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Trial record 4 of 16 for:    IU/mL | BI 201335 OR faldaprevir

Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01728324
Recruitment Status : Completed
First Posted : November 19, 2012
Results First Posted : February 12, 2016
Last Update Posted : February 12, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Drug: BI 207127-placebo: 8-week treatment
Drug: Ribavirin: 24-week treatment
Drug: BI 207127: 24-week treatment
Drug: Faldaprevir: 24-week treatment
Drug: Ribavirin-placebo: 8-week treatment
Drug: Faldaprevir-placebo: 8-week treatment
Drug: Faldaprevir: 16-week treatment
Drug: Ribavirin: 16-week treatment
Drug: RBV: 24-week treatment
Drug: BI 207127: 16-week treatment
Enrollment 496
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 24-wk Non-cirrhotic (NC) Treatment Group 16-wk Non-cirrhotic (NC) Treatment Group 24-wk Cirrhotic (CR) Treatment Group
Hide Arm/Group Description 24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients. Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients. 24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
Period Title: Termination of DBV
Started 211 213 72
Completed 173 177 58
Not Completed 38 36 14
Reason Not Completed
Adverse Event             14             13             4
Lack of Efficacy             14             12             8
Withdrawal by Subject             9             6             2
Other than stated             1             3             0
Adverse Event (Placebo Period)             0             1             0
Protocol Violation (Placebo Period)             0             1             0
Period Title: Termination of FDV
Started 211 213 72
Completed 173 177 58
Not Completed 38 36 14
Reason Not Completed
Adverse Event             14             13             4
Lack of Efficacy             14             12             8
Withdrawal by Subject             9             6             2
Other than stated             1             3             0
Adverse Event (Placebo Period)             0             1             0
Protocol Violation (Placebo Period)             0             1             0
Period Title: Termination of RBV
Started 211 213 72
Completed 172 176 57
Not Completed 39 37 15
Reason Not Completed
Adverse Event             15             16             5
Lack of Efficacy             14             11             7
Withdrawal by Subject             9             5             2
Other than stated             1             3             1
Adverse Event (Placebo Period)             0             1             0
Protocol Violation (Placebo Period)             0             1             0
Arm/Group Title 24-wk Non-cirrhotic (NC) Treatment Group 16-wk Non-cirrhotic (NC) Treatment Group 24-wk Cirrhotic (CR) Treatment Group Total
Hide Arm/Group Description 24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients. Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients. 24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients. Total of all reporting groups
Overall Number of Baseline Participants 211 213 72 496
Hide Baseline Analysis Population Description
Full Analysis Set (FAS): This analysis set includes all randomized patients who were dispensed study medication and were documented to have taken at least one dose of any study medication, either active or placebo.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 211 participants 213 participants 72 participants 496 participants
50.3  (12.5) 50.5  (12.3) 58.0  (8.8) 51.5  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 211 participants 213 participants 72 participants 496 participants
Female
108
  51.2%
120
  56.3%
27
  37.5%
255
  51.4%
Male
103
  48.8%
93
  43.7%
45
  62.5%
241
  48.6%
1.Primary Outcome
Title SVR12 Rates With Historical Control
Hide Description

Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus (HCV) RNA level <25 IU/mL at 12 weeks after end of Treatment (EOT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint.

The number of participants analyzed are actually adjusted number of participant analyzed.

Time Frame 12 Week (post-treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified full analysis set (mFAS): included patients in the full analysis set (FAS) who received at least one dose of active treatment;
Arm/Group Title 24-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group 16-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group
Hide Arm/Group Description:
24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic and cirrhotic patients.
