Download PDF

Clinical Trial Results:
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

Summary
EudraCT number	2014-003347-35
Trial protocol	DK GB DE IT
Global end of trial date	03 May 2017

Results information
Results version number	v2(current)
This version publication date	05 Aug 2018
First version publication date	13 May 2018
Other versions	v1
Version creation reason

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

3682-012

ISRCTN number

US NCT number

NCT02332720

WHO universal trial number (UTN)

Sponsor organisation name

Merck Sharp & Dohme Corp.

Sponsor organisation address

2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033

Public contact

Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com

Scientific contact

Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

03 May 2017

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

03 May 2017

Was the trial ended prematurely?

Main objective of the trial

This is a randomized, three-part, parallel-group, open-label trial of grazoprevir 100 mg and uprifosbuvir 300 mg or 450 mg with either elbasvir 50 mg or ruzasvir 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. In Part A, study therapy will be administered as separate products, each taken once daily (q.d). by mouth. In Part B, participants will take 2 uprifosbuvir + grazoprevir + ruzasvir fixed dose combination (FDC) tablets 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).

Protection of trial subjects

This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research. The following additional measure(s) defined for this individual study was in place for the protection of trial subjects: an option for retreatment of subjects who do not achieve SVR12 for reasons other than HCV virologic breakthrough, rebound or early discontinuation of therapy in Part A or Part B.

Background therapy

Evidence for comparator

Actual start date of recruitment

28 Jan 2015

Long term follow-up planned

Yes

Long term follow-up rationale

Scientific research

Long term follow-up duration

3 Years

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 43

Country: Number of subjects enrolled

Canada: 27

Country: Number of subjects enrolled

Denmark: 39

Country: Number of subjects enrolled

France: 19

Country: Number of subjects enrolled

Germany: 26

Country: Number of subjects enrolled

Israel: 60

Country: Number of subjects enrolled

Italy: 23

Country: Number of subjects enrolled

New Zealand: 23

Country: Number of subjects enrolled

Switzerland: 23

Country: Number of subjects enrolled

United Kingdom: 31

Country: Number of subjects enrolled

United States: 99

Worldwide total number of subjects

413

EEA total number of subjects

138

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

394

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

No participants were randomized to the 'B21: GT5 NC TN MK-3682B (12 weeks)' arm.

Screening details

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.

Period 1 title

Pre-treatment randomization

Is this the baseline period?

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Grazoprevir

Investigational medicinal product code

Other name

MK-5172

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part A: one grazoprevir 100 mg tablet taken q.d. by mouth.

Investigational medicinal product name

Elbasvir

Investigational medicinal product code

Other name

MK-8742

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Part A: one elbasvir 50 mg tablet taken q.d. by mouth.

Investigational medicinal product name

Uprifosbuvir

Investigational medicinal product code

Other name

MK-3682

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part A: two uprifosbuvir 150 mg (300 mg total daily dose) tablets taken q.d. by mouth.

A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Grazoprevir

Investigational medicinal product code

Other name

MK-5172

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part A: one grazoprevir 100 mg tablet taken q.d. by mouth.

Investigational medicinal product name

Uprifosbuvir

Investigational medicinal product code

Other name

MK-3682

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part A: two uprifosbuvir 150 mg (300 mg total daily dose) tablets taken q.d. by mouth.

Investigational medicinal product name

Ruzasvir

Investigational medicinal product code

Other name

MK-8408

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part A: six ruzasvir 10 mg (60 mg total daily dose) capsules taken q.d. by mouth.

A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Grazoprevir

Investigational medicinal product code

Other name

MK-5172

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part A: one grazoprevir 100 mg tablet taken q.d. by mouth.

Investigational medicinal product name

Elbasvir

Investigational medicinal product code

Other name

MK-8742

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Part A: one elbasvir 50 mg tablet taken q.d. by mouth.

Investigational medicinal product name

Uprifosbuvir

Investigational medicinal product code

Other name

MK-3682

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part A: three uprifosbuvir 150 mg (450 mg total daily dose) tablets taken q.d. by mouth.

A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Grazoprevir

Investigational medicinal product code

Other name

MK-5172

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part A: one grazoprevir 100 mg tablet taken q.d. by mouth.

Investigational medicinal product name

Uprifosbuvir

Investigational medicinal product code

Other name

MK-3682

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part A: three uprifosbuvir 150 mg (450 mg total daily dose) tablets taken q.d. by mouth.

Investigational medicinal product name

Ruzasvir

Investigational medicinal product code

Other name

MK-8408

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part A: six ruzasvir 10 mg (60 mg total daily dose) capsules taken q.d. by mouth.

Investigational medicinal product name

Grazoprevir

Investigational medicinal product code

Other name

MK-5172

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part A: one grazoprevir 100 mg tablet taken q.d. by mouth.

Investigational medicinal product name

Uprifosbuvir

Investigational medicinal product code

Other name

MK-3682

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part A: three uprifosbuvir 150 mg (450 mg total daily dose) tablets taken q.d. by mouth.

Investigational medicinal product name

Ruzasvir

Investigational medicinal product code

Other name

MK-8408

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part A: six ruzasvir 10 mg (60 mg total daily dose) capsules taken q.d. by mouth.

B4: GT3 NC TN MK-3682B (8 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

B5: GT3 NC TN MK-3682B + RBV (8 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

Investigational medicinal product name

Ribavirin

Investigational medicinal product code

Other name

Rebetol

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Part B: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight.

B6: GT3 NC TN MK-3682B (12 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

B7: GT3 NC TN MK-3682B + RBV (12 weeks)

Arm description

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

Investigational medicinal product name

Ribavirin

Investigational medicinal product code

Other name

Rebetol

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Part B: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight.

B8: GT3 NC TE MK-3682B (8 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

B9: GT3 NC TE MK-3682B + RBV (8 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

Investigational medicinal product name

Ribavirin

Investigational medicinal product code

Other name

Rebetol

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Part B: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight.

B10: GT3 NC TE MK-3682B (12 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

B11: GT3 NC TE MK-3682B + RBV (12 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

Investigational medicinal product name

Ribavirin

Investigational medicinal product code

Other name

Rebetol

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Part B: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight.

B12: GT3 NC TE MK-3682B (16 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

B13: GT3 C TN MK-3682B (12 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

B14: GT3 C TN MK-3682B + RBV (12 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

Investigational medicinal product name

Ribavirin

Investigational medicinal product code

Other name

Rebetol

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Part B: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight.

B15: GT3 C TN MK-3682B (16 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

B16: GT3 C TE MK-3682B (12 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

B17: GT3 C TE MK-3682B + RBV (12 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

Investigational medicinal product name

Ribavirin

Investigational medicinal product code

Other name

Rebetol

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Part B: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight.

B18: GT3 C TE MK-3682B (16 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

B19: GT3 C TE MK-3682B + RBV (16 weeks)

Arm description

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

Investigational medicinal product name

Ribavirin

Investigational medicinal product code

Other name

Rebetol

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Part B: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight.

B20: GT4 NC TN MK-3682B (8 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

B22: GT6 NC TN MK-3682B (12 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

Number of subjects in period 1	A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)	A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)	A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)	A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)	B4: GT3 NC TN MK-3682B (8 weeks)	B5: GT3 NC TN MK-3682B + RBV (8 weeks)	B6: GT3 NC TN MK-3682B (12 weeks)	B7: GT3 NC TN MK-3682B + RBV (12 weeks)	B8: GT3 NC TE MK-3682B (8 weeks)	B9: GT3 NC TE MK-3682B + RBV (8 weeks)	B10: GT3 NC TE MK-3682B (12 weeks)	B11: GT3 NC TE MK-3682B + RBV (12 weeks)	B12: GT3 NC TE MK-3682B (16 weeks)	B13: GT3 C TN MK-3682B (12 weeks)	B14: GT3 C TN MK-3682B + RBV (12 weeks)	B15: GT3 C TN MK-3682B (16 weeks)	B16: GT3 C TE MK-3682B (12 weeks)	B17: GT3 C TE MK-3682B + RBV (12 weeks)	B18: GT3 C TE MK-3682B (16 weeks)	B19: GT3 C TE MK-3682B + RBV (16 weeks)	B20: GT4 NC TN MK-3682B (8 weeks)	B22: GT6 NC TN MK-3682B (12 weeks)
Started	21	21	22	22	16	36	37	35	15	14	14	15	16	13	16	14	15	14	21	25	7	4
Completed	21	21	22	22	16	36	37	35	15	14	14	15	16	13	16	14	15	14	20	25	7	4
Not completed	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Physician decision	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	1	-	-	-

Period 2 title

Part A and Part B Treatment Period

Is this the baseline period?

Yes ^[1]

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Grazoprevir

Investigational medicinal product code

Other name

MK-5172

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part A: one grazoprevir 100 mg tablet taken q.d. by mouth.

Investigational medicinal product name

Elbasvir

Investigational medicinal product code

Other name

MK-8742

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Part A: one elbasvir 50 mg tablet taken q.d. by mouth.

Investigational medicinal product name

Uprifosbuvir

Investigational medicinal product code

Other name

MK-3682

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part A: two uprifosbuvir 150 mg (300 mg total daily dose) tablets taken q.d. by mouth.

A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Grazoprevir

Investigational medicinal product code

Other name

MK-5172

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part A: one grazoprevir 100 mg tablet taken q.d. by mouth.

Investigational medicinal product name

Ruzasvir

Investigational medicinal product code

Other name

MK-8408

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part A: six ruzasvir 10 mg (60 mg total daily dose) capsules taken q.d. by mouth.

Investigational medicinal product name

Uprifosbuvir

Investigational medicinal product code

Other name

MK-3682

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part A: two uprifosbuvir 150 mg (300 mg total daily dose) tablets taken q.d. by mouth.

A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Grazoprevir

Investigational medicinal product code

Other name

MK-5172

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part A: one grazoprevir 100 mg tablet taken q.d. by mouth.

Investigational medicinal product name

Elbasvir

Investigational medicinal product code

Other name

MK-8742

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Part A: one elbasvir 50 mg tablet taken q.d. by mouth.

