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Observational Study Evaluating the Quality of Pegylated Interferon Alfa-2a and Ribavirin Treatment for Chronic Hepatitis C in Cooperation With the BNG (Association of German Resident Gastroenterologists)

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ClinicalTrials.gov Identifier: NCT02106156
Recruitment Status : Completed
First Posted : April 8, 2014
Results First Posted : September 23, 2016
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Chronic Hepatitis C
Interventions Drug: Pegylated interferon alfa-2a
Drug: Ribavirin
Enrollment 10228
Recruitment Details  
Pre-assignment Details Per protocol participants were not allocated to study arms. Separation of participants was performed post hoc for all analyses. Participants who underwent elastography were allocated to separate arms as another time schedule was used and also untreated participants were documented, who were analyzed separately from treated participants.
Arm/Group Title Main Analysis Set Elastography Analysis Set: Treated Elastography Analysis Set: Untreated
Hide Arm/Group Description Participants with chronic hepatitis C (CHC) treated with pegylated interferon (peginterferon) alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding summary of product characteristics (SmPC). Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with hepatitis C virus (HCV) treatment as indicated. The untreated elastography analysis set includes those participants with CHC, who underwent elastography, were documented in the fibroscan module and were not treated with HCV treatment.
Period Title: Overall Study
Started 9620 90 518
Completed 7071 50 518
Not Completed 2549 40 0
Reason Not Completed
Patient Died             19             0             0
Lack of Tolerability             305             3             0
Lack of Virological Response             1044             8             0
Concomitant Disease             74             2             0
Lack of Compliance             211             7             0
Patients Request             307             9             0
Lost to Follow-up             451             8             0
Unplanned Event             82             2             0
Change of Laboratory Parameter             10             0             0
Hospitalization/Surgical Intervention             6             0             0
Relocation/Change of Physician             40             1             0
Arm/Group Title Main Analysis Set Elastography Analysis Set: Treated Elastography Analysis Set: Untreated Total
Hide Arm/Group Description Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC. Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated. The untreated elastography analysis set includes those participants with CHC, who underwent elastography, were documented in the fibroscan module and were not treated with HCV treatment. Total of all reporting groups
Overall Number of Baseline Participants 9620 90 518 10228
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9620 participants 90 participants 518 participants 10228 participants
42.2  (11.4) 44.9  (10.5) 51.1  (12.8) 42.6  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9620 participants 90 participants 518 participants 10228 participants
Female
3273
  34.0%
23
  25.6%
217
  41.9%
3513
  34.3%
Male
6347
  66.0%
67
  74.4%
301
  58.1%
6715
  65.7%
Number of Participants With Each Hepatitis C Viral Genotype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9620 participants 90 participants 518 participants 10228 participants
Genotype 1 5699 51 377 6127
Genotype 2 544 3 11 558
Genotype 3 2903 30 89 3022
Genotype 4 421 6 18 445
Genotype 5 17 0 2 19
Genotype 6 15 0 1 16
Genotype unknown 21 0 20 41
Number of Participants With Low or High Viral Load   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9620 participants 90 participants 518 participants 10228 participants
Low viral load 3769 24 139 3932
High viral load 5771 66 356 6193
Not determined/not assessable 80 0 23 103
[1]
Measure Description: Low viral load was defined as </=1,000,000 copies/milliliter (copies/ml) or </=400,000 international units/milliliter (IU/ml). High viral load was defined as >1,000,000 copies/ml or >400,000 IU/ml.
1.Primary Outcome
Title Percentage of Participants With Rapid Virologic Response (RVR)
Hide Description RVR is defined as Hepatitis C-Virus (HCV) Polymerase Chain Reaction (PCR) assay result qualitatively negative and/or viral load ≤50 International Units/milliliter (IU/ml) at Week 4.
Time Frame At Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Only treated participants were analyzed for this Outcome Measure. In each analysis set only those participants were included for whom a valid HCV PCR result was available or who discontinued from treatment before Week 4.
