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Trial record 39 of 82 for:    GRAZOPREVIR ANHYDROUS AND ELBASVIR

Efficacy and Safety of Combination Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin (RBV) in Genotype 2 Hepatitis C Infection (MK-5172-047)

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: NCT01932762
Recruitment Status : Completed
First Posted : August 30, 2013
Results First Posted : March 4, 2016
Last Update Posted : September 24, 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
Interventions Drug: Grazoprevir
Drug: Elbasvir
Drug: Ribavirin
Enrollment 98
Recruitment Details  
Pre-assignment Details 98 participants were assigned to treatment at 28 sites worldwide and all enrolled participants received ≥1 dose of study therapy. 30 participants enrolled in Part A and 68 were enrolled and randomized in Part B of the study. Enrollment in Part C, an evaluation of a fixed-dose combination of grazoprevir and elbasvir, was never initiated.
Arm/Group Title GT2: Grazoprevir + Elbasvir + RBV (Arm A1) GT2: Grazoprevir + RBV (Arm B1) GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2) GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
Hide Arm/Group Description During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of ribavirin (RBV) for 12 weeks. During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks. During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks. During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
Period Title: Overall Study
Started 30 30 19 19
Completed 24 28 19 18
Not Completed 6 2 0 1
Reason Not Completed
Withdrawal by Subject             1             2             0             0
Lost to Follow-up             4             0             0             1
Physician Decision             1             0             0             0
Arm/Group Title GT2: Grazoprevir + Elbasvir + RBV (Arm A1) GT2: Grazoprevir + RBV (Arm B1) GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2) GT 4,5,6: Grazoprevir + Elbasvir (Arm B3) Total
Hide Arm/Group Description During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks. During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks. During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks. During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 30 30 19 19 98
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 19 participants 19 participants 98 participants
47.3  (13.6) 48.3  (14.6) 52.2  (9.3) 52.8  (12.3) 49.6  (13.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 19 participants 19 participants 98 participants
Female
11
  36.7%
13
  43.3%
11
  57.9%
7
  36.8%
42
  42.9%
Male
19
  63.3%
17
  56.7%
8
  42.1%
12
  63.2%
56
  57.1%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks After The End of Study Therapy (SVR12)
Hide Description SVR12 was defined as Hepatitis C Virus ribonucleic acid (HCV RNA) <25 IU/mL, either target detected but unquantifiable (TD[u]) or target not detected (TND), at 12 weeks after the end of all study therapy. The percentage of participants with SVR12 and accompanying 95% confidence intervals (CIs) were reported for each treatment arm in the Per-Protocol (PP) Population.
Time Frame 12 weeks after end of all therapy (Study Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy with no important protocol deviations) with available data.
Arm/Group Title GT2: Grazoprevir + Elbasvir + RBV (Arm A1) GT2: Grazoprevir + RBV (Arm B1) GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2) GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
Hide Arm/Group Description:
During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
Overall Number of Participants Analyzed 27 24 17 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
85.2
(66.3 to 95.8)
75.0
(53.3 to 90.2)
94.1
(71.3 to 99.9)
76.9
(46.2 to 95.0)
2.Primary Outcome
Title Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Drug-Related AEs, Drug-Related SAEs, or Discontinuation of Study Treatment Due to AE During the Treatment Period and First 14 Follow-up Days
Hide Description AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. An SAE was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event. The investigator determined the relationship of the AE to the treatment as unrelated or possibly, probably, or definitely related.
Time Frame Treatment period plus the first 14 days of follow-up (up to 14 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All-Subjects-As-Treated (ASAT) Population; all randomized participants who received ≥ 1 dose of study therapy. The percentage of participants with specific AEs and accompanying 95% CI were reported for each treatment arm.