This is the combination of 16 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients and for 24 weeks in cirrhotic patients
Overall Number of Participants Analyzed 283 283
Measure Type: Number
Unit of Measure: percentage of participants
PegIFN eligible 79.95 76.68
PegIFN ineligible 88.28 70.78
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 24-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group
Comments The proportion of patients achieving SVR12 achieved with 24 weeks of treatment with DBV/FDV/RBV in cirrhotic and non-cirrhotic patients was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with PegIFN from historical data. The acceptable minimum SVR rate was an average of 71% (reference for PegIFN-eligible) and 50% (for PegIFN-ineligible patients), weighted by the sample size in each stratum.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method z-test
Comments A stratified one sample z-test with 50% reference for PegIFN-ineligible and 71% for PegIFN-eligible patients was performed.
Method of Estimation Estimation Parameter Adjusted response rate
Estimated Value 81.10
Confidence Interval (2-Sided) 95%
76.34 to 85.87
Estimation Comments The adjusted response rate was tested against the historical control SVR rate of 68% (95% Confidence Interval (CI): 76.3, 85.9).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 16-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group
Comments The proportion of patients achieving SVR12 achieved with 16 weeks of treatment of non-cirrhotic and 24 weeks of treatment of cirrhotic patients was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with PegIFN from historical data. The acceptable minimum SVR rate was an average of 71% (reference for PegIFN-eligible) and 50% (for PegIFN-ineligible patients), weighted by the sample size in each stratum.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0020
Comments [Not Specified]
Method z-test
Comments A stratified one sample z-test with 50% reference for PegIFN-ineligible and 71% for PegIFN-eligible patients was performed.
Method of Estimation Estimation Parameter Adjusted response rate
Estimated Value 75.89
Confidence Interval (2-Sided) 95%
70.63 to 81.14
Estimation Comments [Not Specified]
2.Primary Outcome
Title Comparisons of SVR12 Rates Across Treatment Arms
Hide Description Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.
Time Frame 12 Week (post-treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title 24-wk Non-cirrhotic (NC) Treatment Group 16-wk Non-cirrhotic (NC) Treatment Group 24-wk Cirrhotic (CR) Treatment Group
Hide Arm/Group Description:
24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
Overall Number of Participants Analyzed 211 213 72
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
82.0
(76.8 to 87.2)
75.6
(69.8 to 81.4)
73.6
(63.4 to 83.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 24-wk Non-cirrhotic (NC) Treatment Group, 16-wk Non-cirrhotic (NC) Treatment Group
Comments Koch’s stratum-adjusted Mantel Haenszel methods were used to compare durations, adjusting for stratification factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0532
Comments [Not Specified]
Method Koch’s method
Comments Adjusted for PegIFN eligibility using Koch’s method, with continuity correction.
Method of Estimation Estimation Parameter SVR12 Rates difference
Estimated Value 6.4
Confidence Interval (2-Sided) 95%
-1.4 to 14.2
Estimation Comments [Not Specified]
3.Secondary Outcome
Title SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT.
Hide Description Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4): Plasma HCV RNA level <25 IU/mL at 4 weeks after EOT.
Time Frame 4 weeks (after End Of Treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title 24-wk Non-cirrhotic (NC) Treatment Group 16-wk Non-cirrhotic (NC) Treatment Group 24-wk Cirrhotic (CR) Treatment Group
Hide Arm/Group Description:
24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
Overall Number of Participants Analyzed 211 213 72
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
83.9
(78.9 to 88.8)
80.3
(74.9 to 85.6)
77.8
(68.2 to 87.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 24-wk Non-cirrhotic (NC) Treatment Group, 16-wk Non-cirrhotic (NC) Treatment Group
Comments Koch’s stratum-adjusted Mantel Haenszel methods were used to compare durations, adjusting for stratification factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1671
Comments [Not Specified]
Method Koch´s method
Comments Adjusted for PegIFN eligibility using Koch´s method, with continuity correction.
Method of Estimation Estimation Parameter SVR4 Rates difference
Estimated Value 3.6
Confidence Interval (2-Sided) 95%
-3.7 to 10.9
Estimation Comments [Not Specified]
4.Secondary Outcome
Title SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT.
Hide Description Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24): Plasma HCV RNA level <25 IU/mL at 24 weeks after EOT.
