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Trial record 24 of 82 for:    GRAZOPREVIR ANHYDROUS AND ELBASVIR

Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) With or Without Ribavirin for Participants With Hepatitis C Genotype 1, 4, or 6 Infections Who Have Failed Prior Treatment With Pegylated Interferon + Ribavirin (MK-5172-068)

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: NCT02105701
Recruitment Status : Completed
First Posted : April 7, 2014
Results First Posted : March 4, 2016
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C Infection
Interventions Drug: Grazoprevir + Elbasvir
Drug: Ribavirin
Enrollment 420
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Grazoprevir + Elbasvir 12 Weeks Grazoprevir + Elbasvir + RBV 12 Weeks Grazoprevir + Elbasvir 16 Weeks Grazoprevir + Elbasvir + RBV 16 Weeks
Hide Arm/Group Description Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks. Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks. Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks. Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
Period Title: Overall Study
Started 105 104 105 106
Completed 101 103 102 104
Not Completed 4 1 3 2
Reason Not Completed
Lost to Follow-up             1             0             2             1
Protocol Violation             0             0             1             0
Withdrawal by Subject             2             1             0             1
Death             1             0             0             0
Arm/Group Title Grazoprevir + Elbasvir 12 Weeks Grazoprevir + Elbasvir + RBV 12 Weeks Grazoprevir + Elbasvir 16 Weeks Grazoprevir + Elbasvir + RBV 16 Weeks Total
Hide Arm/Group Description Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks. Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks. Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks. Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks. Total of all reporting groups
Overall Number of Baseline Participants 105 104 105 106 420
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 105 participants 104 participants 105 participants 106 participants 420 participants
55.71  (9.81) 55.46  (8.26) 54.91  (9.79) 54.98  (9.61) 55.27  (9.37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 104 participants 105 participants 106 participants 420 participants
Female
39
  37.1%
32
  30.8%
36
  34.3%
42
  39.6%
149
  35.5%
Male
66
  62.9%
72
  69.2%
69
  65.7%
64
  60.4%
271
  64.5%
1.Primary Outcome
Title Percentage of Participants Achieving Undetectable HCV RNA 12 Weeks After Completing Study Therapy (SVR12)
Hide Description HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
Time Frame 12 weeks after the end of all study treatment (up to 28 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population consists of all randomized subjects who receive at least one dose of study treatment.
Arm/Group Title Grazoprevir + Elbasvir 12 Weeks Grazoprevir + Elbasvir + RBV 12 Weeks Grazoprevir + Elbasvir 16 Weeks Grazoprevir + Elbasvir + RBV 16 Weeks
Hide Arm/Group Description:
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
Overall Number of Participants Analyzed 105 104 105 106
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
92.4
(85.5 to 96.7)
94.2
(87.9 to 97.9)
92.4
(85.5 to 96.7)
98.1
(93.4 to 99.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Grazoprevir + Elbasvir 12 Weeks
Comments The hypothesis was that at least 1 treatment arm would have a SVR12 rate >58%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method One-sided Exact Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Grazoprevir + Elbasvir + RBV 12 Weeks
Comments The hypothesis was that at least 1 treatment arm would have a SVR12 rate >58%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method One-sided Exact Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Grazoprevir + Elbasvir 16 Weeks
Comments The hypothesis was that at least 1 treatment arm would have a SVR12 rate >58%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method One-sided Exact Test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Grazoprevir + Elbasvir + RBV 16 Weeks
Comments The hypothesis was that at least 1 treatment arm would have a SVR12 rate >58%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method One-sided Exact Test
Comments [Not Specified]
2.Primary Outcome
Title Number of Participants Experiencing Adverse Events (AE)
Hide Description An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time Frame Up to 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The All Participants as Treated (APaT) population consists of all participants who received at least one dose of study treatment.
