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Clinical Trial Results:
Phase III, Double-Blind, Randomized, Placebo-Controlled Trial to Investigate the Efficacy, Safety and Immunogenicity of a Tetravalent Dengue Vaccine (TDV) Administered Subcutaneously in Healthy Children Aged 4 - 16 Years Old

Summary
EudraCT number	2018-003979-34
Trial protocol	Outside EU/EEA
Global end of trial date	28 Jun 2024

Results information
Results version number	v2(current)
This version publication date	04 Jul 2025
First version publication date	12 Mar 2023
Other versions	v1
Version creation reason

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

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Trial information

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Sponsor protocol code

DEN-301

ISRCTN number

US NCT number

NCT02747927

WHO universal trial number (UTN)

U1111-1166-8401

Other trial identifiers

PHRR: PHRR150522-001010

Sponsor organisation name

Takeda

Sponsor organisation address

40 Landsdowne, Cambridge MA, United States, 02139

Public contact

Study Director, Takeda, TrialDisclosures@takeda.com

Scientific contact

Study Director, Takeda, TrialDisclosures@takeda.com

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

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

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

Yes

Analysis stage

Final

Date of interim/final analysis

28 Jun 2024

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

28 Jun 2024

Was the trial ended prematurely?

Main objective of the trial

The main objective of this study is to evaluate the efficacy of 2 doses of Tetravalent Dengue Vaccine (TDV) in preventing symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in 4 to 16 year old participants. In addition, the efficacy of a TDV booster dose was assessed.

Protection of trial subjects

All study participants were required to read and sign an informed consent form. Assent was also obtained from the participant where required.

Background therapy

Evidence for comparator

Actual start date of recruitment

07 Sep 2016

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Brazil: 1774

Country: Number of subjects enrolled

Colombia: 3900

Country: Number of subjects enrolled

Dominican Republic: 1600

Country: Number of subjects enrolled

Nicaragua: 825

Country: Number of subjects enrolled

Panama: 3000

Country: Number of subjects enrolled

Philippines: 3927

Country: Number of subjects enrolled

Sri Lanka: 2100

Country: Number of subjects enrolled

Thailand: 2973

Worldwide total number of subjects

20099

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

13661

Adolescents (12-17 years)

6438

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Participants took part in the study at various investigative sites globally from 7 September 2016 to 28 June 2024.

Screening details

Healthy children and adolescents were randomized in a 2:1 ratio to receive either tetravalent dengue vaccine (TDV) or placebo followed by a booster vaccination. The analysis of data for Part 5 is pending and anticipated reporting date for Part 5 is December 2025.

Number of subjects started

20099

Number of subjects completed

20067

Reason: Number of subjects

Did Not Receive Even 1 Dose of Trial Vaccine: 32

Period 1 title

Part 1: Vaccine Efficacy (Months 0-15)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Yes

Placebo

Arm description

Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

TDV placebo-matching, 0.5 ml, SC injection.

TDV 0.5 mL

Arm description

Participants received TDV, 0.5 ml, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.

Arm type

Experimental

Investigational medicinal product name

Tetravalent Dengue Vaccine (TDV)

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solvent for dispersion for injection

Routes of administration

Subcutaneous use

Dosage and administration details

TDV 0.5 ml SC injection.

Number of subjects in period 1 ^[1]	Placebo	TDV 0.5 mL
Started	6687	13380
Completed	6519	13033
Not completed	168	347
Adverse event, non-fatal	5	14
Reason Not Specified	6	13
Pregnancy	19	42
Withdrawal by Subject and/or Their Parent/Guardian	122	245
Without Adult Consent in Place	1	4
Lost to follow-up	13	26
Protocol deviation	2	3

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: The Baseline was collected for Safety Set which included all randomized participants who received at least 1 dose of the trial vaccines (TDV or placebo).

Period 2 title

Part 2: Additional VE (Months 16-21)

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Yes

Placebo

Arm description

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solvent for solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

TDV placebo-matching, 0.5 ml, SC injection

TDV 0.5 mL

Arm description

Arm type

Experimental

Investigational medicinal product name

Tetravalent Dengue Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solvent for dispersion for injection

Routes of administration

Subcutaneous use

Dosage and administration details

TDV 0.5 ml, SC injection

Number of subjects in period 2	Placebo	TDV 0.5 mL
Started	6519	13033
Completed	6487	12961
Not completed	32	72
Adverse event, non-fatal	-	1
Reason Not Specified	3	6
Pregnancy	11	17
Withdrawal by Subject and/or Their Parent/Guardian	13	33
Without Adult Consent in Place	1	7
Lost to follow-up	4	8

Period 3 title

Part 3: Long Term Safety & VE (3 Years)

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Yes

Placebo

Arm description

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

TDV placebo-matching, 0.5 ml, SC injection

TDV 0.5 mL

Arm description

Arm type

Experimental

Investigational medicinal product name

Tetravalent Dengue Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solvent for dispersion for injection

Routes of administration

Subcutaneous use

Dosage and administration details

TDV 0.5 ml, SC injection

Number of subjects in period 3	Placebo	TDV 0.5 mL
Started	6487	12961
Completed	6080	12177
Not completed	407	784
Adverse event, non-fatal	6	10
Reason Not Specified	13	18
Pregnancy	120	228
Withdrawal by Subject and/or Their Parent/Guardian	119	227
Without Adult Consent in Place	82	152
Lost to follow-up	66	147
Protocol deviation	1	2

Period 4 title

Part 4: Booster VE & Safety (13 Months)

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Yes

Placebo

Arm description

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

TDV placebo-matching, 0.5 ml, SC injection

TDV 0.5 mL

Arm description

Arm type

Experimental

Investigational medicinal product name

Tetravalent Dengue Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solvent for dispersion for injection

Routes of administration

Subcutaneous use

Dosage and administration details

TDV, 0.5 ml, SC injection

Number of subjects in period 4 ^[2]	Placebo	TDV 0.5 mL
Started	2985	5990
Completed	2939	5888
Not completed	46	102
Adverse event, non-fatal	1	3
Reason Not Specified	4	9
Pregnancy	8	15
Withdrawal by Subject and/or Their Parent/Guardian	29	60
Without Adult Consent in Place	-	1
Lost to follow-up	4	14

Notes
[2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: Only participants from the PPS who were 4 to 11 years of age at the time of randomization in the trial on Day 1 (Month 0) can participate in the booster phase of this trial.

Baseline characteristics

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Reporting group title

Placebo

Reporting group description

Reporting group title

TDV 0.5 mL

Reporting group description

Reporting group values	Placebo	TDV 0.5 mL	Total
Number of subjects	6687	13380
Age Categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	9.6 ( 3.34 )	9.6 ( 3.36 )	-
Gender categorical
Units: Subjects
Male	3411	6729	10140
Female	3276	6651	9927
Race
Units: Subjects
American Indian or Alaska Native	2621	5234	7855
Asian	2985	5988	8973
Black or African American	758	1451	2209
Native Hawaiian or Other Pacific Islander	1	2	3
White	149	329	478
More than one race or Unknown	173	376	549
Height
Units: cm
arithmetic mean (standard deviation)	135.00 ( 19.027 )	134.95 ( 19.174 )	-
Body Mass Index (BMI)
BMI=weight (kg)/[height (m)^2]
Units: kg/m^2
arithmetic mean (standard deviation)	17.68 ( 3.643 )	17.78 ( 3.834 )	-
Weight
Units: kg
arithmetic mean (standard deviation)	33.86 ( 14.540 )	34.05 ( 14.976 )	-

End points

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Reporting group title

Placebo

Reporting group description

Reporting group title

TDV 0.5 mL

Reporting group description

Reporting group title

Placebo

Reporting group description

Reporting group title

TDV 0.5 mL

Reporting group description

Reporting group title

Placebo

Reporting group description

Reporting group title

TDV 0.5 mL

Reporting group description

Reporting group title

Placebo

Reporting group description

Reporting group title

TDV 0.5 mL

Reporting group description

Primary: Vaccine Efficacy (VE) of Two Doses of Tetravalent Dengue Vaccine (TDV) in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

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End point title

Vaccine Efficacy (VE) of Two Doses of Tetravalent Dengue Vaccine (TDV) in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

End point description

The Vaccine Efficacy is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific reverse transcriptase polymerase chain reaction (RT-PCR). The primary endpoint of vaccine efficacy was assessed using the number of confirmed dengue cases that occurred during Part 1. Per protocol Set (PPS) included all participants in the Full analysis set (FAS) who had no major protocol violations. FAS included all randomised participants who received at least 1 dose of the trial vaccines. Subjects analysed is the number of participants with data available for analyses.

End point type

Primary

End point timeframe

30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 1 (Month 15) when at least 120 cases of dengue fever were confirmed and minimum duration of participant follow-up was 12 months post-second vaccination

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	6316	12700
Units: number of cases	149	61

Statistical Analysis 1

Statistical analysis description

Assuming true VE of 60% and, virologically confirmed cases of dengue fever induced by any dengue serotype occurring from 30 days post 2nd vaccination (Day 120) until end of Part 1 would provide at least 90% power to rule out vaccine effect of ≤25%.

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

19016

Analysis specification

Pre-specified

Analysis type

other ^[1]

P-value

< 0.001 ^[2]

Method

Cox Proportional Hazard Model

Parameter type

Vaccine Efficacy (VE)

Point estimate

80.2

Confidence interval

level

95%

sides

2-sided

lower limit

73.3

upper limit

85.3

Notes
[1] - Statistical significance was concluded if the lower bound of the 95% CI for the VE was above 25%. Since the hypotheses was tested in a confirmatory manner at a 2-sided significance level of 5%, the calculated p-value was compared with 0.025.
[2] - VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.

Secondary: VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

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End point title

VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

End point description

VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases requiring hospitalization due to virologically-confirmed dengue fever that occurred during Part 1 and Part 2. PPS included all participants in the FAS who had no major protocol violations. FAS included all randomised participants who received at least 1 dose of the trial vaccines. Subjects analysed is the number of participants with data available for analyses.

End point type

Secondary

End point timeframe

From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21)

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	6316	12700
Units: number of cases
number (not applicable)	66	13

VE of Two Doses of TDV

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

19016

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001 ^[3]

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

90.4

Confidence interval

level

95%

sides

2-sided

lower limit

82.6

upper limit

94.7

Notes
[3] - Statistical significance was concluded if the lower bound of the 95% CI for the VE was above 0%. Since the hypotheses was tested in a confirmatory manner at a 2-sided significance level of 5%, the calculated p-value was compared with 0.025.

Secondary: VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Each Dengue Serotype

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End point title

VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Each Dengue Serotype

End point description

VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases that occurred during Part 1 and Part 2. PPS included all participants in the FAS who had no major protocol violations. FAS included all randomised participants who received at least 1 dose of the trial vaccines. Subjects analysed is the number of participants with data available for analyses.

