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A Study of Predictors of the Effectiveness of Pegylated Interferon in a Cohort of Participants With Hepatitis C

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ClinicalTrials.gov Identifier: NCT01659567
Recruitment Status : Completed
First Posted : August 8, 2012
Results First Posted : October 3, 2017
Last Update Posted : October 3, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Hepatitis C, Chronic
Interventions Drug: Pegylated Interferon Alfa-2a
Drug: Ribavirin
Enrollment 516
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pegylated Interferon Alfa-2a and Ribavirin
Hide Arm/Group Description Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Period Title: Overall Study
Started 516
Completed 393
Not Completed 123
Reason Not Completed
Lack of Efficacy             22
Switched to Pegferon             6
Adverse Event             12
Good result at early stage of treatment             5
Withdrawal by Subject             64
Progression of the main disease             1
Other             13
Arm/Group Title Pegylated Interferon Alfa-2a and Ribavirin
Hide Arm/Group Description Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Overall Number of Baseline Participants 516
Hide Baseline Analysis Population Description
Analysis population included all treated participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 516 participants
42.12  (10.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 516 participants
Female
62
  12.0%
Male
454
  88.0%
1.Primary Outcome
Title Percentage of Participants Achieving Sustained Virological Response (SVR)
Hide Description SVR was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) level undetectable (less than [<] 15 international units per milliliter [IU/mL]) 24 weeks after completion of the actual treatment period (measured using the COBAS AmpliPrep [CAP]/ COBAS TaqMan [CTM] test). Percentage of participants achieving SVR was reported.
Time Frame At 24 weeks after end of treatment (EOT) (up to 96 weeks), where EOT = up to 72 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.
Arm/Group Title Pegylated Interferon Alfa-2a and Ribavirin
Hide Arm/Group Description:
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Overall Number of Participants Analyzed 225
Measure Type: Number
Unit of Measure: percentage of participants
79.1
2.Primary Outcome
Title Positive Predictive Value (PPV) of Rapid Viral Response (RVR) on SVR
Hide Description RVR was defined as HCV RNA less than or equal to (<=) 25 IU/mL at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops RVR would achieve SVR was termed as PPV of RVR on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time Frame At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.
Arm/Group Title Pegylated Interferon Alfa-2a and Ribavirin
Hide Arm/Group Description:
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Overall Number of Participants Analyzed 185
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
93.1
(89.3 to 96.7)
3.Primary Outcome
Title PPV of Complete Early Viral Response (cEVR) on SVR
Hide Description cEVR was defined as HCV RNA <=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops cEVR would achieve SVR was termed as PPV of cEVR on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time Frame At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.
Arm/Group Title Pegylated Interferon Alfa-2a and Ribavirin
Hide Arm/Group Description:
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Overall Number of Participants Analyzed 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
60.3
(48.3 to 72.3)
4.Secondary Outcome
Title Odds Ratio (OR) for Impact of Age on SVR
Hide Description The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of age (greater than [>] 42 years versus <=42 years) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time Frame Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.
Arm/Group Title Pegylated Interferon Alfa-2a and Ribavirin
Hide Arm/Group Description:
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Overall Number of Participants Analyzed 225
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: odds ratio
0.21
(0.10 to 0.47)
5.Secondary Outcome
Title OR for Impact of Gender on SVR
Hide Description The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of gender (male versus female) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time Frame Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.
Arm/Group Title Pegylated Interferon Alfa-2a and Ribavirin
Hide Arm/Group Description:
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Overall Number of Participants Analyzed 225
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: odds ratio
0.48
(0.13 to 1.69)
6.Secondary Outcome
Title OR for Impact of Body Weight on SVR
Hide Description The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of body weight on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time Frame Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all treated participants.
Arm/Group Title Pegylated Interferon Alfa-2a and Ribavirin
Hide Arm/Group Description:
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Overall Number of Participants Analyzed 516
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: odds ratio
1.01
(0.99 to 1.02)
7.Secondary Outcome
Title OR for Impact of Baseline Level of Fibrosis (kPa) on SVR
Hide Description The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline level of fibrosis on SVR. Level of fibrosis was measured in terms of kilopascals (kPa) using elastography. kPa score was categorized in 4 groups: 0 to 6.0; 6.1 to 9.9; 10.0 to 14.5; and 14.6 and above. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time Frame Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.
Arm/Group Title Pegylated Interferon Alfa-2a and Ribavirin
Hide Arm/Group Description:
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Overall Number of Participants Analyzed 186
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: odds ratio
0.53
(0.38 to 0.74)
8.Secondary Outcome
Title OR for Impact of Baseline Alanine Transaminase (ALT) Level on SVR
Hide Description The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline ALT level (>40 international units per liter [IU/L] versus <=40 IU/L) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time Frame Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.
