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Clinical Trial Results:
Strategic Timing of AntiRetroviral Treatment(START)

Summary
EudraCT number	2008-006439-12
Trial protocol	BE FI ES DE GB GR IT SE PT IE EE NO AT CZ
Global end of trial date	27 Jul 2022

Results information
Results version number	v1(current)
This version publication date	23 Oct 2023
First version publication date	23 Oct 2023
Other versions

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

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Trial information

Top of page

Sponsor protocol code

INSIGHT001:START

ISRCTN number

-

US NCT number

NCT00867048

WHO universal trial number (UTN)

-

Sponsor organisation name

Regents of the University of Minnesota

Sponsor organisation address

Office of the Vice President for Research, 420 Johnston Hall, 101 Pleasant St. SE, Minneapolis, United States, 55455

Public contact

Jens Lundgren, CHIP - Rigshospitalet, University of Copenhagen, 45 3545 5757, jens.lundgren@regionh.dk

Scientific contact

Jens Lundgren, CHIP - Rigshospitalet, University of Copenhagen, 45 3545 5757, jens.lundgren@regionh.dk

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

No

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

No

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

No

Analysis stage

Final

Date of interim/final analysis

30 Jun 2023

Is this the analysis of the primary completion data?

Yes

Primary completion date

27 Jul 2022

Global end of trial reached?

Yes

Global end of trial date

27 Jul 2022

Was the trial ended prematurely?

No

Main objective of the trial

The primary objective of START was to determine whether starting ART early (at CD4 > 500) is superior to deferring ART until indicated by (then-current) guidelines at delaying the occurrence of a composite outcome consisting of AIDS, non-AIDS, or death from any cause. Based on two scientific hypotheses, both which take advantage of the randomized design of START and the extended follow-up through 2021, the primary objective of the extended follow-up period was to determine whether the benefit of early ART as compared to deferred ART in delaying the occurrence of a composite outcome consisting of AIDS, non-AIDS, or death from any cause is maintained, increased or reduced.

Protection of trial subjects

Participants were in regular contact with the study site, as this was where they were getting their primary care for HIV infection. Any side effects or necessary changes in medication could be identified promptly.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

15 Apr 2009

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Morocco: 43

Country: Number of subjects enrolled

Uganda: 348

Country: Number of subjects enrolled

Denmark: 33

Country: Number of subjects enrolled

Luxembourg: 5

Country: Number of subjects enrolled

Switzerland: 31

Country: Number of subjects enrolled

Argentina: 216

Country: Number of subjects enrolled

Australia: 109

Country: Number of subjects enrolled

Chile: 76

Country: Number of subjects enrolled

India: 91

Country: Number of subjects enrolled

Israel: 28

Country: Number of subjects enrolled

Malaysia: 18

Country: Number of subjects enrolled

Mexico: 48

Country: Number of subjects enrolled

Nigeria: 49

Country: Number of subjects enrolled

Thailand: 247

Country: Number of subjects enrolled

Brazil: 619

Country: Number of subjects enrolled

Mali: 41

Country: Number of subjects enrolled

Peru: 215

Country: Number of subjects enrolled

United States: 507

Country: Number of subjects enrolled

South Africa: 518

Country: Number of subjects enrolled

Norway: 15

Country: Number of subjects enrolled

Poland: 68

Country: Number of subjects enrolled

Portugal: 67

Country: Number of subjects enrolled

Spain: 234

Country: Number of subjects enrolled

Sweden: 2

Country: Number of subjects enrolled

United Kingdom: 339

Country: Number of subjects enrolled

Austria: 7

Country: Number of subjects enrolled

Belgium: 102

Country: Number of subjects enrolled

Czechia: 13

Country: Number of subjects enrolled

Estonia: 8

Country: Number of subjects enrolled

Finland: 23

Country: Number of subjects enrolled

France: 111

Country: Number of subjects enrolled

Germany: 312

Country: Number of subjects enrolled

Greece: 101

Country: Number of subjects enrolled

Ireland: 7

Country: Number of subjects enrolled

Italy: 33

Worldwide total number of subjects

4684

EEA total number of subjects

1141

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

4653

From 65 to 84 years

31

85 years and over

0

Subject disposition

Top of page

Recruitment details

-

Screening details

Adults with documented HIV infection and a current CD4+ cell count > 500 cells/mm3 who have never received antiretroviral treatment

Period 1 title

Entire trial (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Immediate antiretroviral therapy

Arm description

Antiretroviral-naiive participants with HIV infection and CD4+ > 500 cell/mm3 will begin antiretroviral treatment immediately following randomization with regimen of any approved drugs, as determined by their treating clinician

Arm type

Experimental

Investigational medicinal product name

Antiretroviral therapy

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule, Tablet

Routes of administration

Oral use

Dosage and administration details

For each participant, the clinician constructed a first-line antiretroviral regimen per current treatment guidelines from drugs approved for use in that country.

