%) 5/10 (50%) 4/25 (16%) 1/10 (10%) 1/9 (11.1%) 0/10 (0%) 7/14 (50%) 6/25 (24%)
    Feeling abnormal 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Feeling cold 0/10 (0%) 0/9 (0%) 1/10 (10%) 2/11 (18.2%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Feeling of body temperature change 0/10 (0%) 0/9 (0%) 1/10 (10%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Influenza like illness 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Injection site discomfort 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Injection site erythema 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 2/10 (20%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Injection site inflammation 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Injection site pain 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Injection site reaction 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Irritability 2/10 (20%) 0/9 (0%) 1/10 (10%) 4/11 (36.4%) 1/10 (10%) 2/10 (20%) 1/10 (10%) 5/25 (20%) 0/25 (0%) 3/25 (12%) 0/10 (0%) 1/9 (11.1%) 4/25 (16%) 0/10 (0%) 1/25 (4%) 0/10 (0%) 0/9 (0%) 1/10 (10%) 2/14 (14.3%) 3/25 (12%)
    Malaise 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/25 (0%) 1/25 (4%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 1/10 (10%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Oedema peripheral 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Pain 1/10 (10%) 0/9 (0%) 1/10 (10%) 1/11 (9.1%) 0/10 (0%) 2/10 (20%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Pyrexia 1/10 (10%) 1/9 (11.1%) 1/10 (10%) 2/11 (18.2%) 0/10 (0%) 5/10 (50%) 0/10 (0%) 0/25 (0%) 1/25 (4%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Spinal pain 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Thirst 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Vessel puncture site bruise 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 1/25 (4%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 2/25 (8%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Vessel puncture site pain 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Hepatobiliary disorders
    Biliary colic 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 0/25 (0%)
    Immune system disorders
    Drug hypersensitivity 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Hypersensitivity 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 0/25 (0%)
    Infections and infestations
    Cellulitis 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Conjunctivitis viral 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/14 (0%) 0/25 (0%)
    Folliculitis 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/25 (8%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Furuncle 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Gastroenteritis 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/25 (0%) 0/10 (0%) 1/25 (4%) 0/10 (0%) 2/9 (22.2%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Gingivitis 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/25 (4%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Groin abscess 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Herpes simplex 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 1/25 (4%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Herpes zoster 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Hordeolum 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/14 (0%) 0/25 (0%)
    Infective exacerbation of bronchiectasis 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Lower respiratory tract infection 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Oral herpes 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 1/10 (10%) 1/10 (10%) 2/25 (8%) 0/25 (0%) 1/25 (4%) 0/10 (0%) 0/9 (0%) 2/25 (8%) 1/10 (10%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Otitis externa 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 0/25 (0%)
    Otitis media 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Pharyngitis 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 1/25 (4%) 0/25 (0%) 1/25 (4%) 1/10 (10%) 0/9 (0%) 2/25 (8%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Pilonidal cyst 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 0/25 (0%)
    Rash pustular 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/25 (4%) 1/25 (4%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Respiratory tract infection 2/10 (20%) 1/9 (11.1%) 0/10 (0%) 1/11 (9.1%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 4/25 (16%) 0/25 (0%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 0/25 (0%) 1/10 (10%) 1/25 (4%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Rhinitis 2/10 (20%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 1/10 (10%) 0/10 (0%) 2/10 (20%) 0/25 (0%) 2/25 (8%) 1/25 (4%) 0/10 (0%) 1/9 (11.1%) 2/25 (8%) 1/10 (10%) 3/25 (12%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Sinusitis 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 1/25 (4%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Tinea pedis 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Upper respiratory tract infection 0/10 (0%) 1/9 (11.1%) 1/10 (10%) 1/11 (9.1%) 2/10 (20%) 1/10 (10%) 1/10 (10%) 4/25 (16%) 6/25 (24%) 3/25 (12%) 3/10 (30%) 3/9 (33.3%) 9/25 (36%) 2/10 (20%) 3/25 (12%) 1/10 (10%) 1/9 (11.1%) 2/10 (20%) 2/14 (14.3%) 3/25 (12%)
