Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosb... | NCT02332720 | Trialant
NCT02332720
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Jul 30, 2019Actual
Enrollment
413Actual
Phase
Phase 2
Conditions
Hepatitis C
Interventions
Grazoprevir
Uprifosbuvir
Elbasvir
Ruzasvir
MK-3682B
Ribavirin (RBV)
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT02332720
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
3682-012
Secondary IDs
ID
Type
Description
Link
2014-003347-35
EudraCT Number
Brief Title
Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) for Chronic Hepatitis C Virus (HCV) Genotype (GT) 3, GT4, GT5, and GT6 Infection (MK-3682-012)
Official Title
A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-3682 With Either MK-8742 or MK-8408 in Subjects With Chronic HCV GT3, GT4, GT5, and GT6 Infection
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Jul 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 28, 2015Actual
Primary Completion Date
Sep 19, 2016Actual
Completion Date
May 3, 2017Actual
First Submitted Date
Jan 6, 2015
First Submission Date that Met QC Criteria
Jan 6, 2015
First Posted Date
Jan 7, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 24, 2018
Results First Submitted that Met QC Criteria
May 31, 2018
Results First Posted Date
Jul 2, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 18, 2019
Last Update Posted Date
Jul 30, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a randomized, three-part, parallel-group, open-label trial of grazoprevir (MK-5172) (100 mg) and uprifosbuvir (MK-3682) (300 mg or 450 mg) with either elbasvir (MK-8742) (50 mg) or ruzasvir (MK-8408) (60 mg), and with or without ribavirin (RBV), in treatment-naive (TN) or treatment-experienced (TE) cirrhotic (C) or non-cirrhotic (NC) participants infected with hepatitis C virus (HCV) genotype (GT) 3, GT4, GT5, or GT6. Part A will consist of 4 arms to evaluate the safety of dose combinations. In Part B, participants will take 2 uprifosbuvir (+) grazoprevir (+) ruzasvir (MK-3682B) fixed dose combination (FDC) tablets once daily (q.d.) by mouth, with or without twice-daily (b.i.d.) RBV (200 mg capsules; weight-based dosing). Participants who relapse following completion of therapy in Part A will be offered the option of retreatment with 16 weeks of uprifosbuvir (+) grazoprevir (+) ruzasvir with RBV in Part C (data obtained from Part C will not be used in the analysis of outcome measures).
Detailed Description
In Part A, study therapy will be administered as separate products, each taken q.d. by mouth. In Part B and Part C, participants will take 2 uprifosbuvir (+) grazoprevir (+) ruzasvir FDC tablets q.d. by mouth; each uprifosbuvir (+) grazoprevir (+) ruzasvir FDC tablet contains grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg.
In Part A, HCV GT3-infected NC TN participants will take grazoprevir (100 mg) + uprifosbuvir (300 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
In Part A, HCV GT3-infected NC TN participants will take grazoprevir (100 mg) + uprifosbuvir (300 mg) + ruzasvir (60 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
In Part A, HCV GT3-infected NC TN participants will take grazoprevir (100 mg) + uprifosbuvir (450 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Grazoprevir
Drug
Part A: one grazoprevir 100 mg tablet taken q.d. by mouth.
Percentage of HCV GT3-infected Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12)
SVR12 is defined as HCV ribonucleic acid (RNA) less than the lower limit of quantification (\
Up to 20 weeks (Part A), up to 28 weeks (Part B)
Number of Participants Experiencing an Adverse Event (AE)
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Part C in the table below combines all (eight) participants from the four distinct arms of Part A who relapsed and were subsequently treated with MK-3682B + RBV for 16 weeks.
Up to 40 weeks
Number of Participants Who Had Study Drug Discontinued Due to an AE
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Part C in the table below combines all (eight) participants from the four distinct arms of Part A who relapsed and were subsequently treated with MK-3682B + RBV for 16 weeks.
Up to 16 weeks
Secondary Outcomes
Measure
Description
Time Frame
Percentage of GT3-infected Participants Achieving SVR at Follow-up Week 24 (SVR24)
SVR24 is defined as HCV RNA \
Up to 40 weeks
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Has documented chronic HCV GT3, GT4, GT5, or GT6 with no evidence of non-typeable or mixed GT infection
Is otherwise healthy as determined by the medical history, physical examination, electrocardiogram (ECG), and clinical laboratory measurements performed at the time of screening
Has cirrhosis of the liver (Part B only) or is non-cirrhotic (Part A and B)
Is HCV treatment-naïve or has experienced virologic failure after completing a prior Pegylated Interferon/Ribavirin (Peg-IFN/RBV) regimen
Is of non childbearing potential or agrees to avoid becoming pregnant or impregnating a partner beginning at least 2 weeks prior to administration of the initial dose of study drug and for 14 days after the last dose of study drug if not taking RBV, or for 6 months after the last dose of study drug if taking RBV (or longer if dictated by local regulations). If not abstinent from heterosexual activity, participants in Part A must use 2 acceptable forms of barrier contraception whereas participants in Parts B and C must use 2 acceptable forms of contraception which may include oral contraceptives
Part B only:
If coinfected with human immunodeficiency virus (HIV) is not currently on antiretroviral therapy (ART) and has no plans to initiate ART treatment while participating in this study OR has well-controlled HIV on ART.
Has at least 1 viable antiretroviral regimen alternative beyond their current regimen in the event of HIV virologic failure and the development of anti-retroviral drug resistance.