Deferred antiretroviral therapy

Arm description

Participants with HIV infection and CD4 > 500 cell/mm3 deferred ART initiation until their CD4 dropped to < 350 cell/mm3 or an AIDS-related condition developed.

Arm type

Standard of care

Investigational medicinal product name

Antiretroviral therapy

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet, Capsule

Routes of administration

Oral use

Dosage and administration details

For each participant, the clinician constructed a first-line antiretroviral regimen per current treatment guidelines from drugs approved for use in that country.

Number of subjects in period 1	Immediate antiretroviral therapy	Deferred antiretroviral therapy
Started	2325	2359
Completed	2325	2359

Baseline characteristics

Top of page

Reporting group title

Immediate antiretroviral therapy

Reporting group description

Antiretroviral-naiive participants with HIV infection and CD4+ > 500 cell/mm3 will begin antiretroviral treatment immediately following randomization with regimen of any approved drugs, as determined by their treating clinician

Reporting group title

Deferred antiretroviral therapy

Reporting group description

Participants with HIV infection and CD4 > 500 cell/mm3 deferred ART initiation until their CD4 dropped to < 350 cell/mm3 or an AIDS-related condition developed.

Reporting group values	Immediate antiretroviral therapy	Deferred antiretroviral therapy	Total
Number of subjects	2325	2359	4684
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	2308	2345	4653
From 65-84 years	17	14	31
85 years and over	0	0	0
Age continuous
Units: years
arithmetic mean (standard deviation)	36.8 ± 10.2	36.8 ± 10.1	-
Gender categorical
Units: Subjects
Female	624	633	1257
Male	1701	1726	3427

Subject analysis set title

All participants with documented HIV infection

Subject analysis set type

Full analysis

Subject analysis set description

Among the 4688 putatively HIV-infected participants enrolled, 4 were ultimately found to be not infected with HIV. These 4 participants are not included in outcome analyses.

Subject analysis sets values	All participants with documented HIV infection
Number of subjects	4684
Age categorical
Units: Subjects
In utero	0
Preterm newborn infants (gestational age < 37 wks)	0
Newborns (0-27 days)	0
Infants and toddlers (28 days-23 months)	0
Children (2-11 years)	0
Adolescents (12-17 years)	0
Adults (18-64 years)	4653
From 65-84 years	31
85 years and over	0
Age continuous
Units: years
arithmetic mean (standard deviation)	36.8 ± 10.2
Gender categorical
Units: Subjects
Female	1257
Male	3427

End points

Top of page

Reporting group title

Immediate antiretroviral therapy

Reporting group description

Antiretroviral-naiive participants with HIV infection and CD4+ > 500 cell/mm3 will begin antiretroviral treatment immediately following randomization with regimen of any approved drugs, as determined by their treating clinician

Reporting group title

Deferred antiretroviral therapy

Reporting group description

Participants with HIV infection and CD4 > 500 cell/mm3 deferred ART initiation until their CD4 dropped to < 350 cell/mm3 or an AIDS-related condition developed.

Subject analysis set title

All participants with documented HIV infection

Subject analysis set type

Full analysis

Subject analysis set description

Among the 4688 putatively HIV-infected participants enrolled, 4 were ultimately found to be not infected with HIV. These 4 participants are not included in outcome analyses.

Primary: Composite primary outcome

Top of page

End point title

Composite primary outcome

End point description

Composite endpoint of an AIDS event, serious non-AIDS event (cardiovascular disease, non-AIDS cancer, end-stage renal disease, decompensated liver disease), or death from any cause.

End point type

Primary

End point timeframe

Randomization through 31 December 2021

End point values	Immediate antiretroviral therapy	Deferred antiretroviral therapy
Number of subjects analysed	2325	2359
Units: participants	133	215

Composite primary outcome

Statistical analysis description

Cox regression, time to first event. Hazard ratio Immediate/Deferred (95% confidence interval); pvalue; alpha=0.05; 2-sided. Model stratified by geographic region.

Comparison groups

Immediate antiretroviral therapy v Deferred antiretroviral therapy

Number of subjects included in analysis

4684

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cox proportional hazards regression

Parameter type

Hazard ratio (HR)

Point estimate

0.61

Confidence interval

level

95%

sides

2-sided

lower limit

0.49

upper limit

0.76

Secondary: AIDS or AIDS-related death

Top of page

End point title

AIDS or AIDS-related death

End point description

A component of the composite primary endpoint. Time to first event: AIDS event or death from AIDS-related event

End point type

Secondary

End point timeframe

Randomization through 31 December 2021

End point values	Immediate antiretroviral therapy	Deferred antiretroviral therapy
Number of subjects analysed	2325	2359
Units: participants	31	83

AIDS

Comparison groups

Immediate antiretroviral therapy v Deferred antiretroviral therapy

Number of subjects included in analysis

4684

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cox proportional hazards regression

Parameter type

Hazard ratio (HR)

Point estimate

0.37

Confidence interval

level

95%

sides

2-sided

lower limit

0.25

upper limit

0.56

Secondary: Serious non-AIDS

Top of page

End point title

Serious non-AIDS

End point description

A component of the composite primary outcome. Time to first event: cardiovascular disease, end-stage renal disease, decompensated liver diseases, non-AIDS-associated cancer, death from causes other than AIDS.