Arm/Group Title Grazoprevir + Elbasvir 12 Weeks Grazoprevir + Elbasvir + RBV 12 Weeks Grazoprevir + Elbasvir 16 Weeks Grazoprevir + Elbasvir + RBV 16 Weeks
Hide Arm/Group Description:
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
Overall Number of Participants Analyzed 105 104 105 106
Measure Type: Number
Unit of Measure: Number of participants
74 85 77 95
3.Primary Outcome
Title Number of Participants Discontinuing Study Treatment Due to an AE
Hide Description An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time Frame Up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The All Participants as Treated (APaT) population consists of all participants who received at least one dose of study treatment.
Arm/Group Title Grazoprevir + Elbasvir 12 Weeks Grazoprevir + Elbasvir + RBV 12 Weeks Grazoprevir + Elbasvir 16 Weeks Grazoprevir + Elbasvir + RBV 16 Weeks
Hide Arm/Group Description:
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
Overall Number of Participants Analyzed 105 104 105 106
Measure Type: Number
Unit of Measure: Number of participants
1 1 0 5
4.Secondary Outcome
Title Percentage of Participants Achieving Undetectable HCV RNA 24 Weeks After the End of All Treatment (SVR24)
Hide Description HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
Time Frame 24 weeks after the end of all study treatment (up to 40 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population consists of all randomized subjects who receive at least one dose of study treatment.
Arm/Group Title Grazoprevir + Elbasvir 12 Weeks Grazoprevir + Elbasvir + RBV 12 Weeks Grazoprevir + Elbasvir 16 Weeks Grazoprevir + Elbasvir + RBV 16 Weeks
Hide Arm/Group Description:
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
Overall Number of Participants Analyzed 105 104 105 106
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
91.4
(84.4 to 96.0)
94.2
(87.9 to 97.9)
89.5
(82.0 to 94.7)
95.3
(89.3 to 98.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Grazoprevir + Elbasvir 12 Weeks
Comments The hypothesis was that at least 1 treatment arm would have a SVR24 rate >58%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method One-sided Exact Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Grazoprevir + Elbasvir + RBV 12 Weeks
Comments The hypothesis was that at least 1 treatment arm would have a SVR24 rate >58%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method One-sided Exact Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Grazoprevir + Elbasvir 16 Weeks
Comments The hypothesis was that at least 1 treatment arm would have a SVR24 rate >58%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method One-sided Exact Test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Grazoprevir + Elbasvir + RBV 16 Weeks
Comments The hypothesis was that at least 1 treatment arm would have a SVR24 rate >58%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method One-sided Exact Test
Comments [Not Specified]
Time Frame Up to Week 40.
Adverse Event Reporting Description An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
 
Arm/Group Title GZR/EBR 12 Weeks GZR/EBR + RBV 12 Weeks GZR/EBR 16 Weeks GZR/EBR + RBV for 16 Weeks
Hide Arm/Group Description Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks. Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks. Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks. Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
