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Clinical Trial Results:
A Phase III, randomized, double blind study of the safety and efficacy of GSK1349572 50 mg once daily to raltegravir 400 mg twice daily both administered with fixed-dose dual nucleoside reverse transcriptase inhibitor therapy over 96 weeks in HIV-1 infected antiretroviral therapy naïve adult subjects

Summary
EudraCT number	2009-017950-11
Trial protocol	ES DE FR GB IT
Global end of trial date	27 Dec 2016

Results information
Results version number	v1(current)
This version publication date	30 Dec 2017
First version publication date	30 Dec 2017
Other versions

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

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Trial information

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Sponsor protocol code

113086

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

ViiV Healthcare

Sponsor organisation address

980 Great West Road, Brentford, Middlesex, United Kingdom,

Public contact

GSK Response Center, GlaxoSmithKline, 1 866-435-7343,

Scientific contact

GSK Response Center, GlaxoSmithKline, 1 866-435-7343,

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

19 Jul 2017

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

27 Dec 2016

Was the trial ended prematurely?

Main objective of the trial

To demonstrate the antiviral activity of GSK1349572 50 mg administered once daily compared to RAL 400 mg twice daily over 48 weeks in HIV-1 infected therapy naïve subjects

Protection of trial subjects

An Independent Data Monitoring Committee (IDMC) was utilized in this study to ensure external objective medical and/or statistical review of safety and/or efficacy issues in order to protect the ethical and safety interests of participants and to protect the scientific validity of the study.

Background therapy

Evidence for comparator

Actual start date of recruitment

19 Oct 2010

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 37

Country: Number of subjects enrolled

Canada: 61

Country: Number of subjects enrolled

France: 93

Country: Number of subjects enrolled

Germany: 95

Country: Number of subjects enrolled

Italy: 48

Country: Number of subjects enrolled

Russian Federation: 90

Country: Number of subjects enrolled

Spain: 242

Country: Number of subjects enrolled

United Kingdom: 17

Country: Number of subjects enrolled

United States: 139

Worldwide total number of subjects

822

EEA total number of subjects

495

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)

816

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

This was a randomized, parallel group, non-inferiority study to demonstrate the antiviral activity of Dolutegravir. Participants were enrolled from 9 countries. Participants in Dolutegravir arm who completed 96 Weeks double-blind phase continued to receive Dolutegravir in open-label phase, until dolutegravir was locally available commercially.

Screening details

Total 1035 participants were screened; 827 participants were randomized, and 822 participants entered the treatment period. Of the 5 participants who were randomized but not treated with investigational product, 4 withdrew consent and 1 was randomized in error. 338 participants were enrolled in open label phase to receive Dolutegravir.

Period 1 title

Double-blind Phase: 96 Weeks Duration

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

DTG 50 mg once a day

Arm description

Participants received DTG 50 mg once a day in combination with NRTI therapy, either with ABC/(3TC or TDF/FTC. Participants were given the opportunity to receive DTG 50 mg once a day during an Open-label Phase of the study.

Arm type

Experimental

Investigational medicinal product name

Dolutegravir

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received Dolutegravir 50 mg once a day for 96 weeks in double-blind treatment phase. Participants who completed 96 weeks of the treatment phase were given the opportunity to receive Dolutegravir 50 mg once a day during an Open-label Phase of the study.

Investigational medicinal product name

Tenofovir/Emtricitabine

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received Tenofovir/Emtricitabine fixed-dose combination as a background therapy.

Investigational medicinal product name

Abacavir/Lamivudine

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received Abacavir/Lamivudine fixed-dose combination as a background therapy.

RTG 400 mg BID

Arm description

Participants received RTG 400 mg BID in combination with NRTI therapy, with either ABC/3TC or TDF/FTC.

Arm type

Active comparator

Investigational medicinal product name

Raltegravir

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received Raltegravir 400 mg BID for 96 weeks in double-blind treatment phase.

Investigational medicinal product name

Tenofovir/Emtricitabine

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received Tenofovir/Emtricitabine fixed-dose combination as a background therapy.

Investigational medicinal product name

Abacavir/Lamivudine

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received Abacavir/Lamivudine fixed-dose combination as a background therapy.

Number of subjects in period 1	DTG 50 mg once a day	RTG 400 mg BID
Started	411	411
Completed	304	332
Not completed	107	79
Adverse event, serious fatal	1	1
Consent withdrawn by subject	18	14
Physician decision	3	-
Met Protocol-defined Stopping Criteria	6	3
Adverse event, non-fatal	11	6
Lost to follow-up	22	10
Study Closed/Terminated	6	4
Lack of efficacy	22	25
Protocol deviation	18	16

Period 2 title

Open-label Phase: median of 1267 days

Is this the baseline period?

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

DTG 50 mg once a day (Open-label)

Arm description

Participants who successfully completed 96 weeks of double blind phase continued to receive DTG 50 mg once a day during open label phase, until dolutegravir was locally available commercially. Participants received DTG 50 mg once a day in combination with NRTI therapy, with either ABC/3TC or TDF/FTC.

Arm type

Experimental

Investigational medicinal product name

Dolutegravir

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Investigational medicinal product name

Abacavir/Lamivudine

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received Abacavir/Lamivudine fixed-dose combination as a background therapy.

Investigational medicinal product name

Tenofovir/Emtricitabine

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received Tenofovir/Emtricitabine fixed-dose combination as a background therapy.

Number of subjects in period 2	DTG 50 mg once a day (Open-label)
Started	338
Completed	294
Not completed	44
Consent withdrawn by subject	8
Physician decision	3
Met Protocol-defined Stopping Criteria	4
Adverse event, non-fatal	4
Lost to follow-up	15
Lack of efficacy	5
Protocol deviation	5

Baseline characteristics

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Reporting group title

DTG 50 mg once a day

Reporting group description

Reporting group title

RTG 400 mg BID

Reporting group description

Participants received RTG 400 mg BID in combination with NRTI therapy, with either ABC/3TC or TDF/FTC.

Reporting group values	DTG 50 mg once a day	RTG 400 mg BID	Total
Number of subjects	411	411
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	37.3 ( 9.19 )	36.6 ( 10.02 )	-
Gender categorical
Units:
Female	63	56	119
Male	348	355	703
Race, Customized
Units: Subjects
African American/African Heritage (Her)	49	39	88
American Indian or Alaska Native	7	9	16
Central/South Asian Her	2	0	2
Japanese/East Asian Her/South East Asian Her	4	10	14
Native Hawaiian or other Pacific Islander	2	0	2
White	346	352	698
African American/African Her and Asian and White	1	0	1
Asian and White	0	1	1

End points

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Reporting group title

DTG 50 mg once a day

Reporting group description

Reporting group title

RTG 400 mg BID

Reporting group description

Participants received RTG 400 mg BID in combination with NRTI therapy, with either ABC/3TC or TDF/FTC.

Reporting group title

DTG 50 mg once a day (Open-label)

Reporting group description

Primary: Percentage of participants with Human Innumodeficiency Virus 1 (HIV-1) Ribonucleic Acid (RNA) [HIV-1RNA] <50 copies (c)/milliliter (mL) through Week 48

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End point title

Percentage of participants with Human Innumodeficiency Virus 1 (HIV-1) Ribonucleic Acid (RNA) [HIV-1RNA] <50 copies (c)/milliliter (mL) through Week 48

End point description

Percentage of participants with plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) with <50 c/mL was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. The algorithm treats all participants without HIV-1 RNA data as non-responders, as well as participants who switch their concomitant Antiretroviral Therapy (ART) prior to Week 48 as follows: background ART substitutions not permitted per study; background ART substitutions permitted per study unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure will be determined by the last available HIV-1 RNA assessment while the subject was on-treatment. Intent-to-Treat Exposed (ITT-E) Population comprised all randomized participants who received at least one dose of study medication.

End point type

Primary

End point timeframe

Baseline up to Week 48

End point values	DTG 50 mg once a day	RTG 400 mg BID
Number of subjects analysed	411 ^[1]	411
Units: Percentage of participants
number (not applicable)	88	85

Notes
[1] - ITT-E Population.

Statistical analysis 1

Statistical analysis description

Analysis was based on Cochran-Mantel Haenszel stratified analysis adjusted for the following Baseline stratification factors: Baseline HIV-1 RNA and background dual NRTI.

Comparison groups

DTG 50 mg once a day v RTG 400 mg BID

Number of subjects included in analysis

822

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[2]

Method

Parameter type

Difference in percentage

Point estimate

2.5

Confidence interval

level

95%

sides

2-sided

lower limit

-2.2

upper limit

7.1

Notes
[2] - Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG - RAL) in percentages between the two treatment arms was > -10%.

Secondary: Number of participants with detectable HIV-1 virus that has genotypic or phenotypic evidence of INI resistance

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End point title

Number of participants with detectable HIV-1 virus that has genotypic or phenotypic evidence of INI resistance

End point description

Number of participants with detectable virus that has genotypic or phenotypic evidence of Integrase Inhibitor (INI) resistance were assessed at Week 48 and Week 96. Integrase inhibitors are a class of antiretroviral drug designed to block the action of integrase, a viral enzyme that inserts the viral genome into the deoxyribonucleic acid (DNA) of the host cell.

End point type

Secondary

End point timeframe

Week 48 and Week 96

End point values	DTG 50 mg once a day	RTG 400 mg BID
Number of subjects analysed	411 ^[3]	411
Units: Participants
Week 48, genotypic	0	1
Week 48, phenotypic	1	2
Week 96, genotypic	0	1
Week 96, phenotypic	1	2

Notes
[3] - ITT-E Population.

No statistical analyses for this end point

Secondary: Number of participants with plasma HIV-1 RNA <50 c/mL

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End point title

Number of participants with plasma HIV-1 RNA <50 c/mL

End point description

The number of participants with plasma HIV-1 RNA level <50 c/mL was assessed at Week 96.

End point type

Secondary

End point timeframe

Week 96

End point values	DTG 50 mg once a day	RTG 400 mg BID
Number of subjects analysed	411 ^[4]	411
Units: Participants	332	314

Notes
[4] - ITT-E Population.

No statistical analyses for this end point

Secondary: Number of participants with plasma HIV-1 RNA <400 c/mL

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End point title

Number of participants with plasma HIV-1 RNA <400 c/mL

End point description

The number of participants with plasma HIV-1 RNA level <400 c/mL was assessed at Week 48 and Week 96.