End point type

Secondary

End point timeframe

Randomization through 31 December 2021

End point values	Immediate antiretroviral therapy	Deferred antiretroviral therapy
Number of subjects analysed	2325	2359
Units: participants	107	137

Serious non-AIDS

Comparison groups

Immediate antiretroviral therapy v Deferred antiretroviral therapy

Number of subjects included in analysis

4684

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.053

Method

Cox proportional hazards regression

Parameter type

Hazard ratio (HR)

Point estimate

0.78

Confidence interval

level

95%

sides

2-sided

lower limit

0.61

upper limit

1

Secondary: All-cause mortality

Top of page

End point title

All-cause mortality

End point description

A component of the primary composite outcome. Time-to-event analysis.

End point type

Secondary

End point timeframe

Randomization through 31 December 2021

End point values	Immediate antiretroviral therapy	Deferred antiretroviral therapy
Number of subjects analysed	2325	2359
Units: participants	66	85

All-cause mortality

Comparison groups

Immediate antiretroviral therapy v Deferred antiretroviral therapy

Number of subjects included in analysis

4684

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.13

Method

Cox proportional hazards regression

Parameter type

Hazard ratio (HR)

Point estimate

0.78

Confidence interval

level

95%

sides

2-sided

lower limit

0.57

upper limit

1.08

Adverse events

Top of page

Timeframe for reporting adverse events

Randomization through 31 December 2017 for serious adverse events; deaths are reported through 31 December 2021.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

25.0

Reporting group title

Immediate antiretroviral therapy

Reporting group description

Participants with HIV infection and CD4+ > 500 cell/mm3 will begin antiretroviral treatment with regimen of any approved drugs, as determined by their treating clinician. Non-serious events were not reported in this trial.

Reporting group title

Deferred antiretroviral therapy

Reporting group description

Participants with HIV infection and CD4 > 500 cells/mm3 waited until they met global treatment guidelines to begin antiretroviral therapy (i.e., until CD4 cell count dropped below 350 cell/mm3 or an AIDS-related condition developed). Non-serious events were not reported in this trial.

Notes
[1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
Justification: No non-serious adverse events were collected in START. As a strategy trial, all medications being used were approved and being used within indication.