Exclusion Criteria:
Parts A, B, and C (unless otherwise specified):
Has evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver disease.
If cirrhotic (Part B only), is Child-Pugh Class B or C or has a Pugh-Turcotte (CPT) score >5.
Is coinfected with hepatitis B virus (Parts A, B, and C) or is coinfected with HIV (Part A only; HIV coinfected participants are eligible for Parts B and C).
If coinfected with HIV, has a history of opportunistic infection in the preceding 6 months prior to screening.
Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ; or is under evaluation for other active or suspected malignancy.
Has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC.
Has clinically-relevant drug or alcohol abuse within 12 months of screening.
Is female and is pregnant or breastfeeding, or expecting to conceive or donate eggs from at least 2 weeks prior to Day 1 and 6 months after the last dose of study medication, or longer if dictated by local regulations OR a male participant who is expecting to donate sperm from at least 2 weeks prior to day 1 until 6 months after the last dose of study medication.
Has any of the following conditions:
Organ transplants (including hematopoietic stem cell transplants) other than cornea and hair.
Poor venous access that precludes routine peripheral blood sampling required for this trial.
History of gastric surgery (e.g., stapling, bypass) or a history of malabsorption disorders (e.g., celiac sprue disease).
Current or history of any clinically significant cardiac abnormalities/dysfunction, including but not limited to: angina, congestive heart failure, myocardial infarction, pulmonary hypertension, complex congenital heart disease, cardiomyopathy, significant arrhythmia, uncontrolled hypertension, a history of use of antianginal or anti-arrythmic agents for cardiac conditions, prolonged ECG QTc interval (>470 ms for males or >480 ms for females by either the Fridericia formula) at the screening visit, personal or family history of Torsade de pointes.
Chronic pulmonary disease, including but not limited to: clinically significant chronic obstructive pulmonary disease, interstitial lung disease, pulmonary fibrosis, sarcoidosis.
Central nervous system (CNS) trauma requiring intubation, intracranial pressure monitoring, brain meningeal or skull surgery, or resulting in seizure, coma, permanent neurologic deficits, abnormal brain imaging, or cerebral spinal fluid (CSF) leak. Prior brain hemorrhage and/or intracranial aneurysms (whether adequately repaired or not).
Current or history of seizure disorder unless seizure was >10 years ago, a single isolated event, no history of or current use of anti-seizure medications prescribed, and a normal neurological examination is documented in trial files within 6 months of Day 1.
Has a history of stroke or transient ischemic attack.
Has a history of a medical/surgical condition that resulted in hospitalization within the 3 months prior to enrollment, other than for minor elective procedures.
Has medical/surgical conditions that may result in a need for hospitalization during the period of the study.
Has any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, tumor necrosis factor (TNF) antagonists, or other immunosuppressant drugs during the course of the trial.
Has any condition, prestudy laboratory or ECG abnormality or history of any illness, which, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs to the participant.
Has had a life-threatening serious adverse event (SAE) during the screening period.
Has evidence of history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, hemochromatosis, Wilson's disease, α1-antitrypsin deficiency, alcoholic liver disease and autoimmune hepatitis Parts B and C only: is a male whose female partner(s) is/are pregnant
Lawitz E, Buti M, Vierling JM, Almasio PL, Bruno S, Ruane PJ, Hassanein TI, Muellhaupt B, Pearlman B, Jancoriene L, Gao W, Huang HC, Shepherd A, Tannenbaum B, Fernsler D, Li JJ, Grandhi A, Liu H, Su FH, Wan S, Dutko FJ, Nguyen BT, Wahl J, Robertson MN, Barr E, Yeh WW, Plank RM, Butterton JR, Yoshida EM. Safety and efficacy of a fixed-dose combination regimen of grazoprevir, ruzasvir, and uprifosbuvir with or without ribavirin in participants with and without cirrhosis with chronic hepatitis C virus genotype 1, 2, or 3 infection (C-CREST-1 and C-CREST-2, part B): two randomised, phase 2, open-label trials. Lancet Gastroenterol Hepatol. 2017 Nov;2(11):814-823. doi: 10.1016/S2468-1253(17)30163-2. Epub 2017 Aug 10.
Participants were enrolled into either Part A or Part B. Part A enrolled non-cirrhotic (NC), treatment-naïve (TN) participants with hepatitis C virus (HCV) genotype (GT) 3; Part B enrolled NC or cirrhotic (C), TN or treatment-experienced (TE) participants with HCV GT3, GT4, GT5 or GT6. Participants who relapsed in Part A were retreated in Part C.
Recruitment Details
No participants were randomized to the 'B21: GT5 NC TN MK-3682B (12 weeks)' arm.
In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
Participants will be randomized to either Part A or Part B. In Part A, HCV GT3-infected NC TN participants will take grazoprevir (100 mg) + uprifosbuvir (450 mg) + ruzasvir (60 mg) q.d. by mouth for 8 weeks. In Part B, HCV GT3-infected NC TN participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
Drug: Grazoprevir
Drug: Uprifosbuvir
Drug: Ruzasvir
Drug: MK-3682B
Drug: Ribavirin (RBV)
B5: GT3 NC TN MK-3682B + RBV (8 weeks)
Experimental
In Part B, HCV GT3-infected NC TN participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.