All-Cause Mortality
GZR/EBR 12 Weeks GZR/EBR + RBV 12 Weeks GZR/EBR 16 Weeks GZR/EBR + RBV for 16 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
GZR/EBR 12 Weeks GZR/EBR + RBV 12 Weeks GZR/EBR 16 Weeks GZR/EBR + RBV for 16 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/105 (5.71%)      8/104 (7.69%)      4/105 (3.81%)      6/106 (5.66%)    
Blood and lymphatic system disorders         
Anaemia  1  0/105 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 1/106 (0.94%)  1
Cardiac disorders         
Angina unstable  1  1/105 (0.95%)  1 0/104 (0.00%)  0 0/105 (0.00%)  0 0/106 (0.00%)  0
Coronary artery disease  1  1/105 (0.95%)  1 0/104 (0.00%)  0 0/105 (0.00%)  0 0/106 (0.00%)  0
Ear and labyrinth disorders         
Sudden hearing loss  1  1/105 (0.95%)  1 0/104 (0.00%)  0 0/105 (0.00%)  0 0/106 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain  1  0/105 (0.00%)  0 1/104 (0.96%)  1 0/105 (0.00%)  0 0/106 (0.00%)  0
Ascites  1  1/105 (0.95%)  1 0/104 (0.00%)  0 0/105 (0.00%)  0 0/106 (0.00%)  0
Colitis  1  0/105 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 1/106 (0.94%)  1
Diarrhoea  1  0/105 (0.00%)  0 1/104 (0.96%)  1 0/105 (0.00%)  0 0/106 (0.00%)  0
Intestinal angioedema  1  0/105 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 1/106 (0.94%)  1
Varices oesophageal  1  0/105 (0.00%)  0 1/104 (0.96%)  1 0/105 (0.00%)  0 0/106 (0.00%)  0
General disorders         
Non-cardiac chest pain  1  0/105 (0.00%)  0 1/104 (0.96%)  1 0/105 (0.00%)  0 0/106 (0.00%)  0
Infections and infestations         
Herpes simplex oesophagitis  1  0/105 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 1/106 (0.94%)  1
Infectious colitis  1  0/105 (0.00%)  0 1/104 (0.96%)  1 0/105 (0.00%)  0 0/106 (0.00%)  0
Parotitis  1  0/105 (0.00%)  0 1/104 (0.96%)  1 0/105 (0.00%)  0 0/106 (0.00%)  0
Pneumonia  1  1/105 (0.95%)  1 0/104 (0.00%)  0 0/105 (0.00%)  0 0/106 (0.00%)  0
Post procedural infection  1  0/105 (0.00%)  0 0/104 (0.00%)  0 1/105 (0.95%)  1 0/106 (0.00%)  0
Injury, poisoning and procedural complications         
Hip fracture  1  1/105 (0.95%)  1 0/104 (0.00%)  0 0/105 (0.00%)  0 0/106 (0.00%)  0
Overdose  1  0/105 (0.00%)  0 0/104 (0.00%)  0 1/105 (0.95%)  1 0/106 (0.00%)  0
Rib fracture  1  0/105 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 1/106 (0.94%)  1
Tibia fracture  1  0/105 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 1/106 (0.94%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Hepatocellular carcinoma  1  0/105 (0.00%)  0 1/104 (0.96%)  1 0/105 (0.00%)  0 0/106 (0.00%)  0
Splenic marginal zone lymphoma  1  0/105 (0.00%)  0 0/104 (0.00%)  0 1/105 (0.95%)  1 0/106 (0.00%)  0
Nervous system disorders         
Loss of consciousness  1  0/105 (0.00%)  0 0/104 (0.00%)  0 1/105 (0.95%)  1 0/106 (0.00%)  0
Transient ischaemic attack  1  0/105 (0.00%)  0 1/104 (0.96%)  1 0/105 (0.00%)  0 0/106 (0.00%)  0
Psychiatric disorders         
Schizophrenia  1  0/105 (0.00%)  0 1/104 (0.96%)  1 0/105 (0.00%)  0 0/106 (0.00%)  0
Renal and urinary disorders         
Nephrolithiasis  1  0/105 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 1/106 (0.94%)  1
Reproductive system and breast disorders         
Uterine polyp  1  0/105 (0.00%)  0 1/104 (0.96%)  1 0/105 (0.00%)  0 0/106 (0.00%)  0
Vascular disorders         