End point type

Secondary

End point timeframe

Week 48 and Week 96

End point values	DTG 50 mg once a day	RTG 400 mg BID
Number of subjects analysed	411 ^[5]	411
Units: Participants
Week 48	369	356
Week 96	338	321

Notes
[5] - ITT-E Population.

No statistical analyses for this end point

Secondary: Change from Baseline in plasma HIV-1 RNA over time

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End point title

Change from Baseline in plasma HIV-1 RNA over time

End point description

Change from Baseline in plasma HIV-1 RNA over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Baseline was defined as the measurements performed on Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).

End point type

Secondary

End point timeframe

Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96

End point values	DTG 50 mg once a day	RTG 400 mg BID
Number of subjects analysed	411 ^[6]	411
Units: log10 c/mL
arithmetic mean (standard deviation)
Baseline n=411, 411	4.538 ( 0.7258 )	4.599 ( 0.7048 )
Week 4, n=402, 406	-2.817 ( 0.6198 )	-2.801 ( 0.6041 )
Week 8, n=397, 402	-2.897 ( 0.6837 )	-2.886 ( 0.6754 )
Week 12, n=396, 395	-2.908 ( 0.6863 )	-2.918 ( 0.6834 )
Week 16, n=395, 388	-2.917 ( 0.6949 )	-2.943 ( 0.6841 )
Week 24, n=393, 390	-2.896 ( 0.7889 )	-2.933 ( 0.7398 )
Week 32, n=386, 377	-2.907 ( 0.7609 )	-2.947 ( 0.7613 )
Week 40, n=375, 358	-2.920 ( 0.7219 )	-2.946 ( 0.6700 )
Week 48, n=374, 358	-2.915 ( 0.7237 )	-2.942 ( 0.6737 )
Week 60, n=366, 355	-2.912 ( 0.7344 )	-2.937 ( 0.6685 )
Week 72, n=361, 350	-2.917 ( 0.7261 )	-2.932 ( 0.6728 )
Week 84, n=352, 338	-2.932 ( 0.7073 )	-2.916 ( 0.6646 )
Week 96, n=342, 329	-2.938 ( 0.7004 )	-2.901 ( 0.7072 )

Notes
[6] - ITT-E Population.

No statistical analyses for this end point

Secondary: Absolute values in plasma HIV-1 RNA over time

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End point title

Absolute values in plasma HIV-1 RNA over time

End point description

Absolute values in plasma HIV-1 RNA over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).

End point type

Secondary

End point timeframe

Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96

End point values	DTG 50 mg once a day	RTG 400 mg BID
Number of subjects analysed	411 ^[7]	411
Units: log10 c/mL
arithmetic mean (standard deviation)
Baseline n=411, 411	4.538 ( 0.7258 )	4.599 ( 0.7048 )
Week 4, n=402, 406	1.718 ( 0.2593 )	1.800 ( 0.4095 )
Week 8, n=397, 402	1.646 ( 0.2006 )	1.709 ( 0.3791 )
Week 12, n=396, 395	1.626 ( 0.1323 )	1.672 ( 0.3125 )
Week 16, n=395, 388	1.620 ( 0.1252 )	1.648 ( 0.2647 )
Week 24, n=393, 390	1.643 ( 0.2950 )	1.655 ( 0.3476 )
Week 32, n=386, 377	1.620 ( 0.1917 )	1.636 ( 0.2721 )
Week 40, n=375, 358	1.603 ( 0.0821 )	1.601 ( 0.0784 )
Week 48, n=374, 358	1.606 ( 0.0866 )	1.599 ( 0.0582 )
Week 60, n=366, 355	1.605 ( 0.1134 )	1.599 ( 0.0560 )
Week 72, n=361, 350	1.601 ( 0.0803 )	1.605 ( 0.0836 )
Week 84, n=352, 338	1.607 ( 0.1337 )	1.614 ( 0.1279 )
Week 96, n=342, 329	1.599 ( 0.830 )	1.630 ( 0.2515 )

Notes
[7] - ITT-E Population.

No statistical analyses for this end point

Secondary: Change from Baseline in cluster of differentiation (CD)4+ cell counts over time

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End point title

Change from Baseline in cluster of differentiation (CD)4+ cell counts over time

End point description

CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immuno compromise. The CD4 count is used to stage the participants disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start ART. Changes from Baseline in CD4+ cell counts over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Baseline was defined as measurements performed on Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).

End point type

Secondary

End point timeframe

Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96

End point values	DTG 50 mg once a day	RTG 400 mg BID
Number of subjects analysed	411 ^[8]	411
Units: Cells per cubic millimeter (cells/mm^3)
arithmetic mean (standard deviation)
Baseline n=411, 411	379.2 ( 178.32 )	374.3 ( 163.37 )
Week 4, n=398, 403	93.3 ( 116.27 )	97.2 ( 129.35 )
Week 8, n=398, 402	121.6 ( 127.97 )	126.6 ( 134.59 )
Week 12, n=392, 397	130.7 ( 131.49 )	145.1 ( 144.08 )
Week 16, n=394, 392	155.1 ( 137.23 )	173.0 ( 159.10 )
Week 24, n=392, 389	199.3 ( 161.23 )	204.2 ( 162.28 )
Week 32, n=384, 375	223.4 ( 165.30 )	241.3 ( 167.64 )
Week 40, n=371, 357	224.1 ( 173.59 )	239.8 ( 173.33 )
Week 48, n=374, 357	238.9 ( 171.81 )	257.5 ( 178.69 )
Week 60, n=367, 355	247.8 ( 184.11 )	264.2 ( 188.63 )
Week 72, n=360, 350	247.8 ( 168.37 )	278.6 ( 182.76 )
Week 84, n=351, 338	281.3 ( 175.07 )	292.9 ( 199.42 )
Week 96, n=343, 328	292.2 ( 195.70 )	286.2 ( 192.45 )

Notes
[8] - ITT-E Population.

No statistical analyses for this end point

Secondary: Absolute values in CD4+ cell counts over time

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End point title

Absolute values in CD4+ cell counts over time

End point description

CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immuno compromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy absolute values in CD4+ cell counts over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).

End point type

Secondary

End point timeframe

Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96

End point values	DTG 50 mg once a day	RTG 400 mg BID
Number of subjects analysed	411 ^[9]	411
Units: cells/mm^3
arithmetic mean (standard deviation)
Baseline n=411, 411	379.2 ( 172.32 )	374.3 ( 163.37 )
Week 4, n=398, 403	474.2 ( 199.06 )	471.8 ( 191.02 )
Week 8, n=398, 402	502.3 ( 205.15 )	502.4 ( 187.99 )
Week 12, n=392, 397	513.3 ( 218.75 )	518.3 ( 195.59 )
Week 16, n=394, 392	536.4 ( 219.47 )	550.1 ( 221.77 )
Week 24, n=392, 389	582.0 ( 232.93 )	580.8 ( 218.76 )
Week 32, n=384, 375	606.5 ( 242.95 )	618.7 ( 237.56 )
Week 40, n=371, 357	609.1 ( 239.11 )	623.1 ( 234.82 )
Week 48, n=374, 357	623.8 ( 247.82 )	641.2 ( 241.75 )
Week 60, n=367, 355	635.6 ( 241.27 )	648.5 ( 238.99 )
Week 72, n=360, 350	635.2 ( 237.78 )	664.0 ( 239.86 )
Week 84, n=351, 338	668.0 ( 246.50 )	677.5 ( 249.64 )
Week 96, n=343, 328	679.8 ( 257.89 )	672.4 ( 237.54 )

Notes
[9] - ITT-E Population.

No statistical analyses for this end point

Secondary: Number of participants with the indicated post-Baseline HIV-associated conditions and progression, excluding recurrences

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End point title

Number of participants with the indicated post-Baseline HIV-associated conditions and progression, excluding recurrences

End point description

Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CDC CAT A at Baseline to a CDC CAT C event (EV); CDC CAT B at Baseline to a CDC CAT C EV; CDC CAT C at Baseline to a new CDC CAT C EV; or CDC CAT A, B, or C at Baseline to death.

End point type

Secondary

End point timeframe

From Baseline until Week 96

End point values	DTG 50 mg once a day	RTG 400 mg BID
Number of subjects analysed	411 ^[10]	411
Units: Participants
Any category condition	10	8
Any Category B condition	3	3
Any Category C condition	6	4
Any death	1	1
Progression from CAT A to CAT C	4	2
Progression from CAT B to CAT C	3	1
Progression from CAT C to new CAT C	0	1
Progression from CAT A, B, or C to death	1	1

Notes
[10] - ITT-E Population.

No statistical analyses for this end point

Secondary: Number of participants with the indicated Grade 1 to 4 clinical chemistry and hematology toxicities/laboratory adverse events (AEs)

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End point title

Number of participants with the indicated Grade 1 to 4 clinical chemistry and hematology toxicities/laboratory adverse events (AEs)

End point description

All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), alkaline phosphatase (ALP), asparate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphorus inorganic, total bilirubin, and triglycerides. All Grade 1 to 4 post-Baseline-emergent hematology toxities included hemoglobin, platelet count, total neutrophils, and white blood cell count. The Division of AIDS (DAIDS) defined toxicity grades as follows: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening; Grade 5, death. Safety Population: all participants who received at least one dose of investigational product

End point type

Secondary

End point timeframe

From Baseline until Week 96

End point values	DTG 50 mg once a day	RTG 400 mg BID
Number of subjects analysed	411 ^[11]	411
Units: Participants
ALT	57	70
ALP	7	15
AST	67	75
CO2 content/bicarbonate	58	67
Cholesterol	90	73
CK	61	47
Creatinine	11	7
Hyperglycaemia	70	87
Hyperkalemia	7	4
Hypernatremia	4	6
Hypoglycaemia	17	27
Hypokalemia	10	15
Hyponatremia	34	48
LDL cholesterol calculation	74	49
Lipase	55	62
Phosphorus, inorganic	65	71
Total bilirubin	27	24
Triglycerides	7	8
Hemoglobin	10	5
Platelet count	19	19
Total neutrophils	54	48
White Blood Cell count	19	7

Notes
[11] - Safety Population.