    Urinary tract infection 1/10 (10%) 0/9 (0%) 0/10 (0%) 2/11 (18.2%) 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 2/25 (8%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Viral infection 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/14 (0%) 1/25 (4%)
    Viral upper respiratory tract infection 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Vulvovaginal candidiasis 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/14 (0%) 0/25 (0%)
    Vulvovaginitis trichomonal 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Injury, poisoning and procedural complications
    Animal bite 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Animal scratch 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Arthropod bite 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Chest injury 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Contusion 2/10 (20%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/25 (12%) 1/25 (4%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 0/25 (0%)
    Excoriation 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 1/10 (10%) 1/9 (11.1%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Laceration 0/10 (0%) 2/9 (22.2%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Ligament sprain 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 1/25 (4%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 1/25 (4%)
    Limb injury 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Muscle strain 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 1/25 (4%) 1/10 (10%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 0/25 (0%)
    Nerve injury 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Peroneal nerve injury 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Road traffic accident 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Thermal burn 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/14 (0%) 1/25 (4%)
    Tooth fracture 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 1/25 (4%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Vessel puncture site bruise 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Wound 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Investigations
    Haemoglobin decreased 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Liver function test abnormal 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 0/25 (0%)
    Weight decreased 0/10 (0%) 0/9 (0%) 1/10 (10%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 1/25 (4%) 0/10 (0%) 2/25 (8%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Weight increased 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Metabolism and nutrition disorders
    Abnormal loss of weight 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Decreased appetite 0/10 (0%) 2/9 (22.2%) 0/10 (0%) 3/11 (27.3%) 0/10 (0%) 5/10 (50%) 0/10 (0%) 2/25 (8%) 2/25 (8%) 3/25 (12%) 1/10 (10%) 0/9 (0%) 2/25 (8%) 0/10 (0%) 2/25 (8%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Food craving 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Increased appetite 0/10 (0%) 1/9 (11.1%) 1/10 (10%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Polydipsia 0/10 (0%) 1/9 (11.1%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 2/25 (8%) 0/10 (0%) 1/9 (11.1%) 0/25 (0%) 0/10 (0%) 1/25 (4%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/10 (0%) 1/9 (11.1%) 3/10 (30%) 1/11 (9.1%) 0/10 (0%) 1/10 (10%) 1/10 (10%) 3/25 (12%) 0/25 (0%) 2/25 (8%) 1/10 (10%) 0/9 (0%) 5/25 (20%) 2/10 (20%) 2/25 (8%) 0/10 (0%) 2/9 (22.2%) 0/10 (0%) 1/14 (7.1%) 1/25 (4%)
    Arthropathy 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Back pain 1/10 (10%) 2/9 (22.2%) 1/10 (10%) 1/11 (9.1%) 1/10 (10%) 2/10 (20%) 0/10 (0%) 2/25 (8%) 0/25 (0%) 1/25 (4%) 1/10 (10%) 0/9 (0%) 2/25 (8%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/14 (0%) 1/25 (4%)
    Costochondritis 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Flank pain 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 2/25 (8%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Muscle atrophy 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 0/25 (0%)
    Muscle spasms 2/10 (20%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/25 (4%) 0/25 (0%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 2/25 (8%) 0/10 (0%) 1/25 (4%) 1/10 (10%) 1/9 (11.1%) 0/10 (0%) 0/14 (0%) 1/25 (4%)