Arm/Group Title GT2: Grazoprevir + Elbasvir + RBV (Arm A1) GT2: Grazoprevir + RBV (Arm B1) GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2) GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
Hide Arm/Group Description:
During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
Overall Number of Participants Analyzed 30 30 19 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
AEs
86.7
(69.3 to 96.2)
86.7
(69.3 to 96.2)
94.7
(74.0 to 99.9)
78.9
(54.4 to 93.9)
SAEs
3.3
(0.1 to 17.2)
3.3
(0.1 to 17.2)
0.0
(0.0 to 17.6)
0.0
(0.0 to 17.6)
Drug-related AE
63.3
(43.9 to 80.1)
63.3
(43.9 to 80.1)
57.9
(33.5 to 79.7)
36.8
(16.3 to 61.6)
Drug-related SAE
0.0
(0.0 to 11.6)
3.3
(0.1 to 17.2)
0.0
(0.0 to 17.6)
0.0
(0.0 to 17.6)
Discontinuation due to AE
0.0
(0.0 to 11.6)
0.0
(0.0 to 11.6)
0.0
(0.0 to 17.6)
5.3
(0.1 to 26.0)
3.Secondary Outcome
Title Mean Time to First Achievement of Undetectable HCV RNA During Treatment
Hide Description HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. Undetectable HCV RNA (or TND) was defined as below the 9.3 IU/ml limit of detection. Kaplan Meier summary statistics were calculated for each treatment arm in the Full Analysis Set (FAS).
Time Frame From TW1 until first achievement of undetectable HCV RNA (up to 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; all randomized participants who received ≥1 dose of study therapy. Participants in the FAS not achieving TND were censored from the analysis.
Arm/Group Title GT2: Grazoprevir + Elbasvir + RBV (Arm A1) GT2: Grazoprevir + RBV (Arm B1) GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2) GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
Hide Arm/Group Description:
During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
Overall Number of Participants Analyzed 30 26 19 18
Mean (Standard Error)
Unit of Measure: days
25.2  (2.8) 26.9  (3.0) 27.4  (4.5) 21.3  (1.7)
4.Secondary Outcome
Title Percentage of Participants Achieving Undetectable HCV RNA During Treatment By Timepoint
Hide Description HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. Undetectable HCV RNA (or TND) was defined as below the 9.3 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW2, TW4, and TW12 for each treatment arm of the PP Population.
Time Frame From TW 2 through TW 12 (up to 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.
Arm/Group Title GT2: Grazoprevir + Elbasvir + RBV (Arm A1) GT2: Grazoprevir + RBV (Arm B1) GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2) GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
Hide Arm/Group Description:
During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
Overall Number of Participants Analyzed 28 24 17 15
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2 (n=28, 24, 16, 15)
42.9
(24.5 to 62.8)
50.0
(29.1 to 70.9)
50.0
(24.7 to 75.3)
53.3
(26.6 to 78.7)
Week 4 (n=28, 24, 17, 15)
85.7
(67.3 to 96.0)
79.2
(57.8 to 92.9)
88.2
(63.6 to 98.5)
80.0
(51.9 to 95.7)
Week 12 (n=28, 24, 17, 14)
96.4
(81.7 to 99.9)
83.3
(62.6 to 95.3)
100.0
(80.5 to 100.0)
78.6
(49.2 to 95.3)
5.Secondary Outcome
Title Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment By Timepoint
Hide Description HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. The Roche COBAS™ Taqman™ HCV Test (v.2.0) has a lower limit of quantification (LLoQ) of 25 IU/ml and a limit of detection of 9.3 IU/ml. The percentage of participants with HCV RNA levels <25 IU/ml (either TD[u] or TND) and accompanying 95% CIs were reported at TW2, TW4, and TW12 for each treatment arm of the PP Population.
Time Frame From TW 2 through TW 12 (up to 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.
Arm/Group Title GT2: Grazoprevir + Elbasvir + RBV (Arm A1) GT2: Grazoprevir + RBV (Arm B1) GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2) GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
Hide Arm/Group Description:
During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
Overall Number of Participants Analyzed 28 24 17 15
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2 (n=28, 24, 16, 15)
96.4
(81.7 to 99.9)
79.2
(57.8 to 92.9)
87.5
(61.7 to 98.4)
93.3
(68.1 to 99.8)
Week 4 (n=28, 24, 17, 15)
100.0
(87.7 to 100.0)
91.7
(73.0 to 99.0)
100.0
(80.5 to 100.0)
93.3
(68.1 to 99.8)
Week 12 (n=28, 24, 17, 14)
96.4
(81.7 to 99.9)
87.5
(67.6 to 97.3)
100.0
(80.5 to 100.0)
85.7
(57.2 to 98.2)
6.Secondary Outcome
Title Percentage of Participants Achieving SVR4
Hide Description SVR4 was defined as HCV RNA <25 IU/mL, either TD(u) or TND, at 4 weeks after the end of all study therapy. The percentage of participants with SVR4 and accompanying 95% CIs were reported for each treatment arm of the PP Population.