No statistical analyses for this end point

Secondary: Area under the plasma concentration-time curve from time zero to time tau [AUC(0-tau)] of DTG

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End point title

Area under the plasma concentration-time curve from time zero to time tau [AUC(0-tau)] of DTG

End point description

AUC is defined as the area under the DTG concentration-time curve as a measure of drug exposure over time. AUC(0-tau) is defined as the area under the plasma concentration-time curve from time zero to time tau over a dosing interval at steady state, where tau is the length of the dosing interval of DTG. The predicted individual AUC(0-tau) were obtained from the final population PK model by an empirical Bayes estimation. Blood samples for PK assessments were collected at pre-dose (within 15 minutes prior to dose) at Week 4, Week 24, and Week 48 and 1 to 3 hours post-dose or 4 to 12 hours post-dose at Week 4 and Week 24. If 1 to 3 hours post-dose was completed at Week 4, then the 4 to12 hour post-dose must be obtained at Week 48, and vice versa. The Pharmacokinetic (PK) Concentration Population comprised of all participants who received DTG, had undergone PK sampling during the study, and provided evaluable DTG plasma concentration data.

End point type

Secondary

End point timeframe

Week 4, Week 24, and Week 48

End point values	DTG 50 mg once a day	RTG 400 mg BID
Number of subjects analysed	403 ^[12]	0 ^[13]
Units: Microgramshour per milliliter(µghr/mL)
geometric mean (geometric coefficient of variation)	53.6 ( 26.8 )	( )

Notes
[12] - PK Concentration Population
[13] - No participants were analyzed in this arm.

No statistical analyses for this end point

Secondary: Maximum plasma concentration (Cmax) and concentration at the end of a dosing interval (Ctau) of DTG

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End point title

Maximum plasma concentration (Cmax) and concentration at the end of a dosing interval (Ctau) of DTG

End point description

The Cmax and Ctau of DTG were assessed at Week 48. The predicted individual Cmax and Ctau were obtained from the final population PK model by simulation of the concentration-time profiles. Blood samples for PK assessments were collected at pre-dose (within 15 minutes prior to dose) at Week 4, Week 24, and Week 48 and 1 to 3 hours post-dose or 4 to 12 hours post-dose at Week 4 and Week 24. If 1 to 3 hour post-dose was completed at Week 4, then the 4 to12 hour post-dose must be obtained at Week 48, and vice versa.

End point type

Secondary

End point timeframe

Week 4, Week 24, and Week 48

End point values	DTG 50 mg once a day	RTG 400 mg BID
Number of subjects analysed	403 ^[14]	0 ^[15]
Units: Micrograms per milliliter (µg/mL)
geometric mean (geometric coefficient of variation)
Cmax	3.69 ( 19.6 )	( )
Ctau	1.10 ( 46.5 )	( )

Notes
[14] - PK Concentration Population
[15] - No participants were analyzed for this arm.

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the study (up to a median of 1267 days).

Adverse event reporting additional description

AEs and non-serious AEs were collected in members of the Safety Population, which comprised of all participants who received at least one dose of investigational product.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

20.0

Reporting group title

DTG 50mg once a day

Reporting group description

Participants received DTG 50 mg one a day in combination with NRTI therapy, either with ABC/3TC or TDF/FTC. Participants were given the opportunity to receive DTG 50 mg once a day during an Open-label Phase of the study.

Reporting group title

DTG 50mg once a day (Open Label)

Reporting group description

Reporting group title

RTG 400mg BID

Reporting group description

Participants received RTG 400 mg BID in combination with NRTI therapy, with either ABC/3TC or TDF/FTC.