Investigational medicinal product name

Uprifosbuvir

Investigational medicinal product code

Other name

MK-3682

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part A: three uprifosbuvir 150 mg (450 mg total daily dose) tablets taken q.d. by mouth.

A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Grazoprevir

Investigational medicinal product code

Other name

MK-5172

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part A: one grazoprevir 100 mg tablet taken q.d. by mouth.

Investigational medicinal product name

Uprifosbuvir

Investigational medicinal product code

Other name

MK-3682

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part A: three uprifosbuvir 150 mg (450 mg total daily dose) tablets taken q.d. by mouth.

Investigational medicinal product name

Ruzasvir

Investigational medicinal product code

Other name

MK-8408

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part A: six ruzasvir 10 mg (60 mg total daily dose) capsules taken q.d. by mouth.

Investigational medicinal product name

Grazoprevir

Investigational medicinal product code

Other name

MK-5172

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part A: one grazoprevir 100 mg tablet taken q.d. by mouth.

Investigational medicinal product name

Uprifosbuvir

Investigational medicinal product code

Other name

MK-3682

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part A: three uprifosbuvir 150 mg (450 mg total daily dose) tablets taken q.d. by mouth.

Investigational medicinal product name

Ruzasvir

Investigational medicinal product code

Other name

MK-8408

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part A: six ruzasvir 10 mg (60 mg total daily dose) capsules taken q.d. by mouth.

B4: GT3 NC TN MK-3682B (8 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

B5: GT3 NC TN MK-3682B + RBV (8 weeks)

Arm description

Arm type

Experimental

Investigational medicinal product name

Ribavirin

Investigational medicinal product code

Other name

Rebetol

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Part B: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight.

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

B6: GT3 NC TN MK-3682B (12 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

B7: GT3 NC TN MK-3682B + RBV (12 weeks)

Arm description

Arm type

Experimental

Investigational medicinal product name

Ribavirin

Investigational medicinal product code

Other name

Rebetol

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Part B: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight.

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

B8: GT3 NC TE MK-3682B (8 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

B9: GT3 NC TE MK-3682B + RBV (8 weeks)

Arm description

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

Investigational medicinal product name

Ribavirin

Investigational medicinal product code

Other name

Rebetol

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Part B: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight.

B10: GT3 NC TE MK-3682B (12 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

B11: GT3 NC TE MK-3682B + RBV (12 weeks)

Arm description

Arm type

Experimental

Investigational medicinal product name

Ribavirin

Investigational medicinal product code

Other name

Rebetol

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Part B: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight.

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

B12: GT3 NC TE MK-3682B (16 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

B13: GT3 C TN MK-3682B (12 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

B14: GT3 C TN MK-3682B + RBV (12 weeks)

Arm description

Arm type

Experimental

Investigational medicinal product name

Ribavirin

Investigational medicinal product code

Other name

Rebetol

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Part B: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight.

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

B15: GT3 C TN MK-3682B (16 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

B16: GT3 C TE MK-3682B (12 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

B17: GT3 C TE MK-3682B + RBV (12 weeks)

Arm description

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

Investigational medicinal product name

Ribavirin

Investigational medicinal product code

Other name

Rebetol

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Part B: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight.

B18: GT3 C TE MK-3682B (16 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

B19: GT3 C TE MK-3682B + RBV (16 weeks)

Arm description

Arm type

Experimental

Investigational medicinal product name

Ribavirin

Investigational medicinal product code

Other name

Rebetol

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Part B: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight.

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

B20: GT4 NC TN MK-3682B (8 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

B22: GT6 NC TN MK-3682B (12 weeks)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part B: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

Notes
[1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
Justification: Baseline participants include 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.

Number of subjects in period 2 ^[2]	A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)	A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)	A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)	A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)	B4: GT3 NC TN MK-3682B (8 weeks)	B5: GT3 NC TN MK-3682B + RBV (8 weeks)	B6: GT3 NC TN MK-3682B (12 weeks)	B7: GT3 NC TN MK-3682B + RBV (12 weeks)	B8: GT3 NC TE MK-3682B (8 weeks)	B9: GT3 NC TE MK-3682B + RBV (8 weeks)	B10: GT3 NC TE MK-3682B (12 weeks)	B11: GT3 NC TE MK-3682B + RBV (12 weeks)	B12: GT3 NC TE MK-3682B (16 weeks)	B13: GT3 C TN MK-3682B (12 weeks)	B14: GT3 C TN MK-3682B + RBV (12 weeks)	B15: GT3 C TN MK-3682B (16 weeks)	B16: GT3 C TE MK-3682B (12 weeks)	B17: GT3 C TE MK-3682B + RBV (12 weeks)	B18: GT3 C TE MK-3682B (16 weeks)	B19: GT3 C TE MK-3682B + RBV (16 weeks)	B20: GT4 NC TN MK-3682B (8 weeks)	B22: GT6 NC TN MK-3682B (12 weeks)
Started	21	21	22	22	16	36	37	35	15	14	14	15	16	13	16	14	15	14	20	25	7	4
Treated	21	21	22	22	16	36	37	35	15	14	14	15	16	13	16	14	15	14	20	25	7	4
Completed	20	21	22	22	16	33	36	34	15	14	14	15	16	13	16	13	15	13	20	24	7	4
Not completed	1	0	0	0	0	3	1	1	0	0	0	0	0	0	0	1	0	1	0	1	0	0
Consent withdrawn by subject	-	-	-	-	-	1	-	-	-	-	-	-	-	-	-	-	-	-	-	1	-	-
Adverse event, non-fatal	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	1	-	-	-	-
Lost to follow-up	1	-	-	-	-	2	1	1	-	-	-	-	-	-	-	1	-	-	-	-	-	-

Notes
[2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: One participant randomized to the 'B18: GT3 C TE MK-3682B (16 weeks)' arm did not receive any study drug.

Period 3 title

Part C Treatment Period

Is this the baseline period?

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)

Arm description

Part C: 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.

Arm type

Experimental

Investigational medicinal product name

Ribavirin

Investigational medicinal product code

Other name

Rebetol

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Part C: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight.

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)

Arm description

Arm type

Experimental

Investigational medicinal product name

Ribavirin

Investigational medicinal product code

Other name

Rebetol

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Part C: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight.

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)

Arm description

Arm type

Experimental

Investigational medicinal product name

Ribavirin

Investigational medicinal product code

Other name

Rebetol

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Part C: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight.

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)

Arm description

Part C: 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.

Arm type

Experimental

Investigational medicinal product name

Ribavirin

Investigational medicinal product code

Other name

Rebetol

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Part C: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight.

Investigational medicinal product name

MK-3682B

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

Number of subjects in period 3 ^[3]	A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)	A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)	A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)	A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)
Started	2	1	3	2
Completed	2	1	3	2

Notes
[3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets q.d. and RBV b.i.d. by mouth for 16 weeks.

Baseline characteristics

Top of page

Reporting group title

A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)

Reporting group description

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.

Reporting group title

A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)

Reporting group description

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.

Reporting group title

A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)

Reporting group description

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.

Reporting group title

A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)

Reporting group description

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.

Reporting group title

B4: GT3 NC TN MK-3682B (8 weeks)

Reporting group description

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.

Reporting group title

B5: GT3 NC TN MK-3682B + RBV (8 weeks)

Reporting group description

Reporting group title

B6: GT3 NC TN MK-3682B (12 weeks)

Reporting group description

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.

Reporting group title

B7: GT3 NC TN MK-3682B + RBV (12 weeks)

Reporting group description

Reporting group title

B8: GT3 NC TE MK-3682B (8 weeks)

Reporting group description

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.

Reporting group title

B9: GT3 NC TE MK-3682B + RBV (8 weeks)

Reporting group description

Reporting group title

B10: GT3 NC TE MK-3682B (12 weeks)

Reporting group description

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.

Reporting group title

B11: GT3 NC TE MK-3682B + RBV (12 weeks)

Reporting group description

Reporting group title

B12: GT3 NC TE MK-3682B (16 weeks)

Reporting group description

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.

Reporting group title

B13: GT3 C TN MK-3682B (12 weeks)

Reporting group description

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.

Reporting group title

B14: GT3 C TN MK-3682B + RBV (12 weeks)

Reporting group description

Reporting group title

B15: GT3 C TN MK-3682B (16 weeks)

Reporting group description

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.

Reporting group title

B16: GT3 C TE MK-3682B (12 weeks)

Reporting group description

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.

Reporting group title

B17: GT3 C TE MK-3682B + RBV (12 weeks)

Reporting group description

Reporting group title

B18: GT3 C TE MK-3682B (16 weeks)

Reporting group description

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.

Reporting group title

B19: GT3 C TE MK-3682B + RBV (16 weeks)

Reporting group description

Reporting group title

B20: GT4 NC TN MK-3682B (8 weeks)

Reporting group description

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.

Reporting group title

B22: GT6 NC TN MK-3682B (12 weeks)

Reporting group description

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.

Reporting group values	A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)	A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)	A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)	A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)	B4: GT3 NC TN MK-3682B (8 weeks)	B5: GT3 NC TN MK-3682B + RBV (8 weeks)	B6: GT3 NC TN MK-3682B (12 weeks)	B7: GT3 NC TN MK-3682B + RBV (12 weeks)	B8: GT3 NC TE MK-3682B (8 weeks)	B9: GT3 NC TE MK-3682B + RBV (8 weeks)	B10: GT3 NC TE MK-3682B (12 weeks)	B11: GT3 NC TE MK-3682B + RBV (12 weeks)	B12: GT3 NC TE MK-3682B (16 weeks)	B13: GT3 C TN MK-3682B (12 weeks)	B14: GT3 C TN MK-3682B + RBV (12 weeks)	B15: GT3 C TN MK-3682B (16 weeks)	B16: GT3 C TE MK-3682B (12 weeks)	B17: GT3 C TE MK-3682B + RBV (12 weeks)	B18: GT3 C TE MK-3682B (16 weeks)	B19: GT3 C TE MK-3682B + RBV (16 weeks)	B20: GT4 NC TN MK-3682B (8 weeks)	B22: GT6 NC TN MK-3682B (12 weeks)	Total
Number of subjects	21	21	22	22	16	36	37	35	15	14	14	15	16	13	16	14	15	14	20	25	7	4	412
Age, Customized
Units: Subjects
Less than 18 years	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
18 to 35 years	4	4	3	4	3	8	9	7	0	1	2	1	0	0	0	0	0	2	0	0	1	0	49
36 to 50 years	12	9	14	12	4	11	14	12	5	5	6	4	6	7	3	3	4	3	6	6	3	1	150
51 to 64 years	5	8	5	3	6	16	13	16	8	7	6	9	9	4	13	9	11	9	13	18	3	3	194
Over 64 years	0	0	0	3	3	1	1	0	2	1	0	1	1	2	0	2	0	0	1	1	0	0	19
Sex: Female, Male
Units: Subjects
Female	9	15	14	11	7	19	23	23	7	2	8	6	5	3	5	3	8	1	2	5	1	2	179
Male	12	6	8	11	9	17	14	12	8	12	6	9	11	10	11	11	7	13	18	20	6	2	233

End points

Top of page

Reporting group title

A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)

Reporting group description

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.