Arm/Group Title Main Analysis Set Elastography Analysis Set: Treated
Hide Arm/Group Description:
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
Overall Number of Participants Analyzed 6442 60
Measure Type: Number
Unit of Measure: percentage of participants
40.0 41.7
2.Primary Outcome
Title Percentage of Participants With Early Virologic Response (EVR)
Hide Description EVR is defined as HCV-PCR assay result qualitatively negative and/or decline of viral load of ≥2 log levels and/or viral load ≤50 IU/ml at Week 12.
Time Frame At Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Only treated participants were analyzed for this Outcome Measure. In each analysis set only those participants were included for whom a valid HCV PCR result was available or who discontinued from treatment before Week 12.
Arm/Group Title Main Analysis Set Elastography Analysis Set: Treated
Hide Arm/Group Description:
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
Overall Number of Participants Analyzed 7383 54
Measure Type: Number
Unit of Measure: percentage of participants
71.2 77.8
3.Primary Outcome
Title Percentage of Participants With End of Treatment (EOT) Response
Hide Description EOT Response is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at the end of treatment.
Time Frame Up to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Only treated participants were analyzed for this Outcome Measure. All participants within each analysis set were included in the analysis.
Arm/Group Title Main Analysis Set Elastography Analysis Set: Treated
Hide Arm/Group Description:
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
Overall Number of Participants Analyzed 9620 90
Measure Type: Number
Unit of Measure: percentage of participants
59.2 51.1
4.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response (SVR)
Hide Description SVR is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at least 12 weeks after the end of treatment at follow up. Follow-up visit occurred at 12 to 24 weeks following discontinuation of treatment.
Time Frame Up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Only treated participants were analyzed for this Outcome Measure. All participants within each analysis set were included in the analysis.
Arm/Group Title Main Analysis Set Elastography Analysis Set: Treated
Hide Arm/Group Description:
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
Overall Number of Participants Analyzed 9620 90
Measure Type: Number
Unit of Measure: percentage of participants
41.4 36.7
5.Primary Outcome
Title Percentage of Participants With Serious Adverse Drug Reactions (SADR)
Hide Description [Not Specified]
Time Frame Up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Only treated participants were analyzed for this Outcome Measure. All participants within each analysis set were included in the analysis.
Arm/Group Title Main Analysis Set Elastography Analysis Set: Treated
Hide Arm/Group Description:
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
Overall Number of Participants Analyzed 9620 90
Measure Type: Number
Unit of Measure: percentage of participants
3.5 3.3
6.Secondary Outcome
Title Percentage Cumulative Dose of Peginterferon Alfa-2a Received
Hide Description Data for the accumulation of the cumulative dose of peginterferon alfa-2a were analyzed and reported as the percentage of the intended dose participants received. Cumulative doses were evaluated for participants for whom dosage data were documented consistently throughout the observational period. If the treatment was ongoing at the study end, the cumulative dose was aggregated for the documented observational period.
Time Frame Up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Only treated participants were analyzed for this Outcome Measure. Only participants with evaluable data for this Outcome Measure were included in the analysis.
Arm/Group Title Main Analysis Set Elastography Analysis Set: Treated
Hide Arm/Group Description:
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
Overall Number of Participants Analyzed 9005 90
Median (Full Range)
Unit of Measure: percentage of cumulated dose
97.9
(1.04 to 400.00)
94.8
(4.17 to 350.00)
7.Secondary Outcome
Title Percentage Cumulative Dose of Ribavirin Received
Time Frame Up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Only treated participants were analyzed for this Outcome Measure. Only participants with evaluable data for this Outcome Measure were included in the analysis.
Arm/Group Title Main Analysis Set Elastography Analysis Set: Treated
Hide Arm/Group Description:
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
Overall Number of Participants Analyzed 8971 89
Median (Full Range)
Unit of Measure: percentage of cumulated dose
100.00
(0.00 to 500.00)
97.92
(8.33 to 480.21)
8.Secondary Outcome
Title Duration of Peginterferon Alfa-2a Therapy
Hide Description Treatment duration was evaluated for participants for whom dates of treatment start and end of therapy were documented.