Serious adverse events	Immediate antiretroviral therapy	Deferred antiretroviral therapy
Total subjects affected by serious adverse events
subjects affected / exposed	430 / 2325 (18.49%)	498 / 2359 (21.11%)
number of deaths (all causes)	66	85
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Adrenal adenoma
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anal cancer
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anal squamous cell carcinoma
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Benign hydatidiform mole
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder transitional cell carcinoma
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Burkitt's lymphoma
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Cancer pain
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Castleman's disease
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cervix carcinoma
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Clear cell renal cell carcinoma
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Extragonadal primary seminoma (pure)
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fibrosarcoma
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung adenocarcinoma
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Lung cancer metastatic
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant melanoma
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Meningioma benign
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to liver
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Metastasis
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic malignant melanoma
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Myeloid leukaemia
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Neurilemmoma benign
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neuroendocrine carcinoma
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neuroma
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Non-small cell lung cancer metastatic
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Papillary thyroid cancer
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal cancer
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Seminoma
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Small cell lung cancer
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Small cell lung cancer metastatic
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Squamous cell carcinoma of lung
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Testicular germ cell cancer
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Testis cancer
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transitional cell cancer of the renal pelvis and ureter
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transitional cell carcinoma metastatic
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Uterine leiomyoma
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal carcinoma
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Vascular disorders
Aortic aneurysm
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aortitis
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Deep vein thrombosis
subjects affected / exposed	5 / 2325 (0.22%)	3 / 2359 (0.13%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertension
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Hypertensive crisis
subjects affected / exposed	2 / 2325 (0.09%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral arterial occlusive disease
subjects affected / exposed	2 / 2325 (0.09%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery thrombosis
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral ischaemia
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vena cava thrombosis
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical and medical procedures
Appendicectomy
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Abortion incomplete
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abortion spontaneous
subjects affected / exposed	1 / 2325 (0.04%)	4 / 2359 (0.17%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Abortion threatened
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cephalo-pelvic disproportion
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ectopic pregnancy
subjects affected / exposed	4 / 2325 (0.17%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Foetal death
subjects affected / exposed	2 / 2325 (0.09%)	3 / 2359 (0.13%)
occurrences causally related to treatment / all	0 / 2	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Foetal distress syndrome
subjects affected / exposed	4 / 2325 (0.17%)	5 / 2359 (0.21%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Gestational hypertension
subjects affected / exposed	1 / 2325 (0.04%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhage in pregnancy
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oligohydramnios
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pre-eclampsia
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Premature delivery
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Premature labour
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Premature rupture of membranes
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prolonged labour
subjects affected / exposed	2 / 2325 (0.09%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ruptured ectopic pregnancy
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Umbilical cord prolapse
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Chest pain
subjects affected / exposed	1 / 2325 (0.04%)	4 / 2359 (0.17%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Chills
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Complication of device insertion
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Death
subjects affected / exposed	4 / 2325 (0.17%)	12 / 2359 (0.51%)
occurrences causally related to treatment / all	0 / 4	0 / 12
deaths causally related to treatment / all	0 / 4	0 / 12
Drowning
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Drug withdrawal syndrome
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fatigue
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gait disturbance
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Influenza like illness
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Impaired self-care
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple organ dysfunction syndrome
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Necrobiosis
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Non-cardiac chest pain
subjects affected / exposed	2 / 2325 (0.09%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral swelling
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	8 / 2325 (0.34%)	11 / 2359 (0.47%)
occurrences causally related to treatment / all	0 / 8	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Strangulated hernia
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Systemic inflammatory response syndrome
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess neck
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute hepatitis B
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
Hypersensitivity
subjects affected / exposed	1 / 2325 (0.04%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	1 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Anaphylactic shock
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Drug hypersensitivity
subjects affected / exposed	1 / 2325 (0.04%)	3 / 2359 (0.13%)
occurrences causally related to treatment / all	1 / 1	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Sarcoidosis
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Social circumstances
Homicide
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Substance use
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Abnormal uterine bleeding
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign prostatic hyperplasia
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cystocele
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Genital rash
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intermenstrual bleeding
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cyst
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Priapism
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatitis
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Testicular pain
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Testicular torsion
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine adhesions
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vaginal prolapse
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Acute respiratory failure
subjects affected / exposed	2 / 2325 (0.09%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Aspiration
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Asthma
subjects affected / exposed	4 / 2325 (0.17%)	5 / 2359 (0.21%)
occurrences causally related to treatment / all	0 / 5	0 / 8
deaths causally related to treatment / all	0 / 1	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cough
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Obstructive airways disorder
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Pleural effusion
subjects affected / exposed	2 / 2325 (0.09%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pleurisy
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	3 / 2325 (0.13%)	5 / 2359 (0.21%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory failure
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Restrictive pulmonary disease
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tonsillar hypertrophy
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tracheomalacia
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Acute psychosis
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Acute stress disorder
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Affective disorder
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Agitation
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol abuse
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol withdrawal syndrome
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Alcoholism
subjects affected / exposed	2 / 2325 (0.09%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anxiety
subjects affected / exposed	1 / 2325 (0.04%)	3 / 2359 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Bipolar I disorder
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bipolar disorder
subjects affected / exposed	3 / 2325 (0.13%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Burnout syndrome
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiovascular somatic symptom disorder
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Completed suicide
subjects affected / exposed	1 / 2325 (0.04%)	5 / 2359 (0.21%)
occurrences causally related to treatment / all	0 / 1	1 / 5
deaths causally related to treatment / all	0 / 1	1 / 5
Conversion disorder
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Delirium
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Depression
subjects affected / exposed	8 / 2325 (0.34%)	13 / 2359 (0.55%)
occurrences causally related to treatment / all	1 / 9	0 / 18
deaths causally related to treatment / all	0 / 0	0 / 0
Depression suicidal
subjects affected / exposed	3 / 2325 (0.13%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	1 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Drug abuse
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Drug dependence
subjects affected / exposed	1 / 2325 (0.04%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hallucination
subjects affected / exposed	2 / 2325 (0.09%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hallucination, auditory
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Homicidal ideation
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intentional self-injury
subjects affected / exposed	1 / 2325 (0.04%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	1 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Major depression