End point type

Secondary

End point timeframe

From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21)

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	6316	12700
Units: number of cases
number (not applicable)
DENV-1	62	38
DENV-2	80	8
DENV-3	60	63
DENV-4	5	5

VE of Two Doses of TDV

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

19016

Analysis specification

Pre-specified

Analysis type

superiority

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

69.8

Confidence interval

level

95%

sides

2-sided

lower limit

54.8

upper limit

79.9

VE of Two Doses of TDV

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

19016

Analysis specification

Pre-specified

Analysis type

superiority

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-69.4

upper limit

85.8

VE of Two Doses of TDV

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

19016

Analysis specification

Pre-specified

Analysis type

superiority

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

48.9

Confidence interval

level

95%

sides

2-sided

lower limit

27.2

upper limit

64.1

VE of Two Doses of TDV

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

19016

Analysis specification

Pre-specified

Analysis type

superiority

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

95.1

Confidence interval

level

95%

sides

2-sided

lower limit

89.9

upper limit

97.6

Secondary: VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seronegative at Baseline

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End point title

VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seronegative at Baseline

End point description

VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases that occurred during Part 1 and Part 2. PPS included all participants in the FAS who had no major protocol violations. FAS included all randomised participants who received at least 1 dose of the trial vaccines. Subjects analysed is the number of participants with seronegative baseline status and with data available for analyses.

End point type

Secondary

End point timeframe

From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21)

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	1726	3531
Units: number of cases
number (not applicable)	56	39

VE of Two Doses of TDV

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

5257

Analysis specification

Pre-specified

Analysis type

superiority

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

66.2

Confidence interval

level

95%

sides

2-sided

lower limit

49.1

upper limit

77.5

Secondary: VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seropositive at Baseline

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End point title

VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seropositive at Baseline

End point description

VE is defined as 1 - (λv/λC), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases that occurred during Part 1 and Part 2. PPS included all participants in the FAS who had no major protocol violations. FAS included all randomised participants who received at least 1 dose of the trial vaccines. Subjects analysed is the number of participants with seropositive baseline status and with data available for analyses.

End point type

Secondary

End point timeframe

From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21)

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	4589	9167
Units: number of cases
number (not applicable)	150	75

VE of Two Doses of TDV

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

13756

Analysis specification

Pre-specified

Analysis type

superiority

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

76.1

Confidence interval

level

95%

sides

2-sided

lower limit

68.5

upper limit

81.9

Secondary: VE of Two Doses of TDV in Preventing Virologically-Confirmed Severe Dengue Fever Induced by Any Dengue Serotype

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End point title

VE of Two Doses of TDV in Preventing Virologically-Confirmed Severe Dengue Fever Induced by Any Dengue Serotype

End point description

VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. Severe cases were determined by Adjudication Committee. VE was assessed using the number of severe cases due to virologically-confirmed dengue fever that occurred during Part 1 and Part 2. PPS included all participants in the FAS who had no major protocol violations. FAS included all randomised participants who received at least 1 dose of the trial vaccines. Subjects analysed is the number of participants with data available for analyses.

End point type

Secondary

End point timeframe

From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21)

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	6316	12700
Units: number of cases
number (not applicable)	1	2

VE of Two Doses of TDV

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

19016

Analysis specification

Pre-specified

Analysis type

superiority

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

2.3

Confidence interval

level

95%

sides

2-sided

lower limit

-977.5

upper limit

91.1

Secondary: Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset

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End point title

Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset

End point description

Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred within 7 days after each vaccination. The participant/legal guardian recorded the severity of each AE (except erythema and swelling) according to the diary card instruction as none, mild, moderate, or severe. Severity grades for erythema and swelling were derived from the recorded diameters. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation. The Safety Set-Immunogenicity Subset included all randomised participants in the safety/immunogenicity subset who received at least 1 dose of the trial vaccines (TDV or placebo). Subjects analysed is the number of participants with data available for analyses. 'n' indicates the number of participants with data available for analyses for the specified category.

End point type

Secondary

End point timeframe

Days 1 through 7 after each vaccination

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	1329	2663
Units: percentage of participants
number (not applicable)
<6Years:After 1 Vaccination:Pain:Mild	19.5	21.1
<6Years:After 1 Vaccination:Pain:Moderate	1.2	2.1
<6 Years:After 1st Vaccination:Pain:Severe	0.6	0.3
<6 Years:After 1st Vaccination:Erythema:Mild	0.6	0.6
<6 Years:After 1st Vaccination:Erythema;Moderate	0	0.6
<6 Years:After 1st Vaccination:Erythema;Severe	0	0
<6 Years:After 1st Vaccination:Swelling;Mild	0.6	1.9
<6 Years:After 1st Vaccination:Swelling;Moderate	0	0.9
<6 Years:After 1st Vaccination:Swelling;Severe	0	0
<6 Years;After 2nd Vaccination;Pain: Mild	13.3	18.2
<6 Years;After 2nd Vaccination;Pain:Moderate	1.2	2.5
<6 Years;After 2nd Vaccination;Pain: Severe	0	0
<6 Years; After 2nd Vaccination;Erythema;Mild	0	0.6
<6 Years;After 2nd Vaccination;Erythema;Moderate	0	0
<6 Years;After 2nd Vaccination;Erythema;Severe	0	0
<6 Years;After 2ndVaccination;Swelling;Mild	0.6	0.9
<6 Years;After 2nd Vaccination;Swelling;Moderate	0	0.6
<6 Years;After 2nd Vaccination;Swelling;Severe	0	0
≥6 Years;After 1st Vaccination;Pain: Mild	16.9	23.4
≥6 Years;After 1st Vaccination;Pain:Moderate	2.2	3.9
≥6 Years;After 1st Vaccination;Pain: Severe	0.3	0.7
≥6 Years;After 1st Vaccination;Erythema;Mild	0	1.0
≥6 Years;After 1st Vaccination;Erythema;Moderate	0	0
≥6 Years;After 1st Vaccination;Erythema;Severe	0	0
≥6 Years;After 1st Vaccination;Swelling;Mild	0.4	1.1
≥6 Years;After 1st Vaccination;Swelling;Moderate	0	0
≥6 Years;After 1st Vaccination;Swelling;Severe	0	0
≥6 Years;After 2nd Vaccination;Pain;Mild	10.7	19.7
≥6 Years;After 2nd Vaccination;Pain;Moderate	1.5	3.2
≥6 Years;After 2nd Vaccination;Pain;Severe	0.3	0.6
≥6 Years;After 2nd Vaccination;Erythema;Mild	0.1	0.9
≥6 Years;After 2nd Vaccination;ErythemaModerate	0	0
≥6 Years;After 2nd Vaccination;Erythema;Severe	0	0
≥6 Years:After 2nd Vaccination;Swelling;Mild	0.1	0.5
≥6 Years:After 2nd Vaccination;Swelling;Moderate	0	0
≥6 Years;After 2nd Vaccination;Swelling;Severe	0	0

No statistical analyses for this end point

Secondary: Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset

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End point title

Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset

End point description

Solicited systemic AEs in children(<6 years)are defined as fever,irritability/fussiness, drowsiness&loss of appetite that occurred within 14 days after each vaccination. Solicited systemic AEs in children (≥6 years) are defined as fever,headache,asthenia,malaise&myalgia that occurred within 14 days after each vaccination. Participant/legal guardian recorded severity of each AE(except fever)according to diary card instruction as none,mild,moderate,orsevere.Severity grades for fever were derived from recorded body temperature measurements&presented using proposed temperature increments published by Brighton Collaboration.Percentages were rounded off to nearest single decimal place except data points where rounding-up may lead to data misinterpretation.SS-Immunogenicity Subset:all randomised participants in safety/immunogenicity subset who received at least 1 dose of trial vaccines(TDV/placebo).'n':number of participants with data available for analyses for specified category. Y=Years.

End point type

Secondary

End point timeframe

Days 1 through 14 after each vaccination on Day 1 (Month 0) and Day 90 (Month 3)

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	1329	2663
Units: percentage of participants
number (not applicable)
<6 Years;After 1 Vaccination;Irritability:Mild	8.3	7.7
<6Years;After 1 Vaccination;Irritability:Moderate	0.6	0.9
<6Years;After 1 Vaccination;Irritability:Severe	0	0.3
<6Years;After 1 Vaccination;Drowsiness;Mild	10.1	8.3
<6 Years After 1 Vaccination;Drowsiness;Moderate	0	2.2
<6Years;After 1 Vaccination;Drowsiness;Severe	0	0.6
<6Years;After 1 Vaccination;Loss of Appetite;Mild	7.1	12.3
<6Y;After 1 Vaccination;Loss of Appetite;Moderate	1.8	1.2
<6 Y;After 1 Vaccination;Loss of Appetite;Severe	0.6	0.6
<6 Years;After 1 Vaccination;Fever;38.0-<38.5	3.1	3.8
<6 Years;After 1 Vaccination;Fever:38.5-<39.0	1.9	1.9
<6 Years;After 1 Vaccination;Fever:39.0-<39.5	1.9	1.9
<6 Years;After 1 Vaccination;Fever:39.5-<40.0	0.6	0.9
<6 Years;After 1 Vaccination;Fever:≥40.0	0	0
<6 Years;After 2 Vaccination;Irritability:Mild	2.1	5.3
<6 Y;After 2 Vaccination;Irritability:Moderate	0	0.4
<6 Y;After 2 Vaccination;Irritability:Severe	0	0.4
<6 Years;After 2 Vaccination;Drowsiness;Mild	4.9	6.0
<6 Years;After 2 Vaccination;Drowsiness;Moderate	0	1.1
<6 Years;After 2 Vaccination;Drowsiness;Severe	0	0
<6 Y;After 2 Vaccination;Loss of Appetite;Mild	4.9	6.0
<6Y;After 2 Vaccination;Loss of Appetite;Moderate	0.7	1.1
<6Y;After 2 Vaccination;Loss of Appetite;Severe	0.7	0.4
<6 Years;After 2 Vaccination;Fever;38.0-<38.5	4.3	1.3
<6 Years;After 2 Vaccination;Fever;38.5-<39.0	1.2	3.4
<6 Years;After 2 Vaccination;Fever;39.0-<39.5	1.2	1.3
<6 Years;After 2 Vaccination;Fever;39.5-<40.0	0	0.6
<6 Years;After 2 Vaccination;Fever;40.0-<40.5	0.6	0.3
<6 Years;After 2 Vaccination;Fever; ≥40.5	0	0
≥6 Years;After 1 Vaccination;Headache:Mild	17.8	17.5
≥6 Years;After 1 Vaccination;Headache:Moderate	3.4	5.3
≥6 Years;After 1 Vaccination;Headache:Severe	1.7	1.8
≥6 Years;After 1 Vaccination;Asthenia: Mild	8.8	8.8
≥6 Years:After 1 Vaccination;Asthenia:Moderate	2.8	2.8
≥6 Years;After 1 Vaccination;Asthenia:Severe	0.5	0.8
≥6 Years;After 1 Vaccination;Malaise:Mild	11.1	11.8
≥6 Years;After 1 Vaccination;Malaise:Moderate	2.3	3.4
≥6 Years;After 1 Vaccination;Malaise:Severe	0.8	1.0
≥6 Years;After 1 Vaccination;Myalgia:Mild	11.8	14.1
≥6 Years;After 1 Vaccination;Myalgia:Moderate	1.9	2.9
≥6 Years;After 1 Vaccination;Myalgia:Severe	0.6	0.9
≥6 Years;After 1 Vaccination;Fever:38.0-<38.5	2.9	2.9
≥6 Years;After 1 Vaccination;Fever:38.5-<39.0	1.7	1.9
≥6 Years;After 1 Vaccination;Fever:39.0-<39.5	1.0	0.5
≥6 Years;After 1 Vaccination;Fever:39.5-<40.0	0.4	0.4
≥6 Years;After 1 Vaccination;Fever:40.0-<40.5	0.0908	0.0454
≥6 Years;After 1 Vaccination;Fever:40.5-<41.0	0.0908	0
≥6 Years; After 1 Vaccination;Fever:>=41.0	0	0
≥6 Years;After 2 Vaccination;Headache:Mild	10.2	10.4
≥6 Years;After 2 Vaccination;Headache:Moderate	2.9	3.5
≥6 Years;After 2 Vaccination;Headache:Severe	1.1	1.3
≥6 Years;After 2 Vaccination;Asthenia:Mild	5.6	6.6
≥6 Years;After 2 Vaccination;Asthenia:Moderate	1.6	1.9
≥6 Years;After 2 Vaccination;Asthenia:Severe	0.4	0.7
≥6 Years;After 2 Vaccination;Malaise: Mild	6.8	8.1
≥6 Years;After 2 Vaccination;Malaise:Moderate	1.8	1.9
≥6 Years;After 2 Vaccination;Malaise:Severe	0.8	1.0
≥6 Years;After 2 Vaccination;Myalgia:Mild	7.6	10.7
≥6 Years;After 2 Vaccination;Myalgia:Moderate	1.3	2.0
≥6 Years;After 2 Vaccination;Myalgia:Severe	0.4	0.9
≥6 Years;After 2 Vaccination;Fever:38.0-<38.5	3.3	2.0
≥6 Years;After 2 Vaccination;Fever:38.5-<39.0	1.2	1.5
≥6 Years;After 2 Vaccination;Fever:39.0-<39.5	1.1	0.7
≥6 Years;After 2 Vaccination;Fever:39.5-<40.0	0.4	0.5
≥6 Years;After 2 Vaccination;Fever:40.0-<40.5	0	0.0454
≥6 Years;After 2 Vaccination;Fever:>=40.5	0	0