Time Frame Up to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Only treated participants were analyzed for this Outcome Measure. Only participants with evaluable data for this Outcome Measure were included in the analysis.
Arm/Group Title Main Analysis Set Elastography Analysis Set: Treated
Hide Arm/Group Description:
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
Overall Number of Participants Analyzed 8993 90
Median (Full Range)
Unit of Measure: weeks
27.3
(1.0 to 106.1)
29.3
(1.1 to 84.1)
9.Secondary Outcome
Title Percentage of Participants With the Most Frequent Concomitant Medications
Hide Description Most frequent concomitant medications were defined as those, which were observed in >1 % of participants.
Time Frame At Baseline (Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Only main analysis set had evaluable data for this outcome measure.
Arm/Group Title Main Analysis Set
Hide Arm/Group Description:
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
Overall Number of Participants Analyzed 9620
Measure Type: Number
Unit of Measure: percentage of participants
Anilides 10.6
Selective serotonin reuptake inhibitors 9.9
Proton pump inhibitors 5.3
Propionic acid derivatives 4.7
Propulsives 2.3
Other antidepressants 2.3
Angiotensin-converting-enzyme (ACE) inhibitors 2.0
Thyroid hormones 1.8
Corticosteroids, potent (group III) 1.7
Benzodiazepine related drugs 1.5
Pyrazolones 1.4
Beta blocking agents, selective 1.3
Non-selective monoamine reuptake inhibitors 1.2
Time Frame Up to Week 96
Adverse Event Reporting Description The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
 
Arm/Group Title Main Analysis Set Elastography Analysis Set: Treated Elastography Analysis Set: Untreated
Hide Arm/Group Description Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC. Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those, who were treated with HCV treatment as indicated. Participants with CHC in the untreated elastography analysis set includes those participants, who underwent elastography, were documented in the fibroscan module and were not treated with HCV treatment.
All-Cause Mortality
Main Analysis Set Elastography Analysis Set: Treated Elastography Analysis Set: Untreated
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Main Analysis Set Elastography Analysis Set: Treated Elastography Analysis Set: Untreated
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   439/9620 (4.56%)   4/90 (4.44%)   0/518 (0.00%) 
Blood and lymphatic system disorders       
Anaemia  1  35/9620 (0.36%)  0/90 (0.00%)  0/518 (0.00%) 
Anaemia macrocytic  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Autoimmune thrombocytopenia  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Granulocytopenia  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Haematotoxicity  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Haemolysis  1  6/9620 (0.06%)  0/90 (0.00%)  0/518 (0.00%) 
Haemorrhagic diathesis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Leukopenia  1  14/9620 (0.15%)  0/90 (0.00%)  0/518 (0.00%) 
Neutropenia  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Normochromic normocytic anaemia  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Pancytopenia  1  8/9620 (0.08%)  1/90 (1.11%)  0/518 (0.00%) 
Thrombocytopenia  1  17/9620 (0.18%)  0/90 (0.00%)  0/518 (0.00%) 
Cardiac disorders       
Acute myocardial infarction  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Angina pectoris  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Arrhythmia  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Arteriospasm coronary  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Atrial fibrillation  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Cardiac failure  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Cardiac perforation  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Cardiomyopathy  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Cardiopulmonary failure  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Coronary artery disease  1  3/9620 (0.03%)  0/90 (0.00%)  0/518 (0.00%) 
Myocardial infarction  1  5/9620 (0.05%)  0/90 (0.00%)  0/518 (0.00%) 
Palpitations  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Pericarditis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Supraventricular tachycardia  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Tachycardia  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Congenital, familial and genetic disorders       
Factor VIII deficiency  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Intestinal atresia  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Ear and labyrinth disorders       
Middle ear inflammation  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Ossicle disorder  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Sudden hearing loss  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Endocrine disorders       
Basedow's disease  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Hyperthyroidism  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Hypothyroidism  1  4/9620 (0.04%)  0/90 (0.00%)  0/518 (0.00%) 
Eye disorders       
Eyelid oedema  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Retinal disorder  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Gastrointestinal disorders       
Abdominal discomfort  1  5/9620 (0.05%)  0/90 (0.00%)  0/518 (0.00%) 