Drug: MK-3682B
Drug: Ribavirin (RBV)
B6: GT3 NC TN MK-3682B (12 weeks)
Experimental
In Part B, HCV GT3-infected NC TN participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
Drug: MK-3682B
B7: GT3 NC TN MK-3682B + RBV (12 weeks)
Experimental
In Part B, HCV GT3-infected NC TN participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
Drug: MK-3682B
Drug: Ribavirin (RBV)
B8: GT3 NC TE MK-3682B (8 weeks)
Experimental
In Part B, HCV GT3-infected NC TE participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
Drug: MK-3682B
B9: GT3 NC TE MK-3682B + RBV (8 weeks)
Experimental
In Part B, HCV GT3-infected NC TE participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.
Drug: MK-3682B
Drug: Ribavirin (RBV)
B10: GT3 NC TE MK-3682B (12 weeks)
Experimental
In Part B, HCV GT3-infected NC TE participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
Drug: MK-3682B
B11: GT3 NC TE MK-3682B + RBV (12 weeks)
Experimental
In Part B, HCV GT3-infected NC TE participants will take 2 MK-3682 FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
Drug: MK-3682B
Drug: Ribavirin (RBV)
B12: GT3 NC TE MK-3682B (16 weeks)
Experimental
In Part B, HCV GT3-infected NC TE participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
Drug: MK-3682B
B13: GT3 C TN MK-3682B (12 weeks)
Experimental
In Part B, HCV GT3-infected C TN participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
Drug: MK-3682B
B14: GT3 C TN MK-3682B + RBV (12 weeks)
Experimental
In Part B, HCV GT3-infected C TN participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
Drug: MK-3682B
Drug: Ribavirin (RBV)
B15: GT3 C TN MK-3682B (16 weeks)
Experimental
In Part B, HCV GT3-infected C TN participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
Drug: MK-3682B
B16: GT3 C TE MK-3682B (12 weeks)
Experimental
In Part B, HCV GT3-infected C TE participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
Drug: MK-3682B
B17: GT3 C TE MK-3682B + RBV (12 weeks)
Experimental
In Part B, HCV GT3-infected C TE participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
Drug: MK-3682B
Drug: Ribavirin (RBV)
B18: GT3 C TE MK-3682B (16 weeks)
Experimental
In Part B, HCV GT3-infected C TE participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
Drug: MK-3682B
B19: GT3 C TE MK-3682B + RBV (16 weeks)
Experimental
In Part B, HCV GT3-infected C TE participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 16 weeks.
Drug: MK-3682B
Drug: Ribavirin (RBV)
B20: GT4 NC TN MK-3682B (8 weeks)
Experimental
In Part B, HCV GT4-infected NC TN participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
Drug: MK-3682B
B21: GT5 NC TN MK-3682B (12 weeks)
Experimental
In Part B, HCV GT5-infected NC TN participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
Drug: MK-3682B
B22: GT6 NC TN MK-3682B (12 weeks)
Experimental
In Part B, HCV GT6-infected NC TN participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
Gane EJ, Pianko S, Roberts SK, Thompson AJ, Zeuzem S, Zuckerman E, Ben-Ari Z, Foster GR, Agarwal K, Laursen AL, Gerstoft J, Gao W, Huang HC, Fitzgerald B, Fernsler D, Li JJ, Grandhi A, Liu H, Su FH, Wan S, Zeng Z, Chen HL, Dutko FJ, Nguyen BT, Wahl J, Robertson MN, Barr E, Yeh WW, Plank RM, Butterton JR, Esteban R. Safety and efficacy of an 8-week regimen of grazoprevir plus ruzasvir plus uprifosbuvir compared with grazoprevir plus elbasvir plus uprifosbuvir in participants without cirrhosis infected with hepatitis C virus genotypes 1, 2, or 3 (C-CREST-1 and C-CREST-2, part A): two randomised, phase 2, open-label trials. Lancet Gastroenterol Hepatol. 2017 Nov;2(11):805-813. doi: 10.1016/S2468-1253(17)30159-0. Epub 2017 Aug 10.
In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + ruzasvir (60 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (450 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
In Part A, HCV GT3-infected NC TN participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy received retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
FG004
B4: GT3 NC TN MK-3682B (8 Weeks)
In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
FG005
B5: GT3 NC TN MK-3682B + RBV (8 Weeks)
In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.
FG006
B6: GT3 NC TN MK-3682B (12 Weeks)
In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
FG007
B7: GT3 NC TN MK-3682B + RBV (12 Weeks)
In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
FG008
B8: GT3 NC TE MK-3682B (8 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
FG009
B9: GT3 NC TE MK-3682B + RBV (8 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.
FG010
B10: GT3 NC TE MK-3682B (12 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
FG011
B11: GT3 NC TE MK-3682B + RBV (12 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682 FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
FG012
B12: GT3 NC TE MK-3682B (16 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
FG013
B13: GT3 C TN MK-3682B (12 Weeks)
In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
FG014
B14: GT3 C TN MK-3682B + RBV (12 Weeks)
In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
FG015
B15: GT3 C TN MK-3682B (16 Weeks)
In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
FG016
B16: GT3 C TE MK-3682B (12 Weeks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
FG017
B17: GT3 C TE MK-3682B + RBV (12 Weeks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
FG018
B18: GT3 C TE MK-3682B (16 Weeks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
FG019
B19: GT3 C TE MK-3682B + RBV (16 Weeks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 16 weeks.