subjects affected / exposed	7 / 2325 (0.30%)	3 / 2359 (0.13%)
occurrences causally related to treatment / all	2 / 8	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Mental disorder
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Panic attack
subjects affected / exposed	2 / 2325 (0.09%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Persecutory delusion
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric decompensation
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psychotic disorder
subjects affected / exposed	2 / 2325 (0.09%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	1 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Schizoaffective disorder
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Schizophrenia
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Self-injurious ideation
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Substance abuse
subjects affected / exposed	0 / 2325 (0.00%)	3 / 2359 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Substance-induced mood disorder
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Substance-induced psychotic disorder
subjects affected / exposed	3 / 2325 (0.13%)	3 / 2359 (0.13%)
occurrences causally related to treatment / all	3 / 6	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Suicidal ideation
subjects affected / exposed	14 / 2325 (0.60%)	16 / 2359 (0.68%)
occurrences causally related to treatment / all	9 / 22	3 / 22
deaths causally related to treatment / all	0 / 0	0 / 0
Suicide attempt
subjects affected / exposed	24 / 2325 (1.03%)	20 / 2359 (0.85%)
occurrences causally related to treatment / all	9 / 34	4 / 22
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Autoimmune hepatitis
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary colic
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangitis
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	3 / 2325 (0.13%)	4 / 2359 (0.17%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	2 / 2325 (0.09%)	5 / 2359 (0.21%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 1
Cholecystitis chronic
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	2 / 2325 (0.09%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithiasis migration
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Drug-induced liver injury
subjects affected / exposed	2 / 2325 (0.09%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	2 / 2	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cirrhosis
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic failure
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	1 / 1
Hepatitis
subjects affected / exposed	2 / 2325 (0.09%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	1 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis acute
subjects affected / exposed	1 / 2325 (0.04%)	3 / 2359 (0.13%)
occurrences causally related to treatment / all	0 / 1	2 / 4
deaths causally related to treatment / all	0 / 0	1 / 1
Hyperbilirubinaemia
subjects affected / exposed	3 / 2325 (0.13%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	4 / 4	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Liver disorder
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Blood glucose increased
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Abdominal injury
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Accidental overdose
subjects affected / exposed	3 / 2325 (0.13%)	4 / 2359 (0.17%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Accidental poisoning
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol poisoning
subjects affected / exposed	1 / 2325 (0.04%)	3 / 2359 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Ankle fracture
subjects affected / exposed	4 / 2325 (0.17%)	4 / 2359 (0.17%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Back injury
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Carbon monoxide poisoning
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Clavicle fracture
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Contusion
subjects affected / exposed	2 / 2325 (0.09%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Craniocerebral injury
subjects affected / exposed	2 / 2325 (0.09%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Extradural haematoma
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eye injury
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Facial bones fracture
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fall
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral neck fracture
subjects affected / exposed	2 / 2325 (0.09%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 2	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	1 / 2325 (0.04%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Fibula fracture
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Foot fracture
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Forearm fracture
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Foreign body in gastrointestinal tract
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Fracture of penis
subjects affected / exposed	0 / 2325 (0.00%)	3 / 2359 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal procedural complication
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal stoma complication
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gun shot wound
subjects affected / exposed	1 / 2325 (0.04%)	4 / 2359 (0.17%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 2
Hand fracture
subjects affected / exposed	3 / 2325 (0.13%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	1 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Head injury
subjects affected / exposed	3 / 2325 (0.13%)	5 / 2359 (0.21%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	2 / 2325 (0.09%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Intentional overdose
subjects affected / exposed	2 / 2325 (0.09%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Joint dislocation
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Joint injury
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ligament injury
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Limb injury
subjects affected / exposed	1 / 2325 (0.04%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Limb traumatic amputation
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lower limb fracture
subjects affected / exposed	2 / 2325 (0.09%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar vertebral fracture
subjects affected / exposed	2 / 2325 (0.09%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Meniscus injury
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple fractures
subjects affected / exposed	2 / 2325 (0.09%)	4 / 2359 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple injuries
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Nasal injury
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Patella fracture
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax traumatic
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Post concussion syndrome
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post lumbar puncture syndrome
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haematoma
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haematuria
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haemorrhage
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Post-traumatic neck syndrome
subjects affected / exposed	2 / 2325 (0.09%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural complication
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Radius fracture
subjects affected / exposed	2 / 2325 (0.09%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Reactive gastropathy
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	2 / 2325 (0.09%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Scrotal haematoma
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin laceration
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Soft tissue injury
subjects affected / exposed	2 / 2325 (0.09%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal cord injury cervical
subjects affected / exposed	2 / 2325 (0.09%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Stab wound
subjects affected / exposed	2 / 2325 (0.09%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Subdural haematoma
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tendon injury
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tendon rupture
subjects affected / exposed	2 / 2325 (0.09%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Testicular injury
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thermal burn
subjects affected / exposed	2 / 2325 (0.09%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Tibia fracture
subjects affected / exposed	1 / 2325 (0.04%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	1 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Toxicity to various agents
subjects affected / exposed	1 / 2325 (0.04%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic haematoma
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic haemothorax
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic intracranial haemorrhage
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Upper limb fracture
subjects affected / exposed	2 / 2325 (0.09%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular graft occlusion
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular graft thrombosis
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound dehiscence
subjects affected / exposed	2 / 2325 (0.09%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wrist fracture
subjects affected / exposed	1 / 2325 (0.04%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	1 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital, familial and genetic disorders
Alagille syndrome
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anencephaly
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital hydrocephalus
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital hydronephrosis
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Microcephaly
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Patent ductus arteriosus
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tracheo-oesophageal fistula
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular septal defect
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Acute coronary syndrome
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute myocardial infarction
subjects affected / exposed	8 / 2325 (0.34%)	6 / 2359 (0.25%)
occurrences causally related to treatment / all	3 / 8	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Angina pectoris
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Angina unstable
subjects affected / exposed	2 / 2325 (0.09%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve stenosis
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arrhythmia
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Arteriosclerosis coronary artery
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial flutter
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure acute
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 6	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure congestive
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiomyopathy
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	2 / 2325 (0.09%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Foetal arrhythmia
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve incompetence
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	5 / 2325 (0.22%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	1 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Palpitations
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Silent myocardial infarction
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus tachycardia