Arm/Group Title Pegylated Interferon Alfa-2a and Ribavirin
Hide Arm/Group Description:
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Overall Number of Participants Analyzed 215
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: odds ratio
0.12
(0.02 to 0.92)
9.Secondary Outcome
Title OR for Impact of Baseline Viral Load Count on SVR
Hide Description The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline viral load count (>800000 IU/mL versus <=800000 IU/mL) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time Frame Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.
Arm/Group Title Pegylated Interferon Alfa-2a and Ribavirin
Hide Arm/Group Description:
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Overall Number of Participants Analyzed 219
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: odds ratio
1.07
(0.56 to 2.03)
10.Secondary Outcome
Title OR for Impact of Overall Duration of Treatment on SVR
Hide Description The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of overall duration of treatment on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time Frame Baseline up to 96 weeks (assessed at Baseline, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all treated participants.
Arm/Group Title Pegylated Interferon Alfa-2a and Ribavirin
Hide Arm/Group Description:
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Overall Number of Participants Analyzed 516
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: odds ratio
1.05
(0.59 to 1.86)
11.Secondary Outcome
Title OR for Impact of Duration of Treatment After Achieving RVR on SVR
Hide Description The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving RVR (>18 weeks versus <=18 weeks) on SVR. RVR was defined as HCV RNA <=25 IU/mL at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time Frame Baseline up to 96 weeks (assessed at Baseline, Week 4, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all treated participants.
Arm/Group Title Pegylated Interferon Alfa-2a and Ribavirin
Hide Arm/Group Description:
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Overall Number of Participants Analyzed 516
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: odds ratio
1.04
(0.92 to 1.18)
12.Secondary Outcome
Title OR for Impact of Duration of Treatment After Achieving cEVR on SVR
Hide Description The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving cEVR (>11 weeks versus <=11 weeks) on SVR. cEVR was defined as HCV RNA <=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time Frame Baseline up to 96 weeks (assessed at Baseline, Weeks 4, 12, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all treated participants.
Arm/Group Title Pegylated Interferon Alfa-2a and Ribavirin
Hide Arm/Group Description:
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Overall Number of Participants Analyzed 516
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: odds ratio
2.77
(1.14 to 6.72)
13.Secondary Outcome
Title OR for Impact of Cumulative Doses of Pegylated Interferon Alfa-2a on SVR
Hide Description The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of pegylated interferon alfa-2a on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time Frame At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all treated participants.
Arm/Group Title Pegylated Interferon Alfa-2a and Ribavirin
Hide Arm/Group Description:
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Overall Number of Participants Analyzed 516
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: odds ratio
0.99
(0.99 to 1.00)
14.Secondary Outcome
Title OR for Impact of Cumulative Doses of Ribavirin on SVR
Hide Description The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of ribavirin on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time Frame At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all treated participants.
Arm/Group Title Pegylated Interferon Alfa-2a and Ribavirin
Hide Arm/Group Description:
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Overall Number of Participants Analyzed 516
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: odds ratio
0.99
(0.99 to 1.00)
Time Frame Baseline up to 96 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pegylated Interferon Alfa-2a and Ribavirin
Hide Arm/Group Description Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
All-Cause Mortality
Pegylated Interferon Alfa-2a and Ribavirin
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Pegylated Interferon Alfa-2a and Ribavirin