Abdominal pain  1  3/9620 (0.03%)  0/90 (0.00%)  0/518 (0.00%) 
Anal fistula  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Anal haemorrhage  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Ascites  1  6/9620 (0.06%)  0/90 (0.00%)  0/518 (0.00%) 
Diarrhoea  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Gastric ulcer  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Gastritis  1  3/9620 (0.03%)  0/90 (0.00%)  0/518 (0.00%) 
Gastrointestinal haemorrhage  1  3/9620 (0.03%)  0/90 (0.00%)  0/518 (0.00%) 
Gastrointestinal pain  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Gastrooesophageal reflux disease  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Haematemesis  1  3/9620 (0.03%)  0/90 (0.00%)  0/518 (0.00%) 
Haematochezia  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Ileus  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Inguinal hernia  1  3/9620 (0.03%)  0/90 (0.00%)  0/518 (0.00%) 
Intestinal infarction  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Intestinal perforation  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Melaena  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Nausea  1  6/9620 (0.06%)  0/90 (0.00%)  0/518 (0.00%) 
Oesophageal varices haemorrhage  1  4/9620 (0.04%)  0/90 (0.00%)  0/518 (0.00%) 
Pancreatitis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Periodontitis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Teeth brittle  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Tooth loss  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Vomiting  1  4/9620 (0.04%)  0/90 (0.00%)  0/518 (0.00%) 
General disorders       
Asthenia  1  3/9620 (0.03%)  0/90 (0.00%)  0/518 (0.00%) 
Chest pain  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Chills  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Death  1  4/9620 (0.04%)  0/90 (0.00%)  0/518 (0.00%) 
Disease progression  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Drug ineffective  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Fatigue  1  5/9620 (0.05%)  0/90 (0.00%)  0/518 (0.00%) 
General physical health deterioration  1  5/9620 (0.05%)  0/90 (0.00%)  0/518 (0.00%) 
Generalised oedema  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Granuloma  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Influenza like illness  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
No therapeutic response  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Pyrexia  1  8/9620 (0.08%)  0/90 (0.00%)  0/518 (0.00%) 
Serositis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Sudden cardiac death  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Hepatobiliary disorders       
Acute hepatic failure  1  3/9620 (0.03%)  0/90 (0.00%)  0/518 (0.00%) 
Autoimmune hepatitis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Cholangitis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Cholecystitis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Cholelithiasis  1  3/9620 (0.03%)  0/90 (0.00%)  0/518 (0.00%) 
Hepatic artery occlusion  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Hepatic cirrhosis  1  3/9620 (0.03%)  0/90 (0.00%)  0/518 (0.00%) 
Hepatic failure  1  3/9620 (0.03%)  0/90 (0.00%)  0/518 (0.00%) 
Hepatic function abnormal  1  4/9620 (0.04%)  0/90 (0.00%)  0/518 (0.00%) 
Hydrocholecystis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Jaundice  1  5/9620 (0.05%)  0/90 (0.00%)  0/518 (0.00%) 
Immune system disorders       
Decreased immune responsiveness  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Sarcoidosis  1  3/9620 (0.03%)  0/90 (0.00%)  0/518 (0.00%) 
Infections and infestations       
Abscess  1  3/9620 (0.03%)  0/90 (0.00%)  0/518 (0.00%) 
Abscess jaw  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Anal abscess  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Appendicitis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Bronchopneumonia  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Cellulitis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Cytomegalovirus chorioretinitis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Device related infection  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Diverticulitis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Empyema  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Endocarditis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Enterocolitis infectious  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Febrile infection  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Furuncle  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Gastroenteritis  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Gastrointestinal infection  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Groin abscess  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Hepatitis C  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Herpes zoster  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
HIV infection  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Infection  1  6/9620 (0.06%)  0/90 (0.00%)  0/518 (0.00%) 