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subvalvular aortic stenosis
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Supraventricular tachycardia
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular tachycardia
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Aphasia
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arachnoid cyst
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bell's palsy
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cauda equina syndrome
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Central nervous system lesion
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral haemorrhage
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cerebrovascular accident
subjects affected / exposed	2 / 2325 (0.09%)	5 / 2359 (0.21%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Cognitive disorder
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Demyelination
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dizziness
subjects affected / exposed	3 / 2325 (0.13%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	2 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Drug withdrawal convulsions
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Encephalopathy
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	3 / 2325 (0.13%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Facial paresis
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Generalised tonic-clonic seizure
subjects affected / exposed	2 / 2325 (0.09%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Guillain-Barre syndrome
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhage intracranial
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Haemorrhagic transformation stroke
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Headache
subjects affected / exposed	3 / 2325 (0.13%)	3 / 2359 (0.13%)
occurrences causally related to treatment / all	2 / 3	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic encephalopathy
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	1 / 1
Hydrocephalus
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Idiopathic intracranial hypertension
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intracranial mass
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolic encephalopathy
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Migraine
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neuropathy peripheral
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Paraesthesia
subjects affected / exposed	1 / 2325 (0.04%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Partial seizures
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Petit mal epilepsy
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Polyneuropathy
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postictal state
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Seizure
subjects affected / exposed	2 / 2325 (0.09%)	3 / 2359 (0.13%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal cord compression
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Syncope
subjects affected / exposed	2 / 2325 (0.09%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	2 / 2325 (0.09%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
VIth nerve paralysis
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	5 / 2325 (0.22%)	7 / 2359 (0.30%)
occurrences causally related to treatment / all	1 / 6	4 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Febrile bone marrow aplasia
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphadenopathy
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenia
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Normochromic normocytic anaemia
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Febrile neutropenia
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pancytopenia
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
Tinnitus
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo positional
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Opsoclonus myoclonus
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal artery occlusion
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Disorder of orbit
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vision blurred
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal hernia
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	2 / 2325 (0.09%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 2	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain lower
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal strangulated hernia
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute abdomen
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Alcoholic pancreatitis
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anal fissure
subjects affected / exposed	2 / 2325 (0.09%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anal haemorrhage
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anal pruritus
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anogenital dysplasia
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis
subjects affected / exposed	4 / 2325 (0.17%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis ulcerative
subjects affected / exposed	4 / 2325 (0.17%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	3 / 2325 (0.13%)	4 / 2359 (0.17%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer perforation
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dysphagia
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Enteritis
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Faecaloma
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Food poisoning
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Functional gastrointestinal disorder
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric disorder
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis
subjects affected / exposed	2 / 2325 (0.09%)	3 / 2359 (0.13%)
occurrences causally related to treatment / all	0 / 2	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal toxicity
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrooesophageal reflux disease
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhoidal haemorrhage
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhoids thrombosed
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hiatus hernia
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Inflammatory bowel disease
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia, obstructive
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	4 / 2325 (0.17%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Intra-abdominal fluid collection
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine perforation
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mallory-Weiss syndrome
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Megacolon
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Obstruction gastric
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Odynophagia
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal achalasia
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal rupture
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	1 / 2325 (0.04%)	4 / 2359 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Proctitis
subjects affected / exposed	2 / 2325 (0.09%)	5 / 2359 (0.21%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal haemorrhage
subjects affected / exposed	1 / 2325 (0.04%)	3 / 2359 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal perforation
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retroperitoneal haemorrhage
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	2 / 2325 (0.09%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Strangulated umbilical hernia
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tooth impacted
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Umbilical hernia
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Dermal cyst
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Drug eruption
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Erythema multiforme
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Panniculitis
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rash
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Skin lesion
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin necrosis
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Toxic skin eruption
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Xanthoma
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	11 / 2325 (0.47%)	6 / 2359 (0.25%)
occurrences causally related to treatment / all	0 / 11	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 2
Anuria
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Calculus urinary
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic nephropathy
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
End stage renal disease
subjects affected / exposed	1 / 2325 (0.04%)	3 / 2359 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Glomerulonephritis
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrolithiasis
subjects affected / exposed	3 / 2325 (0.13%)	4 / 2359 (0.17%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Nephropathy
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrotic syndrome
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal colic
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal failure
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ureterolithiasis
subjects affected / exposed	1 / 2325 (0.04%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Urethral stenosis
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary bladder haemorrhage
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary retention
subjects affected / exposed	2 / 2325 (0.09%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract obstruction
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis reactive
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Back pain
subjects affected / exposed	3 / 2325 (0.13%)	3 / 2359 (0.13%)
occurrences causally related to treatment / all	0 / 3	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Bursitis
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Fracture nonunion
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc disorder
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc protrusion
subjects affected / exposed	4 / 2325 (0.17%)	4 / 2359 (0.17%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar spinal stenosis
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle spasms
subjects affected / exposed	2 / 2325 (0.09%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Muscular weakness
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal chest pain
subjects affected / exposed	4 / 2325 (0.17%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Osteonecrosis
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pain in extremity
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Polyarthritis
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rhabdomyolysis
subjects affected / exposed	2 / 2325 (0.09%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal stenosis
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Synovitis
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Abdominal abscess
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal infection
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Abscess
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess limb
subjects affected / exposed	7 / 2325 (0.30%)	4 / 2359 (0.17%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Acute hepatitis C
subjects affected / exposed	4 / 2325 (0.17%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Anal abscess
subjects affected / exposed	5 / 2325 (0.22%)	13 / 2359 (0.55%)
occurrences causally related to treatment / all	0 / 6	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	24 / 2325 (1.03%)	17 / 2359 (0.72%)