Reporting group title

A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)

Reporting group description

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.

Reporting group title

A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)

Reporting group description

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.

Reporting group title

A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)

Reporting group description

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.

Reporting group title

B4: GT3 NC TN MK-3682B (8 weeks)

Reporting group description

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.

Reporting group title

B5: GT3 NC TN MK-3682B + RBV (8 weeks)

Reporting group description

Reporting group title

B6: GT3 NC TN MK-3682B (12 weeks)

Reporting group description

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.

Reporting group title

B7: GT3 NC TN MK-3682B + RBV (12 weeks)

Reporting group description

Reporting group title

B8: GT3 NC TE MK-3682B (8 weeks)

Reporting group description

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.

Reporting group title

B9: GT3 NC TE MK-3682B + RBV (8 weeks)

Reporting group description

Reporting group title

B10: GT3 NC TE MK-3682B (12 weeks)

Reporting group description

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.

Reporting group title

B11: GT3 NC TE MK-3682B + RBV (12 weeks)

Reporting group description

Reporting group title

B12: GT3 NC TE MK-3682B (16 weeks)

Reporting group description

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.

Reporting group title

B13: GT3 C TN MK-3682B (12 weeks)

Reporting group description

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.

Reporting group title

B14: GT3 C TN MK-3682B + RBV (12 weeks)

Reporting group description

Reporting group title

B15: GT3 C TN MK-3682B (16 weeks)

Reporting group description

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.

Reporting group title

B16: GT3 C TE MK-3682B (12 weeks)

Reporting group description

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.

Reporting group title

B17: GT3 C TE MK-3682B + RBV (12 weeks)

Reporting group description

Reporting group title

B18: GT3 C TE MK-3682B (16 weeks)

Reporting group description

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.

Reporting group title

B19: GT3 C TE MK-3682B + RBV (16 weeks)

Reporting group description

Reporting group title

B20: GT4 NC TN MK-3682B (8 weeks)

Reporting group description

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.

Reporting group title

B22: GT6 NC TN MK-3682B (12 weeks)

Reporting group description

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.

Reporting group title

A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)

Reporting group description

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.

Reporting group title

A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)

Reporting group description

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.

Reporting group title

A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)

Reporting group description

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.

Reporting group title

A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)

Reporting group description

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.

Reporting group title

B4: GT3 NC TN MK-3682B (8 weeks)

Reporting group description

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.

Reporting group title

B5: GT3 NC TN MK-3682B + RBV (8 weeks)

Reporting group description

Reporting group title

B6: GT3 NC TN MK-3682B (12 weeks)

Reporting group description

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.

Reporting group title

B7: GT3 NC TN MK-3682B + RBV (12 weeks)

Reporting group description

Reporting group title

B8: GT3 NC TE MK-3682B (8 weeks)

Reporting group description

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.

Reporting group title

B9: GT3 NC TE MK-3682B + RBV (8 weeks)

Reporting group description

Reporting group title

B10: GT3 NC TE MK-3682B (12 weeks)

Reporting group description

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.

Reporting group title

B11: GT3 NC TE MK-3682B + RBV (12 weeks)

Reporting group description

Reporting group title

B12: GT3 NC TE MK-3682B (16 weeks)

Reporting group description

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.

Reporting group title

B13: GT3 C TN MK-3682B (12 weeks)

Reporting group description

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.

Reporting group title

B14: GT3 C TN MK-3682B + RBV (12 weeks)

Reporting group description

Reporting group title

B15: GT3 C TN MK-3682B (16 weeks)

Reporting group description

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.

Reporting group title

B16: GT3 C TE MK-3682B (12 weeks)

Reporting group description

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.

Reporting group title

B17: GT3 C TE MK-3682B + RBV (12 weeks)

Reporting group description

Reporting group title

B18: GT3 C TE MK-3682B (16 weeks)

Reporting group description

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.

Reporting group title

B19: GT3 C TE MK-3682B + RBV (16 weeks)

Reporting group description

Reporting group title

B20: GT4 NC TN MK-3682B (8 weeks)

Reporting group description

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.

Reporting group title

B22: GT6 NC TN MK-3682B (12 weeks)

Reporting group description

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.

Reporting group title

A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)

Reporting group description

Reporting group title

A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)

Reporting group description

Reporting group title

A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)

Reporting group description

Reporting group title

A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)

Reporting group description

Subject analysis set title

A4+B4: GT3 NC TN MK-3682B (8 weeks)

Subject analysis set type

Sub-group analysis

Subject analysis set description

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.

Subject analysis set title

A4+ B4: GT3 NC TN MK-3682B (8 weeks)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

A4+B4: GT3 NC TN MK-3682B (8 weeks)

Subject analysis set type

Sub-group analysis

Subject analysis set description

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.

Subject analysis set title

Part C: GT3 NC TN: MK-3682B + RBV (16 weeks)

Subject analysis set type

Sub-group analysis

Subject analysis set description

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.

Primary: Percentage of HCV GT3-infected participants achieving Sustained Virologic Response at follow-up Week 12 (SVR12)

Top of page

End point title

Percentage of HCV GT3-infected participants achieving Sustained Virologic Response at follow-up Week 12 (SVR12) ^[1] ^[2]

End point description

SVR12 is defined as HCV ribonucleic acid (RNA) less than the lower limit of quantification (<LLOQ, 15 IU/mL) 12 weeks after the end of all study therapy. A4+B4: GT3 NC TN MK-3682B (8 weeks) arm includes both participants from Part A and Part B who received equivalent dose of MK-3682B. 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.

End point type

Primary

End point timeframe

Up to 20 weeks (Part A), up to 28 weeks (Part B)

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analyses were planned for this endpoint.
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Analysis population consists of HCV GT3 participants who received treatment and did not have major protocol deviations that may substantially affect the results of the SVR endpoints.

A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)

A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)

A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)

A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)

B4: GT3 NC TN MK-3682B (8 weeks)

B5: GT3 NC TN MK-3682B + RBV (8 weeks)

B6: GT3 NC TN MK-3682B (12 weeks)

B7: GT3 NC TN MK-3682B + RBV (12 weeks)

B8: GT3 NC TE MK-3682B (8 weeks)

B9: GT3 NC TE MK-3682B + RBV (8 weeks)

B10: GT3 NC TE MK-3682B (12 weeks)

B11: GT3 NC TE MK-3682B + RBV (12 weeks)

B12: GT3 NC TE MK-3682B (16 weeks)

B13: GT3 C TN MK-3682B (12 weeks)

B14: GT3 C TN MK-3682B + RBV (12 weeks)

B15: GT3 C TN MK-3682B (16 weeks)

B16: GT3 C TE MK-3682B (12 weeks)

B17: GT3 C TE MK-3682B + RBV (12 weeks)

B18: GT3 C TE MK-3682B (16 weeks)

B19: GT3 C TE MK-3682B + RBV (16 weeks)

A4+B4: GT3 NC TN MK-3682B (8 weeks)

Number of subjects analysed

Units: Percentage of participants

number (confidence interval 95%)

90.5 (69.6 to 98.8)

95.2 (76.2 to 99.9)

86.4 (65.1 to 97.1)

90.9 (70.8 to 98.9)

93.8 (69.8 to 99.8)

100.0 (90.0 to 100.0)

97.2 (85.5 to 99.9)

100.0 (90.0 to 100.0)

100.0 (78.2 to 100.0)

92.9 (66.4 to 99.8)

100.0 (76.8 to 100.0)

93.3 (68.1 to 99.8)

93.8 (69.8 to 99.8)

92.3 (64.0 to 99.8)

100.0 (79.4 to 100.0)

100.0 (78.2 to 100.0)

100.0 (76.8 to 100.0)

100.0 (83.2 to 100.0)

96.0 (79.6 to 99.9)

92.1 (78.6 to 98.3)

No statistical analyses for this end point

Primary: Number of participants experiencing an adverse event (AE)

Top of page

End point title

Number of participants experiencing an adverse event (AE) ^[3]

End point description

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. Analysis population included all participants who received at least 1 dose of study drug, categorized according to the treatment actually received. A4+B4: GT3 NC TN MK-3682B (8 weeks) 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.

End point type

Primary

End point timeframe

Up to 40 weeks

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analyses were planned for this endpoint.

