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Trial record 41 of 535 for:    IFNA2 AND RBV AND HCV

Efficacy and Safety of Adding Alisporivir (DEB025) to Peginterferon (IFN) Alfa-2a (Peg-IFN Alfa-2a) and Ribavirin in Chronic HCV Genotype 1 Patients Who Relapsed or Did Not Respond to Previous Treatment

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ClinicalTrials.gov Identifier: NCT01183169
Recruitment Status : Completed
First Posted : August 17, 2010
Results First Posted : August 25, 2016
Last Update Posted : August 25, 2016
Sponsor:
Information provided by (Responsible Party):
Debiopharm International SA

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: Alisporivir
Drug: Peginterferon alfa-2a
Drug: Ribavirin
Drug: Placebo
Enrollment 459
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment A Treatment B Treatment C1 Treatment C2 Treatment D Treatment C1A Treatment C2A
Hide Arm/Group Description Alisporivir (ALV; DEB025) 600 mg once daily (QD) with peginterferon alfa-2a (PEG) and ribavirin (RBV) for up to 48 weeks. ALV 800 mg QD with PEG and RBV for up to 48 weeks. Treatment C subset C1: ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR: hepatitis C virus (HCV) ribonucleic acid (RNA) <LOQ after 12 weeks of treatment) could switch to active ALV 600 mg QD with PEG and RBV. Treatment C subset C2: ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV 400 mg twice daily (BID) with PEG and RBV. ALV 400 mg BID with PEG and RBV for up to 48 weeks. ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1. ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
Period Title: Main Phase
Started 121 115 59 55 109 0 0
Completed Treatment 72 78 17 17 77 0 0
Switched to ALV 0 0 35 30 0 0 0
Completed 94 93 18 18 83 0 0
Not Completed 27 22 41 37 26 0 0
Period Title: Post-switch Phase
Started 0 [1] 0 [1] 0 [1] 0 [1] 0 [1] 35 [2] 30 [3]
Completed Treatment 0 0 0 0 0 12 13
Completed 0 0 0 0 0 21 21
Not Completed 0 0 0 0 0 14 9
[1]
Not a post-switch group
[2]
Participants in Treatment C1 who switched to active ALV
[3]
Participants in Treatment C2 who switched to active ALV
Arm/Group Title Treatment A Treatment B Treatment C Treatment D Total
Hide Arm/Group Description ALV 600 mg QD with PEG and RBV for up to 48 weeks. ALV 800 mg QD with PEG and RBV for up to 48 weeks. Treatment C1 + Treatment C2. ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV. ALV 400 mg BID with PEG and RBV for up to 48 weeks. Total of all reporting groups
Overall Number of Baseline Participants 121 115 114 109 459
Hide Baseline Analysis Population Description
All randomized participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 121 participants 115 participants 114 participants 109 participants 459 participants
50.2  (9.24) 50.9  (10.11) 50.5  (10.50) 51.0  (9.68) 50.6  (9.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 115 participants 114 participants 109 participants 459 participants
Female
58
  47.9%
47
  40.9%
36
  31.6%
40
  36.7%
181
  39.4%
Male
63
  52.1%
68
  59.1%
78
  68.4%
69
  63.3%
278
  60.6%
1.Primary Outcome
Title Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ)
Hide Description cEVR-LOQ was defined as serum HCV RNA below the limit of quantification (< LOQ; i.e., 25 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
Time Frame after 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) For Efficacy, defined as all randomized participants who were randomized after the 2nd protocol amendment
Arm/Group Title Treatment A Treatment B Treatment C Treatment D Treatment C1A Treatment C2A
Hide Arm/Group Description:
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
Overall Number of Participants Analyzed 110 108 110 109 33 30
Measure Type: Number
Unit of Measure: percentage of participants
48.2 61.1 35.5 74.3 45.5 80.0
2.Secondary Outcome
Title Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD)
Hide Description cEVR-LOD was defined as serum HCV RNA below the limit of detection (< LOD; i.e., 10 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
Time Frame after 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS For Efficacy
Arm/Group Title Treatment A Treatment B Treatment C Treatment D Treatment C1A Treatment C2A
Hide Arm/Group Description:
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
Overall Number of Participants Analyzed 110 108 110 109 33 30
Measure Type: Number
Unit of Measure: percentage of participants
39.1 41.7 20.9 58.7 39.4 73.3
3.Secondary Outcome
Title Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD
Hide Description SVR12-LOQ and SVR12-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD 12 weeks after treatment, respectively.