Infectious pleural effusion  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Infective exacerbation of chronic obstructive airways disease  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Injection site abscess  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Intervertebral discitis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Laryngitis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Latent tuberculosis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Malaria  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Nasal vestibulitis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Oropharyngeal candidiasis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Otitis media  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Pilonidal cyst  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Pneumonia  1  27/9620 (0.28%)  1/90 (1.11%)  0/518 (0.00%) 
Pneumonia bacterial  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Pneumonia fungal  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Pneumonia pneumococcal  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Pulmonary tuberculosis  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Pyelonephritis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Sepsis  1  6/9620 (0.06%)  0/90 (0.00%)  0/518 (0.00%) 
Septic shock  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Tuberculosis  1  5/9620 (0.05%)  0/90 (0.00%)  0/518 (0.00%) 
Urinary tract infection  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Urosepsis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Injury, poisoning and procedural complications       
Accident  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Accident at home  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Alcohol poisoning  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Ankle fracture  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Concussion  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Craniocerebral injury  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Fall  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Foot fracture  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Fracture  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Head injury  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Injury  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Laceration  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Overdose  1  6/9620 (0.06%)  0/90 (0.00%)  0/518 (0.00%) 
Road traffic accident  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Shunt stenosis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Tendon rupture  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Therapeutic agent toxicity  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Toxicity to various agents  1  4/9620 (0.04%)  0/90 (0.00%)  0/518 (0.00%) 
Transfusion reaction  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Investigations       
Alanine aminotransferase increased  1  5/9620 (0.05%)  0/90 (0.00%)  0/518 (0.00%) 
Aspartate aminotransferase increased  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Bilirubin conjugated increased  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Biopsy liver  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Blood bilirubin increased  1  3/9620 (0.03%)  0/90 (0.00%)  0/518 (0.00%) 
Blood cholinesterase decreased  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Blood count abnormal  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Blood creatinine increased  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Blood glucose fluctuation  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Blood glucose increased  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Blood urea increased  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Electrocardiogram change  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Gamma-glutamyltransferase increased  1  4/9620 (0.04%)  0/90 (0.00%)  0/518 (0.00%) 
Haemoglobin decreased  1  17/9620 (0.18%)  0/90 (0.00%)  0/518 (0.00%) 
Heart rate increased  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Hepatitis C RNA increased  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Lymphocyte count decreased  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Platelet count decreased  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Prothrombin time prolonged  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Renal function test abnormal  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Transaminases increased  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Viral load increased  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Waist circumference increased  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Weight decreased  1  4/9620 (0.04%)  0/90 (0.00%)  0/518 (0.00%) 
White blood cell count decreased  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Metabolism and nutrition disorders       
Cachexia  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Decreased appetite  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Dehydration  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Diabetes mellitus inadequate control  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Bursa disorder  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Intervertebral disc protrusion  1  3/9620 (0.03%)  0/90 (0.00%)  0/518 (0.00%) 
Muscle oedema  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Muscle spasms  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Musculoskeletal pain  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Tenosynovitis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bladder cancer  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Breast cancer  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Burkitt's lymphoma  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Cholesteatoma  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Germ cell cancer  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Hepatic neoplasm  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Hepatic neoplasm malignant  1  4/9620 (0.04%)  0/90 (0.00%)  0/518 (0.00%) 