No statistical analyses for this end point

Secondary: Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Set Immunogenicity Subset

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End point title

Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Set Immunogenicity Subset

End point description

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study. The SS-Immunogenicity Subset included all randomised participants in the safety/immunogenicity subset who received at least 1 dose of the trial vaccines (TDV or placebo). 'n' indicates the number of participants with data available for analysis for the specified category.

End point type

Secondary

End point timeframe

Days 1 through 28 after each vaccination on Day 1 (Month 0) and Day 90 (Month 3)

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	1329	2663
Units: percentage of participants
number (not applicable)
After First Vaccination (n=1329,2663)	11.5	11.1
After Second Vaccination (n=1301,2606)	9.2	9.3

No statistical analyses for this end point

Secondary: Percentage of Participants With Serious Adverse Events (SAEs) During Parts 1 and 2

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End point title

Percentage of Participants With Serious Adverse Events (SAEs) During Parts 1 and 2

End point description

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Percentages were rounded off to the nearest single decimal place. The Safety Set (SS) included all randomised participants who received at least one dose of the IP (TDV or placebo).

End point type

Secondary

End point timeframe

From Day 1 until the end of Parts 1 (Month 15) and 2 (Month 21)

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	6687	13380
Units: percentage of participnats
number (not applicable)
Part 1	3.8	3.1
Part 2	1.2	1.1
Part 1 and 2 combined	4.8	4.0

No statistical analyses for this end point

Secondary: Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During the First and Second Half of Part 3

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End point title

Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During the First and Second Half of Part 3

End point description

AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. The SS included all randomised participants who received at least one dose of the IP (TDV or placebo). '999' indicates that analysis of Fatal SAEs separately by 18 months periods in Part 3 (that is ‘First 18 months’ and ‘Last 18 months’) would be performed along with Part 5 analysis, anticipated posting date December 2025.

End point type

Secondary

End point timeframe

First and Second half (18 months each) of Part 3 (up to 3 years, beginning at Month 22)

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	6687	13380
Units: percentage of participants
number (not applicable)
SAEs Related to Study: First Half of Part 3	0	0
SAEs Related to Study: Second Half of Part 3	0	0
Fatal SAEs: First Half of Part 3	999	999
Fatal SAEs: Second Half of Part 3	999	999

No statistical analyses for this end point

Secondary: Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset

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End point title

Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset

End point description

Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation. Per-Protocol Set for Immunogenicity (PPSI): all participants in Full Analysis Set for Immunogenicity (FASI) who had no major protocol violations. The FASI were based on FAS & included all randomised participants in subset for whom a valid pre-dosing and at least one valid post-dosing blood sample have been received for immunogenicity. 'n' indicates the number of participants with data available for analysis at the specified time point.

End point type

Secondary

End point timeframe

Pre-vaccination on Day 1 (Baseline), post-first vaccination on Month 1, pre-vaccination on Month 3; post-second vaccination at Months 4, 9 and 15, and then annually (up to 3 years)

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	1247	2518
Units: percentage of participants
number (not applicable)
Baseline: DENV-1 (n=1247, 2518)	65.5	64.3
Baseline: DENV-2 (n=1247, 2517)	70.3	69.6
Baseline: DENV-3 (n=1247, 2517)	63.7	63.5
Baseline: DENV-4 (n=1247, 2518)	63.2	63.5
Month 1: DENV-1 (n=1165, 2353)	65.0	98.0
Month 1: DENV-2 (n=1164, 2353)	70.0	99.5
Month 1: DENV-3 (n=1164, 2353)	64.0	98.7
Month 1: DENV-4 (n=1165, 2353)	62.7	97.1
Month 3: DENV-1 (n=1244, 2515)	66.9	97.1
Month 3: DENV-2 (n=1244, 2515)	71.2	99.7
Month 3: DENV-3 (n=1243, 2515)	63.6	98.1
Month 3: DENV-4 (n=1244, 2515)	63.6	97.3
Month 4: DENV-1 (n=1131, 2262)	67.6	99.8
Month 4: DENV-2 (n=1131, 2262)	71.8	99.912
Month 4: DENV-3 (n=1131, 2262)	65.0	99.9
Month 4: DENV-4 (n=1131, 2262)	65.2	99.912
Month 9: DENV-1 (n=1085, 2196)	67.5	98.3
Month 9: DENV-2 (n=1085, 2196)	73.5	100.0
Month 9: DENV-3 (n=1085, 2196)	65.2	98.8
Month 9: DENV-4 (n=1085, 2196)	65.2	99.0
Month 15: DENV-1 (n=1115, 2213)	67.7	97.6
Month 15: DENV-2 (n=1115, 2214)	70.4	99.954
Month 15: DENV-3 (n=1115, 2215)	64.3	97.7
Month 15: DENV-4 (n=1115, 2215)	66.0	98.4
Year 1: DENV-1 (n=943, 1904)	69.7	97.0
Year 1: DENV-2 (n=943, 1904)	72.0	99.9
Year 1: DENV-3 (n=943, 1904)	67.6	97.3
Year 1: DENV-4 (n=943, 1904)	68.6	98.3
Year 2: DENV-1 (n=955, 1922)	71.5	95.7
Year 2: DENV-2 (n=955, 1922)	73.7	99.948
Year 2: DENV-3 (n=955, 1922)	68.8	95.5
Year 2: DENV-4 (n=955, 1922)	70.7	98.0
Year 3: DENV-1 (n=1015, 2027)	72.5	94.9
Year 3: DENV-2 (n=1015, 2027)	73.6	99.9
Year 3: DENV-3 (n=1015, 2027)	70.2	95.7
Year 3: DENV-4 (n=1015, 2027)	71.1	96.0

No statistical analyses for this end point

Secondary: Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset

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End point title

Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset

End point description

Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for any one (monovalent), two (bivalent), three (trivalent), and four (tetravalent) dengue serotypes, as well as at least bivalent (seropositive for ≥2 dengue serotypes) and at least trivalent (seropositive for ≥3 dengue serotypes), is derived from the titers of dengue-neutralizing antibodies. Seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation. PPSI: all participants in FASI who had no major protocol violations. The FASI were based on FAS & included all randomised participants in subset for whom a valid pre-dosing and at least one valid post-dosing blood sample have been received for immunogenicity. Number of subjects analysed was variable for each category.

End point type

Secondary

End point timeframe

Pre-vaccination on Day 1 (Baseline), post-first vaccination on Month 1, pre-vaccination on Month 3; post-second vaccination at Months 4, 9 and 15, and then annually (up to 3 years)

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	1247	2518
Units: percentage of participants
number (not applicable)
Baseline: Monovalent	5.5	6.6
Baseline: Bivalent	3.8	2.4
Baseline: Trivalent	2.7	2.9
Baseline: Tetravalent	60.4	60.2
Baseline: At Least Bivalent	66.9	65.5
Baseline: At Least Trivalent	63.1	63.1
Month 1: Monovalent	7.4	0.3
Month 1: Bivalent	2.8	0.6
Month 1: Trivalent	3.2	3.7
Month 1: Tetravalent	59.8	95.2
Month 1: At Least Bivalent	65.8	99.4
Month 1: At Least Trivalent	63.0	98.9
Month 3: Monovalent	6.8	0.4
Month 3: Bivalent	3.1	1.1
Month 3: Trivalent	3.1	3.7
Month 3: Tetravalent	60.8	94.6
Month 3: At Least Bivalent	67.0	99.4
Month 3: At Least Trivalent	63.8	98.3
Month 4: Monovalent	6.6	0
Month 4: Bivalent	2.6	0.088
Month 4: Trivalent	2.5	0.1
Month 4: Tetravalent	62.6	99.7
Month 4: At Least Bivalent	67.6	99.956
Month 4: At Least Trivalent	65.1	99.9
Month 9: Monovalent	7.7	0.091
Month 9: Bivalent	3.4	0.8
Month 9: Trivalent	2.0	2.1
Month 9: Tetravalent	62.7	97.0
Month 9: At Least Bivalent	68.1	99.909
Month 9: At Least Trivalent	64.7	99.1
Month 15: Monovalent	3.9	0.5
Month 15: Bivalent	3.6	1.4
Month 15: Trivalent	2.1	2.2
Month 15: Tetravalent	62.8	96.0
Month 15: At Least Bivalent	68.4	99.5
Month 15: At Least Trivalent	64.8	98.1
Year 1: Monovalent	3.5	0.7
Year 1: Bivalent	1.9	1.5
Year 1: Trivalent	2.2	2.2
Year 1: Tetravalent	66.0	95.5
Year 1: At Least Bivalent	70.1	99.3
Year 1: At Least Trivalent	68.2	97.7
Year 2: Monovalent	2.9	1.1
Year 2: Bivalent	2.5	1.9
Year 2: Trivalent	1.8	3.7
Year 2: Tetravalent	67.9	93.3
Year 2: At Least Bivalent	72.1	98.9
Year 2: At Least Trivalent	69.6	97.0
Year 3:Monovalent	2.6	1.6
Year 3: Bivalent	1.9	2.4
Year 3:Trivalent	2.6	3.7
Year 3:Tetravalent	68.4	92.2
Year 3:At Least Bivalent	72.8	98.3
Year 3:At Least Trivalent	70.9	95.9

No statistical analyses for this end point

Secondary: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset

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End point title

Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset

End point description

GMTs of neutralizing antibodies were measured via microneutralization test 50% (MNT50). The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. PPSI: all participants in FASI who had no major protocol violations. The FASI were based on FAS & included all randomised participants in subset for whom a valid pre-dosing and at least one valid post-dosing blood sample have been received for immunogenicity. Number of subjects analysed was variable for each category.