Time Frame 12 weeks after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS For Efficacy
Arm/Group Title Treatment A Treatment B Treatment C Treatment D Treatment C1A Treatment C2A
Hide Arm/Group Description:
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
Overall Number of Participants Analyzed 110 108 110 109 33 30
Measure Type: Number
Unit of Measure: percentage of participants
SVR12-LOQ 42.7 51.9 14.5 65.1 18.2 53.3
SVR12-LOD 40.9 50.9 14.5 63.3 18.2 53.3
4.Secondary Outcome
Title Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD
Hide Description SVR24-LOQ and SVR24-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD 24 weeks after treatment, respectively.
Time Frame 24 weeks after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS For Efficacy
Arm/Group Title Treatment A Treatment B Treatment C Treatment D Treatment C1A Treatment C2A
Hide Arm/Group Description:
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
Overall Number of Participants Analyzed 110 108 110 109 33 30
Measure Type: Number
Unit of Measure: percentage of participants
SVR24-LOQ 41.8 51.9 14.5 65.1 18.2 53.3
SVR24-LOD 40.0 50.0 14.5 63.3 18.2 53.3
5.Secondary Outcome
Title Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD
Hide Description RVR-LOQ and RVR-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD after 4 weeks of treatment, respectively. Post-switch groups were assessed 4 weeks after the switch.
Time Frame after 4 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS For Efficacy
Arm/Group Title Treatment A Treatment B Treatment C Treatment D Treatment C1A Treatment C2A
Hide Arm/Group Description:
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
Overall Number of Participants Analyzed 110 108 110 109 33 30
Measure Type: Number
Unit of Measure: percentage of participants
RVR-LOQ 20.9 25.0 7.3 41.3 39.4 56.7
RVR-LOD 9.1 8.3 2.7 22.9 18.2 50.0
6.Secondary Outcome
Title Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD
Hide Description pEVR-LOQ and pEVR-LOD were defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ and ≥ LOD, respectively) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
Time Frame after 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS For Efficacy
Arm/Group Title Treatment A Treatment B Treatment C Treatment D Treatment C1A Treatment C2A
Hide Arm/Group Description:
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
Overall Number of Participants Analyzed 110 108 110 109 33 30
Measure Type: Number
Unit of Measure: percentage of participants
pEVR-LOQ 38.2 28.7 31.8 11.9 3.0 6.7
pEVR-LOD 47.3 48.1 46.4 27.5 9.1 13.3
7.Secondary Outcome
Title Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD
Hide Description ETR-LOQ and ETR-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD at treatment end (completed or prematurely discontinued), respectively.
Time Frame within 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS For Efficacy
Arm/Group Title Treatment A Treatment B Treatment C Treatment D Treatment C1A Treatment C2A
Hide Arm/Group Description:
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
Overall Number of Participants Analyzed 110 108 110 109 33 30
Measure Type: Number
Unit of Measure: percentage of participants
ETR-LOQ 68.2 74.1 33.6 82.6 51.5 73.3
ETR-LOD 61.8 70.4 31.8 78.9 36.4 66.7
8.Secondary Outcome
Title Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End
Hide Description [Not Specified]
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the FAS For Efficacy with abnormal ALT at baseline and available data at the respective time point
Arm/Group Title Treatment A Treatment B Treatment C Treatment D Treatment C1A Treatment C2A
Hide Arm/Group Description:
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
Overall Number of Participants Analyzed 53 49 61 53 14 7
Measure Type: Number
Unit of Measure: percentage of participants
End of Treatment (n = 53,49,60,53,14,7) 77.4 77.6 59.0 83.0 35.7 28.6
End of Study (n = 49,42,18,46,13,6) 54.7 61.2 18.0 67.9 21.4 28.6
9.Secondary Outcome
Title Percentage of Participants With On-treatment Viral Breakthrough
Hide Description

On-treatment viral breakthrough was defined as either:

  • Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or
  • HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (< LOQ) during treatment
Time Frame within 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS For Efficacy
Arm/Group Title Treatment A Treatment B Treatment C Treatment D Treatment C1A Treatment C2A
Hide Arm/Group Description:
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
Overall Number of Participants Analyzed 110 108 110 109 33 30
Measure Type: Number
Unit of Measure: percentage of participants
12.7 9.3 5.5 2.8 6.1 10.0
10.Secondary Outcome
Title Percentage of Participants With Viral Relapse
Time Frame within 24 weeks after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS For Efficacy
Arm/Group Title Treatment A Treatment B Treatment C Treatment D Treatment C1A Treatment C2A
Hide Arm/Group Description:
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
Overall Number of Participants Analyzed 110 108 110 109 33 30
Measure Type: Number
Unit of Measure: percentage of participants
19.1 18.5 17.3 12.8 30.3 13.3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment A: On-treatment AEs Treatment B: On-treatment AEs Treatment C1: On-treatment AEs Treatment C2: On-treatment AEs Treatment D: On-treatment AEs Treatment A: Post-treatment AEs Treatment B: Post-treatment AEs Treatment C1: Post-treatment AEs Treatment C2: Post-treatment AEs Treatment D: Post-treatment AEs
Hide Arm/Group Description Adverse events (AEs) occurring while on treatment in participants receiving ALV 600 mg QD with PEG and RBV for up to 48 weeks. AEs occurring while on treatment in participants receiving ALV 800 mg QD with PEG and RBV for up to 48 weeks. AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 600 mg QD post-switch) with PEG and RBV for up to 48 weeks. AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 400 mg BID post-switch) with PEG and RBV for up to 48 weeks. AEs occurring while on treatment in participants receiving ALV 400 mg BID with PEG and RBV for up to 48 weeks. AEs occurring after end of treatment in participants receiving ALV 600 mg QD with PEG and RBV for up to 48 weeks. AEs occurring after end of treatment in participants receiving ALV 800 mg QD with PEG and RBV for up to 48 weeks. AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 600 mg QD post-switch) with PEG and RBV for up to 48 weeks. AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 400 mg BID post-switch) with PEG and RBV for up to 48 weeks. AEs occurring after end of treatment in participants receiving ALV 400 mg BID with PEG and RBV for up to 48 weeks.
All-Cause Mortality
Treatment A: On-treatment AEs Treatment B: On-treatment AEs Treatment C1: On-treatment AEs Treatment C2: On-treatment AEs Treatment D: On-treatment AEs Treatment A: Post-treatment AEs Treatment B: Post-treatment AEs Treatment C1: Post-treatment AEs Treatment C2: Post-treatment AEs Treatment D: Post-treatment AEs
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment A: On-treatment AEs Treatment B: On-treatment AEs Treatment C1: On-treatment AEs Treatment C2: On-treatment AEs Treatment D: On-treatment AEs Treatment A: Post-treatment AEs Treatment B: Post-treatment AEs Treatment C1: Post-treatment AEs Treatment C2: Post-treatment AEs Treatment D: Post-treatment AEs
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/120 (5.83%)   11/115 (9.57%)   5/59 (8.47%)   1/55 (1.82%)   18/108 (16.67%)   2/120 (1.67%)   4/115 (3.48%)   0/59 (0.00%)   0/55 (0.00%)   0/108 (0.00%) 
Blood and lymphatic system disorders                     
Anaemia  1  0/120 (0.00%)  2/115 (1.74%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Leukopenia  1  0/120 (0.00%)  0/115 (0.00%)  1/59 (1.69%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Neutropenia  1  0/120 (0.00%)  1/115 (0.87%)  1/59 (1.69%)  0/55 (0.00%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Thrombocytopenia  1  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Cardiac disorders                     
Cardiac failure  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Supraventricular tachycardia  1  1/120 (0.83%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Endocrine disorders                     
Hypopituitarism  1  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Gastrointestinal disorders                     