Time Frame 4 weeks after end of all therapy (Study Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.
Arm/Group Title GT2: Grazoprevir + Elbasvir + RBV (Arm A1) GT2: Grazoprevir + RBV (Arm B1) GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2) GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
Hide Arm/Group Description:
During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
Overall Number of Participants Analyzed 27 24 17 14
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
88.9
(70.8 to 97.6)
83.3
(62.6 to 95.3)
94.1
(71.3 to 99.9)
78.6
(49.2 to 95.3)
7.Secondary Outcome
Title Percentage of Participants Achieving SVR24
Hide Description SVR24 was defined as HCV RNA <25 IU/mL, either TD(u) or TND, at 24 weeks after the end of all study therapy. The percentage of participants with SVR24 and accompanying 95% CIs were reported for each treatment arm of the PP Population.
Time Frame 24 weeks after end of all therapy (Study Week 36)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.
Arm/Group Title GT2: Grazoprevir + Elbasvir + RBV (Arm A1) GT2: Grazoprevir + RBV (Arm B1) GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2) GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
Hide Arm/Group Description:
During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
Overall Number of Participants Analyzed 26 24 17 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
84.6
(65.1 to 95.6)
75.0
(53.3 to 90.2)
94.1
(71.3 to 99.9)
76.9
(46.2 to 95.0)
Time Frame From TW1 through FW 24 (up to 36 weeks)
Adverse Event Reporting Description AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
 
Arm/Group Title GT2: Grazoprevir + Elbasvir + RBV (Arm A1) GT2: Grazoprevir + RBV (Arm B1) GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2) GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
Hide Arm/Group Description During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks. During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks. During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks. During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
All-Cause Mortality
GT2: Grazoprevir + Elbasvir + RBV (Arm A1) GT2: Grazoprevir + RBV (Arm B1) GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2) GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
GT2: Grazoprevir + Elbasvir + RBV (Arm A1) GT2: Grazoprevir + RBV (Arm B1) GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2) GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/30 (3.33%)      1/30 (3.33%)      0/19 (0.00%)      0/19 (0.00%)    
Infections and infestations         
Urinary tract infection  1  1/30 (3.33%)  1 0/30 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0
Renal and urinary disorders         
Renal failure acute  1  1/30 (3.33%)  1 0/30 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0
Vascular disorders         
Flushing  1  0/30 (0.00%)  0 1/30 (3.33%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GT2: Grazoprevir + Elbasvir + RBV (Arm A1) GT2: Grazoprevir + RBV (Arm B1) GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2) GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/30 (86.67%)      25/30 (83.33%)      18/19 (94.74%)      15/19 (78.95%)    
Blood and lymphatic system disorders         
Anaemia  1  4/30 (13.33%)  5 2/30 (6.67%)  2 1/19 (5.26%)  1 0/19 (0.00%)  0
Cardiac disorders         
Palpitations  1  1/30 (3.33%)  1 0/30 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Gastrointestinal disorders         
Abdominal distension  1  0/30 (0.00%)  0 0/30 (0.00%)  0 1/19 (5.26%)  1 1/19 (5.26%)  1
Abdominal pain  1  1/30 (3.33%)  1 1/30 (3.33%)  1 2/19 (10.53%)  2 0/19 (0.00%)  0
Abdominal pain upper  1  2/30 (6.67%)  3 0/30 (0.00%)  0 0/19 (0.00%)  0 2/19 (10.53%)  2
Abdominal tenderness  1  0/30 (0.00%)  0 1/30 (3.33%)  1 0/19 (0.00%)  0 1/19 (5.26%)  1