End point values	A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)	A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)	A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)	A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)	B4: GT3 NC TN MK-3682B (8 weeks)	B5: GT3 NC TN MK-3682B + RBV (8 weeks)	B6: GT3 NC TN MK-3682B (12 weeks)	B7: GT3 NC TN MK-3682B + RBV (12 weeks)	B8: GT3 NC TE MK-3682B (8 weeks)	B9: GT3 NC TE MK-3682B + RBV (8 weeks)	B10: GT3 NC TE MK-3682B (12 weeks)	B11: GT3 NC TE MK-3682B + RBV (12 weeks)	B12: GT3 NC TE MK-3682B (16 weeks)	B13: GT3 C TN MK-3682B (12 weeks)	B14: GT3 C TN MK-3682B + RBV (12 weeks)	B15: GT3 C TN MK-3682B (16 weeks)	B16: GT3 C TE MK-3682B (12 weeks)	B17: GT3 C TE MK-3682B + RBV (12 weeks)	B18: GT3 C TE MK-3682B (16 weeks)	B19: GT3 C TE MK-3682B + RBV (16 weeks)	B20: GT4 NC TN MK-3682B (8 weeks)	B22: GT6 NC TN MK-3682B (12 weeks)	A4+B4: GT3 NC TN MK-3682B (8 weeks)	Part C: GT3 NC TN: MK-3682B + RBV (16 weeks)
Number of subjects analysed	21	21	22	22	16	36	37	35	15	14	14	15	16	13	16	14	15	14	20	25	7	4	38	8
Units: Participants	18	14	16	17	9	30	25	33	12	12	9	13	13	9	14	12	12	12	16	21	3	3	26	7

No statistical analyses for this end point

Primary: Number of participants who had study drug discontinued due to an AE

Top of page

End point title

Number of participants who had study drug discontinued due to an AE ^[4]

End point description

End point type

Primary

End point timeframe

Up to 16 weeks

Notes
[4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analyses were planned for this endpoint.

End point values	A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)	A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)	A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)	A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)	B4: GT3 NC TN MK-3682B (8 weeks)	B5: GT3 NC TN MK-3682B + RBV (8 weeks)	B6: GT3 NC TN MK-3682B (12 weeks)	B7: GT3 NC TN MK-3682B + RBV (12 weeks)	B8: GT3 NC TE MK-3682B (8 weeks)	B9: GT3 NC TE MK-3682B + RBV (8 weeks)	B10: GT3 NC TE MK-3682B (12 weeks)	B11: GT3 NC TE MK-3682B + RBV (12 weeks)	B12: GT3 NC TE MK-3682B (16 weeks)	B13: GT3 C TN MK-3682B (12 weeks)	B14: GT3 C TN MK-3682B + RBV (12 weeks)	B15: GT3 C TN MK-3682B (16 weeks)	B16: GT3 C TE MK-3682B (12 weeks)	B17: GT3 C TE MK-3682B + RBV (12 weeks)	B18: GT3 C TE MK-3682B (16 weeks)	B19: GT3 C TE MK-3682B + RBV (16 weeks)	B20: GT4 NC TN MK-3682B (8 weeks)	B22: GT6 NC TN MK-3682B (12 weeks)	A4+B4: GT3 NC TN MK-3682B (8 weeks)	Part C: GT3 NC TN: MK-3682B + RBV (16 weeks)
Number of subjects analysed	21	21	22	22	16	36	37	35	15	14	14	15	16	13	16	14	15	14	20	25	7	4	38	8
Units: Participants	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	1	0	0	1	0	0	0	0	0

No statistical analyses for this end point

Secondary: Percentage of GT3-infected participants achieving SVR at follow-up Week 24 (SVR24)

Top of page

End point title

Percentage of GT3-infected participants achieving SVR at follow-up Week 24 (SVR24) ^[5]

End point description

SVR24 is defined as HCV RNA <LLOQ of 15 IU/mL 24 weeks after the end of all study therapy. A4+B4: GT3 NC TN MK-3682B (8 weeks) arm includes both participants from Part A and Part B who received equivalent dose of MK-3682B. 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.

End point type

Secondary

End point timeframe

Up to 40 weeks

Notes
[5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: 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.

A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)

A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)

A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks)

A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks)

B4: GT3 NC TN MK-3682B (8 weeks)

B5: GT3 NC TN MK-3682B + RBV (8 weeks)

B6: GT3 NC TN MK-3682B (12 weeks)

B7: GT3 NC TN MK-3682B + RBV (12 weeks)

B8: GT3 NC TE MK-3682B (8 weeks)

B9: GT3 NC TE MK-3682B + RBV (8 weeks)

B10: GT3 NC TE MK-3682B (12 weeks)

B11: GT3 NC TE MK-3682B + RBV (12 weeks)

B12: GT3 NC TE MK-3682B (16 weeks)

B13: GT3 C TN MK-3682B (12 weeks)

B14: GT3 C TN MK-3682B + RBV (12 weeks)

B15: GT3 C TN MK-3682B (16 weeks)

B16: GT3 C TE MK-3682B (12 weeks)

B17: GT3 C TE MK-3682B + RBV (12 weeks)

B18: GT3 C TE MK-3682B (16 weeks)

B19: GT3 C TE MK-3682B + RBV (16 weeks)

A4+B4: GT3 NC TN MK-3682B (8 weeks)

Number of subjects analysed

Units: Percentage of participants

number (confidence interval 95%)

90.0 (68.3 to 98.8)

95.2 (76.2 to 99.9)

86.4 (65.1 to 97.1)

90.9 (70.8 to 98.9)

93.8 (69.8 to 99.8)

100.0 (89.4 to 100.0)

97.2 (85.5 to 99.9)

100.0 (89.7 to 100.0)

100.0 (78.2 to 100.0)

92.9 (66.1 to 99.8)

100.0 (76.8 to 100.0)

93.3 (68.1 to 99.8)

93.8 (69.8 to 99.8)

92.3 (64.0 to 99.8)

100.0 (79.4 to 100.0)

100.0 (75.3 to 100.0)

100.0 (78.2 to 100.0)

100.0 (75.3 to 100.0)

100.0 (83.2 to 100.0)

96.0 (79.6 to 99.9)

92.1 (78.6 to 98.3)

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

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)

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

20.0

Reporting group title

A1: GT3 NC TN EBR+GZR+UPR300 (8 wks)

Reporting group description

In Part A, participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks.

Reporting group title

A1+C: GT3 NC TN EBR+GZR+UPR300 (8 wks); MK-3682B+RBV (16 wks)

Reporting group description

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.

Reporting group title

A2: GT3 NC TN GZR+RZR+UPR300 (8 wks)

Reporting group description

In Part A, participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + ruzasvir (60 mg) q.d. by mouth for 8 weeks.

Reporting group title

A2+C: GT3 NC TN GZR+RZR+UPR300 (8 wks); MK-3682B+RBV (16 wks)

Reporting group description

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.

Reporting group title

A3: GT3 NC TN EBR+GZR+UPR450 (8 wks)

Reporting group description

In Part A, participants received grazoprevir (100 mg) + uprifosbuvir (450 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks.

Reporting group title

A3+C: GT3 NC TN EBR+GZR+UPR450 (8 wks); MK-3682B+RBV (16 wks)

Reporting group description

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.

Reporting group title

A4+C: GT3 NC TN GZR+RZR+UPR450 (8 wks); MK-3682B+RBV (16 wks)

Reporting group description

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.

Reporting group title

A4: GT3 NC TN GZR+RZR+UPR450 (8 wks)

Reporting group description

In Part A, participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks.

Reporting group title

B4: GT3 NC TN MK-3682B (8 wks)

Reporting group description

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.

Reporting group title

B6: GT3 NC TN MK-3682B (12 wks)

Reporting group description

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.

Reporting group title

B5: GT3 NC TN MK-3682B + RBV (8 wks)

Reporting group description

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.

Reporting group title

B7: GT3 NC TN MK-3682B + RBV (12 wks)

Reporting group description

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.

Reporting group title

B8: GT3 NC TE MK-3682B (8 wks)

Reporting group description

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.

Reporting group title

B10: GT3 NC TE MK-3682B (12 wks)

Reporting group description

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.

Reporting group title

B9: GT3 NC TE MK-3682B + RBV (8 wks)

Reporting group description

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.

Reporting group title

B12: GT3 NC TE MK-3682B (16 wks)

Reporting group description

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.

Reporting group title

B11: GT3 NC TE MK-3682B + RBV (12 wks)

Reporting group description

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.

Reporting group title

B13: GT3 C TN MK-3682B (12 wks)

Reporting group description

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.

Reporting group title

B15: GT3 C TN MK-3682B (16 wks)

Reporting group description

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.

Reporting group title

B14: GT3 C TN MK-3682B + RBV (12 wks)

Reporting group description

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.

Reporting group title

B16: GT3 C TE MK-3682B (12 wks)

Reporting group description

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.

Reporting group title

B17: GT3 C TE MK-3682B + RBV (12 wks)

Reporting group description

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.

Reporting group title

B18: GT3 C TE MK-3682B (16 wks)

Reporting group description

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.

Reporting group title

B20: GT4 NC TN MK-3682B (8 wks)

Reporting group description

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.

Reporting group title

B19: GT3 C TE MK-3682B + RBV (16 wks)

Reporting group description

Reporting group title

B22: GT6 NC TN MK-3682B (12 wks)

Reporting group description

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.