Serious adverse events	DTG 50mg once a day	DTG 50mg once a day (Open Label)	RTG 400mg BID
Total subjects affected by serious adverse events
subjects affected / exposed	41 / 411 (9.98%)	21 / 338 (6.21%)	45 / 411 (10.95%)
number of deaths (all causes)	1	0	1
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anogenital warts
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Breast cancer
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Malignant melanoma
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metastatic malignant melanoma
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Papilloma
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Transitional cell carcinoma
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vascular disorders
Thrombosis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Surgical and medical procedures
Keratoplasty
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Chest pain
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Polyserositis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Immune system disorders
Drug hypersensitivity
subjects affected / exposed	3 / 411 (0.73%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	1 / 3	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypersensitivity
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Immune reconstitution inflammatory syndrome
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Social circumstances
Homicide
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Reproductive system and breast disorders
Cervical dysplasia
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Erectile dysfunction
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Menorrhagia
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia aspiration
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Suicide attempt
subjects affected / exposed	2 / 411 (0.49%)	1 / 338 (0.30%)	3 / 411 (0.73%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Suicidal ideation
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Completed suicide
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Depression
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Investigations
Blood creatine phosphokinase increased
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Laceration
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Alcohol poisoning
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intentional overdose
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lower limb fracture
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Multiple fractures
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Penis injury
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Post procedural haemorrhage
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Toxicity to various agents
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Upper limb fracture
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac disorders
Arrhythmia
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nervous system disorders
Seizure
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences causally related to treatment / all	0 / 0	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Aphasia
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cognitive disorder
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sciatica
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Status epilepticus
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lymphadenopathy
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Anal fissure
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anal fistula
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal pain lower
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anal inflammation
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Irritable bowel syndrome
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pancreatic pseudocyst
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peptic ulcer
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Proctitis ulcerative
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Hepatitis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatotoxicity
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Portal vein thrombosis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Nephrolithiasis
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal colic
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal impairment
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthritis
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Back pain
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Costochondritis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Appendicitis
subjects affected / exposed	2 / 411 (0.49%)	1 / 338 (0.30%)	5 / 411 (1.22%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	2 / 411 (0.49%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anal abscess
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arthritis bacterial
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peritonsillar abscess
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia bacterial
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Subcutaneous abscess
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Syphilis
subjects affected / exposed	0 / 411 (0.00%)	2 / 338 (0.59%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abscess
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acute hepatitis C
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Atypical mycobacterial infection
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bacteraemia
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Corneal abscess
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Encephalitis viral
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroenteritis bacterial
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal infection
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Influenza
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lung infection
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lymphadenitis viral
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Meningitis tuberculous
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Neurosyphilis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteomyelitis chronic
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumocystis jirovecii pneumonia
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia cytomegaloviral
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rhinitis
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Secondary syphilis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sepsis
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Staphylococcal infection
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Viral infection
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	DTG 50mg once a day	DTG 50mg once a day (Open Label)	RTG 400mg BID
Total subjects affected by non serious adverse events
subjects affected / exposed	353 / 411 (85.89%)	256 / 338 (75.74%)	344 / 411 (83.70%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
subjects affected / exposed	16 / 411 (3.89%)	8 / 338 (2.37%)	22 / 411 (5.35%)
occurrences all number	17	9	24
Skin papilloma
subjects affected / exposed	9 / 411 (2.19%)	2 / 338 (0.59%)	8 / 411 (1.95%)
occurrences all number	10	2	10
Fibroma
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	2 / 411 (0.49%)
occurrences all number	1	1	2
Lipoma
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	2 / 411 (0.49%)
occurrences all number	1	1	2
Acrochordon
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	2	2	1
Kaposi's sarcoma
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	2	0	1
Melanocytic naevus
subjects affected / exposed	1 / 411 (0.24%)	2 / 338 (0.59%)	0 / 411 (0.00%)
occurrences all number	1	2	0
Basal cell carcinoma
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Oral papilloma
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Seborrhoeic keratosis
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	1	1	0
Anal neoplasm
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Cervix carcinoma
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Dysplastic naevus
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Eye haemangioma
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Fibroadenoma of breast
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Fibrous histiocytoma
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Haemangioma of liver
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Haemangioma of spleen
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Keratoacanthoma
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Papilloma
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Penile wart
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Schwannoma
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Uterine leiomyoma
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Vascular disorders
Hypertension
subjects affected / exposed	7 / 411 (1.70%)	5 / 338 (1.48%)	12 / 411 (2.92%)
occurrences all number	7	6	12
Varicose vein
subjects affected / exposed	1 / 411 (0.24%)	2 / 338 (0.59%)	1 / 411 (0.24%)
occurrences all number	1	2	1
Flushing
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Haematoma
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	0	1	1
Hot flush
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Thrombophlebitis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Circulatory collapse
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Deep vein thrombosis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Phlebitis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Surgical and medical procedures
Tooth extraction
subjects affected / exposed	0 / 411 (0.00%)	2 / 338 (0.59%)	0 / 411 (0.00%)
occurrences all number	0	2	0
Inguinal hernia repair
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Nasal septal operation
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Papilloma excision
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Tonsillectomy
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
General disorders and administration site conditions
Fatigue
subjects affected / exposed	22 / 411 (5.35%)	7 / 338 (2.07%)	24 / 411 (5.84%)
occurrences all number	26	7	27
Pyrexia
subjects affected / exposed	23 / 411 (5.60%)	6 / 338 (1.78%)	24 / 411 (5.84%)
occurrences all number	30	7	26
Asthenia
subjects affected / exposed	14 / 411 (3.41%)	7 / 338 (2.07%)	18 / 411 (4.38%)
occurrences all number	16	7	19
Influenza like illness
subjects affected / exposed	13 / 411 (3.16%)	7 / 338 (2.07%)	9 / 411 (2.19%)
occurrences all number	15	8	11
Chest pain
subjects affected / exposed	5 / 411 (1.22%)	3 / 338 (0.89%)	2 / 411 (0.49%)
occurrences all number	5	3	2
Feeling abnormal
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	3	0	2
Malaise
subjects affected / exposed	3 / 411 (0.73%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	3	0	1
Local swelling
subjects affected / exposed	3 / 411 (0.73%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	3	0	0
Oedema peripheral
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	2	0	1
Pain
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	3 / 411 (0.73%)
occurrences all number	0	0	3
Peripheral swelling
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	2 / 411 (0.49%)
occurrences all number	0	1	2
Chest discomfort
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	3
Cyst
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Granuloma
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Ill-defined disorder
subjects affected / exposed	0 / 411 (0.00%)	2 / 338 (0.59%)	0 / 411 (0.00%)
occurrences all number	0	2	0
Inflammation
subjects affected / exposed	0 / 411 (0.00%)	2 / 338 (0.59%)	0 / 411 (0.00%)
occurrences all number	0	2	0
Mucosal dryness
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Nodule
subjects affected / exposed	0 / 411 (0.00%)	2 / 338 (0.59%)	0 / 411 (0.00%)
occurrences all number	0	2	0
Suprapubic pain
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	1	1	0
Axillary pain
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Chills
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Discomfort
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Facial pain
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Feeling cold
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Mucosal inflammation
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Non-cardiac chest pain
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Oedema mucosal
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Polyp
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Swelling
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Immune system disorders
Seasonal allergy
subjects affected / exposed	8 / 411 (1.95%)	5 / 338 (1.48%)	7 / 411 (1.70%)
occurrences all number	8	7	7
Food allergy
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	3 / 411 (0.73%)
occurrences all number	0	1	3
Drug hypersensitivity
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Immune reconstitution inflammatory syndrome
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	0	0	2
Hypersensitivity
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Jarisch-Herxheimer reaction
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Social circumstances
Stress at work
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Reproductive system and breast disorders
Erectile dysfunction
subjects affected / exposed	5 / 411 (1.22%)	3 / 338 (0.89%)	6 / 411 (1.46%)
occurrences all number	5	3	6
Benign prostatic hyperplasia
subjects affected / exposed	2 / 411 (0.49%)	2 / 338 (0.59%)	1 / 411 (0.24%)
occurrences all number	2	2	1
Cervical dysplasia
subjects affected / exposed	2 / 411 (0.49%)	2 / 338 (0.59%)	0 / 411 (0.00%)
occurrences all number	2	2	0
Prostatitis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	1	0	2
Gynaecomastia
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Menorrhagia
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Sexual dysfunction
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	0	0	2
Testicular pain
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	1	1	0
Vaginal discharge
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	0	1	1
Balanoposthitis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Breast mass
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Breast pain
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Breast tenderness
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Endometriosis
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Epididymal tenderness
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Genital lesion
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Genital rash
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Hypospermia
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Menstruation irregular
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Ovarian cyst
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Penile discharge
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Pelvic discomfort
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Prostatomegaly
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Scrotal swelling
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Testicular oedema
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Testicular swelling
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Testis discomfort
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Varicocele
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Vulval ulceration
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	23 / 411 (5.60%)	9 / 338 (2.66%)	22 / 411 (5.35%)
occurrences all number	27	9	24
Oropharyngeal pain
subjects affected / exposed	19 / 411 (4.62%)	6 / 338 (1.78%)	16 / 411 (3.89%)
occurrences all number	22	7	19
Asthma
subjects affected / exposed	8 / 411 (1.95%)	1 / 338 (0.30%)	4 / 411 (0.97%)
occurrences all number	10	1	4
Rhinitis allergic
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	11 / 411 (2.68%)
occurrences all number	2	0	13
Nasal congestion
subjects affected / exposed	3 / 411 (0.73%)	2 / 338 (0.59%)	5 / 411 (1.22%)
occurrences all number	3	2	5
Rhinorrhoea
subjects affected / exposed	2 / 411 (0.49%)	2 / 338 (0.59%)	4 / 411 (0.97%)
occurrences all number	2	2	4
Sinus congestion
subjects affected / exposed	3 / 411 (0.73%)	1 / 338 (0.30%)	3 / 411 (0.73%)
occurrences all number	3	1	3
Epistaxis
subjects affected / exposed	2 / 411 (0.49%)	2 / 338 (0.59%)	2 / 411 (0.49%)
occurrences all number	2	2	2
Catarrh
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	2 / 411 (0.49%)
occurrences all number	0	1	2
Allergic sinusitis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Chronic obstructive pulmonary disease
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	0	1	2
Dysphonia
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Lung disorder
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	2	1	0
Productive cough
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	0	1	1
Respiratory disorder
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Respiratory tract congestion
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	1	1	0
Tonsillar hypertrophy
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Atelectasis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Dry throat
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Emphysema
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Laryngospasm
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Nasal dryness
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Nasal obstruction
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Nocturnal dyspnoea
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Pneumothorax
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Sleep apnoea syndrome
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Upper respiratory tract congestion
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Upper-airway cough syndrome
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Wheezing
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Psychiatric disorders
Insomnia
subjects affected / exposed	28 / 411 (6.81%)	6 / 338 (1.78%)	19 / 411 (4.62%)
occurrences all number	28	6	20
Depression
subjects affected / exposed	26 / 411 (6.33%)	8 / 338 (2.37%)	18 / 411 (4.38%)
occurrences all number	26	8	18
Anxiety
subjects affected / exposed	19 / 411 (4.62%)	6 / 338 (1.78%)	22 / 411 (5.35%)
occurrences all number	19	7	24
Abnormal dreams
subjects affected / exposed	13 / 411 (3.16%)	1 / 338 (0.30%)	8 / 411 (1.95%)
occurrences all number	14	1	9
Sleep disorder
subjects affected / exposed	7 / 411 (1.70%)	1 / 338 (0.30%)	8 / 411 (1.95%)
occurrences all number	7	1	8
Libido decreased
subjects affected / exposed	3 / 411 (0.73%)	1 / 338 (0.30%)	10 / 411 (2.43%)
occurrences all number	3	1	10
Stress
subjects affected / exposed	4 / 411 (0.97%)	2 / 338 (0.59%)	4 / 411 (0.97%)
occurrences all number	4	2	4
Nightmare