Constipation  1  3/30 (10.00%)  3 0/30 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Diarrhoea  1  1/30 (3.33%)  1 1/30 (3.33%)  2 1/19 (5.26%)  1 4/19 (21.05%)  4
Dry mouth  1  2/30 (6.67%)  2 1/30 (3.33%)  1 3/19 (15.79%)  3 1/19 (5.26%)  1
Dyspepsia  1  2/30 (6.67%)  2 2/30 (6.67%)  2 1/19 (5.26%)  1 0/19 (0.00%)  0
Enteritis  1  0/30 (0.00%)  0 0/30 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Faeces pale  1  0/30 (0.00%)  0 0/30 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Gastrooesophageal reflux disease  1  0/30 (0.00%)  0 2/30 (6.67%)  2 1/19 (5.26%)  1 1/19 (5.26%)  1
Haemorrhoids  1  0/30 (0.00%)  0 0/30 (0.00%)  0 0/19 (0.00%)  0 2/19 (10.53%)  2
Lip dry  1  0/30 (0.00%)  0 0/30 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Mouth ulceration  1  0/30 (0.00%)  0 0/30 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Nausea  1  5/30 (16.67%)  5 4/30 (13.33%)  6 2/19 (10.53%)  3 1/19 (5.26%)  1
Stomatitis  1  1/30 (3.33%)  1 0/30 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  3
Vomiting  1  5/30 (16.67%)  6 2/30 (6.67%)  3 0/19 (0.00%)  0 1/19 (5.26%)  1
General disorders         
Asthenia  1  5/30 (16.67%)  5 6/30 (20.00%)  6 3/19 (15.79%)  3 4/19 (21.05%)  4
Chest pain  1  1/30 (3.33%)  1 1/30 (3.33%)  1 1/19 (5.26%)  1 0/19 (0.00%)  0
Fatigue  1  12/30 (40.00%)  13 6/30 (20.00%)  7 5/19 (26.32%)  5 3/19 (15.79%)  3
Feeling cold  1  0/30 (0.00%)  0 1/30 (3.33%)  1 1/19 (5.26%)  1 0/19 (0.00%)  0
Influenza like illness  1  0/30 (0.00%)  0 0/30 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Pyrexia  1  2/30 (6.67%)  2 1/30 (3.33%)  1 0/19 (0.00%)  0 2/19 (10.53%)  2
Thirst  1  0/30 (0.00%)  0 2/30 (6.67%)  2 0/19 (0.00%)  0 0/19 (0.00%)  0
Hepatobiliary disorders         
Hepatomegaly  1  0/30 (0.00%)  0 0/30 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Infections and infestations         
Bronchitis  1  1/30 (3.33%)  1 0/30 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Influenza  1  3/30 (10.00%)  3 1/30 (3.33%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0
Laryngitis  1  0/30 (0.00%)  0 0/30 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Nasopharyngitis  1  0/30 (0.00%)  0 2/30 (6.67%)  2 1/19 (5.26%)  1 0/19 (0.00%)  0
Oral herpes  1  1/30 (3.33%)  1 0/30 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Rhinitis  1  0/30 (0.00%)  0 2/30 (6.67%)  2 0/19 (0.00%)  0 1/19 (5.26%)  1
Sinusitis  1  0/30 (0.00%)  0 0/30 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Skin infection  1  0/30 (0.00%)  0 0/30 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Urinary tract infection  1  0/30 (0.00%)  0 0/30 (0.00%)  0 1/19 (5.26%)  1 1/19 (5.26%)  1
Viral infection  1  0/30 (0.00%)  0 0/30 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Injury, poisoning and procedural complications         
Accidental overdose  1  4/30 (13.33%)  7 4/30 (13.33%)  6 1/19 (5.26%)  1 0/19 (0.00%)  0
Foot fracture  1  0/30 (0.00%)  0 1/30 (3.33%)  1 0/19 (0.00%)  0 1/19 (5.26%)  1
Inflammation of wound  1  0/30 (0.00%)  0 0/30 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Investigations         
Alanine aminotransferase increased  1  0/30 (0.00%)  0 0/30 (0.00%)  0 0/19 (0.00%)  0 2/19 (10.53%)  2
Aspartate aminotransferase increased  1  0/30 (0.00%)  0 0/30 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Blood bilirubin increased  1  2/30 (6.67%)  2 0/30 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0
Metabolism and nutrition disorders         
Decreased appetite  1  1/30 (3.33%)  1 2/30 (6.67%)  2 1/19 (5.26%)  1 0/19 (0.00%)  0
Dyslipidaemia  1  0/30 (0.00%)  0 0/30 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  1/30 (3.33%)  1 3/30 (10.00%)  4 1/19 (5.26%)  1 3/19 (15.79%)  9
Back pain  1  0/30 (0.00%)  0 0/30 (0.00%)  0 1/19 (5.26%)  1 2/19 (10.53%)  3