End point type

Secondary

End point timeframe

Pre-vaccination on Day 1 (Baseline), post-first vaccination on Month 1, pre-vaccination on Month 3; post-second vaccination at Months 4, 9 and 15, and then annually (up to 3 years)

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	1247	2518
Units: titres
geometric mean (confidence interval 95%)
Baseline: DENV-1	128.6 (109.3 to 151.4)	120.3 (107.3 to 134.8)
Baseline: DENV-2	197.4 (167.8 to 232.2)	186.0 (165.9 to 208.4)
Baseline: DENV-3	109.4 (93.8 to 127.6)	108.7 (97.6 to 121.1)
Baseline: DENV-4	80.8 (70.2 to 93.1)	76.2 (69.2 to 83.9)
Month 1: DENV-1	127.5 (107.7 to 150.9)	1031.5 (944.4 to 1126.6)
Month 1: DENV-2	197.2 (166.7 to 233.4)	6575.7 (6237.2 to 6932.5)
Month 1: DENV-3	108.6 (92.8 to 127.1)	1133.8 (1050.4 to 1223.8)
Month 1: DENV-4	77.6 (67.2 to 89.7)	653.4 (607.0 to 703.4)
Month 3: DENV-1	126.3 (107.9 to 148.0)	828.7 (760.6 to 902.8)
Month 3: DENV-2	201.0 (171.3 to 236.0)	3598.5 (3425.0 to 3780.8)
Month 3: DENV-3	103.9 (89.5 to 120.7)	714.2 (661.1 to 771.6)
Month 3: DENV-4	77.8 (67.8 to 89.3)	463.9 (431.3 to 498.9)
Month 4: DENV-1	139.0 (117.6 to 164.3)	1059.2 (981.6 to 1143.0)
Month 4: DENV-2	215.3 (181.7 to 255.0)	3646.7 (3480.0 to 3821.3)
Month 4: DENV-3	114.5 (97.7 to 134.3)	986.7 (924.5 to 1053.0)
Month 4: DENV-4	86.2 (74.5 to 99.8)	630.0 (593.2 to 668.9)
Month 9: DENV-1	130.5 (110.3 to 154.4)	666.6 (611.8 to 726.2)
Month 9: DENV-2	225.7 (190.5 to 267.3)	2521.0 (2392.4 to 2656.5)
Month 9: DENV-3	105.3 (89.9 to 123.3)	513.0 (474.2 to 555.1)
Month 9: DENV-4	84.4 (72.9 to 97.8)	390.0 (363.6 to 418.4)
Month 15: DENV-1	139.2 (117.6 to 164.7)	584.1 (534.9 to 637.8)
Month 15: DENV-2	211.8 (178.5 to 251.3)	1977.3 (1871.7 to 2088.8)
Month 15: DENV-3	97.3 (83.3 to 113.5)	383.9 (354.0 to 416.3)
Month 15: DENV-4	99.9 (86.0 to 116.0)	408.0 (379.6 to 438.6)
Year 1: DENV-1	161.8 (135.0 to 193.9)	567.8 (516.0 to 624.7)
Year 1: DENV-2	183.6 (154.4 to 218.3)	1123.9 (1054.1 to 1198.3)
Year 1: DENV-3	111.3 (94.4 to 131.3)	377.7 (346.2 to 412.2)
Year 1: DENV-4	98.9 (84.8 to 115.2)	345.0 (319.6 to 372.5)
Year 2: DENV-1	205.1 (170.9 to 246.1)	513.5 (466.2 to 565.6)
Year 2: DENV-2	208.1 (175.3 to 246.9)	896.4 (839.2 to 957.5)
Year 2: DENV-3	127.5 (108.2 to 150.2)	323.3 (295.8 to 353.3)
Year 2: DENV-4	110.4 (94.8 to 128.4)	284.0 (263.1 to 306.5)
Year 3: DENV-1	214.9 (180.5 to 255.7)	485.4 (442.4 to 532.5)
Year 3: DENV-2	194.5 (165.3 to 228.8)	725.8 (680.6 to 774.0)
Year 3: DENV-3	140.2 (119.7 to 164.4)	329.5 (302.7 to 358.7)
Year 3: DENV-4	108.5 (93.8 to 125.5)	244.5 (226.6 to 263.9)

No statistical analyses for this end point

Other pre-specified: VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

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End point title

VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

End point description

VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases due to virologically-confirmed dengue fever that occurred during the first half of Part 3. PPS included all participants in the FAS who had no major protocol violations. FAS included all randomised participants who received at least 1 dose of the trial vaccines. Subjects analysed is the number of participants with data available for analyses.

End point type

Other pre-specified

End point timeframe

First half of Part 3 (18 months beginning at Month 22)

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	6236	12510
Units: number of cases
number (not applicable)	228	252

VE of Two Doses of TDV

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

18746

Analysis specification

Pre-specified

Analysis type

other

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

47.4

Confidence interval

level

95%

sides

2-sided

lower limit

37.1

upper limit

Other pre-specified: VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

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End point title

VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

End point description

VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases due to virologically-confirmed dengue fever that occurred during the second half of Part 3. PPS included all participants in the FAS who had no major protocol violations. FAS included all randomised participants who received at least 1 dose of the trial vaccines. Subjects analysed is the number of participants with data available for analyses.

End point type

Other pre-specified

End point timeframe

Second half of Part 3 (18 months beginning at Month 40)

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	6102	12224
Units: number of cases
number (not applicable)	52	49

VE of Two Doses of TDV

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

18326

Analysis specification

Pre-specified

Analysis type

other

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

55.7

Confidence interval

level

95%

sides

2-sided

lower limit

34.5

upper limit

Other pre-specified: VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

Top of page

End point title

VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

End point description

VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases requiring hospitalization due to virologically-confirmed dengue fever that occurred during the first half of Part 3. PPS included all participants in the FAS who had no major protocol violations. FAS included all randomised participants who received at least 1 dose of the trial vaccines. Subjects analysed is the number of participants with data available for analyses.

End point type

Other pre-specified

End point timeframe

First half of Part 3 (18 months beginning at Month 22)

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	6236	12510
Units: number of cases
number (not applicable)	43	24

VE of Two Doses of TDV

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

18746

Analysis specification

Pre-specified

Analysis type

other

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

73.5

Confidence interval

level

95%

sides

2-sided

lower limit

56.3

upper limit

83.9

Other pre-specified: VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

Top of page

End point title

VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

End point description

VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases requiring hospitalization due to virologically-confirmed dengue fever that occurred during the second half of Part 3. PPS included all participants in the FAS who had no major protocol violations. FAS included all randomised participants who received at least 1 dose of the trial vaccines. Subjects analysed is the number of participants with data available for analyses.

End point type

Other pre-specified

End point timeframe

Second half of Part 3 (18 months beginning at Month 40)

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	6102	12224
Units: number of cases
number (not applicable)	15	2

VE of Two Doses of TDV

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

18326

Analysis specification

Pre-specified

Analysis type

other

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

93.7

Confidence interval

level

95%

sides

2-sided

lower limit

72.4

upper limit

98.6

Other pre-specified: VE of a TDV Booster Dose in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30 Booster [b] (Month 1b)) Until the End of Part 4

Top of page

End point title

VE of a TDV Booster Dose in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30 Booster [b] (Month 1b)) Until the End of Part 4

End point description

The VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. The Per-Protocol Set-Booster (PPS-B) included all participants in the FAS-B who had no major protocol violations. The Full Analysis Set-Booster (FAS-B) included all participants 4 to 11 years of age at the time of randomisation in the trial (Day 1 [Month 0]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).

End point type

Other pre-specified

End point timeframe

From 30 days post-booster vaccination (Day 30 booster [b] (Month 1b)) until the end of Part 4 (Month 13b)

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	2981	5966
Units: number of cases
number (not applicable)	93	39

VE of a TDV Booster Dose

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

8947

Analysis specification

Pre-specified

Analysis type

other

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

79.4

Confidence interval

level

95%

sides

2-sided

lower limit

70.1

upper limit

85.9

Other pre-specified: VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype From 30 days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4

Top of page

End point title

VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype From 30 days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4

End point description

VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomisation in the trial (Day 1 [Month 0]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).

End point type

Other pre-specified

End point timeframe

From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 4 (Month 13b)

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	2981	5966
Units: number of cases
number (not applicable)
DENV-1	32	15
DENV-2	31	9
DENV-3	4	3
DENV-4	26	12

VE of a TDV Booster Dose

Statistical analysis description

DENV-1

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

8947

Analysis specification

Pre-specified

Analysis type

other

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

76.8

Confidence interval

level

95%

sides

2-sided

lower limit

57.1

upper limit

87.4

VE of a TDV Booster Dose

Statistical analysis description

DENV-2

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

8947

Analysis specification

Pre-specified

Analysis type

other

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

85.7

Confidence interval

level

95%

sides

2-sided

lower limit

69.9

upper limit

93.2

VE of a TDV Booster Dose

Statistical analysis description

DENV-3

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

8947

Analysis specification

Pre-specified

Analysis type

other

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-69.7

upper limit

91.5

VE of a TDV Booster Dose

Statistical analysis description

DENV-4

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

8947

Analysis specification

Pre-specified

Analysis type

other

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

77.2

Confidence interval

level

95%

sides

2-sided

lower limit

54.8

upper limit

88.5

Other pre-specified: VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4

Top of page

End point title

VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4

End point description

VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomisation in the trial (Day 1 [Month 0]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo). Subjects analysed is the number of participants with seronegative baseline status and with data available for analyses.

End point type

Other pre-specified

End point timeframe

From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 4 (Month 13b)

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	986	1928
Units: number of cases
number (not applicable)
Any Dengue Serotype	26	11
DENV-1	14	4
DENV-2	5	1
DENV-3	2	2
DENV-4	5	4

VE of a TDV Booster Dose

Statistical analysis description

Any serotype

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

2914

Analysis specification

Pre-specified

Analysis type

other

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

79.2

Confidence interval

level

95%

sides

2-sided

lower limit

57.8

upper limit

89.7

VE of a TDV Booster Dose

Statistical analysis description

DENV-1

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

2914

Analysis specification

Pre-specified

Analysis type

other

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

57.6

upper limit

95.4

VE of a TDV Booster Dose

Statistical analysis description

DENV-2

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

2914

Analysis specification

Pre-specified

Analysis type

other

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

89.9

Confidence interval

level

95%

sides

2-sided

lower limit

13.5

upper limit

98.8

VE of a TDV Booster Dose

Statistical analysis description

DENV-3

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

2914

Analysis specification

Pre-specified

Analysis type

other

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

42.7

Confidence interval

level

95%

sides

2-sided

lower limit

-307.5

upper limit

VE of a TDV Booster Dose

Statistical analysis description

DENV-4

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

2914

Analysis specification

Pre-specified

Analysis type

other

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-45.1

upper limit

89.5

Other pre-specified: VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4

Top of page

End point title

VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4

End point description

VE is defined as 1 - (λv/λC), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomisation in the trial (Day 1 [Month 0]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo). Subjects analysed is the number of participants with seropositive baseline status and with data available for analyses.