Abdominal pain  1  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Ascites  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Diarrhoea  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Nausea  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Pancreatitis acute  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Rectal haemorrhage  1  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Vomiting  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
General disorders                     
Chest discomfort  1  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Chest pain  1  1/120 (0.83%)  0/115 (0.00%)  1/59 (1.69%)  0/55 (0.00%)  2/108 (1.85%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Drug interaction  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Fatigue  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Multi-organ failure  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Pyrexia  1  1/120 (0.83%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Hepatobiliary disorders                     
Cholecystitis acute  1  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Cholelithiasis  1  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Hyperbilirubinaemia  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Infections and infestations                     
Appendicitis  1  0/120 (0.00%)  2/115 (1.74%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Arthritis viral  1  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Cystitis  1  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Ear infection  1  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Gastroenteritis viral  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Hepatitis C  1  1/120 (0.83%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Orchitis  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Osteomyelitis  1  1/120 (0.83%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Peritonitis  1  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Pneumonia  1  0/120 (0.00%)  0/115 (0.00%)  1/59 (1.69%)  0/55 (0.00%)  3/108 (2.78%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Pyelonephritis  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  1/120 (0.83%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Salpingitis  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Septic shock  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Urinary tract infection  1  1/120 (0.83%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Injury, poisoning and procedural complications                     
Contusion  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  1/120 (0.83%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Upper limb fracture  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Vascular pseudoaneurysm  1  1/120 (0.83%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Investigations                     
Alanine aminotransferase increased  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Metabolism and nutrition disorders                     
Hyperamylasaemia  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Hyperlipasaemia  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Hypoglycaemia  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Musculoskeletal and connective tissue disorders                     
Arthritis  1  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                     
Malignant melanoma  1  0/120 (0.00%)  0/115 (0.00%)  1/59 (1.69%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Non-small cell lung cancer stage I  1  1/120 (0.83%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Nervous system disorders                     
Dizziness  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Headache  1  1/120 (0.83%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Loss of consciousness  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  2/108 (1.85%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Syncope  1  1/120 (0.83%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Vertebrobasilar insufficiency  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  1/55 (1.82%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Psychiatric disorders                     