FG020
B20: GT4 NC TN MK-3682B (8 Weeks)
In Part B, HCV GT4-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
FG021
B21: GT5 NC TN MK-3682B (12 Weeks)
In Part B, HCV GT5-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
FG022
B22: GT6 NC TN MK-3682B (12 Weeks)
In Part B, HCV GT6-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
FG00021 subjects
FG00121 subjects
FG00222 subjects
FG00322 subjects
FG00416 subjects
FG00536 subjects
FG00637 subjects
FG00735 subjects
FG00815 subjects
FG00914 subjects
FG01014 subjects
FG01115 subjects
FG01216 subjects
FG01313 subjects
FG01416 subjects
FG01514 subjects
FG01615 subjects
FG01714 subjects
FG01821 subjects
FG01925 subjects
FG0207 subjects
FG0210 subjects
FG0224 subjects
Treated
FG00021 subjects
FG00121 subjects
FG00222 subjects
FG00322 subjects
FG00416 subjects
FG00536 subjects
FG00637 subjects
FG00735 subjects
FG00815 subjects
FG00914 subjects
FG01014 subjects
FG01115 subjects
FG01216 subjects
FG01313 subjects
FG01416 subjects
FG01514 subjects
FG01615 subjects
FG01714 subjects
FG01820 subjects
FG01925 subjects
FG0207 subjects
FG0210 subjects
FG0224 subjects
COMPLETED
FG00020 subjects
FG00121 subjects
FG00222 subjects
FG00322 subjects
FG00416 subjects
FG00533 subjects
FG00636 subjects
FG00734 subjects
FG00815 subjects
FG00914 subjects
FG01014 subjects
FG01115 subjects
FG01216 subjects
FG01313 subjects
FG01416 subjects
FG01513 subjects
FG01615 subjects
FG01713 subjects
FG01820 subjects
FG01924 subjects
FG0207 subjects
FG0210 subjects
FG0224 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0053 subjects
FG0061 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0151 subjects
FG0160 subjects
FG0171 subjects
FG0181 subjects
FG0191 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0052 subjects
FG0061 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0151 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part C
Type
Comment
Milestone Data
STARTED
FG0002 subjectsPart A participants who had relapsed were offered the option of retreatment in Part C.
FG0011 subjectsPart A participants who had relapsed were offered the option of retreatment in Part C.
FG0023 subjectsPart A participants who had relapsed were offered the option of retreatment in Part C.
FG0032 subjectsPart A participants who had relapsed were offered the option of retreatment in Part C.
FG0040 subjectsPart B participants were not included in Part C.
FG0050 subjectsPart B participants were not included in Part C.
FG0060 subjectsPart B participants were not included in Part C.
FG0070 subjectsPart B participants were not included in Part C.
FG0080 subjectsPart B participants were not included in Part C.
FG0090 subjectsPart B participants were not included in Part C.
FG0100 subjectsPart B participants were not included in Part C.
FG0110 subjectsPart B participants were not included in Part C.
FG0120 subjectsPart B participants were not included in Part C.
FG0130 subjectsPart B participants were not included in Part C.
FG0140 subjectsPart B participants were not included in Part C.
FG0150 subjectsPart B participants were not included in Part C.
FG0160 subjectsPart B participants were not included in Part C.
FG0170 subjectsPart B participants were not included in Part C.
FG0180 subjectsPart B participants were not included in Part C.
FG0190 subjectsPart B participants were not included in Part C.
FG0200 subjectsPart B participants were not included in Part C.
FG0210 subjects
FG0220 subjectsPart B participants were not included in Part C.
COMPLETED
FG0002 subjects
FG0011 subjects
FG0023 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Overall Number of Baseline Participants includes participants who received at least one dose of study drug. One 'B18: GT3 C TE MK-3682B (16 weeks)' participant did not receive any study drug.
In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + ruzasvir (60 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (450 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
In Part A, HCV GT3-infected NC TN participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy received retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
BG004
B4: GT3 NC TN MK-3682B (8 Weeks)
In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
BG005
B5: GT3 NC TN MK-3682B + RBV (8 Weeks)
In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.
BG006
B6: GT3 NC TN MK-3682B (12 Weeks)
In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
BG007
B7: GT3 NC TN MK-3682B + RBV (12 Weeks)
In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
BG008
B8: GT3 NC TE MK-3682B (8 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
BG009
B9: GT3 NC TE MK-3682B + RBV (8 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.