A1: GT3 NC TN EBR+GZR+UPR300 (8 wks)

A1+C: GT3 NC TN EBR+GZR+UPR300 (8 wks); MK-3682B+RBV (16 wks)

A2: GT3 NC TN GZR+RZR+UPR300 (8 wks)

A2+C: GT3 NC TN GZR+RZR+UPR300 (8 wks); MK-3682B+RBV (16 wks)

A3: GT3 NC TN EBR+GZR+UPR450 (8 wks)

A3+C: GT3 NC TN EBR+GZR+UPR450 (8 wks); MK-3682B+RBV (16 wks)

A4+C: GT3 NC TN GZR+RZR+UPR450 (8 wks); MK-3682B+RBV (16 wks)

A4: GT3 NC TN GZR+RZR+UPR450 (8 wks)

B4: GT3 NC TN MK-3682B (8 wks)

B6: GT3 NC TN MK-3682B (12 wks)

B5: GT3 NC TN MK-3682B + RBV (8 wks)

B7: GT3 NC TN MK-3682B + RBV (12 wks)

B8: GT3 NC TE MK-3682B (8 wks)

B10: GT3 NC TE MK-3682B (12 wks)

B9: GT3 NC TE MK-3682B + RBV (8 wks)

B12: GT3 NC TE MK-3682B (16 wks)

B11: GT3 NC TE MK-3682B + RBV (12 wks)

B13: GT3 C TN MK-3682B (12 wks)

B15: GT3 C TN MK-3682B (16 wks)

B14: GT3 C TN MK-3682B + RBV (12 wks)

B16: GT3 C TE MK-3682B (12 wks)

B17: GT3 C TE MK-3682B + RBV (12 wks)

B18: GT3 C TE MK-3682B (16 wks)

B20: GT4 NC TN MK-3682B (8 wks)

B19: GT3 C TE MK-3682B + RBV (16 wks)

B22: GT6 NC TN MK-3682B (12 wks)

Total subjects affected by serious adverse events

subjects affected / exposed

1 / 19 (5.26%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

1 / 19 (5.26%)

0 / 3 (0.00%)

1 / 2 (50.00%)

0 / 20 (0.00%)

0 / 16 (0.00%)

0 / 37 (0.00%)

1 / 36 (2.78%)

1 / 35 (2.86%)

0 / 15 (0.00%)

0 / 14 (0.00%)

1 / 16 (6.25%)

0 / 15 (0.00%)

1 / 13 (7.69%)

2 / 14 (14.29%)

0 / 16 (0.00%)

2 / 15 (13.33%)

2 / 14 (14.29%)

2 / 20 (10.00%)

0 / 7 (0.00%)

1 / 25 (4.00%)

0 / 4 (0.00%)

number of deaths (all causes)

number of deaths resulting from adverse events

Investigations

Blood sodium decreased

subjects affected / exposed

0 / 19 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 3 (0.00%)

1 / 2 (50.00%)

0 / 20 (0.00%)

0 / 16 (0.00%)

0 / 37 (0.00%)

0 / 36 (0.00%)

0 / 35 (0.00%)

0 / 15 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

0 / 15 (0.00%)

0 / 13 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

0 / 15 (0.00%)

0 / 14 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 25 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Hepatocellular carcinoma

subjects affected / exposed

0 / 19 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 16 (0.00%)

0 / 37 (0.00%)

0 / 36 (0.00%)

0 / 35 (0.00%)

0 / 15 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

0 / 15 (0.00%)

1 / 13 (7.69%)

0 / 14 (0.00%)

0 / 16 (0.00%)

1 / 15 (6.67%)

0 / 14 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 25 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Inflammatory pseudotumour

subjects affected / exposed

0 / 19 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 16 (0.00%)

0 / 37 (0.00%)

0 / 36 (0.00%)

0 / 35 (0.00%)

0 / 15 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

0 / 15 (0.00%)

0 / 13 (0.00%)

1 / 14 (7.14%)

0 / 16 (0.00%)

0 / 15 (0.00%)

0 / 14 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 25 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Lip and/or oral cavity cancer stage 0

subjects affected / exposed

0 / 19 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 16 (0.00%)

0 / 37 (0.00%)

0 / 36 (0.00%)

0 / 35 (0.00%)

0 / 15 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

0 / 15 (0.00%)

0 / 13 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

0 / 15 (0.00%)

1 / 14 (7.14%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 25 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Injury, poisoning and procedural complications

Tendon rupture

subjects affected / exposed

0 / 19 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 16 (0.00%)

0 / 37 (0.00%)

0 / 36 (0.00%)

0 / 35 (0.00%)

0 / 15 (0.00%)

0 / 14 (0.00%)

1 / 16 (6.25%)

0 / 15 (0.00%)

0 / 13 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

0 / 15 (0.00%)

0 / 14 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 25 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

Coronary artery disease

subjects affected / exposed

0 / 19 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 16 (0.00%)

0 / 37 (0.00%)

0 / 36 (0.00%)

0 / 35 (0.00%)

0 / 15 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

0 / 15 (0.00%)

0 / 13 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

0 / 15 (0.00%)

0 / 14 (0.00%)

1 / 20 (5.00%)

0 / 7 (0.00%)

0 / 25 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Nervous system disorders

Cerebral haemorrhage

subjects affected / exposed

0 / 19 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 16 (0.00%)

0 / 37 (0.00%)

0 / 36 (0.00%)

0 / 35 (0.00%)

0 / 15 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

0 / 15 (0.00%)

0 / 13 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

0 / 15 (0.00%)

1 / 14 (7.14%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 25 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Migraine

subjects affected / exposed

0 / 19 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 16 (0.00%)

0 / 37 (0.00%)

0 / 36 (0.00%)

1 / 35 (2.86%)

0 / 15 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

0 / 15 (0.00%)

0 / 13 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

0 / 15 (0.00%)

0 / 14 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 25 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Eye disorders

Keratitis

subjects affected / exposed

0 / 19 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

1 / 19 (5.26%)

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 16 (0.00%)

0 / 37 (0.00%)

0 / 36 (0.00%)

0 / 35 (0.00%)

0 / 15 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

0 / 15 (0.00%)

0 / 13 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

0 / 15 (0.00%)

0 / 14 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 25 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

Abdominal pain lower

subjects affected / exposed

0 / 19 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 16 (0.00%)

0 / 37 (0.00%)

0 / 36 (0.00%)

0 / 35 (0.00%)

0 / 15 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

0 / 15 (0.00%)

0 / 13 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

0 / 15 (0.00%)

0 / 14 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

1 / 25 (4.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatobiliary disorders

Biliary colic

subjects affected / exposed

0 / 19 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 16 (0.00%)

0 / 37 (0.00%)

0 / 36 (0.00%)

0 / 35 (0.00%)

0 / 15 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

0 / 15 (0.00%)

0 / 13 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

0 / 15 (0.00%)

0 / 14 (0.00%)

1 / 20 (5.00%)

0 / 7 (0.00%)

0 / 25 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory, thoracic and mediastinal disorders

Chronic obstructive pulmonary disease

subjects affected / exposed

0 / 19 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 16 (0.00%)

0 / 37 (0.00%)

1 / 36 (2.78%)

0 / 35 (0.00%)

0 / 15 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

0 / 15 (0.00%)

0 / 13 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

0 / 15 (0.00%)

0 / 14 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 25 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Psychiatric disorders

Alcohol abuse

subjects affected / exposed

0 / 19 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 16 (0.00%)

0 / 37 (0.00%)

0 / 36 (0.00%)

0 / 35 (0.00%)

0 / 15 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

0 / 15 (0.00%)

0 / 13 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

1 / 15 (6.67%)

0 / 14 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 25 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Anxiety

subjects affected / exposed

0 / 19 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 3 (0.00%)

1 / 2 (50.00%)

0 / 20 (0.00%)

0 / 16 (0.00%)

0 / 37 (0.00%)

0 / 36 (0.00%)

0 / 35 (0.00%)

0 / 15 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

0 / 15 (0.00%)

0 / 13 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

0 / 15 (0.00%)

0 / 14 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 25 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Mental status changes

subjects affected / exposed

0 / 19 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 16 (0.00%)

0 / 37 (0.00%)

0 / 36 (0.00%)

0 / 35 (0.00%)

0 / 15 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

0 / 15 (0.00%)

0 / 13 (0.00%)

1 / 14 (7.14%)

0 / 16 (0.00%)

0 / 15 (0.00%)

0 / 14 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 25 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

Pharyngeal abscess

subjects affected / exposed

1 / 19 (5.26%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 20 (0.00%)

0 / 16 (0.00%)

0 / 37 (0.00%)

0 / 36 (0.00%)

0 / 35 (0.00%)

0 / 15 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

0 / 15 (0.00%)

0 / 13 (0.00%)

0 / 14 (0.00%)

0 / 16 (0.00%)

0 / 15 (0.00%)

0 / 14 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 25 (0.00%)