    Muscle tightness 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Muscle twitching 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Musculoskeletal chest pain 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 1/25 (4%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 1/25 (4%) 0/10 (0%) 1/25 (4%) 1/10 (10%) 1/9 (11.1%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Musculoskeletal discomfort 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 2/25 (8%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Musculoskeletal pain 0/10 (0%) 0/9 (0%) 1/10 (10%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/25 (0%) 2/25 (8%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 2/25 (8%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 2/9 (22.2%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Musculoskeletal stiffness 2/10 (20%) 0/9 (0%) 0/10 (0%) 2/11 (18.2%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Myalgia 2/10 (20%) 3/9 (33.3%) 3/10 (30%) 3/11 (27.3%) 1/10 (10%) 4/10 (40%) 0/10 (0%) 2/25 (8%) 6/25 (24%) 0/25 (0%) 0/10 (0%) 3/9 (33.3%) 2/25 (8%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Neck pain 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 1/25 (4%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Pain in extremity 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 1/25 (4%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 2/25 (8%) 0/10 (0%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Upper extremity mass 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 1/10 (10%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lipoma 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Skin papilloma 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Nervous system disorders
    Amnesia 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 1/25 (4%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Balance disorder 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Disturbance in attention 2/10 (20%) 1/9 (11.1%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/25 (4%) 1/25 (4%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/25 (0%) 0/10 (0%) 2/25 (8%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 2/25 (8%)
    Dizziness 4/10 (40%) 4/9 (44.4%) 2/10 (20%) 3/11 (27.3%) 2/10 (20%) 1/10 (10%) 1/10 (10%) 1/25 (4%) 1/25 (4%) 2/25 (8%) 0/10 (0%) 2/9 (22.2%) 3/25 (12%) 0/10 (0%) 1/25 (4%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 0/25 (0%)
    Dizziness postural 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 2/10 (20%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Dysgeusia 2/10 (20%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/25 (4%) 1/25 (4%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 0/25 (0%)
    Head discomfort 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Headache 4/10 (40%) 7/9 (77.8%) 9/10 (90%) 8/11 (72.7%) 8/10 (80%) 6/10 (60%) 4/10 (40%) 8/25 (32%) 11/25 (44%) 6/25 (24%) 2/10 (20%) 6/9 (66.7%) 11/25 (44%) 4/10 (40%) 8/25 (32%) 3/10 (30%) 2/9 (22.2%) 4/10 (40%) 5/14 (35.7%) 8/25 (32%)
    Hyperaesthesia 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 2/25 (8%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Hypogeusia 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Lethargy 1/10 (10%) 2/9 (22.2%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 3/25 (12%) 4/25 (16%) 1/25 (4%) 0/10 (0%) 0/9 (0%) 3/25 (12%) 0/10 (0%) 1/25 (4%) 2/10 (20%) 2/9 (22.2%) 0/10 (0%) 1/14 (7.1%) 2/25 (8%)
    Memory impairment 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Migraine 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 1/25 (4%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Paraesthesia 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 1/25 (4%) 1/25 (4%) 1/25 (4%) 0/10 (0%) 1/9 (11.1%) 2/25 (8%) 0/10 (0%) 1/25 (4%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Presyncope 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 1/25 (4%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 1/10 (10%) 0/14 (0%) 1/25 (4%)
    Restless legs syndrome 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 2/25 (8%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Somnolence 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/14 (0%) 0/25 (0%)
    Syncope 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/25 (8%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 1/25 (4%) 1/10 (10%) 1/25 (4%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Tremor 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/25 (4%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 1/10 (10%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Psychiatric disorders
    Abnormal dreams 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Affect lability 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/25 (0%) 0/10 (0%) 1/25 (4%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Anxiety 1/10 (10%) 2/9 (22.2%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/25 (0%) 2/25 (8%) 1/25 (4%) 1/10 (10%) 1/9 (11.1%) 0/25 (0%) 0/10 (0%) 1/25 (4%) 0/10 (0%) 2/9 (22.2%) 2/10 (20%) 0/14 (0%) 1/25 (4%)
    Depressed mood 0/10 (0%) 2/9 (22.2%) 0/10 (0%) 2/11 (18.2%) 1/10 (10%) 1/10 (10%) 1/10 (10%) 1/25 (4%) 0/25 (0%) 2/25 (8%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 1/10 (10%) 1/9 (11.1%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Depression 2/10 (20%) 1/9 (11.1%) 0/10 (0%) 3/11 (27.3%) 0/10 (0%) 1/10 (10%) 1/10 (10%) 0/25 (0%) 0/25 (0%) 2/25 (8%) 1/10 (10%) 2/9 (22.2%) 4/25 (16%) 1/10 (10%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 1/10 (10%) 1/14 (7.1%) 0/25 (0%)