BG010
B10: GT3 NC TE MK-3682B (12 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
BG011
B11: GT3 NC TE MK-3682B + RBV (12 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682 FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
BG012
B12: GT3 NC TE MK-3682B (16 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
BG013
B13: GT3 C TN MK-3682B (12 Weeks)
In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
BG014
B14: GT3 C TN MK-3682B + RBV (12 Weeks)
In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
BG015
B15: GT3 C TN MK-3682B (16 Weeks)
In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
BG016
B16: GT3 C TE MK-3682B (12 Weeks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
BG017
B17: GT3 C TE MK-3682B + RBV (12 Weeks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
BG018
B18: GT3 C TE MK-3682B (16 Weeks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
BG019
B19: GT3 C TE MK-3682B + RBV (16 Weeks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 16 weeks
BG020
B20: GT4 NC TN MK-3682B (8 Weeks)
In Part B, HCV GT4-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
BG021
B21: GT5 NC TN MK-3682B (12 Weeks)
In Part B, HCV GT5-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
BG022
B22: GT6 NC TN MK-3682B (12 Weeks)
In Part B, HCV GT6-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
BG023
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00021
BG00121
BG00222
BG00322
BG00416
BG00536
BG00637
BG00735
BG00815
BG00914
BG01014
BG01115
BG01216
BG01313
BG01416
BG01514
BG01615
BG01714
BG01820
BG01925
BG0207
BG0210
BG0224
BG023412
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
Participants
Title
Denominators
Categories
Less than 18 years
Title
Measurements
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0009
BG00115
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of HCV GT3-infected Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12)
SVR12 is defined as HCV ribonucleic acid (RNA) less than the lower limit of quantification (\
Analysis population included HCV GT3 participants who received treatment and did not have major protocol deviations that may substantially affect the results of the SVR endpoints. Therefore, only GT3 treatment arms are presented in the table below.
In Part A, HCV GT3-infected NC TN participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks.
OG004
A4+B4: GT3 NC TN MK-3682B (8 Weeks)
HCV GT3-infected NC TN participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks during Part A or 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks during Part B.
OG005
B4: GT3 NC TN MK-3682B (8 Weeks)
HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks during Part B
OG006
B5: GT3 NC TN MK-3682B + RBV (8 Weeks)
In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.
OG007
B6: GT3 NC TN MK-3682B (12 Weeks)
In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
OG008
B7: GT3 NC TN MK-3682B + RBV (12 Weeks)
In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
OG009
B8: GT3 NC TE MK-3682B (8 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
OG010
B9: GT3 NC TE MK-3682B + RBV (8 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.
OG011
B10: GT3 NC TE MK-3682B (12 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
OG012
B11: GT3 NC TE MK-3682B + RBV (12 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682 FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
OG013
B12: GT3 NC TE MK-3682B (16 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
OG014
B13: GT3 C TN MK-3682B (12 Weeks)
In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
OG015
B14: GT3 C TN MK-3682B + RBV (12 Weeks)
In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
OG016
B15: GT3 C TN MK-3682B (16 Weeks)
In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
OG017
B16: GT3 C TE MK-3682B (12 Weeks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
OG018
B17: GT3 C TE MK-3682B + RBV (12 Weeks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
OG019
B18: GT3 C TE MK-3682B (16 Weeks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
OG020
B19: GT3 C TE MK-3682B + RBV (16 Weeks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 16 weeks.
Units
Counts
Participants
OG00021
OG00121
OG00222
OG003
Title
Denominators
Categories
Title
Measurements
OG00090.5(69.6 to 98.8)
OG00195.2(76.2 to 99.9)
OG00286.4(65.1 to 97.1)
OG003
Primary
Number of Participants Experiencing an Adverse Event (AE)
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Part C in the table below combines all (eight) participants from the four distinct arms of Part A who relapsed and were subsequently treated with MK-3682B + RBV for 16 weeks.
All participants who received at least 1 dose of study drug, categorized according to the treatment actually received. A4+B4 arm includes both participants from Part A and Part B who received equivalent dose of MK-3682B. Part C arm includes participants who relapsed following the completion of Part A therapy and received treatment during Part C.
In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
Number of Participants Who Had Study Drug Discontinued Due to an AE
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Part C in the table below combines all (eight) participants from the four distinct arms of Part A who relapsed and were subsequently treated with MK-3682B + RBV for 16 weeks.
All participants who received at least 1 dose of study drug, categorized according to the treatment actually received. A4+B4 arm includes both participants from Part A and Part B who received equivalent dose of MK-3682B. Part C arm includes participants who relapsed following the completion of Part A therapy and received treatment during Part C.
In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
Percentage of GT3-infected Participants Achieving SVR at Follow-up Week 24 (SVR24)
SVR24 is defined as HCV RNA \
Analysis population included HCV GT3 participants who received treatment and did not have major protocol deviations that may substantially affect the results of the SVR endpoints. Therefore, only GT3 treatment arms are presented in the table below.
In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + ruzasvir (60 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
Time Frame
Up to 80 weeks (Parts A and B: 8 weeks or up to 16 weeks of treatment, respectively, plus 24-week follow-up; Part C: up to 16 weeks of retreatment plus 24-week follow-up)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
A1: GT3 NC TN EBR+GZR+UPR300 (8 Wks)
In Part A, participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks.
In Part A, participants received grazoprevir (100 mg) + uprifosbuvir 300 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. After relapsing, participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks in Part C.
0
2
0
2
1
2
EG002
A2: GT3 NC TN GZR+RZR+UPR300 (8 Wks)
In Part A, participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + ruzasvir (60 mg) q.d. by mouth for 8 weeks.
In Part A, participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + ruzasvir (60 mg) q.d. by mouth for 8 weeks. After relapsing, participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks in Part C.
0
1
0
1
1
1
EG004
A3: GT3 NC TN EBR+GZR+UPR450 (8 Wks)
In Part A, participants received grazoprevir (100 mg) + uprifosbuvir (450 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks.
In Part A, participants received grazoprevir (100 mg) + uprifosbuvir (450 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. After relapsing, participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks in Part C.
0
3
0
3
3
3
EG006
A4: GT3 NC TN GZR+RZR+UPR450 (8 Wks)
In Part A, participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks.