subjects affected / exposed	6 / 411 (1.46%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	6	0	2
Depressed mood
subjects affected / exposed	4 / 411 (0.97%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	4	1	1
Panic attack
subjects affected / exposed	2 / 411 (0.49%)	1 / 338 (0.30%)	2 / 411 (0.49%)
occurrences all number	2	1	2
Acute stress disorder
subjects affected / exposed	0 / 411 (0.00%)	2 / 338 (0.59%)	2 / 411 (0.49%)
occurrences all number	0	2	2
Drug use disorder
subjects affected / exposed	1 / 411 (0.24%)	2 / 338 (0.59%)	1 / 411 (0.24%)
occurrences all number	1	2	1
Burnout syndrome
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	1	0	2
Disorientation
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	3 / 411 (0.73%)
occurrences all number	0	0	4
Euphoric mood
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	1	0	2
Irritability
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	1	0	2
Suicidal ideation
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	2	0	1
Agitation
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Emotional disorder
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Adjustment disorder
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Adjustment disorder with depressed mood
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Aggression
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Agoraphobia
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Alcohol withdrawal syndrome
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Alcoholic psychosis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Anxiety disorder
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Apathy
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Attention deficit/hyperactivity disorder
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Confusional state
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Hallucination
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Major depression
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Mental disorder
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Mental fatigue
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Middle insomnia
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Mood swings
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Nervousness
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Panic reaction
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Persistent depressive disorder
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Phobia of flying
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Sleep-related eating disorder
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Somnambulism
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Substance-induced psychotic disorder
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	2
Terminal insomnia
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Thinking abnormal
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Withdrawal syndrome
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Hepatobiliary disorders
Hepatic steatosis
subjects affected / exposed	2 / 411 (0.49%)	1 / 338 (0.30%)	3 / 411 (0.73%)
occurrences all number	2	1	3
Cholelithiasis
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	1	1	0
Hepatitis toxic
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	0	0	3
Biliary colic
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Cholecystitis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Drug-induced liver injury
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Gallbladder polyp
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Hepatic cyst
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Hepatic lesion
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Hepatitis
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Hepatocellular injury
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Hepatomegaly
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Investigations
Alanine aminotransferase increased
subjects affected / exposed	6 / 411 (1.46%)	1 / 338 (0.30%)	4 / 411 (0.97%)
occurrences all number	8	1	10
Aspartate aminotransferase increased
subjects affected / exposed	3 / 411 (0.73%)	2 / 338 (0.59%)	4 / 411 (0.97%)
occurrences all number	3	2	9
Weight increased
subjects affected / exposed	4 / 411 (0.97%)	0 / 338 (0.00%)	5 / 411 (1.22%)
occurrences all number	4	0	5
Weight decreased
subjects affected / exposed	3 / 411 (0.73%)	1 / 338 (0.30%)	3 / 411 (0.73%)
occurrences all number	4	1	3
Blood pressure increased
subjects affected / exposed	3 / 411 (0.73%)	0 / 338 (0.00%)	3 / 411 (0.73%)
occurrences all number	3	0	3
Blood creatine phosphokinase increased
subjects affected / exposed	0 / 411 (0.00%)	3 / 338 (0.89%)	2 / 411 (0.49%)
occurrences all number	0	3	2
Lipase increased
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	3 / 411 (0.73%)
occurrences all number	1	1	3
Transaminases increased
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	2 / 411 (0.49%)
occurrences all number	1	1	2
Blood creatinine increased
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Blood glucose increased
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Urinary sediment present
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	0	0	2
Blood alkaline phosphatase increased
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Blood bilirubin increased
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Blood cholesterol increased
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Blood glucose decreased
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Blood phosphorus decreased
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Blood testosterone decreased
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Blood thyroid stimulating hormone increased
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Heart sounds abnormal
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Human papilloma virus test positive
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Liver function test increased
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Oestradiol increased
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Parasite stool test positive
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Protein urine present
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
QRS axis abnormal
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Shigella test positive
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Streptococcus test positive
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Urine analysis abnormal
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Vitamin D decreased
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Injury, poisoning and procedural complications
Ligament sprain
subjects affected / exposed	6 / 411 (1.46%)	6 / 338 (1.78%)	5 / 411 (1.22%)
occurrences all number	6	8	5
Muscle strain
subjects affected / exposed	7 / 411 (1.70%)	3 / 338 (0.89%)	3 / 411 (0.73%)
occurrences all number	7	3	3
Limb injury
subjects affected / exposed	2 / 411 (0.49%)	3 / 338 (0.89%)	5 / 411 (1.22%)
occurrences all number	2	3	5
Contusion
subjects affected / exposed	4 / 411 (0.97%)	1 / 338 (0.30%)	2 / 411 (0.49%)
occurrences all number	4	2	2
Epicondylitis
subjects affected / exposed	4 / 411 (0.97%)	3 / 338 (0.89%)	0 / 411 (0.00%)
occurrences all number	4	3	0
Laceration
subjects affected / exposed	4 / 411 (0.97%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	4	0	2
Arthropod bite
subjects affected / exposed	2 / 411 (0.49%)	1 / 338 (0.30%)	2 / 411 (0.49%)
occurrences all number	2	1	2
Fall
subjects affected / exposed	1 / 411 (0.24%)	2 / 338 (0.59%)	2 / 411 (0.49%)
occurrences all number	1	2	2
Rib fracture
subjects affected / exposed	2 / 411 (0.49%)	1 / 338 (0.30%)	2 / 411 (0.49%)
occurrences all number	2	1	3
Skin abrasion
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	3 / 411 (0.73%)
occurrences all number	1	1	4
Bone contusion
subjects affected / exposed	3 / 411 (0.73%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	3	0	1
Foot fracture
subjects affected / exposed	3 / 411 (0.73%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	3	0	1
Meniscus injury
subjects affected / exposed	2 / 411 (0.49%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	2	1	0
Back injury
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Concussion
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	0	1	1
Exposure to communicable disease
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	2
Hand fracture
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Injury
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Ligament rupture
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Post-traumatic neck syndrome
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Procedural pain
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Road traffic accident
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Scar
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	1	1	0
Tendon rupture
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	0	1	1
Thermal burn
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Upper limb fracture
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	0	0	2
Accident
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Animal bite
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Ankle fracture
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Arthropod sting
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Bone fissure
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Burns second degree
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Cartilage injury
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Ear injury
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Excoriation
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Eye contusion
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Eye injury
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Fracture
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Head injury
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Human bite
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Joint injury
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Joint dislocation
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Lower limb fracture
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Neck injury
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Patella fracture
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Penis injury
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Poisoning
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Post lumbar puncture syndrome
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Post procedural discomfort
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Post-traumatic pain
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Scratch
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Subdural haematoma
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Tendon injury
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Traumatic haematoma
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Ulnar nerve injury
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Wound
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Congenital, familial and genetic disorders
Hereditary non-polyposis colorectal cancer syndrome
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Ichthyosis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Kidney duplex
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Odontogenic cyst
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Cardiac disorders
Angina pectoris
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	4 / 411 (0.97%)
occurrences all number	1	1	4
Palpitations
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	2 / 411 (0.49%)
occurrences all number	1	1	2
Tachycardia
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	1	1	0
Cardiomyopathy
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Myocarditis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Ventricular hypokinesia
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Nervous system disorders
Headache
subjects affected / exposed	56 / 411 (13.63%)	9 / 338 (2.66%)	55 / 411 (13.38%)
occurrences all number	63	9	70
Dizziness
subjects affected / exposed	24 / 411 (5.84%)	0 / 338 (0.00%)	24 / 411 (5.84%)
occurrences all number	25	0	24
Sciatica
subjects affected / exposed	4 / 411 (0.97%)	4 / 338 (1.18%)	7 / 411 (1.70%)
occurrences all number	4	4	9
Migraine
subjects affected / exposed	4 / 411 (0.97%)	1 / 338 (0.30%)	5 / 411 (1.22%)
occurrences all number	5	1	10
Lethargy
subjects affected / exposed	3 / 411 (0.73%)	0 / 338 (0.00%)	6 / 411 (1.46%)
occurrences all number	3	0	7
Hypoaesthesia
subjects affected / exposed	4 / 411 (0.97%)	2 / 338 (0.59%)	2 / 411 (0.49%)
occurrences all number	5	2	2
Paraesthesia
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	5 / 411 (1.22%)
occurrences all number	1	0	6
Somnolence
subjects affected / exposed	4 / 411 (0.97%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	4	0	2
Disturbance in attention
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	4 / 411 (0.97%)
occurrences all number	1	0	5
Dysgeusia
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	4 / 411 (0.97%)
occurrences all number	1	0	4
Facial paralysis
subjects affected / exposed	2 / 411 (0.49%)	1 / 338 (0.30%)	2 / 411 (0.49%)
occurrences all number	2	1	2
Amnesia
subjects affected / exposed	3 / 411 (0.73%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	3	0	1
Cervicobrachial syndrome
subjects affected / exposed	1 / 411 (0.24%)	2 / 338 (0.59%)	1 / 411 (0.24%)
occurrences all number	2	2	1
Memory impairment
subjects affected / exposed	0 / 411 (0.00%)	2 / 338 (0.59%)	1 / 411 (0.24%)
occurrences all number	0	2	1
Syncope
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	1	0	2
Balance disorder
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Burning sensation
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Cognitive disorder
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	1	1	0
Dysaesthesia
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	0	1	2
Neuralgia
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Neuropathy peripheral
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	0	0	2
Poor quality sleep
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	0	0	2
Agnosia
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Anosmia
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Apraxia
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Brain injury
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Cerebral haemorrhage
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Cervical radiculopathy
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Circadian rhythm sleep disorder
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Cluster headache
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Dizziness postural
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Dystonia
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Hyperaesthesia
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Morton's neuralgia
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Nerve compression
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Peripheral sensory neuropathy
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Peroneal nerve palsy
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Post herpetic neuralgia
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Presyncope
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Sensory disturbance
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Trigeminal neuralgia
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Vascular headache
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Blood and lymphatic system disorders
Lymphadenopathy
subjects affected / exposed	9 / 411 (2.19%)	3 / 338 (0.89%)	4 / 411 (0.97%)
occurrences all number	13	4	4
Anaemia
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	4 / 411 (0.97%)
occurrences all number	0	0	4
Iron deficiency anaemia
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	2 / 411 (0.49%)
occurrences all number	1	1	2
Neutropenia
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	2	0	2
Lymphadenitis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Eosinophilia
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Granulocytopenia
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Leukopenia
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Polycythaemia
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Red blood cell abnormality
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Thrombocytopenia
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Thymus disorder
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	6 / 411 (1.46%)	1 / 338 (0.30%)	5 / 411 (1.22%)
occurrences all number	6	1	5
Tinnitus
subjects affected / exposed	5 / 411 (1.22%)	0 / 338 (0.00%)	4 / 411 (0.97%)
occurrences all number	5	0	5
Ear pain
subjects affected / exposed	1 / 411 (0.24%)	2 / 338 (0.59%)	0 / 411 (0.00%)
occurrences all number	1	2	0
Hypoacusis
subjects affected / exposed	2 / 411 (0.49%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	2	1	0
Deafness
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	0	0	2
Ear disorder
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Excessive cerumen production
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Eustachian tube obstruction
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
External ear inflammation
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
External ear pain
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Middle ear effusion
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Tympanic membrane disorder
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Eye disorders
Vision blurred
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	5 / 411 (1.22%)
occurrences all number	2	0	5
Conjunctivitis allergic
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	2 / 411 (0.49%)
occurrences all number	1	1	2
Ocular hyperaemia
subjects affected / exposed	3 / 411 (0.73%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	3	0	0
Visual acuity reduced
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	1	1	1
Chalazion
subjects affected / exposed	0 / 411 (0.00%)	2 / 338 (0.59%)	0 / 411 (0.00%)
occurrences all number	0	2	0
Conjunctival haemorrhage
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Conjunctival hyperaemia
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Dry eye
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Eye pruritus
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Blepharitis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Cataract
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Corneal erosion
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Diplopia
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Eye inflammation
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Eye pain
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Eyelids pruritus
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Hypermetropia