End point type

Other pre-specified

End point timeframe

From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 4 (Month 13b)

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	1995	4036
Units: number of cases
number (not applicable)
Any Dengue Serotype	67	28
DENV-1	18	11
DENV-2	26	8
DENV-3	2	1
DENV-4	21	8

VE of a TDV Booster Dose

Statistical analysis description

Any serotype

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

6031

Analysis specification

Pre-specified

Analysis type

other

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

79.6

Confidence interval

level

95%

sides

2-sided

lower limit

68.3

upper limit

86.9

VE of a TDV Booster Dose

Statistical analysis description

DENV-1

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

6031

Analysis specification

Pre-specified

Analysis type

other

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

69.9

Confidence interval

level

95%

sides

2-sided

lower limit

36.3

upper limit

85.8

VE of a TDV Booster Dose

Statistical analysis description

DENV-2

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

6031

Analysis specification

Pre-specified

Analysis type

other

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

84.9

Confidence interval

level

95%

sides

2-sided

lower limit

66.6

upper limit

93.2

VE of a TDV Booster Dose

Statistical analysis description

DENV-3

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

6031

Analysis specification

Pre-specified

Analysis type

other

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

75.6

Confidence interval

level

95%

sides

2-sided

lower limit

-168.8

upper limit

97.8

VE of a TDV Booster Dose

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

6031

Analysis specification

Pre-specified

Analysis type

other

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

57.2

upper limit

91.6

Other pre-specified: VE of a TDV Booster Dose in Preventing Hospitalization Due to Virologically Confirmed Dengue Fever Induced by Any Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4

Top of page

End point title

VE of a TDV Booster Dose in Preventing Hospitalization Due to Virologically Confirmed Dengue Fever Induced by Any Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4

End point description

VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases requiring hospitalization due to virologically-confirmed dengue fever. The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomisation in the trial (Day 1 [Month 0]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).

End point type

Other pre-specified

End point timeframe

From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 4 (Month 13b)

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	2981	5966
Units: number of cases
number (not applicable)	24	3

VE of a TDV Booster Dose

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

8947

Analysis specification

Pre-specified

Analysis type

other

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

93.8

Confidence interval

level

95%

sides

2-sided

lower limit

79.3

upper limit

98.1

Other pre-specified: VE of a TDV Booster Dose in Preventing Virologically Confirmed Severe Dengue Fever Induced by Any Dengue Serotype From 30 days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4

Top of page

End point title

VE of a TDV Booster Dose in Preventing Virologically Confirmed Severe Dengue Fever Induced by Any Dengue Serotype From 30 days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4

End point description

VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. Severe cases were determined by Adjudication Committee. VE was assessed using the number of severe cases due to virologically-confirmed dengue fever. The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomisation in the trial (Day 1 [Month 0]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).

End point type

Other pre-specified

End point timeframe

From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 4 (Month 13b)

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	2981	5966
Units: number of cases
number (not applicable)	1	0

VE of a TDV Booster Dose

Comparison groups

Placebo v TDV 0.5 mL

Number of subjects included in analysis

8947

Analysis specification

Pre-specified

Analysis type

other

Method

Cox Proportional Hazard Model

Parameter type

Point estimate

100

Confidence interval

level

95%

sides

2-sided

lower limit

-999

upper limit

999

Other pre-specified: Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4

Top of page

End point title

Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4

End point description

Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred within 7 days after each vaccination. The participant/legal guardian recorded the severity of each AE (except erythema and swelling) according to the diary card instruction as none, mild, moderate, or severe. Severity grades for erythema and swelling were derived from the recorded diameters. Percentages were rounded off to the nearest single decimal place. Safety Set-Booster-Immunogenicity Subset included all participants 4 to 11 years of age at the time of randomisation in the trial (Day 1 [Month 0]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo) in the safety subset. Subjects analysed is the number of participants with data available for analyses. Number of subjects analysed was variable for each category.

End point type

Other pre-specified

End point timeframe

Days 1b through 7b after booster vaccination in Part 4

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	595	1182
Units: percentage of participants
number (not applicable)
Pain: Mild	12.1	20.1
Pain: Moderate	3.9	4.6
Pain: Severe	0.7	1.2
Erythema: Mild	0.2	1.6
Erythema: Moderate	0	0
Erythema: Severe	0	0
Swelling: Mild	0.5	1.0
Swelling: Moderate	0	0
Swelling: Severe	0	0

No statistical analyses for this end point

Other pre-specified: Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4

Top of page

End point title

Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4

End point description

Solicited systemic AEs are defined as fever, headache, asthenia, malaise and myalgia that occurred within 14 days after each vaccination. Participant/legal guardian recorded the severity of each AE (except fever) according to diary card instruction as none, mild, moderate, or severe. Severity grades for fever were derived from recorded body temperature measurements and presented using proposed temperature increments published by the Brighton Collaboration. Percentages were rounded off to nearest single decimal place except data point where rounding-up may lead to data misinterpretation. Safety Set-Booster-Immunogenicity Subset included all participants 4 to 11 years of age at the time of randomisation in the trial (Day 1 [Month 0]) who were included in the PPS and who received booster dose of trial vaccine (TDV or placebo) in the safety subset. Subjects analysed: number of participants with data available for analyses. Number of subjects analysed was variable for each category.

End point type

Other pre-specified

End point timeframe

Days 1b through 14b after booster vaccination in Part 4

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	594	1184
Units: percentage of participants
number (not applicable)
Headache: Mild	8.6	12.3
Headache: Moderate	4.7	3.7
Headache: Severe	0.5	1.1
Asthenia: Mild	7.1	7.2
Asthenia: Moderate	1.9	2.4
Asthenia: Severe	0.3	0.7
Malaise: Mild	7.6	8.6
Malaise: Moderate	2.0	2.6
Malaise: Severe	0.5	0.7
Myalgia: Mild	9.9	11.7
Myalgia: Moderate	1.5	3.6
Myalgia: Severe	1.0	0.8
Fever: 38.0-<38.5	1.0	1.8
Fever: 38.5-<39.0	0.5	1.0
Fever: 39.0-<39.5	0.2	0.2
Fever: 39.5-<40.0	0	0.3
Fever: 40.0-<40.5	0.2	0
Fever: 40.5-<41.0	0	0.0873
Fever: >=41.0	0	0

No statistical analyses for this end point

Other pre-specified: Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Set-Booster-Immunogenicity Subset During Part 4

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End point title

Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Set-Booster-Immunogenicity Subset During Part 4

End point description

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study. Percentages were rounded off to the nearest single decimal place. Safety Set-Booster-Immunogenicity Subset included all participants 4 to 11 years of age at the time of randomisation in the trial (Day 1 [Month 0]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo) in the safety subset.

End point type

Other pre-specified

End point timeframe

Days 1b through 28b after booster vaccination in Part 4

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	600	1200
Units: percentage of participants
number (not applicable)	1.8	1.9

No statistical analyses for this end point

Other pre-specified: Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During Part 4

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End point title

Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During Part 4

End point description

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. SS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 [Month 0]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).

End point type

Other pre-specified

End point timeframe

From Day 1b until the end of Part 4 (Month 13b)

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	2985	5990
Units: percentage of participants
number (not applicable)
Fatal SAEs	0.0335	0.0501
SAEs Related to Study Drug	0	0

No statistical analyses for this end point

Other pre-specified: Percentage of Participants With Serious Adverse Events (SAEs) During Part 4

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End point title

Percentage of Participants With Serious Adverse Events (SAEs) During Part 4

End point description

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Percentages were rounded off to the nearest single decimal place. Safety Set-Booster (SS-B) included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 [Month 0]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).

End point type

Other pre-specified

End point timeframe

From Day 1b until the end of Part 4 (Month 13b)

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	2985	5990
Units: percentage of participants
number (not applicable)	4.2	2.7

No statistical analyses for this end point

Other pre-specified: Seropositivity Rate for Each of the 4 Dengue Serotypes During Part 4

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End point title

Seropositivity Rate for Each of the 4 Dengue Serotypes During Part 4

End point description

Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation. Per-Protocol Set for Immunogenicity-Booster (PPSI-B):all participants in Full Analysis Set for Immunogenicity-Booster (FASI-B) who had no major protocol violations. FASI-B: all participants from FAS-B who were included in booster immunogenicity subset & for whom there is valid pre-booster measurement & at least 1 valid post-booster measurement for immunogenicity assessments. Number of subjects analysed was variable for each category.

End point type

Other pre-specified

End point timeframe

Pre-booster Vaccination on Day 1b (Month 0b) and post-booster vaccination on Day 30b (Month 1b), Day 180b (Month 6b), Day 395b (Month 13b) in Part 4

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	597	1186
Units: percentage of participants
number (not applicable)
Day 1b: DENV-1	70.2	94.4
Day 1b: DENV-2	72.5	99.2
Day 1b: DENV-3	69.0	97.0
Day 1b: DENV-4	67.0	93.4
Month 1b: DENV-1	71.6	99.907
Month 1b: DENV-2	74.5	99.907
Month 1b: DENV-3	72.9	100.0
Month 1b: DENV-4	69.2	99.7
Month 6b: DENV-1	72.8	99.7
Month 6b: DENV-2	75.8	99.8
Month 6b: DENV-3	73.0	99.6
Month 6b: DENV-4	70.3	99.7
Month 13b: DENV-1	74.5	99.911
Month 13b: DENV-2	77.4	99.5
Month 13b: DENV-3	74.9	100.0
Month 13b: DENV-4	72.4	99.8

No statistical analyses for this end point

Other pre-specified: Seropositivity Rate for Multiple Dengue Serotypes During Part 4

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End point title

Seropositivity Rate for Multiple Dengue Serotypes During Part 4

End point description

Seropositivity rate for multiple Dengue serotypes, defined as percentage of participants seropositive for any one (monovalent), two (bivalent), three (trivalent),& four (tetravalent) dengue serotypes, as well as at least bivalent (seropositive for ≥2 dengue serotypes) & at least trivalent (seropositive for ≥3 dengue serotypes), is derived from titers of dengue-neutralizing antibodies. Seropositive response: reciprocal neutralizing titer ≥ 10. Four DENV serotypes are DENV-1, DENV-2, DENV-3 & DENV-4. Percentages were rounded off to nearest single decimal place except data points where rounding-up may lead to data misinterpretation. PPSI-B: all participants in FASI-B who had no major protocol violations. FASI-B: all participants from FAS-B who were included in booster immunogenicity subset & for whom there is valid pre-booster measurement & at least 1 valid post-booster measurement for immunogenicity assessments. Number of subjects analysed was variable for each category.

End point type

Other pre-specified

End point timeframe

Pre-booster vaccination on Day 1b (Month 0b) and post-booster vaccination on Day 30b (Month 1b), Day 180b (Month 6b), Day 395b (Month 13b) in Part 4 in Part 4

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	597	1186
Units: percentage of participants
number (not applicable)
Day 1b: Monovalent	5.7	1.3
Day 1b: Bivalent	2.0	3.7
Day 1b: Trivalent	2.3	4.6
Day 1b: Tetravalent	65.5	90.4
Day 1b: At Least Bivalent	69.8	98.7
Day 1b: At Least Trivalent	67.8	95.0
Month 1b: Monovalent	6.6	0
Month 1b: Bivalent	2.0	0
Month 1b: Trivalent	3.7	0.5
Month 1b: Tetravalent	66.6	99.5
Month 1b:At Least Bivalent	72.3	100.0
Month 1b:At Least Trivalent	70.3	100.0
Month 6b:Monovalent	6.8	0.0887
Month 6b: Bivalent	2.5	0.0887
Month 6b: Trivalent	3.2	0.6
Month 6b: Tetravalent	67.6	99.2
Month 6b:At Least Bivalent	73.3	99.911
Month 6b:At Least Trivalent	70.8	99.8
Month 13b: Monovalent	6.6	0
Month 13b: Bivalent	2.1	0
Month 13b: Trivalent	2.7	0.8
Month 13b: Tetravalent	70.1	99.2
Month 13b: At Least Bivalent	74.9	100.0
Month 13b: At Least Trivalent	72.7	100.0

No statistical analyses for this end point

Other pre-specified: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Part 4

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End point title

Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Part 4

End point description

GMTs of neutralizing antibodies were measured via MNT50. The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. PPSI-B: all participants in FASI-B who had no major protocol violations. FASI-B: all participants from FAS-B who were included in booster immunogenicity subset & for whom there is valid pre-booster measurement & at least 1 valid post-booster measurement for immunogenicity assessments. Number of subjects analysed was variable for each category.