Hepatic neoplasm malignant recurrent  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Hepatic neoplasm malignant resectable  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Lymphoma  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Mycosis fungoides  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Neoplasm  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Pancreatic carcinoma  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Seminoma  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Testis cancer  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Nervous system disorders       
Altered state of consciousness  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Aphasia  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Brain stem infarction  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Carotid artery occlusion  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Cerebral haemorrhage  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Cerebral ischaemia  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Cerebrovascular accident  1  4/9620 (0.04%)  0/90 (0.00%)  0/518 (0.00%) 
Coma  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Convulsion  1  3/9620 (0.03%)  0/90 (0.00%)  0/518 (0.00%) 
Cubital tunnel syndrome  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Dementia  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Dizziness  1  3/9620 (0.03%)  0/90 (0.00%)  0/518 (0.00%) 
Dysarthria  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Encephalopathy  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Facial paresis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Haemorrhage intracranial  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Headache  1  3/9620 (0.03%)  0/90 (0.00%)  0/518 (0.00%) 
Hemianopia  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Hepatic encephalopathy  1  3/9620 (0.03%)  0/90 (0.00%)  0/518 (0.00%) 
Hyperaesthesia  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Hypoaesthesia  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Intercostal neuralgia  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Loss of consciousness  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Multiple sclerosis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Nervous system disorder  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Paraesthesia  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Polyneuropathy  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Syncope  1  4/9620 (0.04%)  0/90 (0.00%)  0/518 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
Pregnancy  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Psychiatric disorders       
Acute psychosis  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Aggression  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Alcohol abuse  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Alcohol problem  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Alcohol withdrawal syndrome  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Alcoholism  1  10/9620 (0.10%)  0/90 (0.00%)  0/518 (0.00%) 
Anger  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Anxiety  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Completed suicide  1  3/9620 (0.03%)  0/90 (0.00%)  0/518 (0.00%) 
Confusional state  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Delirium  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Dependence  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Depressed mood  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Depression  1  20/9620 (0.21%)  0/90 (0.00%)  0/518 (0.00%) 
Drug dependence  1  8/9620 (0.08%)  0/90 (0.00%)  0/518 (0.00%) 
Psychotic disorder  1  17/9620 (0.18%)  1/90 (1.11%)  0/518 (0.00%) 
Schizophrenia  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Sleep disorder  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Suicidal ideation  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Suicide attempt  1  5/9620 (0.05%)  0/90 (0.00%)  0/518 (0.00%) 
Renal and urinary disorders       
Calculus ureteric  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Renal failure  1  3/9620 (0.03%)  0/90 (0.00%)  0/518 (0.00%) 
Renal failure acute  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Urinary retention  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Reproductive system and breast disorders       
Breast induration  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Breast pain  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Endometriosis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Scrotal ulcer  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Vaginal haemorrhage  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  5/9620 (0.05%)  0/90 (0.00%)  0/518 (0.00%) 
Cough  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Dyspnoea  1  5/9620 (0.05%)  0/90 (0.00%)  0/518 (0.00%) 