    Depressive symptom 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Dysphoria 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Dysthymic disorder 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 1/10 (10%) 1/9 (11.1%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Impatience 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Insomnia 3/10 (30%) 6/9 (66.7%) 5/10 (50%) 5/11 (45.5%) 6/10 (60%) 1/10 (10%) 4/10 (40%) 5/25 (20%) 3/25 (12%) 3/25 (12%) 2/10 (20%) 4/9 (44.4%) 4/25 (16%) 1/10 (10%) 3/25 (12%) 0/10 (0%) 1/9 (11.1%) 2/10 (20%) 3/14 (21.4%) 6/25 (24%)
    Libido decreased 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Loss of libido 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Mood altered 0/10 (0%) 0/9 (0%) 2/10 (20%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 2/25 (8%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Mood swings 1/10 (10%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Panic attack 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/25 (0%) 1/25 (4%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Sleep disorder 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/25 (0%) 1/25 (4%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Renal and urinary disorders
    Chromaturia 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/25 (0%) 1/10 (10%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 1/25 (4%)
    Dysuria 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 3/25 (12%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Haematuria 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 0/25 (0%)
    Micturition urgency 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Nocturia 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Pollakiuria 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/25 (0%) 1/25 (4%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Polyuria 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 2/25 (8%) 0/10 (0%) 1/25 (4%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Urine odour abnormal 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Reproductive system and breast disorders
    Amenorrhoea 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/14 (0%) 0/25 (0%)
    Breast pain 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Cervical dysplasia 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Dysmenorrhoea 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Erectile dysfunction 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Menstruation delayed 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Metrorrhagia 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Vaginal haemorrhage 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Respiratory, thoracic and mediastinal disorders
    Asthma 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/25 (0%) 1/25 (4%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Cough 2/10 (20%) 1/9 (11.1%) 0/10 (0%) 0/11 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 1/25 (4%) 0/25 (0%) 1/25 (4%) 0/10 (0%) 3/9 (33.3%) 3/25 (12%) 0/10 (0%) 1/25 (4%) 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 1/25 (4%)
    Dyspnoea 0/10 (0%) 0/9 (0%) 1/10 (10%) 4/11 (36.4%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 1/25 (4%) 1/25 (4%) 4/25 (16%) 0/10 (0%) 0/9 (0%) 4/25 (16%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 1/14 (7.1%) 0/25 (0%)
    Dyspnoea exertional 0/10 (0%) 0/9 (0%) 1/10 (10%) 2/11 (18.2%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 1/25 (4%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 1/25 (4%) 0/10 (0%) 1/25 (4%) 1/10 (10%) 0/9 (0%) 0/10 (0%) 2/14 (14.3%) 1/25 (4%)
    Epistaxis 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 1/10 (10%) 1/9 (11.1%) 2/25 (8%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 0/25 (0%)
    Increased upper airway secretion 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Nasal congestion 1/10 (10%) 1/9 (11.1%) 2/10 (20%) 1/11 (9.1%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 1/25 (4%) 0/25 (0%) 1/25 (4%) 0/10 (0%) 1/9 (11.1%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Oropharyngeal pain 2/10 (20%) 1/9 (11.1%) 1/10 (10%) 1/11 (9.1%) 2/10 (20%) 1/10 (10%) 1/10 (10%) 0/25 (0%) 2/25 (8%) 0/25 (0%) 0/10 (0%) 3/9 (33.3%) 2/25 (8%) 1/10 (10%) 1/25 (4%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 3/25 (12%)
    Pharyngeal erythema 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Productive cough 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Rhinorrhoea 0/10 (0%) 0/9 (0%) 1/10 (10%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 2/25 (8%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Sneezing 1/10 (10%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Throat irritation 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Upper respiratory tract congestion 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Upper-airway cough syndrome 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Skin and subcutaneous tissue disorders