occurrences causally related to treatment / all	0 / 24	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis perforated
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriovenous graft site abscess
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis bacterial
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bacteraemia
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial diarrhoea
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial pyelonephritis
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	3 / 2325 (0.13%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis viral
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Burn infection
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Campylobacter gastroenteritis
subjects affected / exposed	1 / 2325 (0.04%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Campylobacter sepsis
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Catheter site infection
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	5 / 2325 (0.22%)	10 / 2359 (0.42%)
occurrences causally related to treatment / all	0 / 5	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis staphylococcal
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Complicated appendicitis
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cryptosporidiosis infection
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dengue fever
subjects affected / exposed	2 / 2325 (0.09%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dengue haemorrhagic fever
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Device related infection
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic foot infection
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea infectious
subjects affected / exposed	1 / 2325 (0.04%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	1 / 2325 (0.04%)	3 / 2359 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis intestinal haemorrhagic
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dysentery
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Embolic pneumonia
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endocarditis
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endocarditis bacterial
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Epididymitis
subjects affected / exposed	4 / 2325 (0.17%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Epiglottic abscess
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	2 / 2325 (0.09%)	4 / 2359 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia pyelonephritis
subjects affected / exposed	1 / 2325 (0.04%)	3 / 2359 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia urinary tract infection
subjects affected / exposed	2 / 2325 (0.09%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Extradural abscess
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Febrile infection
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fournier's gangrene
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Furuncle
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	4 / 2325 (0.17%)	10 / 2359 (0.42%)
occurrences causally related to treatment / all	0 / 4	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis Escherichia coli
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis bacterial
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis cryptosporidial
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis salmonella
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis shigella
subjects affected / exposed	2 / 2325 (0.09%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis viral
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal infection
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Genital herpes simplex
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Giardiasis
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gonorrhoea
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Groin abscess
subjects affected / exposed	2 / 2325 (0.09%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HIV associated nephropathy
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HIV peripheral neuropathy
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis A
subjects affected / exposed	6 / 2325 (0.26%)	4 / 2359 (0.17%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis C
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Herpes simplex necrotising retinopathy
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Herpes zoster
subjects affected / exposed	2 / 2325 (0.09%)	3 / 2359 (0.13%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Infected skin ulcer
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infection
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Influenza
subjects affected / exposed	3 / 2325 (0.13%)	7 / 2359 (0.30%)
occurrences causally related to treatment / all	0 / 3	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral discitis
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Liver abscess
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine infection
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Localised infection
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lower respiratory tract infection
subjects affected / exposed	2 / 2325 (0.09%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymph node abscess
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphogranuloma venereum
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malaria
subjects affected / exposed	4 / 2325 (0.17%)	9 / 2359 (0.38%)
occurrences causally related to treatment / all	0 / 4	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Meningitis
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Meningitis streptococcal
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Meningitis viral
subjects affected / exposed	1 / 2325 (0.04%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Meningoencephalitis herpetic
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mononucleosis syndrome
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mycobacterium abscessus infection
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Necrotising fasciitis
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neurosyphilis
subjects affected / exposed	2 / 2325 (0.09%)	6 / 2359 (0.25%)
occurrences causally related to treatment / all	0 / 2	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenic sepsis
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ophthalmic herpes zoster
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound sepsis
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Orchitis
subjects affected / exposed	2 / 2325 (0.09%)	4 / 2359 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis chronic
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Otitis media acute
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Paronychia
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Parotid abscess
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Parotitis
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic inflammatory disease
subjects affected / exposed	2 / 2325 (0.09%)	4 / 2359 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Perirectal abscess
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	1 / 2325 (0.04%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonsillar abscess
subjects affected / exposed	3 / 2325 (0.13%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pertussis
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngitis
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngotonsillitis
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pilonidal disease
subjects affected / exposed	2 / 2325 (0.09%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumococcal bacteraemia
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	2 / 2325 (0.09%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Pneumonia aspiration
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative wound infection
subjects affected / exposed	1 / 2325 (0.04%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Proctitis chlamydial
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	4 / 2325 (0.17%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	3 / 2325 (0.13%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pyomyositis
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal abscess
subjects affected / exposed	1 / 2325 (0.04%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Renal abscess
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rubella
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Scrotal abscess
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Secondary syphilis
subjects affected / exposed	1 / 2325 (0.04%)	3 / 2359 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Sepsis
subjects affected / exposed	2 / 2325 (0.09%)	6 / 2359 (0.25%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 1	0 / 2
Sepsis syndrome
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Septic shock
subjects affected / exposed	2 / 2325 (0.09%)	3 / 2359 (0.13%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Shigella infection
subjects affected / exposed	2 / 2325 (0.09%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Soft tissue infection
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal abscess
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal sepsis
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal skin infection
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Streptococcal bacteraemia
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Streptococcal sepsis
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Strongyloidiasis
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subcutaneous abscess
subjects affected / exposed	1 / 2325 (0.04%)	3 / 2359 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Syphilis
subjects affected / exposed	0 / 2325 (0.00%)	4 / 2359 (0.17%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Tertiary syphilis
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tonsillitis
subjects affected / exposed	0 / 2325 (0.00%)	3 / 2359 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Tonsillitis streptococcal
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tooth abscess
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tuberculosis
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Tubo-ovarian abscess
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Typhoid fever
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	1 / 2325 (0.04%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	5 / 2325 (0.22%)	3 / 2359 (0.13%)
occurrences causally related to treatment / all	0 / 7	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Varicella
subjects affected / exposed	1 / 2325 (0.04%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Viral infection
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Viral pharyngitis
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Viral upper respiratory tract infection
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound infection
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Wound infection staphylococcal
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Abnormal loss of weight
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dehydration
subjects affected / exposed	2 / 2325 (0.09%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes mellitus
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes mellitus inadequate control
subjects affected / exposed	2 / 2325 (0.09%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic ketoacidosis
subjects affected / exposed	0 / 2325 (0.00%)	2 / 2359 (0.08%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic metabolic decompensation
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gout
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	1 / 2325 (0.04%)	0 / 2359 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	0 / 2325 (0.00%)	1 / 2359 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0.1%