Disorientation  1  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Psychotic disorder  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Renal and urinary disorders                     
Renal failure  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%)  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Reproductive system and breast disorders                     
Endometriosis  1  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Respiratory, thoracic and mediastinal disorders                     
Chronic obstructive pulmonary disease  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Dyspnoea  1  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Pneumonitis  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Pulmonary mass  1  1/120 (0.83%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Respiratory distress  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Skin and subcutaneous tissue disorders                     
Psoriasis  1  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Rash erythematous  1  0/120 (0.00%)  0/115 (0.00%)  1/59 (1.69%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Vascular disorders                     
Hypertension  1  1/120 (0.83%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  2/108 (1.85%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Vena cava thrombosis  1  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment A: On-treatment AEs Treatment B: On-treatment AEs Treatment C1: On-treatment AEs Treatment C2: On-treatment AEs Treatment D: On-treatment AEs Treatment A: Post-treatment AEs Treatment B: Post-treatment AEs Treatment C1: Post-treatment AEs Treatment C2: Post-treatment AEs Treatment D: Post-treatment AEs
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   116/120 (96.67%)   108/115 (93.91%)   58/59 (98.31%)   54/55 (98.18%)   106/108 (98.15%)   22/120 (18.33%)   21/115 (18.26%)   13/59 (22.03%)   10/55 (18.18%)   19/108 (17.59%) 
Blood and lymphatic system disorders                     
Anaemia  1  49/120 (40.83%)  41/115 (35.65%)  24/59 (40.68%)  21/55 (38.18%)  51/108 (47.22%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  1/55 (1.82%)  0/108 (0.00%) 
Leukopenia  1  17/120 (14.17%)  13/115 (11.30%)  8/59 (13.56%)  6/55 (10.91%)  20/108 (18.52%)  0/120 (0.00%)  0/115 (0.00%)  3/59 (5.08%)  0/55 (0.00%)  0/108 (0.00%) 
Lymphopenia  1  5/120 (4.17%)  2/115 (1.74%)  4/59 (6.78%)  0/55 (0.00%)  8/108 (7.41%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%) 
Neutropenia  1  49/120 (40.83%)  40/115 (34.78%)  22/59 (37.29%)  16/55 (29.09%)  46/108 (42.59%)  0/120 (0.00%)  0/115 (0.00%)  2/59 (3.39%)  1/55 (1.82%)  0/108 (0.00%) 
Thrombocytopenia  1  24/120 (20.00%)  19/115 (16.52%)  4/59 (6.78%)  6/55 (10.91%)  28/108 (25.93%)  1/120 (0.83%)  0/115 (0.00%)  0/59 (0.00%)  1/55 (1.82%)  1/108 (0.93%) 
Cardiac disorders                     
Palpitations  1  11/120 (9.17%)  7/115 (6.09%)  3/59 (5.08%)  2/55 (3.64%)  2/108 (1.85%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Tachycardia  1  2/120 (1.67%)  1/115 (0.87%)  2/59 (3.39%)  3/55 (5.45%)  5/108 (4.63%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Ear and labyrinth disorders                     
Tinnitus  1  4/120 (3.33%)  4/115 (3.48%)  3/59 (5.08%)  3/55 (5.45%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Endocrine disorders                     
Hypothyroidism  1  7/120 (5.83%)  6/115 (5.22%)  2/59 (3.39%)  7/55 (12.73%)  14/108 (12.96%)  2/120 (1.67%)  0/115 (0.00%)  1/59 (1.69%)  1/55 (1.82%)  1/108 (0.93%) 
Eye disorders                     
Dry eye  1  7/120 (5.83%)  7/115 (6.09%)  3/59 (5.08%)  1/55 (1.82%)  3/108 (2.78%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Ocular icterus  1  5/120 (4.17%)  8/115 (6.96%)  1/59 (1.69%)  3/55 (5.45%)  14/108 (12.96%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  1/55 (1.82%)  0/108 (0.00%) 
Vision blurred  1  4/120 (3.33%)  8/115 (6.96%)  3/59 (5.08%)  1/55 (1.82%)  3/108 (2.78%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Gastrointestinal disorders                     