Affected / at Risk (%)
Total   17/516 (3.29%) 
Blood and lymphatic system disorders   
Anemia * 1  1/516 (0.19%) 
Anemia fourth degree * 1  1/516 (0.19%) 
Thrombocytopenia * 1  2/516 (0.39%) 
Thrombocytopenia fourth degree * 1  1/516 (0.19%) 
Leukopenia * 1  1/516 (0.19%) 
Neutropenia * 1  1/516 (0.19%) 
Neutropenia fourth degree * 1  6/516 (1.16%) 
Hypoalbuminemia * 1  1/516 (0.19%) 
Cardiac disorders   
Tachyarrhythmia * 1  1/516 (0.19%) 
Gastrointestinal disorders   
Rectal bleeding * 1  1/516 (0.19%) 
Lingual bleeding * 1  1/516 (0.19%) 
Infections and infestations   
Pneumonia * 1  1/516 (0.19%) 
Nervous system disorders   
Agitation * 1  1/516 (0.19%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  1/516 (0.19%) 
Skin and subcutaneous tissue disorders   
Dry skin * 1  1/516 (0.19%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pegylated Interferon Alfa-2a and Ribavirin
Affected / at Risk (%)
Total   256/516 (49.61%) 
Blood and lymphatic system disorders   
Anemia * 1  10/516 (1.94%) 
Bilirubinemia * 1  2/516 (0.39%) 
Thyrotoxicosis second degree * 1  1/516 (0.19%) 
Thrombocytopenia * 1  16/516 (3.10%) 
Thrombocytopenia second degree * 1  1/516 (0.19%) 
Thrombocytopenia third degree * 1  5/516 (0.97%) 
Leukopenia * 1  5/516 (0.97%) 
Leukopenia second degree * 1  4/516 (0.78%) 
Leukopenia third degree * 1  4/516 (0.78%) 
Neutropenia * 1  14/516 (2.71%) 
Neutropenia second degree * 1  3/516 (0.58%) 
Neutropenia third degree * 1  23/516 (4.46%) 
Liver enzymes incresed (ALT, AST other) * 1  6/516 (1.16%) 
Cardiac disorders   
ST elevation * 1  1/516 (0.19%) 
Hypertension * 1  3/516 (0.58%) 
Hypotension * 1  2/516 (0.39%) 
Tachycardia * 1  1/516 (0.19%) 
Paresthesia (numbness in hands) * 1  1/516 (0.19%) 
Hemorrhoid varicose veins * 1  1/516 (0.19%) 
Hyperemia * 1  1/516 (0.19%) 
Flushing * 1  1/516 (0.19%) 
Ear and labyrinth disorders   
Tinnitus * 1  1/516 (0.19%) 
Earache * 1  1/516 (0.19%) 
Eye disorders   
Blurred vision * 1  1/516 (0.19%) 
Gastrointestinal disorders   
Nausea * 1  5/516 (0.97%) 
Diarrhea * 1  1/516 (0.19%) 
Constipation * 1  2/516 (0.39%) 
Vomiting * 1  2/516 (0.39%) 
Heartburn * 1  1/516 (0.19%) 
Abdominal pain upper/epigastric pain * 1  3/516 (0.58%) 
Meteorism (flatulence) * 1  2/516 (0.39%) 
Ascites * 1  1/516 (0.19%) 
General disorders   
Fatigue * 1  3/516 (0.58%) 
Pyrexia * 1  128/516 (24.81%) 
Adynamy * 1  10/516 (1.94%) 
General weakness * 1  75/516 (14.53%) 
Rigors * 1  2/516 (0.39%) 
Sweating - general * 1  1/516 (0.19%) 
Immune system disorders   
Allergic reactions * 1  8/516 (1.55%) 
Autoimmune thyroiditis * 1  2/516 (0.39%) 
Metabolism and nutrition disorders   
Weight decrease * 1  1/516 (0.19%) 
Hyperthyroidism * 1  4/516 (0.78%) 
Hypothyroidism * 1  2/516 (0.39%) 
Loss of appetite * 1  8/516 (1.55%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  65/516 (12.60%) 
Myalgia * 1  18/516 (3.49%) 
Back pain * 1  2/516 (0.39%) 
Muscle weakness in legs * 1  1/516 (0.19%) 
Nervous system disorders   
Headache * 1  31/516 (6.01%) 
Irritability * 1  8/516 (1.55%) 
Migraine * 1  1/516 (0.19%) 
Dizziness * 1  1/516 (0.19%) 
Sexual potency impairment * 1  1/516 (0.19%) 
Psychiatric disorders   
Anxiety * 1  10/516 (1.94%) 
Depression * 1  10/516 (1.94%) 
Insomnia * 1  11/516 (2.13%) 
Emotional liability * 1  3/516 (0.58%) 
Renal and urinary disorders   
Pollakiuria * 1  2/516 (0.39%) 
Scalding during urination/urine scald * 1  1/516 (0.19%) 
Sexual potency impairment * 1  1/516 (0.19%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  9/516 (1.74%) 
Bronchitis * 1  1/516 (0.19%) 
Pneumonia * 1  1/516 (0.19%) 
Flue-like syndrome * 1  15/516 (2.91%) 
Sour throat * 1  1/516 (0.19%) 
Dyspnea * 1  1/516 (0.19%) 
Skin and subcutaneous tissue disorders   
Alopecia/hair loss * 1  5/516 (0.97%) 
Itching/pruritus * 1  9/516 (1.74%) 
Dry skin * 1  6/516 (1.16%) 
Anal itching * 1  1/516 (0.19%) 
Rash * 1  4/516 (0.78%) 
Herpes rash * 1  1/516 (0.19%) 
Left nostril furuncle * 1  1/516 (0.19%) 
Sweating - general * 1  1/516 (0.19%) 
Dry mouth * 1  3/516 (0.58%) 
Toxidermia * 1  1/516 (0.19%) 
Sty * 1  1/516 (0.19%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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: NCT01659567    
Other Study ID Numbers: ML25544
First Submitted: July 27, 2012
First Posted: August 8, 2012
Results First Submitted: May 5, 2017
Results First Posted: October 3, 2017
Last Update Posted: October 3, 2017