0 / 4 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	A1: GT3 NC TN EBR+GZR+UPR300 (8 wks)	A1+C: GT3 NC TN EBR+GZR+UPR300 (8 wks); MK-3682B+RBV (16 wks)	A2: GT3 NC TN GZR+RZR+UPR300 (8 wks)	A2+C: GT3 NC TN GZR+RZR+UPR300 (8 wks); MK-3682B+RBV (16 wks)	A3: GT3 NC TN EBR+GZR+UPR450 (8 wks)	A3+C: GT3 NC TN EBR+GZR+UPR450 (8 wks); MK-3682B+RBV (16 wks)	A4+C: GT3 NC TN GZR+RZR+UPR450 (8 wks); MK-3682B+RBV (16 wks)	A4: GT3 NC TN GZR+RZR+UPR450 (8 wks)	B4: GT3 NC TN MK-3682B (8 wks)	B6: GT3 NC TN MK-3682B (12 wks)	B5: GT3 NC TN MK-3682B + RBV (8 wks)	B7: GT3 NC TN MK-3682B + RBV (12 wks)	B8: GT3 NC TE MK-3682B (8 wks)	B10: GT3 NC TE MK-3682B (12 wks)	B9: GT3 NC TE MK-3682B + RBV (8 wks)	B12: GT3 NC TE MK-3682B (16 wks)	B11: GT3 NC TE MK-3682B + RBV (12 wks)	B13: GT3 C TN MK-3682B (12 wks)	B15: GT3 C TN MK-3682B (16 wks)	B14: GT3 C TN MK-3682B + RBV (12 wks)	B16: GT3 C TE MK-3682B (12 wks)	B17: GT3 C TE MK-3682B + RBV (12 wks)	B18: GT3 C TE MK-3682B (16 wks)	B20: GT4 NC TN MK-3682B (8 wks)	B19: GT3 C TE MK-3682B + RBV (16 wks)	B22: GT6 NC TN MK-3682B (12 wks)
Total subjects affected by non serious adverse events
subjects affected / exposed	17 / 19 (89.47%)	1 / 2 (50.00%)	12 / 20 (60.00%)	1 / 1 (100.00%)	13 / 19 (68.42%)	3 / 3 (100.00%)	2 / 2 (100.00%)	16 / 20 (80.00%)	9 / 16 (56.25%)	24 / 37 (64.86%)	30 / 36 (83.33%)	32 / 35 (91.43%)	12 / 15 (80.00%)	9 / 14 (64.29%)	12 / 14 (85.71%)	13 / 16 (81.25%)	13 / 15 (86.67%)	9 / 13 (69.23%)	12 / 14 (85.71%)	14 / 16 (87.50%)	12 / 15 (80.00%)	11 / 14 (78.57%)	15 / 20 (75.00%)	3 / 7 (42.86%)	21 / 25 (84.00%)	3 / 4 (75.00%)
Vascular disorders
Arteriosclerosis
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Flushing
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0
Hot flush
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 35 (2.86%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Hypertension
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	2 / 25 (8.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	2	0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 16 (0.00%)	3 / 37 (8.11%)	3 / 36 (8.33%)	3 / 35 (8.57%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 14 (7.14%)	1 / 16 (6.25%)	2 / 15 (13.33%)	1 / 13 (7.69%)	0 / 14 (0.00%)	1 / 16 (6.25%)	1 / 15 (6.67%)	3 / 14 (21.43%)	1 / 20 (5.00%)	1 / 7 (14.29%)	2 / 25 (8.00%)	0 / 4 (0.00%)
occurrences all number	0	0	1	0	1	0	0	1	0	3	3	3	0	0	1	1	2	2	0	1	1	3	2	1	2	0
Chest discomfort
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	1 / 35 (2.86%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Chest pain
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	1	0	0	0
Chills
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	1 / 16 (6.25%)	1 / 37 (2.70%)	1 / 36 (2.78%)	1 / 35 (2.86%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	2 / 25 (8.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	1	1	1	1	0	0	1	1	0	0	1	0	0	0	0	2	0
Energy increased
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Fatigue
subjects affected / exposed	4 / 19 (21.05%)	0 / 2 (0.00%)	5 / 20 (25.00%)	0 / 1 (0.00%)	4 / 19 (21.05%)	1 / 3 (33.33%)	1 / 2 (50.00%)	4 / 20 (20.00%)	2 / 16 (12.50%)	5 / 37 (13.51%)	10 / 36 (27.78%)	13 / 35 (37.14%)	3 / 15 (20.00%)	4 / 14 (28.57%)	5 / 14 (35.71%)	4 / 16 (25.00%)	5 / 15 (33.33%)	3 / 13 (23.08%)	3 / 14 (21.43%)	4 / 16 (25.00%)	3 / 15 (20.00%)	5 / 14 (35.71%)	4 / 20 (20.00%)	0 / 7 (0.00%)	9 / 25 (36.00%)	0 / 4 (0.00%)
occurrences all number	4	0	5	0	4	1	2	4	2	5	11	13	3	4	6	4	5	3	3	5	3	7	4	0	10	0
Feeling abnormal
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Feeling cold
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	0 / 35 (0.00%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Feeling hot
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0
Feeling jittery
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 13 (7.69%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Influenza like illness
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	2 / 15 (13.33%)	0 / 14 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	1	0	1	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	2	0	1	0	0	0
Local swelling
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Malaise
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0
Pain
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	2 / 37 (5.41%)	2 / 36 (5.56%)	1 / 35 (2.86%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	1 / 25 (4.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	2	1	0	0	0	1	0	0	0	0	0	0	1	0	1	0
Pyrexia
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	3 / 37 (8.11%)	0 / 36 (0.00%)	3 / 35 (8.57%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	3 / 20 (15.00%)	0 / 7 (0.00%)	2 / 25 (8.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	3	0	3	0	0	1	0	0	0	0	0	0	0	3	0	2	0
Vessel puncture site pain
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Immune system disorders
Seasonal allergy
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0
Reproductive system and breast disorders
Breast tenderness
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Erectile dysfunction
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0
Vulval haematoma
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Cough
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	0 / 20 (0.00%)	1 / 1 (100.00%)	2 / 19 (10.53%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	3 / 36 (8.33%)	2 / 35 (5.71%)	3 / 15 (20.00%)	1 / 14 (7.14%)	2 / 14 (14.29%)	1 / 16 (6.25%)	0 / 15 (0.00%)	1 / 13 (7.69%)	0 / 14 (0.00%)	4 / 16 (25.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	3 / 20 (15.00%)	0 / 7 (0.00%)	3 / 25 (12.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	1	2	0	0	0	0	1	3	2	3	1	2	1	0	1	0	5	0	1	3	0	3	0
Dry throat
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 35 (2.86%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Dysphonia
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Dyspnoea
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	2 / 35 (5.71%)	0 / 15 (0.00%)	0 / 14 (0.00%)	2 / 14 (14.29%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 20 (0.00%)	0 / 7 (0.00%)	2 / 25 (8.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	2	0	0	2	0	1	0	0	1	0	1	0	0	2	0
Dyspnoea exertional
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	3 / 36 (8.33%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	4 / 15 (26.67%)	1 / 13 (7.69%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	3	0	0	0	1	0	4	1	0	0	0	0	0	0	0	0
Epistaxis
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	1 / 2 (50.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 35 (2.86%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Haemoptysis
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Nasal discomfort
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Oropharyngeal pain
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	1 / 16 (6.25%)	1 / 37 (2.70%)	0 / 36 (0.00%)	2 / 35 (5.71%)	2 / 15 (13.33%)	0 / 14 (0.00%)	1 / 14 (7.14%)	1 / 16 (6.25%)	0 / 15 (0.00%)	1 / 13 (7.69%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	1	0	2	2	0	1	2	0	1	0	0	0	0	0	0	0	0
Paranasal sinus discomfort
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Productive cough
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Rhinitis allergic
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Rhinorrhoea
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0
Sinus congestion
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	1 / 35 (2.86%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	1	0	0	1	0	0	0	0	1	0	0	1	0	0	0
Throat irritation
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Psychiatric disorders
Affect lability
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 25 (4.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	2	0
Anxiety
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	2 / 37 (5.41%)	2 / 36 (5.56%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 25 (4.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	2	2	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0
Depressed mood
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	1 / 16 (6.25%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	2 / 20 (10.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	1	0	1	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	1	2	0	0	0
Depression
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	3 / 37 (8.11%)	0 / 36 (0.00%)	3 / 35 (8.57%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	1 / 13 (7.69%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	3	0	3	1	0	0	0	1	1	0	0	0	0	0	0	0	0
Emotional disorder
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	2 / 35 (5.71%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 25 (4.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	2	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Insomnia
subjects affected / exposed	2 / 19 (10.53%)	0 / 2 (0.00%)	1 / 20 (5.00%)	1 / 1 (100.00%)	2 / 19 (10.53%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 16 (0.00%)	2 / 37 (5.41%)	3 / 36 (8.33%)	3 / 35 (8.57%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 14 (7.14%)	1 / 16 (6.25%)	2 / 15 (13.33%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	2 / 14 (14.29%)	1 / 20 (5.00%)	0 / 7 (0.00%)	1 / 25 (4.00%)	0 / 4 (0.00%)
occurrences all number	3	0	2	2	2	0	0	1	0	2	3	3	0	0	1	1	2	0	0	1	0	2	1	0	1	0
Irritability
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 20 (0.00%)	1 / 16 (6.25%)	0 / 37 (0.00%)	3 / 36 (8.33%)	3 / 35 (8.57%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	2 / 15 (13.33%)	1 / 13 (7.69%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	2 / 25 (8.00%)	0 / 4 (0.00%)
occurrences all number	0	0	1	0	1	1	0	0	1	0	3	3	1	0	0	0	2	1	0	1	0	0	1	0	2	0
Panic attack
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	1 / 16 (6.25%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 35 (2.86%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Sleep disorder
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	2 / 36 (5.56%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	2 / 14 (14.29%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 13 (0.00%)	1 / 14 (7.14%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	2	0	0	0	2	0	1	0	1	1	0	0	2	0	0	0
Tearfulness
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Investigations
Alanine aminotransferase increased
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 13 (7.69%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Amylase increased
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 13 (7.69%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Aspartate aminotransferase increased
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Bacterial test positive
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Blood bilirubin increased
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Blood creatine phosphokinase increased
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Blood creatinine increased
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Blood potassium increased
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Blood urine present
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Haemoglobin decreased
subjects affected / exposed	0 / 19 (0.00%)	1 / 2 (50.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 35 (2.86%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Heart rate increased
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	2 / 35 (5.71%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Lipase increased
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 13 (7.69%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0
Protein urine present
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 35 (2.86%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Transaminases increased
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
White blood cells urine positive
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Injury, poisoning and procedural complications
Accidental overdose
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	1 / 1 (100.00%)	3 / 19 (15.79%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	8 / 36 (22.22%)	5 / 35 (14.29%)	1 / 15 (6.67%)	1 / 14 (7.14%)	6 / 14 (42.86%)	0 / 16 (0.00%)	2 / 15 (13.33%)	0 / 13 (0.00%)	0 / 14 (0.00%)	4 / 16 (25.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 20 (0.00%)	0 / 7 (0.00%)	3 / 25 (12.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	3	0	0	1	0	1	8	5	1	1	6	0	2	0	0	4	0	1	0	0	4	0
Arthropod bite
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	1 / 14 (7.14%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0
Arthropod sting
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Bone contusion
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Clavicle fracture
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Contusion
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	1	0	0	1
Fall
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	1 / 35 (2.86%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Foot fracture
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Foreign body
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Ligament sprain
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Muscle strain
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	1 / 2 (50.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0
Rib fracture
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1
Tendon injury
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Thermal burn
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Cardiac disorders
Arrhythmia
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Atrial fibrillation
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	1 / 16 (6.25%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 25 (4.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Bundle branch block right
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 13 (7.69%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Palpitations
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	2 / 36 (5.56%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	1 / 13 (7.69%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	2	0	0	0	0	0	1	1	0	0	0	0	1	0	0	0
Sinus tachycardia
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Tachycardia
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	1 / 35 (2.86%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Nervous system disorders
Disturbance in attention
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	2 / 19 (10.53%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	3 / 35 (8.57%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	2 / 20 (10.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	2	0	0	0	0	0	1	3	0	0	1	0	0	0	0	0	0	0	2	0	0	0
Dizziness
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	1 / 20 (5.00%)	1 / 1 (100.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	1 / 2 (50.00%)	1 / 20 (5.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	2 / 36 (5.56%)	3 / 35 (8.57%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	3 / 16 (18.75%)	1 / 15 (6.67%)	2 / 13 (15.38%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	2 / 14 (14.29%)	1 / 20 (5.00%)	0 / 7 (0.00%)	1 / 25 (4.00%)	0 / 4 (0.00%)
occurrences all number	1	0	1	1	1	0	1	1	0	1	2	3	0	0	0	3	1	2	0	0	1	2	1	0	1	0
Dizziness postural
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 13 (7.69%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Dysgeusia
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 16 (0.00%)	2 / 37 (5.41%)	2 / 36 (5.56%)	1 / 35 (2.86%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	1	0	0	0	0	1	0	2	2	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Dyskinesia
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 13 (7.69%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Headache
subjects affected / exposed	4 / 19 (21.05%)	1 / 2 (50.00%)	5 / 20 (25.00%)	1 / 1 (100.00%)	5 / 19 (26.32%)	0 / 3 (0.00%)	1 / 2 (50.00%)	5 / 20 (25.00%)	5 / 16 (31.25%)	7 / 37 (18.92%)	12 / 36 (33.33%)	8 / 35 (22.86%)	2 / 15 (13.33%)	2 / 14 (14.29%)	5 / 14 (35.71%)	6 / 16 (37.50%)	5 / 15 (33.33%)	1 / 13 (7.69%)	4 / 14 (28.57%)	4 / 16 (25.00%)	1 / 15 (6.67%)	2 / 14 (14.29%)	3 / 20 (15.00%)	1 / 7 (14.29%)	9 / 25 (36.00%)	2 / 4 (50.00%)
occurrences all number	5	3	6	2	8	0	1	6	6	7	13	8	2	2	5	6	6	1	5	4	1	3	3	1	11	2
Hypersomnia
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 13 (7.69%)	0 / 14 (0.00%)	0 / 16 (0.00%)	2 / 15 (13.33%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	2	0	0	0	0	0
Lethargy
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	0 / 20 (0.00%)	1 / 1 (100.00%)	1 / 19 (5.26%)	1 / 3 (33.33%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	2 / 35 (5.71%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	1	1	1	0	1	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Memory impairment
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	0 / 20 (0.00%)	1 / 1 (100.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	1	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Migraine
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	1 / 36 (2.78%)	2 / 35 (5.71%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	1	2	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Paraesthesia
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 35 (2.86%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 25 (4.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0	1	0	0	1	0
Parosmia
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Poor quality sleep
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Sciatica
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Somnolence
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Tension headache
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 13 (7.69%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	2 / 35 (5.71%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	2	0	0	0	0	1	0	0	1	0	0	0	0	0	0
Haemolysis
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Haemolytic anaemia
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Lymph node pain
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Lymphadenopathy
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Ear and labyrinth disorders
Tinnitus
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	1 / 35 (2.86%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	1	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Vertigo
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	1 / 36 (2.78%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	1	0	0	0	1	0	1	0	0	2	1	0	0	0	0	0
Eye disorders
Dry eye
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Eye pain
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Ocular discomfort