Time Frame 4 weeks (after End Of Treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title 24-wk Non-cirrhotic (NC) Treatment Group 16-wk Non-cirrhotic (NC) Treatment Group 24-wk Cirrhotic (CR) Treatment Group
Hide Arm/Group Description:
24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
Overall Number of Participants Analyzed 211 213 72
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
81.0
(75.8 to 86.3)
74.2
(68.3 to 80.1)
72.2
(61.9 to 82.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 24-wk Non-cirrhotic (NC) Treatment Group, 16-wk Non-cirrhotic (NC) Treatment Group
Comments Koch’s stratum-adjusted Mantel Haenszel methods were used to compare durations, adjusting for stratification factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0447
Comments [Not Specified]
Method Koch´s method
Comments Adjusted for PegIFN eligibility using Koch´s method, with continuity correction.
Method of Estimation Estimation Parameter SVR24 Rates difference
Estimated Value -6.9
Confidence Interval (2-Sided) 95%
-14.8 to 1.1
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Prognostic Value of SVR12 Predicting SVR24
Hide Description The positive predictive value of SVR12 predicting SVR24 are the patients with an SVR12 (=YES) and the SVR24 was assessed.
Time Frame 24 Week (post-treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title 24-wk Non-cirrhotic (NC) Treatment Group 16-wk Non-cirrhotic (NC) Treatment Group 24-wk Cirrhotic (CR) Treatment Group
Hide Arm/Group Description:
24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
Overall Number of Participants Analyzed 211 213 72
Measure Type: Number
Unit of Measure: Percentage of participants
99.0 99.0 98.0
Time Frame From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 24-wk Non-cirrhotic (NC) Treatment Group 16-wk Non-cirrhotic (NC) Treatment Group 24-wk Cirrhotic (CR) Treatment Group
Hide Arm/Group Description 24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients. Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients. 24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
All-Cause Mortality
24-wk Non-cirrhotic (NC) Treatment Group 16-wk Non-cirrhotic (NC) Treatment Group 24-wk Cirrhotic (CR) Treatment Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
24-wk Non-cirrhotic (NC) Treatment Group 16-wk Non-cirrhotic (NC) Treatment Group 24-wk Cirrhotic (CR) Treatment Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/211 (3.32%)   12/213 (5.63%)   8/72 (11.11%) 
Blood and lymphatic system disorders       
Anaemia  1  1/211 (0.47%)  2/213 (0.94%)  1/72 (1.39%) 
Febrile neutropenia  1  0/211 (0.00%)  0/213 (0.00%)  1/72 (1.39%) 
Thrombocytosis  1  1/211 (0.47%)  0/213 (0.00%)  0/72 (0.00%) 
Cardiac disorders       
Pericarditis  1  0/211 (0.00%)  0/213 (0.00%)  1/72 (1.39%) 
Gastrointestinal disorders       
Diarrhoea  1  0/211 (0.00%)  2/213 (0.94%)  0/72 (0.00%) 
Gastric ulcer  1  0/211 (0.00%)  0/213 (0.00%)  1/72 (1.39%) 
Gastrointestinal haemorrhage  1  0/211 (0.00%)  0/213 (0.00%)  1/72 (1.39%) 