Abdominal distension  1  2/120 (1.67%)  5/115 (4.35%)  2/59 (3.39%)  2/55 (3.64%)  7/108 (6.48%)  1/120 (0.83%)  0/115 (0.00%)  1/59 (1.69%)  0/55 (0.00%)  2/108 (1.85%) 
Abdominal pain  1  9/120 (7.50%)  7/115 (6.09%)  7/59 (11.86%)  6/55 (10.91%)  6/108 (5.56%)  0/120 (0.00%)  0/115 (0.00%)  1/59 (1.69%)  0/55 (0.00%)  0/108 (0.00%) 
Abdominal pain upper  1  15/120 (12.50%)  8/115 (6.96%)  5/59 (8.47%)  5/55 (9.09%)  13/108 (12.04%)  0/120 (0.00%)  1/115 (0.87%)  2/59 (3.39%)  1/55 (1.82%)  0/108 (0.00%) 
Aphthous stomatitis  1  6/120 (5.00%)  3/115 (2.61%)  3/59 (5.08%)  2/55 (3.64%)  6/108 (5.56%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Cheilitis  1  1/120 (0.83%)  6/115 (5.22%)  2/59 (3.39%)  1/55 (1.82%)  3/108 (2.78%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Constipation  1  10/120 (8.33%)  7/115 (6.09%)  2/59 (3.39%)  5/55 (9.09%)  15/108 (13.89%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Diarrhoea  1  19/120 (15.83%)  18/115 (15.65%)  11/59 (18.64%)  9/55 (16.36%)  10/108 (9.26%)  0/120 (0.00%)  0/115 (0.00%)  2/59 (3.39%)  0/55 (0.00%)  0/108 (0.00%) 
Dry mouth  1  15/120 (12.50%)  10/115 (8.70%)  5/59 (8.47%)  8/55 (14.55%)  10/108 (9.26%)  1/120 (0.83%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Dyspepsia  1  15/120 (12.50%)  4/115 (3.48%)  5/59 (8.47%)  2/55 (3.64%)  15/108 (13.89%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Haemorrhoids  1  2/120 (1.67%)  1/115 (0.87%)  2/59 (3.39%)  3/55 (5.45%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  1/59 (1.69%)  0/55 (0.00%)  0/108 (0.00%) 
Mouth ulceration  1  7/120 (5.83%)  10/115 (8.70%)  3/59 (5.08%)  5/55 (9.09%)  3/108 (2.78%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Nausea  1  46/120 (38.33%)  35/115 (30.43%)  17/59 (28.81%)  17/55 (30.91%)  51/108 (47.22%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%) 
Toothache  1  3/120 (2.50%)  3/115 (2.61%)  3/59 (5.08%)  1/55 (1.82%)  2/108 (1.85%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Vomiting  1  19/120 (15.83%)  18/115 (15.65%)  7/59 (11.86%)  9/55 (16.36%)  19/108 (17.59%)  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
General disorders                     
Asthenia  1  19/120 (15.83%)  30/115 (26.09%)  9/59 (15.25%)  14/55 (25.45%)  17/108 (15.74%)  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Chest pain  1  3/120 (2.50%)  4/115 (3.48%)  2/59 (3.39%)  6/55 (10.91%)  4/108 (3.70%)  1/120 (0.83%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Chills  1  14/120 (11.67%)  13/115 (11.30%)  6/59 (10.17%)  5/55 (9.09%)  14/108 (12.96%)  1/120 (0.83%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Fatigue  1  47/120 (39.17%)  45/115 (39.13%)  25/59 (42.37%)  27/55 (49.09%)  45/108 (41.67%)  1/120 (0.83%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%) 
Influenza like illness  1  13/120 (10.83%)  10/115 (8.70%)  15/59 (25.42%)  6/55 (10.91%)  11/108 (10.19%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Injection site erythema  1  8/120 (6.67%)  11/115 (9.57%)  5/59 (8.47%)  3/55 (5.45%)  3/108 (2.78%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Injection site rash  1  1/120 (0.83%)  1/115 (0.87%)  4/59 (6.78%)  1/55 (1.82%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Irritability  1  8/120 (6.67%)  7/115 (6.09%)  3/59 (5.08%)  3/55 (5.45%)  6/108 (5.56%)  0/120 (0.00%)  0/115 (0.00%)  1/59 (1.69%)  0/55 (0.00%)  0/108 (0.00%) 
Malaise  1  9/120 (7.50%)  8/115 (6.96%)  2/59 (3.39%)  2/55 (3.64%)  9/108 (8.33%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Pyrexia  1  32/120 (26.67%)  34/115 (29.57%)  18/59 (30.51%)  18/55 (32.73%)  28/108 (25.93%)  1/120 (0.83%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Hepatobiliary disorders                     
Hyperbilirubinaemia  1  19/120 (15.83%)  14/115 (12.17%)  4/59 (6.78%)  6/55 (10.91%)  36/108 (33.33%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Jaundice  1  14/120 (11.67%)  11/115 (9.57%)  5/59 (8.47%)  6/55 (10.91%)  18/108 (16.67%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Infections and infestations                     
Nasopharyngitis  1  6/120 (5.00%)  5/115 (4.35%)  1/59 (1.69%)  3/55 (5.45%)  4/108 (3.70%)  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  3/108 (2.78%) 