Bone pain  1  0/30 (0.00%)  0 0/30 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Flank pain  1  0/30 (0.00%)  0 0/30 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Joint swelling  1  1/30 (3.33%)  1 0/30 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Muscle contracture  1  0/30 (0.00%)  0 0/30 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Musculoskeletal pain  1  0/30 (0.00%)  0 0/30 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Myalgia  1  0/30 (0.00%)  0 0/30 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Neck pain  1  1/30 (3.33%)  1 0/30 (0.00%)  0 0/19 (0.00%)  0 2/19 (10.53%)  2
Pain in extremity  1  0/30 (0.00%)  0 1/30 (3.33%)  1 1/19 (5.26%)  1 0/19 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Adenoma benign  1  0/30 (0.00%)  0 0/30 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Nervous system disorders         
Disturbance in attention  1  1/30 (3.33%)  1 0/30 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Dizziness  1  7/30 (23.33%)  8 1/30 (3.33%)  2 0/19 (0.00%)  0 1/19 (5.26%)  2
Dysgeusia  1  2/30 (6.67%)  2 0/30 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0
Headache  1  6/30 (20.00%)  8 4/30 (13.33%)  5 6/19 (31.58%)  8 5/19 (26.32%)  20
Hypoaesthesia  1  0/30 (0.00%)  0 0/30 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Lethargy  1  0/30 (0.00%)  0 0/30 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Memory impairment  1  1/30 (3.33%)  1 0/30 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Poor quality sleep  1  1/30 (3.33%)  1 0/30 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Somnolence  1  0/30 (0.00%)  0 0/30 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Psychiatric disorders         
Depressed mood  1  2/30 (6.67%)  2 0/30 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Depression  1  0/30 (0.00%)  0 0/30 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Insomnia  1  2/30 (6.67%)  3 1/30 (3.33%)  1 3/19 (15.79%)  3 2/19 (10.53%)  3
Irritability  1  3/30 (10.00%)  3 1/30 (3.33%)  1 1/19 (5.26%)  1 1/19 (5.26%)  1
Sleep disorder  1  0/30 (0.00%)  0 2/30 (6.67%)  2 0/19 (0.00%)  0 0/19 (0.00%)  0
Renal and urinary disorders         
Dysuria  1  0/30 (0.00%)  0 0/30 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Reproductive system and breast disorders         
Genital tract inflammation  1  0/30 (0.00%)  0 0/30 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough  1  5/30 (16.67%)  5 1/30 (3.33%)  1 4/19 (21.05%)  4 4/19 (21.05%)  5
Dyspnoea  1  4/30 (13.33%)  4 1/30 (3.33%)  1 1/19 (5.26%)  1 0/19 (0.00%)  0
Dyspnoea exertional  1  1/30 (3.33%)  1 0/30 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Oropharyngeal pain  1  1/30 (3.33%)  1 1/30 (3.33%)  2 0/19 (0.00%)  0 3/19 (15.79%)  3
Rhinorrhoea  1  1/30 (3.33%)  1 0/30 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Skin and subcutaneous tissue disorders         
Alopecia  1  3/30 (10.00%)  3 0/30 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0
Dry skin  1  1/30 (3.33%)  1 1/30 (3.33%)  1 1/19 (5.26%)  1 0/19 (0.00%)  0
Eczema  1  0/30 (0.00%)  0 1/30 (3.33%)  1 0/19 (0.00%)  0 1/19 (5.26%)  2
Pruritus  1  2/30 (6.67%)  3 1/30 (3.33%)  1 2/19 (10.53%)  3 1/19 (5.26%)  2
Rash  1  2/30 (6.67%)  2 2/30 (6.67%)  2 3/19 (15.79%)  5 0/19 (0.00%)  0
Vascular disorders         
Hypertension  1  1/30 (3.33%)  1 0/30 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Hypotension  1  0/30 (0.00%)  0 0/30 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
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.
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. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
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: NCT01932762    
Other Study ID Numbers: 5172-047
2013-002169-21 ( EudraCT Number )
First Submitted: August 27, 2013
First Posted: August 30, 2013
Results First Submitted: February 3, 2016
Results First Posted: March 4, 2016
Last Update Posted: September 24, 2018