In Part A, participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks. After relapsing, participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks in Part C.
0
2
1
2
2
2
EG008
B4: GT3 NC TN MK-3682B (8 Wks)
In Part B, participants received 2 MK- 3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
0
16
0
16
9
16
EG009
B5: GT3 NC TN MK-3682B + RBV (8 Wks)
In Part B , participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.
0
36
1
36
30
36
EG010
B6: GT3 NC TN MK-3682B (12 Wks)
In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
0
37
0
37
24
37
EG011
B7: GT3 NC TN MK-3682B + RBV (12 Wks)
In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
0
35
1
35
32
35
EG012
B8: GT3 NC TE MK-3682B (8 Wks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
0
15
0
15
12
15
EG013
B9: GT3 NC TE MK-3682B + RBV (8 Wks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.
0
14
0
14
12
14
EG014
B10: GT3 NC TE MK-3682B (12 Wks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
0
14
0
14
9
14
EG015
B11: GT3 NC TE MK-3682B + RBV (12 Wks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682 FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
0
15
0
15
13
15
EG016
B12: GT3 NC TE MK-3682B (16 Wks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
0
16
1
16
13
16
EG017
B13: GT3 C TN MK-3682B (12 Wks)
In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
0
13
1
13
9
13
EG018
B14: GT3 C TN MK-3682B + RBV (12 Wks)
In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
0
16
0
16
14
16
EG019
B15: GT3 C TN MK-3682B (16 Wks)
In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
0
14
2
14
12
14
EG020
B16: GT3 C TE MK-3682B (12 Wks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
0
15
2
15
12
15
EG021
B17: GT3 C TE MK-3682B + RBV (12 Wks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
0
14
2
14
11
14
EG022
B18: GT3 C TE MK-3682B (16 Wks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
0
20
2
20
15
20
EG023
B19: GT3 C TE MK-3682B + RBV (16 Wks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 16 weeks.
0
25
1
25
21
25
EG024
B20: GT4 NC TN MK-3682B (8 Wks)
In Part B, HCV GT4-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
0
7
0
7
3
7
EG025
B22: GT6 NC TN MK-3682B (12 Wks)
In Part B, HCV GT6-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
0
4
0
4
3
4
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Coronary artery disease
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected20 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected16 at risk
EG0090 events0 affected36 at risk
EG0100 events0 affected37 at risk
EG0110 events0 affected35 at risk
EG0120 events0 affected15 at risk
EG0130 events0 affected14 at risk
EG0140 events0 affected14 at risk
EG0150 events0 affected15 at risk
EG0160 events0 affected16 at risk
EG0170 events0 affected13 at risk
EG0180 events0 affected16 at risk
EG0190 events0 affected14 at risk
EG0200 events0 affected15 at risk
EG0210 events0 affected14 at risk
EG0221 events1 affected20 at risk
EG0230 events0 affected25 at risk
EG0240 events0 affected7 at risk
EG0250 events0 affected4 at risk
Keratitis
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Biliary colic
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Pharyngeal abscess
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Blood sodium decreased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Hepatocellular carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Inflammatory pseudotumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Lip and/or oral cavity cancer stage 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Migraine
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Alcohol abuse
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected20 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected16 at risk
EG0090 events0 affected36 at risk
EG0101 events1 affected37 at risk
EG0112 events2 affected35 at risk
EG0120 events0 affected15 at risk
EG0130 events0 affected14 at risk
EG0140 events0 affected14 at risk
EG0151 events1 affected15 at risk
EG0160 events0 affected16 at risk
EG0170 events0 affected13 at risk
EG0181 events1 affected16 at risk
EG0190 events0 affected14 at risk
EG0200 events0 affected15 at risk
EG0210 events0 affected14 at risk
EG0220 events0 affected20 at risk
EG0230 events0 affected25 at risk
EG0240 events0 affected7 at risk
EG0250 events0 affected4 at risk
Haemolysis
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Haemolytic anaemia
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Bundle branch block right
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Dry eye
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Eye pain
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Ocular discomfort
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Pinguecula
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Vision blurred
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Visual impairment
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected20 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0022 events2 affected20 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected19 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected20 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected20 at risk
EG003
Faeces soft
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected19 at risk
EG0010 events0 affected2 at risk
EG0022 events2 affected20 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected20 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Infrequent bowel movements
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0003 events2 affected19 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected20 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Salivary hypersecretion
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Tongue ulceration
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Asthenia
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected20 at risk
EG003
Chest discomfort
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Chest pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected20 at risk
EG003
Chills
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Energy increased
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Fatigue
General disorders
MedDRA 20.0
Systematic Assessment
EG0004 events4 affected19 at risk
EG0010 events0 affected2 at risk
EG0025 events5 affected20 at risk
EG003
Feeling abnormal
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Feeling cold
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Feeling hot
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Feeling jittery
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Influenza like illness
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected20 at risk
EG003
Local swelling
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Malaise
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Pyrexia
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Vessel puncture site pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected20 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Cystitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Ear infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Genital herpes
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Infected dermal cyst
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Influenza