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Pinguecula
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	1 / 16 (6.25%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Vision blurred
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 13 (7.69%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 25 (4.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0
Visual impairment
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Gastrointestinal disorders
Abdominal discomfort
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 35 (2.86%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 13 (7.69%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0	1	1	0	0	2	0	0	0	0
Abdominal distension
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	0 / 35 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	1 / 14 (7.14%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	3 / 25 (12.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	1	0	0	1	1	2	0	0	0	0	0	0	1	0	3	0
Abdominal pain
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	1 / 20 (5.00%)	1 / 1 (100.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	3 / 35 (8.57%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	3 / 20 (15.00%)	0 / 7 (0.00%)	1 / 25 (4.00%)	0 / 4 (0.00%)
occurrences all number	1	0	1	1	0	0	0	0	0	1	0	3	0	1	0	2	0	0	0	1	0	0	4	0	1	0
Abdominal pain upper
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	1 / 16 (6.25%)	0 / 37 (0.00%)	2 / 36 (5.56%)	1 / 35 (2.86%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	2 / 14 (14.29%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 25 (4.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	1	0	0	1	1	0	2	1	0	0	0	1	1	0	0	0	0	2	0	0	1	0
Aphthous ulcer
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	1 / 35 (2.86%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Constipation
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	2 / 20 (10.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	2 / 3 (66.67%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	2 / 35 (5.71%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 13 (7.69%)	1 / 14 (7.14%)	0 / 16 (0.00%)	1 / 15 (6.67%)	1 / 14 (7.14%)	0 / 20 (0.00%)	1 / 7 (14.29%)	2 / 25 (8.00%)	0 / 4 (0.00%)
occurrences all number	0	0	2	0	1	2	0	1	0	1	0	2	0	0	0	0	0	1	1	0	1	1	0	1	2	0
Dental caries
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Diarrhoea
subjects affected / exposed	2 / 19 (10.53%)	0 / 2 (0.00%)	1 / 20 (5.00%)	1 / 1 (100.00%)	0 / 19 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	3 / 20 (15.00%)	2 / 16 (12.50%)	5 / 37 (13.51%)	3 / 36 (8.33%)	3 / 35 (8.57%)	2 / 15 (13.33%)	0 / 14 (0.00%)	0 / 14 (0.00%)	4 / 16 (25.00%)	1 / 15 (6.67%)	0 / 13 (0.00%)	1 / 14 (7.14%)	1 / 16 (6.25%)	3 / 15 (20.00%)	1 / 14 (7.14%)	1 / 20 (5.00%)	0 / 7 (0.00%)	1 / 25 (4.00%)	0 / 4 (0.00%)
occurrences all number	2	0	1	1	0	1	0	3	2	6	3	4	2	0	0	4	1	0	2	2	3	1	1	0	2	0
Diverticulum
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Dry mouth
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	2 / 35 (5.71%)	2 / 15 (13.33%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	1	0	0	0	0	0	1	2	3	0	0	0	1	0	0	0	0	1	0	0	0	0
Dyspepsia
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 16 (0.00%)	2 / 37 (5.41%)	1 / 36 (2.78%)	3 / 35 (8.57%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 13 (7.69%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 25 (4.00%)	0 / 4 (0.00%)
occurrences all number	0	0	1	0	1	0	0	1	0	2	1	3	0	0	1	0	0	1	0	0	0	1	0	0	1	0
Faeces soft
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	2 / 35 (5.71%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	2	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Flatulence
subjects affected / exposed	2 / 19 (10.53%)	0 / 2 (0.00%)	2 / 20 (10.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	2 / 36 (5.56%)	1 / 35 (2.86%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	2 / 16 (12.50%)	0 / 15 (0.00%)	1 / 13 (7.69%)	2 / 14 (14.29%)	0 / 16 (0.00%)	1 / 15 (6.67%)	2 / 14 (14.29%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	2	0	2	0	1	0	0	1	0	0	2	1	0	0	0	2	0	1	2	0	1	2	0	0	0	0
Frequent bowel movements
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Gastritis
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	1 / 16 (6.25%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	1 / 36 (2.78%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 14 (7.14%)	2 / 16 (12.50%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 25 (4.00%)	0 / 4 (0.00%)
occurrences all number	0	0	1	0	1	0	0	0	0	1	1	0	0	0	1	2	0	0	0	0	1	0	0	0	1	0
Hiatus hernia
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Infrequent bowel movements
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Irritable bowel syndrome
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Lip dry
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Nausea
subjects affected / exposed	2 / 19 (10.53%)	0 / 2 (0.00%)	1 / 20 (5.00%)	1 / 1 (100.00%)	5 / 19 (26.32%)	0 / 3 (0.00%)	0 / 2 (0.00%)	6 / 20 (30.00%)	2 / 16 (12.50%)	4 / 37 (10.81%)	6 / 36 (16.67%)	5 / 35 (14.29%)	1 / 15 (6.67%)	1 / 14 (7.14%)	3 / 14 (21.43%)	3 / 16 (18.75%)	2 / 15 (13.33%)	2 / 13 (15.38%)	3 / 14 (21.43%)	2 / 16 (12.50%)	1 / 15 (6.67%)	2 / 14 (14.29%)	2 / 20 (10.00%)	0 / 7 (0.00%)	4 / 25 (16.00%)	0 / 4 (0.00%)
occurrences all number	3	0	1	1	6	0	0	6	2	5	8	6	1	1	3	3	2	2	3	3	1	3	2	0	5	0
Oral pain
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Paraesthesia oral
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 35 (2.86%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	1 / 14 (7.14%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	1	0	0	0	0
Salivary hypersecretion
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Tongue ulceration
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Vomiting
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	1 / 3 (33.33%)	0 / 2 (0.00%)	3 / 20 (15.00%)	2 / 16 (12.50%)	3 / 37 (8.11%)	1 / 36 (2.78%)	3 / 35 (8.57%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 13 (7.69%)	3 / 14 (21.43%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	1	0	3	3	3	1	3	0	0	0	0	0	1	3	1	0	0	0	0	0	0
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0
Actinic keratosis
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Alopecia
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 3 (33.33%)	1 / 2 (50.00%)	1 / 20 (5.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	1 / 35 (2.86%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 13 (7.69%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 25 (4.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0	1	1	1	0	0	1	1	0	0	0	0	0	1	0	0	1	0	0	0	1	0
Dermatitis
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Dermatitis contact
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Dry skin
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	1 / 2 (50.00%)	1 / 20 (5.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	3 / 36 (8.33%)	2 / 35 (5.71%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	2 / 25 (8.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	1	0	0	3	2	1	0	0	1	0	0	0	0	0	0	1	0	2	0
Ecchymosis
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Eczema
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	1 / 35 (2.86%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	1	0	0	0	0	0	1	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Erythema
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hyperhidrosis
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	2 / 35 (5.71%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hyperkeratosis
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Macule
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Night sweats
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 35 (2.86%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	1 / 13 (7.69%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	1	0	1	0	0	0	0	0	0	0	0
Photosensitivity reaction
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0
Pruritus
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	1 / 16 (6.25%)	0 / 37 (0.00%)	2 / 36 (5.56%)	2 / 35 (5.71%)	2 / 15 (13.33%)	0 / 14 (0.00%)	2 / 14 (14.29%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 13 (7.69%)	0 / 14 (0.00%)	1 / 16 (6.25%)	1 / 15 (6.67%)	1 / 14 (7.14%)	1 / 20 (5.00%)	0 / 7 (0.00%)	5 / 25 (20.00%)	0 / 4 (0.00%)
occurrences all number	0	0	1	0	1	0	0	1	1	0	2	2	2	0	2	0	0	1	0	1	1	1	1	0	5	0
Rash
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	1 / 1 (100.00%)	0 / 19 (0.00%)	2 / 3 (66.67%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	4 / 36 (11.11%)	2 / 35 (5.71%)	1 / 15 (6.67%)	0 / 14 (0.00%)	2 / 14 (14.29%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	2 / 14 (14.29%)	1 / 20 (5.00%)	0 / 7 (0.00%)	1 / 25 (4.00%)	0 / 4 (0.00%)
occurrences all number	0	0	1	1	0	2	0	0	0	0	5	2	1	0	2	1	0	0	0	1	0	3	3	0	1	0
Rash erythematous
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 35 (2.86%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0	1	0	0	0	0
Rash macular
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 35 (2.86%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Rash maculo-papular
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 14 (7.14%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 25 (4.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	1	0
Skin discolouration
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Skin lesion
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	1 / 16 (6.25%)	0 / 37 (0.00%)	1 / 36 (2.78%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Urticaria
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Renal and urinary disorders
Nephrolithiasis
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 13 (7.69%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Nephropathy
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Renal cyst
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 13 (7.69%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Arthralgia
subjects affected / exposed	2 / 19 (10.53%)	0 / 2 (0.00%)	0 / 20 (0.00%)	1 / 1 (100.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	2 / 20 (10.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	2 / 36 (5.56%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	2 / 16 (12.50%)	0 / 15 (0.00%)	0 / 13 (0.00%)	2 / 14 (14.29%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	2 / 25 (8.00%)	0 / 4 (0.00%)
occurrences all number	2	0	0	1	1	0	0	3	0	1	2	0	0	0	0	2	0	0	2	0	0	0	1	0	2	0
Back pain
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	2 / 19 (10.53%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	2 / 16 (12.50%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	2 / 16 (12.50%)	1 / 15 (6.67%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	3 / 20 (15.00%)	1 / 7 (14.29%)	0 / 25 (0.00%)	1 / 4 (25.00%)
occurrences all number	1	0	0	0	2	0	0	0	2	0	0	0	0	0	0	2	1	0	1	0	0	1	3	1	0	1
Fibromyalgia
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Groin pain
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Intervertebral disc degeneration
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Joint swelling
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Muscle spasms
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 35 (2.86%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	4	0	0	0	0	0	1	0	0	0	0
Musculoskeletal chest pain
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0
Musculoskeletal pain
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	3 / 35 (8.57%)	1 / 15 (6.67%)	1 / 14 (7.14%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	4	1	1	0	0	0	0	0	0	0	0	1	0	0	0
Musculoskeletal stiffness
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Myalgia
subjects affected / exposed	2 / 19 (10.53%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 16 (0.00%)	2 / 37 (5.41%)	2 / 36 (5.56%)	0 / 35 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	2	0	1	0	0	0	0	1	0	3	3	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0
Neck pain
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 35 (2.86%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 25 (4.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	1	1
Pain in extremity
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 14 (7.14%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 14 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	1 / 25 (4.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	1	0	0	1	0	0	0	0	0	0	1	1	0	0	1	0	1	0	1	0	1	0
Plantar fasciitis
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Rhabdomyolysis
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Infections and infestations
Acute sinusitis
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	1 / 16 (6.25%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Bronchitis
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0	0
Cellulitis
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0
Cystitis
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Ear infection
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	1	0	0	0
Gastroenteritis
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	2 / 35 (5.71%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	1	2	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Genital herpes
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Gingivitis
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Herpes simplex
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Hordeolum
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	1	0	0	0	0
Infected dermal cyst
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Influenza
subjects affected / exposed	1 / 19 (5.26%)	1 / 2 (50.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	1 / 36 (2.78%)	0 / 35 (0.00%)	1 / 15 (6.67%)	0 / 14 (0.00%)	1 / 14 (7.14%)	1 / 16 (6.25%)	1 / 15 (6.67%)	0 / 13 (0.00%)	2 / 14 (14.29%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 25 (4.00%)	0 / 4 (0.00%)
occurrences all number	1	1	0	0	0	1	0	0	0	2	1	0	1	0	1	1	1	0	2	0	0	1	0	0	1	0
Lower respiratory tract infection
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0
Nasopharyngitis
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	1	0	0	0	0	0	0
Oral herpes
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0
Otitis media
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 13 (7.69%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Paronychia
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Periodontitis
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Pharyngitis
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Pharyngitis streptococcal
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Pneumonia
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 35 (2.86%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0	1	0	0	0	0	0	0
Respiratory tract infection
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0
Rhinitis
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	2 / 15 (13.33%)	1 / 14 (7.14%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 13 (7.69%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	2 / 25 (8.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0	0	0	1	0	0	0	0	5	2	0	0	0	1	0	1	0	0	0	0	3	0
Sinusitis
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	1 / 35 (2.86%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	2 / 16 (12.50%)	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 25 (4.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	3	0	0	1	0	0	0	0	0	1	0
Tooth abscess
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Tooth infection
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Upper respiratory tract infection
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	1 / 20 (5.00%)	1 / 1 (100.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	1 / 16 (6.25%)	0 / 37 (0.00%)	1 / 36 (2.78%)	2 / 35 (5.71%)	1 / 15 (6.67%)	1 / 14 (7.14%)	1 / 14 (7.14%)	1 / 16 (6.25%)	0 / 15 (0.00%)	1 / 13 (7.69%)	2 / 14 (14.29%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	1 / 4 (25.00%)
occurrences all number	1	0	1	1	0	0	0	1	1	0	1	2	1	1	2	1	0	1	2	0	0	0	0	0	0	1
Urinary tract infection
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	3 / 36 (8.33%)	2 / 35 (5.71%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	1 / 25 (4.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	1	3	2	1	0	0	0	0	0	0	0	0	0	1	0	1	1
Viral infection
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	1 / 2 (50.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Viral upper respiratory tract infection
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	2 / 19 (10.53%)	1 / 3 (33.33%)	0 / 2 (0.00%)	2 / 20 (10.00%)	2 / 16 (12.50%)	4 / 37 (10.81%)	6 / 36 (16.67%)	1 / 35 (2.86%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 14 (0.00%)	3 / 16 (18.75%)	0 / 15 (0.00%)	1 / 13 (7.69%)	3 / 14 (21.43%)	1 / 16 (6.25%)	4 / 15 (26.67%)	2 / 14 (14.29%)	1 / 20 (5.00%)	0 / 7 (0.00%)	2 / 25 (8.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	3	2	0	3	2	4	7	1	1	0	0	3	0	1	3	1	4	2	1	0	2	0
Wound infection staphylococcal
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	1 / 19 (5.26%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	1 / 36 (2.78%)	3 / 35 (8.57%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	1 / 13 (7.69%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	2 / 14 (14.29%)	1 / 20 (5.00%)	0 / 7 (0.00%)	3 / 25 (12.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	1	0	0	0	0	1	1	3	1	0	0	0	1	1	0	1	0	2	1	0	3	0
Gout
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	1 / 36 (2.78%)	0 / 35 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Hyperamylasaemia
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hyperglycaemia
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Hyperlipasaemia
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hyperlipidaemia
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	1 / 20 (5.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	1 / 16 (6.25%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Hypokalaemia
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	1 / 14 (7.14%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Increased appetite
subjects affected / exposed	2 / 19 (10.53%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	1 / 35 (2.86%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	1 / 15 (6.67%)	0 / 14 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	2	0	0	0	1	0	0	0	0	1	0	1	0	0	0	0	1	0	0	0	1	0	0	0	0	0
Vitamin D deficiency
subjects affected / exposed	0 / 19 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 20 (0.00%)	0 / 16 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 35 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 16 (0.00%)	0 / 15 (0.00%)	0 / 14 (0.00%)	2 / 20 (10.00%)	0 / 7 (0.00%)	0 / 25 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