Oral herpes  1  4/120 (3.33%)  7/115 (6.09%)  2/59 (3.39%)  0/55 (0.00%)  3/108 (2.78%)  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Pharyngitis  1  4/120 (3.33%)  3/115 (2.61%)  2/59 (3.39%)  2/55 (3.64%)  6/108 (5.56%)  1/120 (0.83%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Upper respiratory tract infection  1  12/120 (10.00%)  5/115 (4.35%)  3/59 (5.08%)  6/55 (10.91%)  6/108 (5.56%)  1/120 (0.83%)  0/115 (0.00%)  2/59 (3.39%)  1/55 (1.82%)  1/108 (0.93%) 
Urinary tract infection  1  7/120 (5.83%)  2/115 (1.74%)  4/59 (6.78%)  3/55 (5.45%)  9/108 (8.33%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%) 
Investigations                     
Aspartate aminotransferase increased  1  6/120 (5.00%)  1/115 (0.87%)  1/59 (1.69%)  1/55 (1.82%)  3/108 (2.78%)  1/120 (0.83%)  2/115 (1.74%)  0/59 (0.00%)  1/55 (1.82%)  2/108 (1.85%) 
Lipase increased  1  2/120 (1.67%)  1/115 (0.87%)  4/59 (6.78%)  2/55 (3.64%)  5/108 (4.63%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Total bile acids increased  1  5/120 (4.17%)  3/115 (2.61%)  3/59 (5.08%)  1/55 (1.82%)  8/108 (7.41%)  0/120 (0.00%)  0/115 (0.00%)  1/59 (1.69%)  0/55 (0.00%)  0/108 (0.00%) 
Weight decreased  1  9/120 (7.50%)  9/115 (7.83%)  3/59 (5.08%)  4/55 (7.27%)  9/108 (8.33%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%) 
Metabolism and nutrition disorders                     
Decreased appetite  1  31/120 (25.83%)  23/115 (20.00%)  9/59 (15.25%)  12/55 (21.82%)  26/108 (24.07%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Hypertriglyceridaemia  1  16/120 (13.33%)  21/115 (18.26%)  4/59 (6.78%)  3/55 (5.45%)  18/108 (16.67%)  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%) 
Musculoskeletal and connective tissue disorders                     
Arthralgia  1  19/120 (15.83%)  19/115 (16.52%)  8/59 (13.56%)  8/55 (14.55%)  9/108 (8.33%)  2/120 (1.67%)  1/115 (0.87%)  1/59 (1.69%)  0/55 (0.00%)  4/108 (3.70%) 
Back pain  1  20/120 (16.67%)  5/115 (4.35%)  4/59 (6.78%)  6/55 (10.91%)  10/108 (9.26%)  2/120 (1.67%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%) 
Muscle spasms  1  14/120 (11.67%)  12/115 (10.43%)  3/59 (5.08%)  5/55 (9.09%)  17/108 (15.74%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Myalgia  1  23/120 (19.17%)  21/115 (18.26%)  16/59 (27.12%)  13/55 (23.64%)  18/108 (16.67%)  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Neck pain  1  4/120 (3.33%)  1/115 (0.87%)  3/59 (5.08%)  3/55 (5.45%)  3/108 (2.78%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Osteopenia  1  5/120 (4.17%)  6/115 (5.22%)  0/59 (0.00%)  2/55 (3.64%)  6/108 (5.56%)  2/120 (1.67%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%) 
Pain in extremity  1  7/120 (5.83%)  5/115 (4.35%)  3/59 (5.08%)  1/55 (1.82%)  5/108 (4.63%)  1/120 (0.83%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%) 
Nervous system disorders                     
Disturbance in attention  1  9/120 (7.50%)  10/115 (8.70%)  3/59 (5.08%)  5/55 (9.09%)  4/108 (3.70%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%) 
Dizziness  1  20/120 (16.67%)  22/115 (19.13%)  11/59 (18.64%)  8/55 (14.55%)  15/108 (13.89%)  0/120 (0.00%)  1/115 (0.87%)  1/59 (1.69%)  2/55 (3.64%)  4/108 (3.70%) 
Dysgeusia  1  5/120 (4.17%)  7/115 (6.09%)  4/59 (6.78%)  5/55 (9.09%)  9/108 (8.33%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Headache  1  59/120 (49.17%)  47/115 (40.87%)  24/59 (40.68%)  22/55 (40.00%)  38/108 (35.19%)  2/120 (1.67%)  2/115 (1.74%)  1/59 (1.69%)  0/55 (0.00%)  0/108 (0.00%) 
Hypoaesthesia  1  6/120 (5.00%)  2/115 (1.74%)  1/59 (1.69%)  1/55 (1.82%)  2/108 (1.85%)  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  1/55 (1.82%)  0/108 (0.00%) 
Memory impairment  1  5/120 (4.17%)  4/115 (3.48%)  2/59 (3.39%)  6/55 (10.91%)  3/108 (2.78%)  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%) 
Psychiatric disorders                     
Anxiety  1  19/120 (15.83%)  8/115 (6.96%)  4/59 (6.78%)  5/55 (9.09%)  11/108 (10.19%)  2/120 (1.67%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%) 
Depressed mood  1  3/120 (2.50%)  4/115 (3.48%)  3/59 (5.08%)  0/55 (0.00%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Depression  1  22/120 (18.33%)  14/115 (12.17%)  10/59 (16.95%)  7/55 (12.73%)  13/108 (12.04%)  0/120 (0.00%)  2/115 (1.74%)  1/59 (1.69%)  1/55 (1.82%)  0/108 (0.00%) 