Haematemesis  1  0/211 (0.00%)  1/213 (0.47%)  0/72 (0.00%) 
Pancreatitis  1  0/211 (0.00%)  1/213 (0.47%)  0/72 (0.00%) 
Portal hypertensive gastropathy  1  0/211 (0.00%)  0/213 (0.00%)  1/72 (1.39%) 
Vomiting  1  0/211 (0.00%)  2/213 (0.94%)  0/72 (0.00%) 
General disorders       
Fatigue  1  0/211 (0.00%)  1/213 (0.47%)  0/72 (0.00%) 
Malaise  1  1/211 (0.47%)  0/213 (0.00%)  0/72 (0.00%) 
Hepatobiliary disorders       
Hyperbilirubinaemia  1  0/211 (0.00%)  0/213 (0.00%)  1/72 (1.39%) 
Immune system disorders       
Drug hypersensitivity  1  1/211 (0.47%)  0/213 (0.00%)  0/72 (0.00%) 
Infections and infestations       
Cellulitis  1  0/211 (0.00%)  0/213 (0.00%)  1/72 (1.39%) 
Pneumonia  1  1/211 (0.47%)  0/213 (0.00%)  1/72 (1.39%) 
Tonsillitis  1  0/211 (0.00%)  1/213 (0.47%)  0/72 (0.00%) 
Injury, poisoning and procedural complications       
Fall  1  1/211 (0.47%)  0/213 (0.00%)  0/72 (0.00%) 
Jaw fracture  1  1/211 (0.47%)  0/213 (0.00%)  0/72 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Basal cell carcinoma  1  1/211 (0.47%)  0/213 (0.00%)  0/72 (0.00%) 
Hepatocellular carcinoma  1  0/211 (0.00%)  1/213 (0.47%)  1/72 (1.39%) 
Prostate cancer  1  0/211 (0.00%)  1/213 (0.47%)  0/72 (0.00%) 
Nervous system disorders       
Amnesia  1  0/211 (0.00%)  0/213 (0.00%)  1/72 (1.39%) 
Loss of consciousness  1  1/211 (0.47%)  0/213 (0.00%)  0/72 (0.00%) 
Psychiatric disorders       
Bipolar I disorder  1  0/211 (0.00%)  1/213 (0.47%)  0/72 (0.00%) 
Depression  1  1/211 (0.47%)  2/213 (0.94%)  0/72 (0.00%) 
Insomnia  1  0/211 (0.00%)  1/213 (0.47%)  0/72 (0.00%) 
Suicide attempt  1  0/211 (0.00%)  1/213 (0.47%)  0/72 (0.00%) 
Renal and urinary disorders       
Acute prerenal failure  1  0/211 (0.00%)  1/213 (0.47%)  0/72 (0.00%) 
Renal failure acute  1  0/211 (0.00%)  1/213 (0.47%)  0/72 (0.00%) 
Skin and subcutaneous tissue disorders       
Drug eruption  1  1/211 (0.47%)  0/213 (0.00%)  0/72 (0.00%) 
Photosensitivity reaction  1  0/211 (0.00%)  0/213 (0.00%)  1/72 (1.39%) 
Vascular disorders       
Hypertensive crisis  1  0/211 (0.00%)  0/213 (0.00%)  1/72 (1.39%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
24-wk Non-cirrhotic (NC) Treatment Group 16-wk Non-cirrhotic (NC) Treatment Group 24-wk Cirrhotic (CR) Treatment Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   198/211 (93.84%)   202/213 (94.84%)   66/72 (91.67%) 
Blood and lymphatic system disorders       
Anaemia  1  26/211 (12.32%)  22/213 (10.33%)  13/72 (18.06%) 
Ear and labyrinth disorders       
Vertigo  1  8/211 (3.79%)  6/213 (2.82%)  5/72 (6.94%) 
Eye disorders       
Ocular icterus  1  27/211 (12.80%)  16/213 (7.51%)  2/72 (2.78%) 
Gastrointestinal disorders       
Abdominal distension  1  6/211 (2.84%)  8/213 (3.76%)  7/72 (9.72%) 
Abdominal pain  1  16/211 (7.58%)  16/213 (7.51%)  4/72 (5.56%) 
Abdominal pain upper  1  26/211 (12.32%)  19/213 (8.92%)  7/72 (9.72%) 
Constipation  1  22/211 (10.43%)  16/213 (7.51%)  12/72 (16.67%) 
Diarrhoea  1  59/211 (27.96%)  54/213 (25.35%)  24/72 (33.33%) 