Emphysema  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Epistaxis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Haemoptysis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Interstitial lung disease  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Lung disorder  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Nasal polyps  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Obstructive airways disorder  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Painful respiration  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Pleural effusion  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Pleurisy  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Pulmonary embolism  1  5/9620 (0.05%)  0/90 (0.00%)  0/518 (0.00%) 
Pulmonary fibrosis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Respiratory failure  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Skin and subcutaneous tissue disorders       
Eczema  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Erythrodermic psoriasis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Pruritus  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Psoriasis  1  3/9620 (0.03%)  0/90 (0.00%)  0/518 (0.00%) 
Rash  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Rash generalised  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Skin discomfort  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Skin disorder  1  5/9620 (0.05%)  0/90 (0.00%)  0/518 (0.00%) 
Social circumstances       
Drug abuse  1  3/9620 (0.03%)  0/90 (0.00%)  0/518 (0.00%) 
Drug abuser  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Substance use  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Surgical and medical procedures       
Abortion induced  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Cardiac pacemaker insertion  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Detoxification  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Hospitalisation  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Liver transplant  1  0/9620 (0.00%)  1/90 (1.11%)  0/518 (0.00%) 
Oophorectomy  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Vascular disorders       
Angiodysplasia  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Circulatory collapse  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Deep vein thrombosis  1  4/9620 (0.04%)  0/90 (0.00%)  0/518 (0.00%) 
Femoral artery embolism  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Haemorrhage  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Hypertension  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Hypertensive crisis  1  2/9620 (0.02%)  0/90 (0.00%)  0/518 (0.00%) 
Thrombosis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Venous thrombosis  1  1/9620 (0.01%)  0/90 (0.00%)  0/518 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Main Analysis Set Elastography Analysis Set: Treated Elastography Analysis Set: Untreated
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5721/9620 (59.47%)   82/90 (91.11%)   0/518 (0.00%) 
Blood and lymphatic system disorders       
Anaemia  1  471/9620 (4.90%)  37/90 (41.11%)  0/518 (0.00%) 
Leukopenia  1  311/9620 (3.23%)  30/90 (33.33%)  0/518 (0.00%) 
Thrombocytopenia  1  299/9620 (3.11%)  31/90 (34.44%)  0/518 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  187/9620 (1.94%)  7/90 (7.78%)  0/518 (0.00%) 
Cheilitis  1  10/9620 (0.10%)  6/90 (6.67%)  0/518 (0.00%) 
Gastritis  1  28/9620 (0.29%)  6/90 (6.67%)  0/518 (0.00%) 
Gastrointestinal pain  1  121/9620 (1.26%)  5/90 (5.56%)  0/518 (0.00%) 
Nausea  1  820/9620 (8.52%)  16/90 (17.78%)  0/518 (0.00%) 
Vomiting  1  71/9620 (0.74%)  5/90 (5.56%)  0/518 (0.00%) 
General disorders       
Fatigue  1  3380/9620 (35.14%)  49/90 (54.44%)  0/518 (0.00%) 
Influenza like illness  1  433/9620 (4.50%)  6/90 (6.67%)  0/518 (0.00%) 
Irritability  1  637/9620 (6.62%)  0/90 (0.00%)  0/518 (0.00%) 
Pyrexia  1  801/9620 (8.33%)  6/90 (6.67%)  0/518 (0.00%) 
Infections and infestations       
Oral candidiasis  1  54/9620 (0.56%)  6/90 (6.67%)  0/518 (0.00%) 
Investigations       
Weight decreased  1  890/9620 (9.25%)  22/90 (24.44%)  0/518 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1258/9620 (13.08%)  7/90 (7.78%)  0/518 (0.00%) 
Myalgia  1  873/9620 (9.07%)  9/90 (10.00%)  0/518 (0.00%) 
Nervous system disorders       
Dizziness  1  232/9620 (2.41%)  6/90 (6.67%)  0/518 (0.00%) 
Headache  1  1348/9620 (14.01%)  15/90 (16.67%)  0/518 (0.00%) 
Visual field defect  1  4/9620 (0.04%)  5/90 (5.56%)  0/518 (0.00%) 
Psychiatric disorders       
Depressed mood  1  865/9620 (8.99%)  16/90 (17.78%)  0/518 (0.00%) 
Depression  1  705/9620 (7.33%)  18/90 (20.00%)  0/518 (0.00%) 
Insomnia  1  857/9620 (8.91%)  9/90 (10.00%)  0/518 (0.00%) 
Sleep disorder  1  234/9620 (2.43%)  7/90 (7.78%)  0/518 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  247/9620 (2.57%)  12/90 (13.33%)  0/518 (0.00%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  555/9620 (5.77%)  6/90 (6.67%)  0/518 (0.00%) 
Eczema  1  62/9620 (0.64%)  7/90 (7.78%)  0/518 (0.00%) 
Pruritus  1  569/9620 (5.91%)  10/90 (11.11%)  0/518 (0.00%) 
Skin disorder  1  1316/9620 (13.68%)  19/90 (21.11%)  0/518 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
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.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02106156     History of Changes
Other Study ID Numbers: ML21645
First Submitted: April 3, 2014
First Posted: April 8, 2014
Results First Submitted: August 2, 2016
Results First Posted: September 23, 2016
Last Update Posted: September 23, 2016