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Otitis media
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Paronychia
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Periodontitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected20 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected20 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Viral infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Wound infection staphylococcal
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Bone contusion
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Foreign body
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Tendon injury
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Amylase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Bacterial test positive
Investigations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected20 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected20 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Blood potassium increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Blood urine present
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Heart rate increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Lipase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Protein urine present
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Transaminases increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
White blood cells urine positive
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Hyperamylasaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Hyperlipasaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected20 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Ankylosing spondylitis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Fibromyalgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected19 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected20 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected20 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected20 at risk
EG003
Dyskinesia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0005 events4 affected19 at risk
EG0013 events1 affected2 at risk
EG0026 events5 affected20 at risk
EG003
Hypersomnia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Migraine
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Parosmia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Poor quality sleep
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Tension headache
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Affect lability
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected20 at risk
EG003
Depression
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Emotional disorder
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0003 events2 affected19 at risk
EG0010 events0 affected2 at risk
EG0022 events1 affected20 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected20 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Tearfulness
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Nephropathy
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Renal cyst
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Breast tenderness
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Vulval haematoma
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Nasal discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Paranasal sinus discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected20 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Macule
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected20 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected20 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Arteriosclerosis
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Flushing
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Hot flush
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Hypertension
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected20 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
1-800-672-6372
ClinicalTrialsDisclosure@merck.com
ID
Term
D006526
Hepatitis C
Ancestor Terms
ID
Term
D000086982
Blood-Borne Infections
D003141
Communicable Diseases
D007239
Infections
D006525
Hepatitis, Viral, Human
D014777
Virus Diseases
D018178
Flaviviridae Infections
D012327
RNA Virus Infections
D006505
Hepatitis
D008107
Liver Diseases
D004066
Digestive System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C578009
grazoprevir
C000627758
uprifosbuvir
C000589335
elbasvir
C000621654
ruzasvir
D012254
Ribavirin
Ancestor Terms
ID
Term
D012263
Ribonucleosides
D009705
Nucleosides
D009706
Nucleic Acids, Nucleotides, and Nucleosides
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0171 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0181 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0191 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
0
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0220
BG0230
18 to 35 years
Title
Measurements
BG0004
BG0014
BG0023
BG0034
BG0043
BG0058
BG0069
BG0077
BG0080
BG0091
BG0102
BG0111
BG0120
BG0130
BG0140
BG0150
BG0160
BG0172
BG0180
BG0190
BG0201
BG0220
BG02349
36 to 50 years
Title
Measurements
BG00012
BG0019
BG00214
BG00312
BG0044
BG00511
BG00614
BG00712
BG0085
BG0095
BG0106
BG0114
BG0126
BG0137
BG0143
BG0153
BG0164
BG0173
BG0186
BG0196
BG0203
BG0221
BG023150
51 to 64 years
Title
Measurements
BG0005
BG0018
BG0025
BG0033
BG0046
BG00516
BG00613
BG00716
BG0088
BG0097
BG0106
BG0119
BG0129
BG0134
BG01413
BG0159
BG01611
BG0179
BG01813
BG01918
BG0203
BG0223
BG023194
Over 64 years
Title
Measurements
BG0000
BG0010
BG0020
BG0033
BG0043
BG0051
BG0061
BG0070
BG0082
BG0091
BG0100
BG0111
BG0121
BG0132
BG0140
BG0152
BG0160
BG0170
BG0181
BG0191
BG0200
BG0220
BG02319
14
BG00311
BG0047
BG00519
BG00623
BG00723
BG0087
BG0092
BG0108
BG0116
BG0125
BG0133
BG0145
BG0153
BG0168
BG0171
BG0182
BG0195
BG0201
BG0222
BG023179
Male
BG00012
BG0016
BG0028
BG00311
BG0049
BG00517
BG00614
BG00712
BG0088
BG00912
BG0106
BG0119
BG01211
BG01310
BG01411
BG01511
BG0167
BG01713
BG01818
BG01920
BG0206
BG0222
BG023233
22
OG00438
OG00516
OG00635
OG00736
OG00835
OG00915
OG01014
OG01114
OG01215
OG01316
OG01413
OG01516
OG01613
OG01715
OG01814
OG01920
OG02025
90.9
(70.8 to 98.9)
OG00492.1(78.6 to 98.3)
OG00593.8(69.8 to 99.8)
OG006100.0(90.0 to 100.0)
OG00797.2(85.5 to 99.9)
OG008100.0(90.0 to 100.0)
OG009100.0(78.2 to 100.0)
OG01092.9(66.1 to 99.8)
OG011100.0(76.8 to 100.0)
OG01293.3(68.1 to 99.8)
OG01393.8(69.8 to 99.8)
OG01492.3(64.0 to 99.8)
OG015100.0(79.4 to 100.0)
OG016100.0(75.3 to 100.0)
OG017100.0(78.2 to 100.0)
OG018100.0(76.8 to 100.0)
OG019100.0(83.2 to 100.0)
OG02096.0(79.6 to 99.9)
In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + ruzasvir (60 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (450 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
In Part A, HCV GT3-infected NC TN participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy received retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
OG004
A4+ B4: GT3 NC TN MK-3682B (8 Weeks)
HCV GT3-infected NC TN participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks during Part A or 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks during Part B.
OG005
B4: GT3 NC TN MK-3682B (8 Weeks)
In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks
OG006
B5: GT3 NC TN MK-3682B + RBV (8 Weeks)
In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.