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Keratitis
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Ocular discomfort
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Photophobia
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Retinal tear
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Retinal haemorrhage
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Scleritis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	58 / 411 (14.11%)	21 / 338 (6.21%)	54 / 411 (13.14%)
occurrences all number	72	25	65
Nausea
subjects affected / exposed	60 / 411 (14.60%)	3 / 338 (0.89%)	55 / 411 (13.38%)
occurrences all number	70	3	66
Abdominal pain
subjects affected / exposed	18 / 411 (4.38%)	7 / 338 (2.07%)	16 / 411 (3.89%)
occurrences all number	21	7	20
Vomiting
subjects affected / exposed	16 / 411 (3.89%)	5 / 338 (1.48%)	18 / 411 (4.38%)
occurrences all number	21	7	19
Constipation
subjects affected / exposed	15 / 411 (3.65%)	1 / 338 (0.30%)	14 / 411 (3.41%)
occurrences all number	16	1	17
Abdominal pain upper
subjects affected / exposed	12 / 411 (2.92%)	5 / 338 (1.48%)	12 / 411 (2.92%)
occurrences all number	13	5	14
Haemorrhoids
subjects affected / exposed	15 / 411 (3.65%)	5 / 338 (1.48%)	9 / 411 (2.19%)
occurrences all number	15	6	9
Flatulence
subjects affected / exposed	12 / 411 (2.92%)	1 / 338 (0.30%)	11 / 411 (2.68%)
occurrences all number	12	1	11
Dyspepsia
subjects affected / exposed	6 / 411 (1.46%)	2 / 338 (0.59%)	11 / 411 (2.68%)
occurrences all number	6	3	11
Toothache
subjects affected / exposed	9 / 411 (2.19%)	6 / 338 (1.78%)	3 / 411 (0.73%)
occurrences all number	10	6	3
Gastrooesophageal reflux disease
subjects affected / exposed	4 / 411 (0.97%)	1 / 338 (0.30%)	12 / 411 (2.92%)
occurrences all number	4	1	12
Abdominal distension
subjects affected / exposed	6 / 411 (1.46%)	4 / 338 (1.18%)	6 / 411 (1.46%)
occurrences all number	6	5	7
Proctitis
subjects affected / exposed	5 / 411 (1.22%)	4 / 338 (1.18%)	5 / 411 (1.22%)
occurrences all number	5	4	6
Anogenital dysplasia
subjects affected / exposed	3 / 411 (0.73%)	5 / 338 (1.48%)	4 / 411 (0.97%)
occurrences all number	3	5	4
Abdominal discomfort
subjects affected / exposed	10 / 411 (2.43%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	11	0	1
Anal fissure
subjects affected / exposed	3 / 411 (0.73%)	2 / 338 (0.59%)	6 / 411 (1.46%)
occurrences all number	3	2	6
Gastritis
subjects affected / exposed	4 / 411 (0.97%)	5 / 338 (1.48%)	1 / 411 (0.24%)
occurrences all number	4	5	1
Aphthous ulcer
subjects affected / exposed	3 / 411 (0.73%)	2 / 338 (0.59%)	4 / 411 (0.97%)
occurrences all number	3	2	6
Odynophagia
subjects affected / exposed	3 / 411 (0.73%)	1 / 338 (0.30%)	4 / 411 (0.97%)
occurrences all number	3	1	4
Rectal haemorrhage
subjects affected / exposed	2 / 411 (0.49%)	2 / 338 (0.59%)	3 / 411 (0.73%)
occurrences all number	2	2	3
Dental caries
subjects affected / exposed	3 / 411 (0.73%)	0 / 338 (0.00%)	3 / 411 (0.73%)
occurrences all number	3	0	3
Abdominal pain lower
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	3 / 411 (0.73%)
occurrences all number	1	1	3
Enteritis
subjects affected / exposed	1 / 411 (0.24%)	2 / 338 (0.59%)	2 / 411 (0.49%)
occurrences all number	1	2	2
Inguinal hernia
subjects affected / exposed	2 / 411 (0.49%)	1 / 338 (0.30%)	2 / 411 (0.49%)
occurrences all number	2	1	2
Anal fistula
subjects affected / exposed	2 / 411 (0.49%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	2	1	1
Colitis
subjects affected / exposed	2 / 411 (0.49%)	2 / 338 (0.59%)	0 / 411 (0.00%)
occurrences all number	2	2	0
Gastrointestinal disorder
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	3 / 411 (0.73%)
occurrences all number	1	0	3
Hiatus hernia
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	3 / 411 (0.73%)
occurrences all number	0	1	3
Proctalgia
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	3	0	2
Anal haemorrhage
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	2	0	1
Anal pruritus
subjects affected / exposed	3 / 411 (0.73%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	3	0	0
Dry mouth
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	1	1	1
Mouth ulceration
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	2	0	1
Oesophagitis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	1	0	2
Abdominal tenderness
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	0	0	2
Abnormal faeces
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	0	0	2
Anal ulcer
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	2	0	1
Anorectal discomfort
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	1	1	0
Cheilitis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Dysphagia
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	0	1	1
Food poisoning
subjects affected / exposed	0 / 411 (0.00%)	2 / 338 (0.59%)	0 / 411 (0.00%)
occurrences all number	0	2	0
Gastrointestinal pain
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	0	0	2
Haematochezia
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	1	1	0
Haemorrhoidal haemorrhage
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Oesophageal spasm
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Oral disorder
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Abdominal rigidity
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Anal skin tags
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Anal spasm
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Anorectal disorder
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Chronic gastritis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Diverticulum
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	3
Epigastric discomfort
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Erosive duodenitis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Faeces pale
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Gastric ulcer
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Gastrointestinal haemorrhage
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Gingival hypertrophy
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Gingival pain
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Gingival swelling
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Haemorrhoids thrombosed
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Hyperchlorhydria
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Irritable bowel syndrome
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Large intestine polyp
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Lip haematoma
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Lip swelling
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Loose tooth
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Mouth cyst
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Oesophageal pain
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Oral pain
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Palatal disorder
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Pancreatitis acute
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	2	0
Palatal ulcer
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Paraesthesia oral
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Periodontal disease
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Rectal discharge
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Rectal fissure
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Saliva altered
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Salivary hypersecretion
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Stomatitis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Tongue disorder
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Tooth disorder
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Tooth impacted
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Ulcerative gastritis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Skin and subcutaneous tissue disorders
Rash
subjects affected / exposed	18 / 411 (4.38%)	1 / 338 (0.30%)	19 / 411 (4.62%)
occurrences all number	22	1	23
Pruritus
subjects affected / exposed	17 / 411 (4.14%)	5 / 338 (1.48%)	10 / 411 (2.43%)
occurrences all number	18	5	10
Acne
subjects affected / exposed	9 / 411 (2.19%)	2 / 338 (0.59%)	8 / 411 (1.95%)
occurrences all number	9	2	9
Eczema
subjects affected / exposed	7 / 411 (1.70%)	1 / 338 (0.30%)	7 / 411 (1.70%)
occurrences all number	9	1	10
Night sweats
subjects affected / exposed	5 / 411 (1.22%)	2 / 338 (0.59%)	8 / 411 (1.95%)
occurrences all number	5	2	8
Alopecia
subjects affected / exposed	5 / 411 (1.22%)	4 / 338 (1.18%)	4 / 411 (0.97%)
occurrences all number	5	4	4
Seborrhoeic dermatitis
subjects affected / exposed	3 / 411 (0.73%)	1 / 338 (0.30%)	8 / 411 (1.95%)
occurrences all number	3	1	9
Dry skin
subjects affected / exposed	5 / 411 (1.22%)	1 / 338 (0.30%)	5 / 411 (1.22%)
occurrences all number	5	1	5
Dermatitis
subjects affected / exposed	3 / 411 (0.73%)	2 / 338 (0.59%)	3 / 411 (0.73%)
occurrences all number	3	2	3
Dermatitis contact
subjects affected / exposed	4 / 411 (0.97%)	1 / 338 (0.30%)	3 / 411 (0.73%)
occurrences all number	4	1	3
Skin lesion
subjects affected / exposed	2 / 411 (0.49%)	1 / 338 (0.30%)	4 / 411 (0.97%)
occurrences all number	2	1	5
Hyperhidrosis
subjects affected / exposed	3 / 411 (0.73%)	0 / 338 (0.00%)	3 / 411 (0.73%)
occurrences all number	3	0	3
Urticaria
subjects affected / exposed	3 / 411 (0.73%)	1 / 338 (0.30%)	2 / 411 (0.49%)
occurrences all number	3	1	2
Intertrigo
subjects affected / exposed	4 / 411 (0.97%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	4	0	0
Photosensitivity reaction
subjects affected / exposed	2 / 411 (0.49%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	2	1	1
Rosacea
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	3 / 411 (0.73%)
occurrences all number	1	0	3
Dermatitis acneiform
subjects affected / exposed	2 / 411 (0.49%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	2	1	0
Erythema
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	1	0	2
Psoriasis
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	2	0	1
Rash papular
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	3	0	1
Actinic keratosis
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Dermatitis allergic
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Drug eruption
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	0	1	1
Dyshidrotic eczema
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	0	1	1
Eczema nummular
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	0	1	1
Facial wasting
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Macule
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Neurodermatitis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Pityriasis rosea
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Rash macular
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Rash pruritic
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	2
Skin fissures
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	1	1	0
Acne conglobata
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Acne cystic
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Alopecia areata
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Angioedema
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Cutaneous lupus erythematosus
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Dermal cyst
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Dermatosis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Eczema asteatotic
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Hidradenitis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Hyperkeratosis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Lentigo
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Lipoatrophy
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Mechanical urticaria
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Nail discolouration
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Nail ridging
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Pain of skin
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Papule
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Penile ulceration
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Pityriasis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Post inflammatory pigmentation change
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Pruritus generalised
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Rash erythematous
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Rash generalised
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Rash maculo-papular
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Scab
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Skin burning sensation
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Skin exfoliation
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Skin hyperpigmentation
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Skin irritation
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Skin mass
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Skin plaque
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Skin ulcer
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Spider naevus
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Swelling face
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Telangiectasia
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Toxic skin eruption
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Vitiligo
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Xeroderma
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Renal and urinary disorders
Dysuria
subjects affected / exposed	4 / 411 (0.97%)	0 / 338 (0.00%)	4 / 411 (0.97%)
occurrences all number	5	0	5
Urethral discharge
subjects affected / exposed	1 / 411 (0.24%)	2 / 338 (0.59%)	3 / 411 (0.73%)
occurrences all number	1	2	3
Haematuria
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	2	0	2
Micturition urgency
subjects affected / exposed	2 / 411 (0.49%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	2	1	1
Nephrolithiasis
subjects affected / exposed	1 / 411 (0.24%)	2 / 338 (0.59%)	1 / 411 (0.24%)
occurrences all number	1	2	1
Leukocyturia
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	1	0	2
Urethral pain
subjects affected / exposed	2 / 411 (0.49%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	2	1	0
Chronic kidney disease
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	1	1	0
Pollakiuria
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Polyuria
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Proteinuria
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Renal colic
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Glycosuria
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Microalbuminuria
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Renal impairment
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Tubulointerstitial nephritis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Urethral haemorrhage
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Urethral stenosis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Urinary hesitation
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Urinary retention
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Urinary tract disorder
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Urine flow decreased
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Endocrine disorders
Hypothyroidism
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	1	1	1
Goitre
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	1	1	0
Androgen deficiency
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Basedow's disease
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Hyperthyroidism
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Hypogonadism
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Thyroid mass
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	24 / 411 (5.84%)	10 / 338 (2.96%)	26 / 411 (6.33%)
occurrences all number	27	15	29
Arthralgia
subjects affected / exposed	11 / 411 (2.68%)	7 / 338 (2.07%)	14 / 411 (3.41%)
occurrences all number	13	8	17
Tendonitis
subjects affected / exposed	7 / 411 (1.70%)	5 / 338 (1.48%)	9 / 411 (2.19%)
occurrences all number	7	5	9
Myalgia
subjects affected / exposed	10 / 411 (2.43%)	3 / 338 (0.89%)	7 / 411 (1.70%)
occurrences all number	10	3	7
Pain in extremity
subjects affected / exposed	7 / 411 (1.70%)	1 / 338 (0.30%)	10 / 411 (2.43%)
occurrences all number	7	1	11
Musculoskeletal pain
subjects affected / exposed	5 / 411 (1.22%)	2 / 338 (0.59%)	7 / 411 (1.70%)
occurrences all number	5	2	7
Osteopenia
subjects affected / exposed	2 / 411 (0.49%)	5 / 338 (1.48%)	7 / 411 (1.70%)
occurrences all number	2	5	7
Neck pain
subjects affected / exposed	4 / 411 (0.97%)	2 / 338 (0.59%)	5 / 411 (1.22%)
occurrences all number	4	2	8
Muscle spasms
subjects affected / exposed	3 / 411 (0.73%)	2 / 338 (0.59%)	4 / 411 (0.97%)
occurrences all number	3	2	4
Musculoskeletal chest pain
subjects affected / exposed	5 / 411 (1.22%)	1 / 338 (0.30%)	3 / 411 (0.73%)
occurrences all number	6	1	3
Bursitis
subjects affected / exposed	3 / 411 (0.73%)	2 / 338 (0.59%)	2 / 411 (0.49%)
occurrences all number	3	2	2
Osteoarthritis
subjects affected / exposed	3 / 411 (0.73%)	2 / 338 (0.59%)	1 / 411 (0.24%)
occurrences all number	3	3	1
Osteoporosis
subjects affected / exposed	1 / 411 (0.24%)	3 / 338 (0.89%)	2 / 411 (0.49%)
occurrences all number	1	3	2
Flank pain
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	3 / 411 (0.73%)
occurrences all number	2	1	5
Spinal osteoarthritis
subjects affected / exposed	2 / 411 (0.49%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	2	1	1
Intervertebral disc protrusion
subjects affected / exposed	1 / 411 (0.24%)	2 / 338 (0.59%)	0 / 411 (0.00%)
occurrences all number	1	2	0
Joint swelling
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	1	0	2
Muscle contracture
subjects affected / exposed	2 / 411 (0.49%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	2	1	0
Plantar fasciitis
subjects affected / exposed	0 / 411 (0.00%)	2 / 338 (0.59%)	1 / 411 (0.24%)
occurrences all number	0	2	1
Synovial cyst
subjects affected / exposed	1 / 411 (0.24%)	2 / 338 (0.59%)	0 / 411 (0.00%)
occurrences all number	1	2	0
Intervertebral disc disorder
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	0	1	1
Limb discomfort
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Musculoskeletal discomfort
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Musculoskeletal stiffness
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	0	0	2
Rotator cuff syndrome
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Spinal pain
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Arthritis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Bone erosion
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Bone pain
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Chondritis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Costochondritis
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Dupuytren's contracture