Femoral artery occlusion  1  1/105 (0.95%)  1 0/104 (0.00%)  0 0/105 (0.00%)  0 0/106 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GZR/EBR 12 Weeks GZR/EBR + RBV 12 Weeks GZR/EBR 16 Weeks GZR/EBR + RBV for 16 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   55/105 (52.38%)      72/104 (69.23%)      58/105 (55.24%)      84/106 (79.25%)    
Blood and lymphatic system disorders         
Anaemia  1  0/105 (0.00%)  0 12/104 (11.54%)  13 0/105 (0.00%)  0 17/106 (16.04%)  19
Gastrointestinal disorders         
Abdominal pain  1  6/105 (5.71%)  6 3/104 (2.88%)  3 1/105 (0.95%)  1 3/106 (2.83%)  3
Constipation  1  1/105 (0.95%)  1 3/104 (2.88%)  3 7/105 (6.67%)  8 5/106 (4.72%)  5
Diarrhoea  1  5/105 (4.76%)  5 4/104 (3.85%)  4 8/105 (7.62%)  9 9/106 (8.49%)  9
Dyspepsia  1  3/105 (2.86%)  3 4/104 (3.85%)  4 0/105 (0.00%)  0 7/106 (6.60%)  9
Nausea  1  9/105 (8.57%)  10 15/104 (14.42%)  19 4/105 (3.81%)  4 18/106 (16.98%)  20
Vomiting  1  2/105 (1.90%)  2 7/104 (6.73%)  8 1/105 (0.95%)  1 9/106 (8.49%)  10
General disorders         
Asthenia  1  8/105 (7.62%)  9 11/104 (10.58%)  13 9/105 (8.57%)  10 10/106 (9.43%)  10
Fatigue  1  20/105 (19.05%)  21 28/104 (26.92%)  32 17/105 (16.19%)  18 32/106 (30.19%)  33
Infections and infestations         
Upper respiratory tract infection  1  3/105 (2.86%)  3 2/104 (1.92%)  2 6/105 (5.71%)  9 5/106 (4.72%)  6
Injury, poisoning and procedural complications         
Accidental overdose  1  3/105 (2.86%)  3 15/104 (14.42%)  22 1/105 (0.95%)  1 14/106 (13.21%)  23
Investigations         
Haemoglobin decreased  1  0/105 (0.00%)  0 1/104 (0.96%)  1 0/105 (0.00%)  0 7/106 (6.60%)  7
Metabolism and nutrition disorders         
Decreased appetite  1  2/105 (1.90%)  2 6/104 (5.77%)  6 1/105 (0.95%)  1 6/106 (5.66%)  6
Musculoskeletal and connective tissue disorders         
Arthralgia  1  4/105 (3.81%)  4 3/104 (2.88%)  4 7/105 (6.67%)  8 4/106 (3.77%)  5
Myalgia  1  2/105 (1.90%)  2 6/104 (5.77%)  7 8/105 (7.62%)  8 7/106 (6.60%)  7
Nervous system disorders         
Dizziness  1  7/105 (6.67%)  7 8/104 (7.69%)  8 5/105 (4.76%)  10 6/106 (5.66%)  8
Headache  1  21/105 (20.00%)  23 21/104 (20.19%)  23 21/105 (20.00%)  23 20/106 (18.87%)  22
Psychiatric disorders         
Insomnia  1  5/105 (4.76%)  5 11/104 (10.58%)  12 7/105 (6.67%)  7 10/106 (9.43%)  10
Irritability  1  4/105 (3.81%)  6 5/104 (4.81%)  5 2/105 (1.90%)  2 8/106 (7.55%)  8
Respiratory, thoracic and mediastinal disorders         
Cough  1  6/105 (5.71%)  6 10/104 (9.62%)  10 4/105 (3.81%)  4 10/106 (9.43%)  10
Dyspnoea  1  1/105 (0.95%)  1 9/104 (8.65%)  11 1/105 (0.95%)  1 10/106 (9.43%)  10
Dyspnoea exertional  1  1/105 (0.95%)  1 3/104 (2.88%)  4 0/105 (0.00%)  0 8/106 (7.55%)  8
Skin and subcutaneous tissue disorders         
Pruritus  1  1/105 (0.95%)  1 11/104 (10.58%)  13 6/105 (5.71%)  6 11/106 (10.38%)  11
Rash  1  3/105 (2.86%)  3 4/104 (3.85%)  4 1/105 (0.95%)  1 8/106 (7.55%)  10
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
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 Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02105701     History of Changes
Other Study ID Numbers: 5172-068
2014-000824-12 ( EudraCT Number )
First Submitted: April 2, 2014
First Posted: April 7, 2014
Results First Submitted: February 3, 2016
Results First Posted: March 4, 2016
Last Update Posted: October 3, 2018