Dyspepsia  1  26/211 (12.32%)  26/213 (12.21%)  13/72 (18.06%) 
Gastrooesophageal reflux disease  1  9/211 (4.27%)  5/213 (2.35%)  4/72 (5.56%) 
Nausea  1  129/211 (61.14%)  121/213 (56.81%)  41/72 (56.94%) 
Vomiting  1  69/211 (32.70%)  64/213 (30.05%)  25/72 (34.72%) 
General disorders       
Asthenia  1  43/211 (20.38%)  34/213 (15.96%)  18/72 (25.00%) 
Fatigue  1  74/211 (35.07%)  73/213 (34.27%)  26/72 (36.11%) 
Hepatobiliary disorders       
Hyperbilirubinaemia  1  8/211 (3.79%)  6/213 (2.82%)  7/72 (9.72%) 
Jaundice  1  27/211 (12.80%)  15/213 (7.04%)  18/72 (25.00%) 
Infections and infestations       
Nasopharyngitis  1  11/211 (5.21%)  9/213 (4.23%)  2/72 (2.78%) 
Upper respiratory tract infection  1  8/211 (3.79%)  4/213 (1.88%)  5/72 (6.94%) 
Injury, poisoning and procedural complications       
Sunburn  1  13/211 (6.16%)  14/213 (6.57%)  3/72 (4.17%) 
Investigations       
Weight decreased  1  19/211 (9.00%)  11/213 (5.16%)  6/72 (8.33%) 
Metabolism and nutrition disorders       
Decreased appetite  1  34/211 (16.11%)  27/213 (12.68%)  14/72 (19.44%) 
Vitamin D deficiency  1  8/211 (3.79%)  5/213 (2.35%)  8/72 (11.11%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  10/211 (4.74%)  6/213 (2.82%)  6/72 (8.33%) 
Muscle spasms  1  11/211 (5.21%)  8/213 (3.76%)  2/72 (2.78%) 
Myalgia  1  7/211 (3.32%)  11/213 (5.16%)  1/72 (1.39%) 
Nervous system disorders       
Dizziness  1  19/211 (9.00%)  21/213 (9.86%)  6/72 (8.33%) 
Dysgeusia  1  14/211 (6.64%)  8/213 (3.76%)  5/72 (6.94%) 
Headache  1  33/211 (15.64%)  46/213 (21.60%)  5/72 (6.94%) 
Paraesthesia  1  15/211 (7.11%)  17/213 (7.98%)  3/72 (4.17%) 
Tremor  1  2/211 (0.95%)  2/213 (0.94%)  5/72 (6.94%) 
Psychiatric disorders       
Anxiety  1  8/211 (3.79%)  21/213 (9.86%)  6/72 (8.33%) 
Depression  1  16/211 (7.58%)  9/213 (4.23%)  4/72 (5.56%) 
Insomnia  1  35/211 (16.59%)  25/213 (11.74%)  10/72 (13.89%) 
Irritability  1  8/211 (3.79%)  8/213 (3.76%)  4/72 (5.56%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  14/211 (6.64%)  20/213 (9.39%)  7/72 (9.72%) 
Dyspnoea  1  18/211 (8.53%)  11/213 (5.16%)  6/72 (8.33%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  15/211 (7.11%)  3/213 (1.41%)  3/72 (4.17%) 
Dry skin  1  18/211 (8.53%)  12/213 (5.63%)  5/72 (6.94%) 
Erythema  1  33/211 (15.64%)  39/213 (18.31%)  10/72 (13.89%) 
Photosensitivity reaction  1  38/211 (18.01%)  26/213 (12.21%)  6/72 (8.33%) 
Pruritus  1  47/211 (22.27%)  47/213 (22.07%)  23/72 (31.94%) 
Rash  1  43/211 (20.38%)  39/213 (18.31%)  10/72 (13.89%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
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.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01728324     History of Changes
Other Study ID Numbers: 1241.36
2012-003535-27 ( EudraCT Number: EudraCT )
First Submitted: November 2, 2012
First Posted: November 19, 2012
Results First Submitted: January 14, 2016
Results First Posted: February 12, 2016
Last Update Posted: February 12, 2016