End point type

Other pre-specified

End point timeframe

Pre-booster Vaccination on Day 1b (Month 0b) and post-booster vaccination on Day 30b (Month 1b), Day 180b (Month 6b), Day 395b (Month 13b) in Part 4

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	597	1186
Units: titres
geometric mean (confidence interval 95%)
Day 1b: DENV-1	172.7 (137.8 to 216.5)	374.7 (332.7 to 422.1)
Day 1b: DENV-2	164.5 (133.2 to 203.2)	609.4 (558.6 to 664.7)
Day 1b: DENV-3	129.4 (105.0 to 159.4)	305.2 (274.6 to 339.3)
Day 1b: DENV-4	81.5 (67.8 to 98.1)	172.9 (156.1 to 191.4)
Month 1b: DENV-1	179.8 (142.4 to 227.0)	1493.8 (1383.2 to 1613.3)
Month 1b: DENV-2	174.8 (140.5 to 217.6)	1611.5 (1492.1 to 1740.4)
Month 1b: DENV-3	159.9 (128.4 to 199.0)	1546.6 (1450.0 to 1649.6)
Month 1b: DENV-4	87.3 (72.0 to 105.9)	793.8 (742.5 to 848.7)
Month 6b: DENV-1	191.5 (152.2 to 241.0)	1000.9 (916.8 to 1092.7)
Month 6b: DENV-2	208.0 (167.6 to 258.0)	1167.2 (1080.8 to 1260.5)
Month 6b: DENV-3	156.0 (126.1 to 192.9)	851.0 (788.9 to 917.9)
Month 6b: DENV-4	86.4 (71.9 to 103.9)	457.6 (427.4 to 490.0)
Month 13b: DENV-1	259.3 (204.8 to 328.4)	949.1 (862.2 to 1044.7)
Month 13b: DENV-2	248.9 (199.4 to 310.6)	1003.2 (920.1 to 1093.9)
Month 13b: DENV-3	199.1 (159.9 to 248.0)	804.1 (739.2 to 874.8)
Month 13b: DENV-4	115.0 (94.4 to 140.0)	433.1 (401.2 to 467.6)

No statistical analyses for this end point

Other pre-specified: Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each Dengue Serotype

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End point title

Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each Dengue Serotype

End point description

The GMR is the geometric mean of the ratio of the two visits being compared. PPSI-B: all participants in FASI-B who had no major protocol violations. FASI-B: all participants from FAS-B who were included in booster immunogenicity subset & for whom there is valid pre-booster measurement & at least 1 valid post-booster measurement for immunogenicity assessments. Subjects analyzed: number of participants with data available for analyses. Number of subjects analysed was variable for each category.

End point type

Other pre-specified

End point timeframe

Pre-booster Vaccination on Day 1b (Month 0b) versus post-booster vaccination on Day 30b (Month 1b) in Part 4

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	396	1067
Units: unitless ratio
geometric mean (confidence interval 95%)
DENV-1	0.9 (0.8 to 1.0)	3.1 (2.8 to 3.4)
DENV-2	0.9 (0.9 to 1.0)	2.4 (2.3 to 2.6)
DENV-3	1.1 (1.0 to 1.2)	4.3 (3.9 to 4.7)
DENV-4	0.9 (0.9 to 1.0)	3.5 (3.2 to 3.9)

No statistical analyses for this end point

Other pre-specified: GMR of Neutralizing Antibodies for Each Dengue Serotype

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End point title

GMR of Neutralizing Antibodies for Each Dengue Serotype

End point description

The GMR is the geometric mean of the ratio of the two visits being compared. PPSI-B: all participants in FASI-B who had no major protocol violations. FASI-B: all participants from FAS-B who were included in booster immunogenicity subset & for whom there is valid pre-booster measurement & at least 1 valid post-booster measurement for immunogenicity assessments. Subjects analysed: number of participants with data available for analyses. Number of subjects analysed was variable for each category.

End point type

Other pre-specified

End point timeframe

Pre-booster Vaccination on Day 1b (Month 0b) versus post-booster vaccination on Day 180b (Month 6b) in Part 4

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	408	1120
Units: unitless ratio
geometric mean (confidence interval 95%)
DENV-1	1.0 (0.9 to 1.1)	2.2 (2.0 to 2.4)
DENV-2	1.1 (1.0 to 1.3)	1.8 (1.7 to 2.0)
DENV-3	1.0 (0.9 to 1.1)	2.5 (2.3 to 2.7)
DENV-4	0.9 (0.8 to 1.0)	2.1 (2.0 to 2.3)

No statistical analyses for this end point

Other pre-specified: GMR of Neutralizing Antibodies for Each Dengue Serotype

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End point title

GMR of Neutralizing Antibodies for Each Dengue Serotype

End point description

The geometric mean ratio is the geometric mean of the ratio of the two visits being compared. PPSI-B: all participants in FASI-B who had no major protocol violations. FASI-B: all participants from FAS-B who were included in booster immunogenicity subset & for whom there is valid pre-booster measurement & at least 1 valid post-booster measurement for immunogenicity assessments. Subjects analysed: number of participants with data available for analyses. Number of subjects analysed was variable for each category.

End point type

Other pre-specified

End point timeframe

Pre-booster Vaccination on Day 1b (Month 0b) versus post-booster vaccination on Day 395b (Month 13b) in Part 4

End point values	Placebo	TDV 0.5 mL
Number of subjects analysed	408	1114
Units: unitless ratio
geometric mean (confidence interval 95%)
DENV-1	1.3 (1.1 to 1.5)	2.1 (1.9 to 2.3)
DENV-2	1.3 (1.1 to 1.5)	1.6 (1.5 to 1.7)
DENV-3	1.3 (1.1 to 1.5)	2.4 (2.2 to 2.6)
DENV-4	1.3 (1.1 to 1.4)	2.0 (1.9 to 2.2)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Deaths&SAEs:Parts1+2:Day1 to end of Part2(approx.21 months);Part3:approx.3years; Part4:from booster vaccination(Day1b)until end of Part4[approx.13 months];Other AEs:Part1:up to 28 days post 1st/2nd vaccination;Part4:up to 28 days post booster vaccination.

Adverse event reporting additional description

As pre-specified in protocol, AEs are reported separately for Placebo & TDV arms of each Part. For Parts 1-3: Safety Set; For Part 4-5: Safety Set-Booster. Analysis of data for Part 5 is pending & anticipated reporting date for Part 5 is December 2025. Other (Non-serious) AEs:not collected for Parts 2 and 3 as no vaccination was received.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

27.1

Reporting group title

Placebo (Part 1)

Reporting group description

Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study.

Reporting group title

Placebo (Part 2)

Reporting group description

Participants went through extended follow-up period for six months up to Month 21 in Part 2 of the study.

Reporting group title

TDV (Part 4)

Reporting group description

Participants eligible for Booster Phase received TDV, SC injection, based on the randomization on Day 1 (Month 0) in Part 4 of the study.

Reporting group title

Placebo (Part 3)

Reporting group description

Participants went through long-term follow-up (3 years) to evaluate the safety.

Reporting group title

TDV (Part 3)

Reporting group description

Participants went through long-term follow-up (3 years) to evaluate the safety.

Reporting group title

Placebo (Part 4)

Reporting group description

Participants eligible for Booster Phase received placebo matching TDV, SC injection, based on the randomization on Day 1 (Month 0) in Part 4 of the study.

Reporting group title

TDV (Part 1)

Reporting group description

Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study.

Reporting group title

TDV (Part 2)

Reporting group description

Participants went through extended follow-up period for six months up to Month 21 in Part 2 of the study.