Non-serious adverse events	Immediate antiretroviral therapy	Deferred antiretroviral therapy
Total subjects affected by non serious adverse events
subjects affected / exposed	0 / 2325 (0.00%)	0 / 2359 (0.00%)

More information

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Were there any global substantial amendments to the protocol? Yes

25 Oct 2010

Removed "consecutive" from CD4 eligibility criterion (2 CD4+ cell counts > 500 cells/mL) Clarified exclusion criteria 3 and 7 to specify that these were as assessed at randomization and before randomization respectively. Incorporated language regarding appropriate clinical management for participants in the deferred group whose CD4+ cell count is declining. Sample size section modified after performing the planned sample size re-estimation.

01 Feb 2016

The Data Safety Monitoring Board (DSMB) unblinded the trial on 26 May 2015. At a planned review the DSMB informed the trial leadership and sponsor that an interim monitoring boundary for efficacy had been crossed and recommended all participants begin antiretroviral therapy and continue follow-up. This protocol version described follow-up through 2021. Study objectives were revised and expanded, but the primary endpoint remains the same. Data collection reduced. Antiretroviral therapy will continue to be provided through the study through 2017 only; alternate arrangements for therapy must be made before that time.

28 Aug 2017

Further reduced data collection to one time point/year, to be collected primarily by abstraction from medical records of participants' regular care. Serious events no longer reported on a real-time basis or forwarded to regulators by the sponsor. Unscheduled hospitalizations will continue to be reported as part of the annual data collection.

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

http://www.ncbi.nlm.nih.gov/pubmed/26192873
http://www.ncbi.nlm.nih.gov/pubmed/37213438

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