OG007
B6: GT3 NC TN MK-3682B (12 Weeks)
In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks
OG008
B7: GT3 NC TN MK-3682B + RBV (12 Weeks)
In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks
OG009
B8: GT3 NC TE MK-3682B (8 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
OG010
B9: GT3 NC TE MK-3682B + RBV (8 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.
OG011
B10: GT3 NC TE MK-3682B (12 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
OG012
B11: GT3 NC TE MK-3682B + RBV (12 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682 FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
OG013
B12: GT3 NC TE MK-3682B (16 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
OG014
B13: GT3 C TN MK-3682B (12 Weeks)
In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
OG015
B14: GT3 C TN MK-3682B + RBV (12 Weeks)
In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
OG016
B15: GT3 C TN MK-3682B (16 Weeks)
In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
OG017
B16: GT3 C TE MK-3682B (12 Weeks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
OG018
B17: GT3 C TE MK-3682B + RBV (12 Weeks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
OG019
B18: GT3 C TE MK-3682B (16 Weeks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
OG020
B19: GT3 C TE MK-3682B + RBV (16 Weeks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 16 weeks.
OG021
B20: GT4 NC TN MK-3682B (8 Weeks)
In Part B, HCV GT4-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
OG022
B22: GT6 NC TN MK-3682B (12 Weeks)
In Part B, HCV GT6-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
OG023
Part C: GT3 NC TN: MK-3682B + RBV (16 Weeks)
Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
Units
Counts
Participants
OG00021
OG00121
OG00222
OG00322
OG00438
OG00516
OG00636
OG00737
OG00835
OG00915
OG01014
OG01114
OG01215
OG01316
OG01413
OG01516
OG01614
OG01715
OG01814
OG01920
OG02025
OG0217
OG0224
OG0238
Title
Denominators
Categories
Title
Measurements
OG00018
OG00114
OG00216
OG00317
OG00426
OG0059
OG00630
OG00725
OG00833
OG00912
OG01012
OG0119
OG01213
OG01313
OG0149
OG01514
OG01612
OG01712
OG01812
OG01916
OG02021
OG0213
OG0223
OG0237
In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + ruzasvir (60 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (450 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
In Part A, HCV GT3-infected NC TN participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy received retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
OG004
A4+ B4: GT3 NC TN MK-3682B (8 Weeks)
HCV GT3-infected NC TN participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks during Part A or 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks during Part B.
OG005
B4: GT3 NC TN MK-3682B (8 Weeks)
In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks
OG006
B5: GT3 NC TN MK-3682B + RBV (8 Weeks)
In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.
OG007
B6: GT3 NC TN MK-3682B (12 Weeks)
In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks
OG008
B7: GT3 NC TN MK-3682B + RBV (12 Weeks)
In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks
OG009
B8: GT3 NC TE MK-3682B (8 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
OG010
B9: GT3 NC TE MK-3682B + RBV (8 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.
OG011
B10: GT3 NC TE MK-3682B (12 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
OG012
B11: GT3 NC TE MK-3682B + RBV (12 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682 FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
OG013
B12: GT3 NC TE MK-3682B (16 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
OG014
B13: GT3 C TN MK-3682B (12 Weeks)
In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
OG015
B14: GT3 C TN MK-3682B + RBV (12 Weeks)
In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
OG016
B15: GT3 C TN MK-3682B (16 Weeks)
In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
OG017
B16: GT3 C TE MK-3682B (12 Weeks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
OG018
B17: GT3 C TE MK-3682B + RBV (12 Weeks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
OG019
B18: GT3 C TE MK-3682B (16 Weeks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
OG020
B19: GT3 C TE MK-3682B + RBV (16 Weeks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 16 weeks.
OG021
B20: GT4 NC TN MK-3682B (8 Weeks)
In Part B, HCV GT4-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
OG022
B22: GT6 NC TN MK-3682B (12 Weeks)
In Part B, HCV GT6-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
OG023
Part C: GT3 NC TN: MK-3682B + RBV (16 Weeks)
Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (450 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
In Part A, HCV GT3-infected NC TN participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy received retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
OG004
A4+B4: GT3 NC TN MK-3682B (8 Weeks)
In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
OG005
B4: GT3 NC TN MK-3682B (8 Weeks)
In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
OG006
B5: GT3 NC TN MK-3682B + RBV (8 Weeks)
In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.
OG007
B6: GT3 NC TN MK-3682B (12 Weeks)
In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
OG008
B7: GT3 NC TN MK-3682B + RBV (12 Weeks)
In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
OG009
B8: GT3 NC TE MK-3682B (8 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.
OG010
B9: GT3 NC TE MK-3682B + RBV (8 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.
OG011
B10: GT3 NC TE MK-3682B (12 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
OG012
B11: GT3 NC TE MK-3682B + RBV (12 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682 FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
OG013
B12: GT3 NC TE MK-3682B (16 Weeks)
In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
OG014
B13: GT3 C TN MK-3682B (12 Weeks)
In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
OG015
B14: GT3 C TN MK-3682B + RBV (12 Weeks)
In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
OG016
B15: GT3 C TN MK-3682B (16 Weeks)
In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
OG017
B16: GT3 C TE MK-3682B (12 Weeks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
OG018
B17: GT3 C TE MK-3682B + RBV (12 Weeks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.
OG019
B18: GT3 C TE MK-3682B (16 Weeks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.
OG020
B19: GT3 C TE MK-3682B + RBV (16 Weeks)
In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 16 weeks.