    Acne 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Alopecia 0/10 (0%) 0/9 (0%) 5/10 (50%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Blister 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/25 (4%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 1/25 (4%) 0/10 (0%) 1/25 (4%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Catheter site bruise 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Cold sweat 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Dermal cyst 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Dermatitis contact 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/25 (0%) 1/25 (4%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Dry skin 1/10 (10%) 1/9 (11.1%) 4/10 (40%) 0/11 (0%) 0/10 (0%) 2/10 (20%) 1/10 (10%) 1/25 (4%) 4/25 (16%) 1/25 (4%) 0/10 (0%) 1/9 (11.1%) 5/25 (20%) 0/10 (0%) 2/25 (8%) 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/14 (0%) 1/25 (4%)
    Eczema 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 1/25 (4%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 2/25 (8%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Erythema 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Hyperhidrosis 0/10 (0%) 2/9 (22.2%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 1/10 (10%) 1/10 (10%) 0/25 (0%) 1/25 (4%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Macule 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Night sweats 0/10 (0%) 0/9 (0%) 1/10 (10%) 1/11 (9.1%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 1/25 (4%) 1/25 (4%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 2/25 (8%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Onychoclasis 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Pruritus 1/10 (10%) 3/9 (33.3%) 3/10 (30%) 2/11 (18.2%) 0/10 (0%) 2/10 (20%) 2/10 (20%) 0/25 (0%) 1/25 (4%) 2/25 (8%) 2/10 (20%) 0/9 (0%) 2/25 (8%) 0/10 (0%) 3/25 (12%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 0/25 (0%)
    Pruritus generalised 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/14 (7.1%) 0/25 (0%)
    Psoriasis 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Rash 3/10 (30%) 3/9 (33.3%) 3/10 (30%) 3/11 (27.3%) 1/10 (10%) 6/10 (60%) 3/10 (30%) 4/25 (16%) 6/25 (24%) 1/25 (4%) 1/10 (10%) 1/9 (11.1%) 4/25 (16%) 1/10 (10%) 5/25 (20%) 0/10 (0%) 0/9 (0%) 1/10 (10%) 1/14 (7.1%) 3/25 (12%)
    Rash macular 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Rash maculo-papular 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 1/25 (4%) 0/10 (0%) 1/9 (11.1%) 0/25 (0%) 0/10 (0%) 1/25 (4%) 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Rash papular 0/10 (0%) 0/9 (0%) 1/10 (10%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 1/10 (10%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Rash pruritic 0/10 (0%) 0/9 (0%) 1/10 (10%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 1/25 (4%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Skin discolouration 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Skin fissures 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 2/9 (22.2%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Skin irritation 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/14 (0%) 0/25 (0%)
    Skin lesion 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 1/10 (10%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Skin ulcer 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/11 (9.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Urticaria 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/25 (4%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Surgical and medical procedures
    Tooth extraction 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/25 (4%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Vascular disorders
    Haematoma 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)
    Hot flush 0/10 (0%) 1/9 (11.1%) 2/10 (20%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 0/10 (0%) 1/9 (11.1%) 0/10 (0%) 1/14 (7.1%) 0/25 (0%)
    Hypertension 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 0/10 (0%) 0/25 (0%) 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 1/25 (4%)
    Thrombophlebitis superficial 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/25 (0%) 1/10 (10%) 0/25 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/14 (0%) 0/25 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years

    Results Point of Contact

    Name/Title Clinical Trial Disclosures
    Organization Gilead Sciences, Inc.
    Phone
    Email ClinicalTrialDisclosures@gilead.com
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT01260350
    Other Study ID Numbers:
    • P7977-0523
    • Medsafe
    First Posted:
    Dec 15, 2010
    Last Update Posted:
    Nov 17, 2014
    Last Verified:
    Nov 1, 2014