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Enthesopathy
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Fasciitis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Fistula
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Foot deformity
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Gouty arthritis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Groin pain
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Intervertebral disc degeneration
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Jaw disorder
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Joint stiffness
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Muscle fatigue
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Muscle tightness
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Muscle twitching
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Myosclerosis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Myositis
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Osteochondrosis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	3
Osteonecrosis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Periarthritis
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Plantar fascial fibromatosis
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Psoriatic arthropathy
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Scoliosis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Torticollis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Infections and infestations
Viral upper respiratory tract infection
subjects affected / exposed	54 / 411 (13.14%)	24 / 338 (7.10%)	54 / 411 (13.14%)
occurrences all number	73	27	77
Upper respiratory tract infection
subjects affected / exposed	34 / 411 (8.27%)	27 / 338 (7.99%)	31 / 411 (7.54%)
occurrences all number	43	36	38
Syphilis
subjects affected / exposed	24 / 411 (5.84%)	24 / 338 (7.10%)	28 / 411 (6.81%)
occurrences all number	25	30	30
Bronchitis
subjects affected / exposed	24 / 411 (5.84%)	15 / 338 (4.44%)	22 / 411 (5.35%)
occurrences all number	33	16	25
Sinusitis
subjects affected / exposed	25 / 411 (6.08%)	12 / 338 (3.55%)	16 / 411 (3.89%)
occurrences all number	36	19	18
Gastroenteritis
subjects affected / exposed	18 / 411 (4.38%)	10 / 338 (2.96%)	18 / 411 (4.38%)
occurrences all number	21	11	23
Influenza
subjects affected / exposed	16 / 411 (3.89%)	7 / 338 (2.07%)	22 / 411 (5.35%)
occurrences all number	17	7	23
Pharyngitis
subjects affected / exposed	23 / 411 (5.60%)	9 / 338 (2.66%)	14 / 411 (3.41%)
occurrences all number	31	9	16
Respiratory tract infection
subjects affected / exposed	19 / 411 (4.62%)	5 / 338 (1.48%)	12 / 411 (2.92%)
occurrences all number	19	9	14
Rhinitis
subjects affected / exposed	13 / 411 (3.16%)	7 / 338 (2.07%)	13 / 411 (3.16%)
occurrences all number	20	8	15
Oral herpes
subjects affected / exposed	8 / 411 (1.95%)	7 / 338 (2.07%)	13 / 411 (3.16%)
occurrences all number	9	8	17
Conjunctivitis
subjects affected / exposed	8 / 411 (1.95%)	8 / 338 (2.37%)	11 / 411 (2.68%)
occurrences all number	8	9	11
Urinary tract infection
subjects affected / exposed	12 / 411 (2.92%)	4 / 338 (1.18%)	7 / 411 (1.70%)
occurrences all number	14	4	8
Respiratory tract infection viral
subjects affected / exposed	11 / 411 (2.68%)	4 / 338 (1.18%)	7 / 411 (1.70%)
occurrences all number	13	6	8
Urethritis
subjects affected / exposed	9 / 411 (2.19%)	5 / 338 (1.48%)	8 / 411 (1.95%)
occurrences all number	10	6	10
Chlamydial infection
subjects affected / exposed	5 / 411 (1.22%)	7 / 338 (2.07%)	9 / 411 (2.19%)
occurrences all number	6	8	13
Gonorrhoea
subjects affected / exposed	7 / 411 (1.70%)	8 / 338 (2.37%)	6 / 411 (1.46%)
occurrences all number	8	9	7
Herpes zoster
subjects affected / exposed	9 / 411 (2.19%)	2 / 338 (0.59%)	9 / 411 (2.19%)
occurrences all number	9	2	9
Gingivitis
subjects affected / exposed	8 / 411 (1.95%)	0 / 338 (0.00%)	11 / 411 (2.68%)
occurrences all number	8	0	11
Tonsillitis
subjects affected / exposed	10 / 411 (2.43%)	5 / 338 (1.48%)	4 / 411 (0.97%)
occurrences all number	10	8	4
Folliculitis
subjects affected / exposed	6 / 411 (1.46%)	4 / 338 (1.18%)	8 / 411 (1.95%)
occurrences all number	7	4	9
Ear infection
subjects affected / exposed	7 / 411 (1.70%)	2 / 338 (0.59%)	7 / 411 (1.70%)
occurrences all number	7	2	11
Genital herpes
subjects affected / exposed	5 / 411 (1.22%)	5 / 338 (1.48%)	4 / 411 (0.97%)
occurrences all number	6	6	5
Pneumonia
subjects affected / exposed	8 / 411 (1.95%)	2 / 338 (0.59%)	4 / 411 (0.97%)
occurrences all number	8	2	4
Tooth infection
subjects affected / exposed	7 / 411 (1.70%)	3 / 338 (0.89%)	4 / 411 (0.97%)
occurrences all number	8	3	4
Nasopharyngitis
subjects affected / exposed	6 / 411 (1.46%)	3 / 338 (0.89%)	4 / 411 (0.97%)
occurrences all number	7	3	4
Secondary syphilis
subjects affected / exposed	4 / 411 (0.97%)	5 / 338 (1.48%)	4 / 411 (0.97%)
occurrences all number	4	5	5
Cellulitis
subjects affected / exposed	5 / 411 (1.22%)	2 / 338 (0.59%)	4 / 411 (0.97%)
occurrences all number	5	2	5
Herpes simplex
subjects affected / exposed	1 / 411 (0.24%)	3 / 338 (0.89%)	7 / 411 (1.70%)
occurrences all number	1	5	8
Herpes virus infection
subjects affected / exposed	3 / 411 (0.73%)	3 / 338 (0.89%)	5 / 411 (1.22%)
occurrences all number	3	5	8
Onychomycosis
subjects affected / exposed	4 / 411 (0.97%)	3 / 338 (0.89%)	4 / 411 (0.97%)
occurrences all number	5	3	4
Fungal skin infection
subjects affected / exposed	5 / 411 (1.22%)	0 / 338 (0.00%)	5 / 411 (1.22%)
occurrences all number	5	0	5
Urethritis gonococcal
subjects affected / exposed	2 / 411 (0.49%)	3 / 338 (0.89%)	5 / 411 (1.22%)
occurrences all number	2	3	5
Viral infection
subjects affected / exposed	6 / 411 (1.46%)	0 / 338 (0.00%)	4 / 411 (0.97%)
occurrences all number	6	0	4
Furuncle
subjects affected / exposed	3 / 411 (0.73%)	2 / 338 (0.59%)	4 / 411 (0.97%)
occurrences all number	3	2	5
Otitis externa
subjects affected / exposed	1 / 411 (0.24%)	3 / 338 (0.89%)	5 / 411 (1.22%)
occurrences all number	1	3	7
Tooth abscess
subjects affected / exposed	4 / 411 (0.97%)	2 / 338 (0.59%)	3 / 411 (0.73%)
occurrences all number	4	3	3
Tinea infection
subjects affected / exposed	5 / 411 (1.22%)	0 / 338 (0.00%)	3 / 411 (0.73%)
occurrences all number	5	0	3
Anal chlamydia infection
subjects affected / exposed	3 / 411 (0.73%)	3 / 338 (0.89%)	1 / 411 (0.24%)
occurrences all number	3	3	1
Lymphogranuloma venereum
subjects affected / exposed	0 / 411 (0.00%)	2 / 338 (0.59%)	5 / 411 (1.22%)
occurrences all number	0	2	5
Otitis media
subjects affected / exposed	4 / 411 (0.97%)	1 / 338 (0.30%)	2 / 411 (0.49%)
occurrences all number	4	1	4
Skin infection
subjects affected / exposed	2 / 411 (0.49%)	3 / 338 (0.89%)	2 / 411 (0.49%)
occurrences all number	2	3	2
Tinea versicolour
subjects affected / exposed	3 / 411 (0.73%)	2 / 338 (0.59%)	2 / 411 (0.49%)
occurrences all number	3	2	2
Acarodermatitis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	5 / 411 (1.22%)
occurrences all number	1	0	5
Laryngitis
subjects affected / exposed	2 / 411 (0.49%)	1 / 338 (0.30%)	3 / 411 (0.73%)
occurrences all number	2	1	3
Anal abscess
subjects affected / exposed	2 / 411 (0.49%)	1 / 338 (0.30%)	2 / 411 (0.49%)
occurrences all number	2	1	3
Erysipelas
subjects affected / exposed	2 / 411 (0.49%)	1 / 338 (0.30%)	2 / 411 (0.49%)
occurrences all number	2	1	2
Genital infection fungal
subjects affected / exposed	1 / 411 (0.24%)	4 / 338 (1.18%)	0 / 411 (0.00%)
occurrences all number	1	5	0
Infection
subjects affected / exposed	3 / 411 (0.73%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	3	0	2
Labyrinthitis
subjects affected / exposed	2 / 411 (0.49%)	1 / 338 (0.30%)	2 / 411 (0.49%)
occurrences all number	2	1	2
Proctitis gonococcal
subjects affected / exposed	1 / 411 (0.24%)	2 / 338 (0.59%)	2 / 411 (0.49%)
occurrences all number	1	2	2
Subcutaneous abscess
subjects affected / exposed	3 / 411 (0.73%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	3	1	1
Tinea cruris
subjects affected / exposed	1 / 411 (0.24%)	2 / 338 (0.59%)	2 / 411 (0.49%)
occurrences all number	1	2	2
Fungal infection
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	3 / 411 (0.73%)
occurrences all number	1	0	3
Lower respiratory tract infection
subjects affected / exposed	2 / 411 (0.49%)	2 / 338 (0.59%)	0 / 411 (0.00%)
occurrences all number	2	4	0
Orchitis
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	2 / 411 (0.49%)
occurrences all number	1	1	2
Pharyngitis streptococcal
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	2 / 411 (0.49%)
occurrences all number	1	1	2
Rash pustular
subjects affected / exposed	0 / 411 (0.00%)	2 / 338 (0.59%)	2 / 411 (0.49%)
occurrences all number	0	2	2
Staphylococcal infection
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	2	0	2
Tinea pedis
subjects affected / exposed	2 / 411 (0.49%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	2	1	1
Abscess
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	4	0	1
Acute hepatitis C
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	1	1	1
Acute sinusitis
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	2	0	1
Balanitis candida
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	1	1	1
Cystitis
subjects affected / exposed	3 / 411 (0.73%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	3	0	0
Epididymitis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	1	0	2
Gastroenteritis viral
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	1	0	2
Gastrointestinal infection
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	1	0	2
Giardiasis
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	1	1	1
Helicobacter infection
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	1	0	2
Hordeolum
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	1	0	4
Localised infection
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	2 / 411 (0.49%)
occurrences all number	0	1	2
Lung infection
subjects affected / exposed	2 / 411 (0.49%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	3	1	0
Oral candidiasis
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	1	1	1
Parotitis
subjects affected / exposed	2 / 411 (0.49%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	2	1	0
Pharyngotonsillitis
subjects affected / exposed	1 / 411 (0.24%)	2 / 338 (0.59%)	0 / 411 (0.00%)
occurrences all number	1	2	0
Pilonidal cyst
subjects affected / exposed	2 / 411 (0.49%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	2	1	0
Primary syphilis
subjects affected / exposed	0 / 411 (0.00%)	2 / 338 (0.59%)	1 / 411 (0.24%)
occurrences all number	0	2	1
Tracheitis
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	1	1	1
Angular cheilitis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Beta haemolytic streptococcal infection
subjects affected / exposed	0 / 411 (0.00%)	2 / 338 (0.59%)	0 / 411 (0.00%)
occurrences all number	0	2	0
Cervicitis
subjects affected / exposed	0 / 411 (0.00%)	2 / 338 (0.59%)	0 / 411 (0.00%)
occurrences all number	0	2	0
Chronic sinusitis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	2
Dermatophytosis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Eye infection
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Gastroenteritis shigella
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Genital herpes simplex
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Genital infection bacterial
subjects affected / exposed	0 / 411 (0.00%)	2 / 338 (0.59%)	0 / 411 (0.00%)
occurrences all number	0	2	0
Helicobacter gastritis
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	1	1	0
Hepatitis A
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	1	1	0
Hepatitis C
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Infected bite
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	0	0	3
Infection parasitic
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Molluscum contagiosum
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	0	0	2
Oral infection
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Parasitic gastroenteritis
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	1	1	0
Paronychia
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	3	0	0
Proctitis chlamydial
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	1	0	1
Vulvovaginal mycotic infection
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Abscess oral
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Amoebiasis
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Asymptomatic bacteriuria
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Bacterial disease carrier
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Bacterial infection
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Bacterial vaginosis
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Bacteriuria
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Body tinea
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	2
Campylobacter gastroenteritis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Campylobacter infection
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Carbuncle
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	2	0	0
Cervicitis human papilloma virus
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Chronic hepatitis C
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Chronic tonsillitis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Clostridium difficile colitis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Conjunctivitis viral
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Dysentery
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Ear infection fungal
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Enterobiasis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Enterovirus infection
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Gastroenteritis clostridial
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Gastrointestinal viral infection
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Genitourinary chlamydia infection
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Genitourinary tract infection
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Groin abscess
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Hepatitis E
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Hepatitis viral
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Impetigo
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Infected cyst
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Latent syphilis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Latent tuberculosis
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Lung abscess
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Nail infection
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Ophthalmic herpes simplex
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Oral viral infection
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Oropharyngeal gonococcal infection
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Papilloma viral infection
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Pericoronitis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Periorbital cellulitis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Peritonsillar abscess
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Pharyngitis bacterial
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Pneumonia cytomegaloviral
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Post procedural infection
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Proctitis bacterial
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Pulpitis dental
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Pyelonephritis chronic
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Pyuria
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Scrotal abscess
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	2
Sexually transmitted disease
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Sialoadenitis
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Sinobronchitis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Sycosis barbae
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Tonsillitis bacterial
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Tonsillitis streptococcal
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Urethritis chlamydial
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Urinary tract infection bacterial
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Vaginitis gardnerella
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Viral pharyngitis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Vulvovaginal candidiasis
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Yersinia infection
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Metabolism and nutrition disorders
Vitamin D deficiency
subjects affected / exposed	7 / 411 (1.70%)	7 / 338 (2.07%)	6 / 411 (1.46%)
occurrences all number	7	7	6
Decreased appetite
subjects affected / exposed	6 / 411 (1.46%)	1 / 338 (0.30%)	8 / 411 (1.95%)
occurrences all number	6	1	9
Hyperglycaemia
subjects affected / exposed	0 / 411 (0.00%)	4 / 338 (1.18%)	0 / 411 (0.00%)
occurrences all number	0	4	0
Hypophosphataemia
subjects affected / exposed	1 / 411 (0.24%)	3 / 338 (0.89%)	0 / 411 (0.00%)
occurrences all number	1	5	0
Gout
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	1	1	1
Hypercholesterolaemia
subjects affected / exposed	2 / 411 (0.49%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	2	1	0
Hyperlipidaemia
subjects affected / exposed	2 / 411 (0.49%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	2	0	1
Iron deficiency
subjects affected / exposed	1 / 411 (0.24%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	1	1	1
Dyslipidaemia
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	1 / 411 (0.24%)
occurrences all number	0	1	1
Increased appetite
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	2 / 411 (0.49%)
occurrences all number	0	0	2
Alcohol intolerance
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Body fat disorder
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Dehydration
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Diabetes mellitus
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Diabetes mellitus inadequate control
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Folate deficiency
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Food intolerance
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Hyperlipasaemia
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Hypertriglyceridaemia
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Hypovitaminosis
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Lactase deficiency
subjects affected / exposed	0 / 411 (0.00%)	1 / 338 (0.30%)	0 / 411 (0.00%)
occurrences all number	0	1	0
Obesity
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Polydipsia
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1
Type 2 diabetes mellitus
subjects affected / exposed	1 / 411 (0.24%)	0 / 338 (0.00%)	0 / 411 (0.00%)
occurrences all number	1	0	0
Vitamin B12 deficiency
subjects affected / exposed	0 / 411 (0.00%)	0 / 338 (0.00%)	1 / 411 (0.24%)
occurrences all number	0	0	1