Insomnia  1  35/120 (29.17%)  24/115 (20.87%)  11/59 (18.64%)  19/55 (34.55%)  17/108 (15.74%)  1/120 (0.83%)  2/115 (1.74%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%) 
Nervousness  1  1/120 (0.83%)  1/115 (0.87%)  2/59 (3.39%)  4/55 (7.27%)  2/108 (1.85%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Restlessness  1  7/120 (5.83%)  4/115 (3.48%)  2/59 (3.39%)  4/55 (7.27%)  1/108 (0.93%)  1/120 (0.83%)  0/115 (0.00%)  1/59 (1.69%)  0/55 (0.00%)  0/108 (0.00%) 
Sleep disorder  1  2/120 (1.67%)  4/115 (3.48%)  4/59 (6.78%)  1/55 (1.82%)  2/108 (1.85%)  0/120 (0.00%)  0/115 (0.00%)  2/59 (3.39%)  0/55 (0.00%)  0/108 (0.00%) 
Suspiciousness  1  1/120 (0.83%)  4/115 (3.48%)  1/59 (1.69%)  3/55 (5.45%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Respiratory, thoracic and mediastinal disorders                     
Cough  1  38/120 (31.67%)  29/115 (25.22%)  18/59 (30.51%)  17/55 (30.91%)  16/108 (14.81%)  2/120 (1.67%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%) 
Dry throat  1  0/120 (0.00%)  1/115 (0.87%)  3/59 (5.08%)  0/55 (0.00%)  1/108 (0.93%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Dyspnoea  1  21/120 (17.50%)  8/115 (6.96%)  6/59 (10.17%)  5/55 (9.09%)  16/108 (14.81%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Dyspnoea exertional  1  6/120 (5.00%)  9/115 (7.83%)  3/59 (5.08%)  6/55 (10.91%)  8/108 (7.41%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Epistaxis  1  5/120 (4.17%)  3/115 (2.61%)  4/59 (6.78%)  2/55 (3.64%)  10/108 (9.26%)  1/120 (0.83%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Oropharyngeal pain  1  9/120 (7.50%)  8/115 (6.96%)  5/59 (8.47%)  4/55 (7.27%)  8/108 (7.41%)  1/120 (0.83%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Skin and subcutaneous tissue disorders                     
Alopecia  1  22/120 (18.33%)  23/115 (20.00%)  10/59 (16.95%)  9/55 (16.36%)  19/108 (17.59%)  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%) 
Blister  1  1/120 (0.83%)  0/115 (0.00%)  3/59 (5.08%)  0/55 (0.00%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Dermatitis  1  3/120 (2.50%)  2/115 (1.74%)  3/59 (5.08%)  2/55 (3.64%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Dry skin  1  15/120 (12.50%)  16/115 (13.91%)  11/59 (18.64%)  12/55 (21.82%)  16/108 (14.81%)  1/120 (0.83%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Erythema  1  6/120 (5.00%)  7/115 (6.09%)  0/59 (0.00%)  0/55 (0.00%)  5/108 (4.63%)  0/120 (0.00%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Hyperhidrosis  1  2/120 (1.67%)  1/115 (0.87%)  5/59 (8.47%)  2/55 (3.64%)  3/108 (2.78%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  1/55 (1.82%)  0/108 (0.00%) 
Pruritus  1  36/120 (30.00%)  30/115 (26.09%)  21/59 (35.59%)  17/55 (30.91%)  32/108 (29.63%)  2/120 (1.67%)  2/115 (1.74%)  1/59 (1.69%)  1/55 (1.82%)  0/108 (0.00%) 
Rash  1  23/120 (19.17%)  22/115 (19.13%)  15/59 (25.42%)  9/55 (16.36%)  17/108 (15.74%)  3/120 (2.50%)  2/115 (1.74%)  1/59 (1.69%)  0/55 (0.00%)  0/108 (0.00%) 
Skin lesion  1  0/120 (0.00%)  2/115 (1.74%)  0/59 (0.00%)  3/55 (5.45%)  0/108 (0.00%)  0/120 (0.00%)  0/115 (0.00%)  0/59 (0.00%)  0/55 (0.00%)  0/108 (0.00%) 
Vascular disorders                     
Hypertension  1  21/120 (17.50%)  22/115 (19.13%)  5/59 (8.47%)  11/55 (20.00%)  28/108 (25.93%)  2/120 (1.67%)  1/115 (0.87%)  0/59 (0.00%)  0/55 (0.00%)  1/108 (0.93%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
In April 2012, ALV and placebo were discontinued in all participants. Participants remained on PEG and RBV treatment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President Clinical Research & Development
Organization: Debiopharm International S.A.
Phone: 4121 321 01 11
EMail: info-international@debiopharm.com
Layout table for additonal information
Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT01183169     History of Changes
Other Study ID Numbers: CDEB025A2210
2010-020033-14 ( EudraCT Number )
First Submitted: August 16, 2010
First Posted: August 17, 2010
Results First Submitted: July 14, 2016
Results First Posted: August 25, 2016
Last Update Posted: August 25, 2016