Serious adverse events	Placebo (Part 1)	Placebo (Part 2)	TDV (Part 4)	Placebo (Part 3)	TDV (Part 3)	Placebo (Part 4)	TDV (Part 1)	TDV (Part 2)
Total subjects affected by serious adverse events
subjects affected / exposed	256 / 6687 (3.83%)	82 / 6519 (1.26%)	161 / 5990 (2.69%)	397 / 6487 (6.12%)	666 / 12961 (5.14%)	126 / 2985 (4.22%)	414 / 13380 (3.09%)	152 / 13033 (1.17%)
number of deaths (all causes)	8	7	6	7	17	1	22	18
number of deaths resulting from adverse events	1	0	3	6	11	1	4	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Alveolar rhabdomyosarcoma
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Adenocarcinoma of colon
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
Benign hydatidiform mole
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Desmoplastic small round cell tumour
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cutaneous T-cell lymphoma
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Carcinoma in situ
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Benign ovarian tumour
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ependymoma malignant
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
Lipoma
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Leukaemia
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Inflammatory myofibroblastic tumour
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hodgkin's disease
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Fibroadenoma of breast
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Medulloblastoma
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Osteochondroma
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ovarian germ cell endodermal sinus tumour stage IV
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Papillary thyroid cancer
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Schwannoma
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ulcerated haemangioma
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Behcet's syndrome
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Embolism
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	1 / 2985 (0.03%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Extremity necrosis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypertension
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	2 / 6487 (0.03%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 2	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypertensive urgency
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Kawasaki's disease
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Polyarteritis nodosa
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Shock
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Subgaleal haematoma
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vasculitis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Surgical and medical procedures
Abortion induced
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Abortion
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abortion missed
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abortion incomplete
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	2 / 12961 (0.02%)	1 / 2985 (0.03%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abortion complete
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abortion spontaneous
subjects affected / exposed	1 / 6687 (0.01%)	1 / 6519 (0.02%)	1 / 5990 (0.02%)	7 / 6487 (0.11%)	6 / 12961 (0.05%)	0 / 2985 (0.00%)	2 / 13380 (0.01%)	2 / 13033 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1	0 / 7	0 / 6	0 / 0	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abortion threatened
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	2 / 6487 (0.03%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Anembryonic gestation
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abortion spontaneous incomplete
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cephalo-pelvic disproportion
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Eclampsia
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
False labour
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gestational hypertension
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
High risk pregnancy
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hyperemesis gravidarum
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Labour complication
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Placental insufficiency
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Postpartum haemorrhage
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	1 / 5990 (0.02%)	1 / 6487 (0.02%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 1	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Polyhydramnios
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pre-eclampsia
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	4 / 6487 (0.06%)	9 / 12961 (0.07%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 4	0 / 9	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Premature delivery
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	3 / 6487 (0.05%)	8 / 12961 (0.06%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 4	0 / 8	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pregnancy
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Stillbirth
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ruptured ectopic pregnancy
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Premature separation of placenta
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	1 / 2985 (0.03%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Premature rupture of membranes
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	3 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Premature labour
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	3 / 6487 (0.05%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 3	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Unstable foetal lie
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	1 / 2985 (0.03%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Traumatic delivery
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Threatened labour
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	2 / 6487 (0.03%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	2 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 2	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Influenza like illness
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hanging
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Drowning
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	2 / 6487 (0.03%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
Chest pain
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Multiple organ dysfunction syndrome
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Non-cardiac chest pain
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Organ failure
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	2 / 6487 (0.03%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	1 / 12961 (0.01%)	1 / 2985 (0.03%)	5 / 13380 (0.04%)	2 / 13033 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 1	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Serositis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Immune system disorders
Allergy to arthropod bite
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Anaphylactic shock
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Anaphylactic reaction
subjects affected / exposed	2 / 6687 (0.03%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	1 / 2985 (0.03%)	1 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0	0 / 1	0 / 0	0 / 2	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Drug hypersensitivity
subjects affected / exposed	2 / 6687 (0.03%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Food allergy
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypersensitivity
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Haemophagocytic lymphohistiocytosis
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Type I hypersensitivity
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Social circumstances
Physical assault
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
High risk sexual behaviour
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sexual abuse
subjects affected / exposed	3 / 6687 (0.04%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	4 / 13033 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Substance use
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Victim of sexual abuse
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Victim of crime
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Abnormal uterine bleeding
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	1 / 2985 (0.03%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Balanoposthitis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	1 / 2985 (0.03%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ovarian cyst
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Penile adhesion
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Scrotal pain
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vulval haematoma
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Testicular torsion
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	3 / 12961 (0.02%)	1 / 2985 (0.03%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 3	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Asphyxia
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
Asthma
subjects affected / exposed	2 / 6687 (0.03%)	1 / 6519 (0.02%)	3 / 5990 (0.05%)	2 / 6487 (0.03%)	5 / 12961 (0.04%)	0 / 2985 (0.00%)	7 / 13380 (0.05%)	7 / 13033 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 3	0 / 2	0 / 5	0 / 0	0 / 8	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bronchospasm
subjects affected / exposed	1 / 6687 (0.01%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	2 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Asthmatic crisis
subjects affected / exposed	3 / 6687 (0.04%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	2 / 6487 (0.03%)	0 / 12961 (0.00%)	1 / 2985 (0.03%)	1 / 13380 (0.01%)	2 / 13033 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 0	0 / 2	0 / 0	0 / 1	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lupus pleurisy
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypoxia
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Obstructive sleep apnoea syndrome
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	1 / 2985 (0.03%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sinus polyp
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Wheezing
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Acute psychosis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Aggression
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Adjustment disorder with depressed mood
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Adjustment disorder
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Antisocial behaviour
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Anxiety
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	1 / 6487 (0.02%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Completed suicide
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	4 / 12961 (0.03%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 4	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 4	0 / 0	0 / 0	0 / 0
Bipolar I disorder
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Behaviour disorder
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Anxiety disorder
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Depression
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	2 / 6487 (0.03%)	7 / 12961 (0.05%)	2 / 2985 (0.07%)	2 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 2	0 / 8	0 / 2	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Disruptive mood dysregulation disorder
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Drug abuse
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intentional self-injury
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Major depression
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Mania
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychotic disorder
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric symptom
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Oppositional defiant disorder
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Mixed anxiety and depressive disorder
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Substance use disorder
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Suicidal ideation
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Suicidal behaviour
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Suicide attempt
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	5 / 6487 (0.08%)	5 / 12961 (0.04%)	0 / 2985 (0.00%)	2 / 13380 (0.01%)	2 / 13033 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 7	0 / 6	0 / 0	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Product issues
Device extrusion
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Device malfunction
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Cholelithiasis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cholangitis sclerosing
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Autoimmune hepatitis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatic steatosis
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatosplenomegaly
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	1 / 2985 (0.03%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatitis acute
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolic dysfunction-associated steatohepatitis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Portal hypertension
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 6	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
False positive investigation result
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Red blood cell sedimentation rate increased
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Accident at work
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abdominal injury
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	4 / 12961 (0.03%)	1 / 2985 (0.03%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 4	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Accidental exposure to product by child
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Alcohol poisoning
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Animal bite
subjects affected / exposed	4 / 6687 (0.06%)	1 / 6519 (0.02%)	2 / 5990 (0.03%)	3 / 6487 (0.05%)	10 / 12961 (0.08%)	0 / 2985 (0.00%)	8 / 13380 (0.06%)	2 / 13033 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1	0 / 2	0 / 3	0 / 10	0 / 0	0 / 8	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ankle fracture
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	2 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Arthropod bite
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Arthropod sting
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Back injury
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Avulsion fracture
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	1 / 2985 (0.03%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Blindness traumatic
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Burns second degree
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	3 / 12961 (0.02%)	1 / 2985 (0.03%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 3	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Chemical burn of oral cavity
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Clavicle fracture
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Chest injury
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Concussion
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	2 / 6487 (0.03%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	3 / 13380 (0.02%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 2	0 / 1	0 / 0	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Craniocerebral injury
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	3 / 13380 (0.02%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 2	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Contusion
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Craniofacial fracture
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	1 / 6487 (0.02%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 2	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Electric injury
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Electrical burn
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	2 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Electric shock
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Epidural haemorrhage
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Eye injury
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Extradural haematoma
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Epiphyseal injury
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	2 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Exposure to communicable disease
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Eyelid injury
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Face injury
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	2 / 13033 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Fall
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	4 / 12961 (0.03%)	3 / 2985 (0.10%)	2 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 4	0 / 3	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	2 / 6487 (0.03%)	3 / 12961 (0.02%)	0 / 2985 (0.00%)	3 / 13380 (0.02%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 3	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Fibula fracture
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	1 / 2985 (0.03%)	2 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Fractured coccyx
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Foreign body in gastrointestinal tract
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Forearm fracture
subjects affected / exposed	2 / 6687 (0.03%)	1 / 6519 (0.02%)	3 / 5990 (0.05%)	2 / 6487 (0.03%)	9 / 12961 (0.07%)	4 / 2985 (0.13%)	8 / 13380 (0.06%)	2 / 13033 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 3	0 / 2	0 / 9	0 / 4	0 / 8	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Foot fracture
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	3 / 6487 (0.05%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	2 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 3	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gun shot wound
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	3 / 6487 (0.05%)	3 / 12961 (0.02%)	0 / 2985 (0.00%)	3 / 13380 (0.02%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 3	0 / 3	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
Hand fracture
subjects affected / exposed	1 / 6687 (0.01%)	2 / 6519 (0.03%)	0 / 5990 (0.00%)	3 / 6487 (0.05%)	5 / 12961 (0.04%)	1 / 2985 (0.03%)	2 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0	0 / 3	0 / 5	0 / 2	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatic rupture
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Head injury
subjects affected / exposed	3 / 6687 (0.04%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	3 / 12961 (0.02%)	1 / 2985 (0.03%)	4 / 13380 (0.03%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 1	0 / 0	0 / 3	0 / 1	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	3 / 6687 (0.04%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	2 / 6487 (0.03%)	7 / 12961 (0.05%)	1 / 2985 (0.03%)	10 / 13380 (0.07%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 2	0 / 7	0 / 1	0 / 10	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ilium fracture
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Jaw fracture
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intentional overdose
subjects affected / exposed	1 / 6687 (0.01%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	2 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 1	0 / 1	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Joint dislocation
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	2 / 2985 (0.07%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ligament sprain
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Joint injury
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Limb crushing injury
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Limb traumatic amputation
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	1 / 12961 (0.01%)	1 / 2985 (0.03%)	2 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 1	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Limb injury
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	2 / 6487 (0.03%)	4 / 12961 (0.03%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	3 / 13033 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 2	0 / 4	0 / 0	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lip injury
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lower limb fracture
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	4 / 12961 (0.03%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 4	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Liver contusion
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Multiple injuries
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	4 / 12961 (0.03%)	1 / 2985 (0.03%)	3 / 13380 (0.02%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 4	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Muscle strain
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Muscle injury
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pelvic fracture
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Patella fracture
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Overdose
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Open globe injury
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Penetrating abdominal trauma
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Perineal injury
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumothorax traumatic
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	1 / 5990 (0.02%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Post procedural discharge
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Postoperative adhesion
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Shunt malfunction
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	3 / 5990 (0.05%)	2 / 6487 (0.03%)	9 / 12961 (0.07%)	3 / 2985 (0.10%)	8 / 13380 (0.06%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 3	0 / 2	0 / 9	0 / 3	0 / 8	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 1
Rib fracture
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Radius fracture
subjects affected / exposed	7 / 6687 (0.10%)	1 / 6519 (0.02%)	3 / 5990 (0.05%)	2 / 6487 (0.03%)	12 / 12961 (0.09%)	1 / 2985 (0.03%)	3 / 13380 (0.02%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 7	0 / 1	0 / 3	0 / 2	0 / 12	0 / 1	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin injury
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin laceration
subjects affected / exposed	2 / 6687 (0.03%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	3 / 13380 (0.02%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skull fracture
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	2 / 6487 (0.03%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	3 / 13380 (0.02%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 1	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skull fractured base
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Snake bite
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Soft tissue injury
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Spinal cord injury thoracic
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Splenic rupture
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	3 / 13380 (0.02%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Stab wound
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sports injury
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	1 / 2985 (0.03%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tendon rupture
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Testicular injury
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tendon injury
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Thermal burn
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Toxicity to various agents
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	1 / 5990 (0.02%)	1 / 6487 (0.02%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 1	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Traumatic haematoma
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Thoracic vertebral fracture
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	2 / 6687 (0.03%)	1 / 6519 (0.02%)	4 / 5990 (0.07%)	2 / 6487 (0.03%)	5 / 12961 (0.04%)	0 / 2985 (0.00%)	2 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 4	0 / 2	0 / 5	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tooth fracture
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Traumatic intracranial haemorrhage