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Were there any global substantial amendments to the protocol? Yes

29 Oct 2010

Amendment 01: Country Specific Amendment for the United Kingdom.

14 Jan 2011

Amendment 02: This amendment included reference to an Independent Data Monitoring Committee (IDMC) which regularly review targeted safety information. Additionally, standard hematology and clinical chemistry laboratory assessments were made required for all participants at the Week 2 study visit. Minor clarifications and corrections were incorporated.

10 Oct 2011

Amendment 03: This amendment allowed for a change in the management of participants with protocol-defined virologic failure. Additional follow-up assessments were added to the Liver Chemistry Stopping criteria panel.

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

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of participants with Human Innumodeficiency Virus 1 (HIV-1) Ribonucleic Acid (RNA) [HIV-1RNA] <50 copies (c)/milliliter (mL) through Week 48

Primary: Percentage of participants with Human Innumodeficiency Virus 1 (HIV-1) Ribonucleic Acid (RNA) [HIV-1RNA] <50 copies (c)/milliliter (mL) through Week 48

Secondary: Number of participants with detectable HIV-1 virus that has genotypic or phenotypic evidence of INI resistance

Secondary: Number of participants with detectable HIV-1 virus that has genotypic or phenotypic evidence of INI resistance

Secondary: Number of participants with plasma HIV-1 RNA <50 c/mL

Secondary: Number of participants with plasma HIV-1 RNA <50 c/mL

Secondary: Number of participants with plasma HIV-1 RNA <400 c/mL

Secondary: Number of participants with plasma HIV-1 RNA <400 c/mL

Secondary: Change from Baseline in plasma HIV-1 RNA over time

Secondary: Change from Baseline in plasma HIV-1 RNA over time

Secondary: Absolute values in plasma HIV-1 RNA over time

Secondary: Absolute values in plasma HIV-1 RNA over time

Secondary: Change from Baseline in cluster of differentiation (CD)4+ cell counts over time

Secondary: Change from Baseline in cluster of differentiation (CD)4+ cell counts over time

Secondary: Absolute values in CD4+ cell counts over time

Secondary: Absolute values in CD4+ cell counts over time

Secondary: Number of participants with the indicated post-Baseline HIV-associated conditions and progression, excluding recurrences

Secondary: Number of participants with the indicated post-Baseline HIV-associated conditions and progression, excluding recurrences

Secondary: Number of participants with the indicated Grade 1 to 4 clinical chemistry and hematology toxicities/laboratory adverse events (AEs)

Secondary: Number of participants with the indicated Grade 1 to 4 clinical chemistry and hematology toxicities/laboratory adverse events (AEs)

Secondary: Area under the plasma concentration-time curve from time zero to time tau [AUC(0-tau)] of DTG

Secondary: Area under the plasma concentration-time curve from time zero to time tau [AUC(0-tau)] of DTG

Secondary: Maximum plasma concentration (Cmax) and concentration at the end of a dosing interval (Ctau) of DTG

Secondary: Maximum plasma concentration (Cmax) and concentration at the end of a dosing interval (Ctau) of DTG

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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