15 Dec 2014

Amendment 1: major revisions include changes to dosage and number of treatment arms

03 Jun 2015

Amendment 2: major revisions include changes to dosage, number of treatment arms, and sample sizes

23 Sep 2015

Amendment 3: major revisions include changes to the number of treatment arms, the durations of treatment to be studied, the number of participants per arm, the inclusion of ribavirin in some treatment arms, and the timing of initiation of each treatment arm.

16 Feb 2016

Amendment 4: major revisions include changes to the number of treatment arms

14 Mar 2016

Amendment 5: major revisions include changes to the assignment of participants to treatment arms

22 Jun 2016

Amendment 6: major revisions include changes to a long-term follow-up study.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Clinical trials

Clinical Trial Results:
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

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of HCV GT3-infected participants achieving Sustained Virologic Response at follow-up Week 12 (SVR12)

Primary: Percentage of HCV GT3-infected participants achieving Sustained Virologic Response at follow-up Week 12 (SVR12)

Primary: Number of participants experiencing an adverse event (AE)

Primary: Number of participants experiencing an adverse event (AE)

Primary: Number of participants who had study drug discontinued due to an AE

Primary: Number of participants who had study drug discontinued due to an AE

Secondary: Percentage of GT3-infected participants achieving SVR at follow-up Week 24 (SVR24)

Secondary: Percentage of GT3-infected participants achieving SVR at follow-up Week 24 (SVR24)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: 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

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of HCV GT3-infected participants achieving Sustained Virologic Response at follow-up Week 12 (SVR12)

Primary: Percentage of HCV GT3-infected participants achieving Sustained Virologic Response at follow-up Week 12 (SVR12)

Primary: Number of participants experiencing an adverse event (AE)

Primary: Number of participants experiencing an adverse event (AE)

Primary: Number of participants who had study drug discontinued due to an AE

Primary: Number of participants who had study drug discontinued due to an AE

Secondary: Percentage of GT3-infected participants achieving SVR at follow-up Week 24 (SVR24)

Secondary: Percentage of GT3-infected participants achieving SVR at follow-up Week 24 (SVR24)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
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