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Traumatic haemothorax
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Traumatic liver injury
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Traumatic lung injury
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
Ulna fracture
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Venom poisoning
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Upper limb fracture
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	2 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vulvovaginal injury
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Wound dehiscence
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Wound
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Congenital, familial and genetic disorders
Arteriovenous malformation
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cerebrovascular arteriovenous malformation
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
Cerebral arteriovenous malformation haemorrhagic
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Atrial septal defect
subjects affected / exposed	1 / 6687 (0.01%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Congenital cystic kidney disease
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cryptorchism
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Muscular dystrophy
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Familial periodic paralysis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 3	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dermoid cyst
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Phimosis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Thalassaemia alpha
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Acute myocardial infarction
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Aortic valve incompetence
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sinus node dysfunction
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rheumatic heart disease
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Arrhythmia
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Supraventricular tachycardia
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Bell's palsy
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ataxia
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Aqueductal stenosis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Acute disseminated encephalomyelitis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Brain hypoxia
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Cerebral infarction
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cerebellar infarction
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cerebral venous thrombosis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Diplegia
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dizziness
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Febrile convulsion
subjects affected / exposed	1 / 6687 (0.01%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	1 / 12961 (0.01%)	1 / 2985 (0.03%)	4 / 13380 (0.03%)	2 / 13033 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 1	0 / 1	0 / 1	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	2 / 13033 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Generalised tonic-clonic seizure
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	1 / 12961 (0.01%)	1 / 2985 (0.03%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Headache
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	3 / 13380 (0.02%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 1	0 / 0	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Guillain-Barre syndrome
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hydrocephalus
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypoaesthesia
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Idiopathic generalised epilepsy
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Migraine
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	3 / 12961 (0.02%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 3	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Optic neuritis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	2 / 6487 (0.03%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Partial seizures
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Post-traumatic headache
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Myelopathy
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychogenic seizure
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Presyncope
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Quadriparesis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ruptured cerebral aneurysm
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Seizure
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	3 / 12961 (0.02%)	0 / 2985 (0.00%)	2 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 3	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Simple partial seizures
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Serotonin syndrome
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Status migrainosus
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tension headache
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Syncope
subjects affected / exposed	2 / 6687 (0.03%)	0 / 6519 (0.00%)	2 / 5990 (0.03%)	2 / 6487 (0.03%)	3 / 12961 (0.02%)	0 / 2985 (0.00%)	2 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 2	0 / 2	0 / 3	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia of pregnancy
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Anaemia
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	1 / 12961 (0.01%)	1 / 2985 (0.03%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Blood loss anaemia
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Disseminated intravascular coagulation
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
Febrile neutropenia
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Immune thrombocytopenia
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Mesenteric lymphadenitis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	4 / 12961 (0.03%)	0 / 2985 (0.00%)	5 / 13380 (0.04%)	2 / 13033 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 4	0 / 0	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lymphadenopathy
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lymphadenitis
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	2 / 6487 (0.03%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	2 / 13033 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 2	0 / 1	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	2 / 6487 (0.03%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Thrombocytopenic purpura
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Thrombotic thrombocytopenic purpura
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Eye disorders
Corneal opacity
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Conjunctivitis allergic
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cataract
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Amaurosis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Myopia
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Orbital myositis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Refraction disorder
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Retinal haemorrhage
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	1 / 6687 (0.01%)	1 / 6519 (0.02%)	1 / 5990 (0.02%)	3 / 6487 (0.05%)	4 / 12961 (0.03%)	2 / 2985 (0.07%)	3 / 13380 (0.02%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1	0 / 3	0 / 4	0 / 2	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Constipation
subjects affected / exposed	2 / 6687 (0.03%)	1 / 6519 (0.02%)	1 / 5990 (0.02%)	3 / 6487 (0.05%)	5 / 12961 (0.04%)	1 / 2985 (0.03%)	1 / 13380 (0.01%)	2 / 13033 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 1	0 / 3	0 / 5	0 / 1	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Colitis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Aphthous ulcer
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Acid peptic disease
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	3 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Duodenal ulcer
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dyspepsia
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	1 / 2985 (0.03%)	2 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Faecaloma
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	1 / 2985 (0.03%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Food poisoning
subjects affected / exposed	3 / 6687 (0.04%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	1 / 2985 (0.03%)	2 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastritis
subjects affected / exposed	1 / 6687 (0.01%)	3 / 6519 (0.05%)	0 / 5990 (0.00%)	3 / 6487 (0.05%)	6 / 12961 (0.05%)	0 / 2985 (0.00%)	6 / 13380 (0.04%)	2 / 13033 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 0	0 / 3	0 / 6	0 / 0	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastritis erosive
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ileus paralytic
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Haemorrhagic erosive gastritis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Incarcerated umbilical hernia
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	2 / 12961 (0.02%)	1 / 2985 (0.03%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 2	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	2 / 6487 (0.03%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 3	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intra-abdominal fluid collection
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Irritable bowel syndrome
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lymphoid hyperplasia of intestine
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Large intestine polyp
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Mallory-Weiss syndrome
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Mechanical ileus
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Mesenteric cyst
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Oesophageal varices haemorrhage
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 6	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Oesophagitis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Peptic ulcer
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pancreatic pseudocyst
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Small intestinal perforation
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rectal polyp
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Umbilical hernia
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	2 / 6487 (0.03%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vomiting
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Hyperkeratosis
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Henoch-Schonlein purpura
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	2 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Erythema annulare
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	1 / 2985 (0.03%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lichen planus
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psoriasis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urticaria
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	4 / 13380 (0.03%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 2	0 / 0	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Calculus urinary
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Glomerulonephritis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
End stage renal disease
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Glomerulonephritis acute
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	1 / 6487 (0.02%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 1	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Glomerulonephritis proliferative
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	2 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Glomerulonephritis chronic
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Glomerulonephritis rapidly progressive
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypertensive nephropathy
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lupus nephritis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	1 / 2985 (0.03%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
IgA nephropathy
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nephritic syndrome
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Post infection glomerulonephritis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Post streptococcal glomerulonephritis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	1 / 2985 (0.03%)	5 / 13380 (0.04%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyelocaliectasis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nephrolithiasis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nephrotic syndrome
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal colic
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	2 / 12961 (0.02%)	1 / 2985 (0.03%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal failure
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ureterolithiasis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urethral caruncle
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urinary bladder rupture
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Endocrine disorders
Cushing's syndrome
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Goitre
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypothyroidism
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hyperthyroidism
subjects affected / exposed	2 / 6687 (0.03%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Epiphysiolysis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Arthritis reactive
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Back pain
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Costochondritis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Exostosis of jaw
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Extremity contracture
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Fibromyalgia
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Greater trochanteric pain syndrome
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Muscle fatigue
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Knee deformity
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Juvenile idiopathic arthritis
subjects affected / exposed	2 / 6687 (0.03%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Muscular weakness
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Neck pain
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pain in extremity
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rheumatic fever
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Spondylitis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Synovitis
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Systemic lupus erythematosus
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Abortion infected
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abdominal abscess
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abscess jaw
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abscess neck
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abscess limb
subjects affected / exposed	2 / 6687 (0.03%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	2 / 6487 (0.03%)	7 / 12961 (0.05%)	0 / 2985 (0.00%)	5 / 13380 (0.04%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 2	0 / 7	0 / 0	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abscess of external ear
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abscess soft tissue
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Acarodermatitis
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Amoebiasis
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	3 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Amniotic cavity infection
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	3 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Acute sinusitis
subjects affected / exposed	1 / 6687 (0.01%)	2 / 6519 (0.03%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	2 / 13033 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Amoebic dysentery
subjects affected / exposed	2 / 6687 (0.03%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	1 / 6487 (0.02%)	6 / 12961 (0.05%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1	0 / 1	0 / 6	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Anal abscess
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Appendiceal abscess
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	14 / 6687 (0.21%)	6 / 6519 (0.09%)	7 / 5990 (0.12%)	27 / 6487 (0.42%)	60 / 12961 (0.46%)	5 / 2985 (0.17%)	30 / 13380 (0.22%)	14 / 13033 (0.11%)
occurrences causally related to treatment / all	0 / 14	0 / 6	0 / 7	0 / 27	0 / 60	0 / 5	0 / 30	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Appendicitis perforated
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	3 / 5990 (0.05%)	6 / 6487 (0.09%)	7 / 12961 (0.05%)	0 / 2985 (0.00%)	2 / 13380 (0.01%)	3 / 13033 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 3	0 / 6	0 / 7	0 / 0	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Arboviral infection
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Arthritis bacterial
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Atypical pneumonia
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bacteraemia
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ascariasis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bacterial infection
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bacterial vaginosis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bacteriuria
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bartholin's abscess
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Breast abscess
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	3 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bacterial sepsis
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Breast cellulitis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	4 / 13380 (0.03%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 2	0 / 0	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bronchitis viral
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bullous impetigo
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Burkholderia pseudomallei infection
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Burn infection
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
COVID-19
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	65 / 5990 (1.09%)	24 / 6487 (0.37%)	69 / 12961 (0.53%)	39 / 2985 (1.31%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 68	0 / 24	0 / 69	0 / 40	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
COVID-19 pneumonia
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	3 / 6487 (0.05%)	7 / 12961 (0.05%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 3	0 / 7	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	1 / 6687 (0.01%)	1 / 6519 (0.02%)	3 / 5990 (0.05%)	7 / 6487 (0.11%)	15 / 12961 (0.12%)	2 / 2985 (0.07%)	10 / 13380 (0.07%)	3 / 13033 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 3	0 / 9	0 / 15	0 / 2	0 / 10	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cellulitis orbital
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cholera
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Chikungunya virus infection
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	2 / 6487 (0.03%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Complicated appendicitis
subjects affected / exposed	1 / 6687 (0.01%)	1 / 6519 (0.02%)	2 / 5990 (0.03%)	7 / 6487 (0.11%)	12 / 12961 (0.09%)	4 / 2985 (0.13%)	6 / 13380 (0.04%)	2 / 13033 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 2	0 / 7	0 / 12	0 / 4	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Conjunctivitis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Croup infectious
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Coronavirus infection
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cystitis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dengue haemorrhagic fever
subjects affected / exposed	19 / 6687 (0.28%)	6 / 6519 (0.09%)	0 / 5990 (0.00%)	12 / 6487 (0.18%)	9 / 12961 (0.07%)	4 / 2985 (0.13%)	4 / 13380 (0.03%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	1 / 19	0 / 6	0 / 0	0 / 12	0 / 10	0 / 4	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dengue fever
subjects affected / exposed	52 / 6687 (0.78%)	10 / 6519 (0.15%)	7 / 5990 (0.12%)	83 / 6487 (1.28%)	56 / 12961 (0.43%)	32 / 2985 (1.07%)	13 / 13380 (0.10%)	9 / 13033 (0.07%)
occurrences causally related to treatment / all	1 / 52	0 / 10	0 / 7	0 / 83	0 / 56	0 / 32	1 / 13	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dermatitis infected
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Device related infection
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Disseminated tuberculosis
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	1 / 2985 (0.03%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Diarrhoea infectious
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dysentery
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Enteritis infectious
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 2	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Escherichia sepsis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	1 / 2985 (0.03%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Erythema infectiosum
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Epididymitis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Escherichia urinary tract infection
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	3 / 13380 (0.02%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Extradural abscess
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Eye infection gonococcal
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Focal peritonitis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastritis viral
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis shigella
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis salmonella
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis bacterial
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	8 / 6687 (0.12%)	2 / 6519 (0.03%)	1 / 5990 (0.02%)	11 / 6487 (0.17%)	18 / 12961 (0.14%)	2 / 2985 (0.07%)	29 / 13380 (0.22%)	7 / 13033 (0.05%)
occurrences causally related to treatment / all	0 / 8	0 / 2	0 / 1	0 / 11	0 / 18	0 / 2	0 / 29	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis viral
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	3 / 13380 (0.02%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 1	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal bacterial infection
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal infection
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Groin abscess
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Giardiasis
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hand-foot-and-mouth disease
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatitis A
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	3 / 12961 (0.02%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 3	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Herpes simplex encephalitis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatitis viral
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Herpes zoster
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infected bite
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Impetigo
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infectious mononucleosis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	3 / 13380 (0.02%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infective myositis
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infective exacerbation of asthma
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	2 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Influenza
subjects affected / exposed	7 / 6687 (0.10%)	5 / 6519 (0.08%)	0 / 5990 (0.00%)	9 / 6487 (0.14%)	12 / 12961 (0.09%)	1 / 2985 (0.03%)	14 / 13380 (0.10%)	6 / 13033 (0.05%)
occurrences causally related to treatment / all	0 / 7	0 / 5	0 / 0	0 / 9	0 / 12	0 / 1	0 / 14	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Joint abscess
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ludwig angina
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lower respiratory tract infection
subjects affected / exposed	3 / 6687 (0.04%)	1 / 6519 (0.02%)	1 / 5990 (0.02%)	3 / 6487 (0.05%)	3 / 12961 (0.02%)	0 / 2985 (0.00%)	10 / 13380 (0.07%)	3 / 13033 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 1	0 / 3	0 / 3	0 / 0	0 / 10	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Localised infection
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Leptospirosis
subjects affected / exposed	2 / 6687 (0.03%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	2 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 1	0 / 2	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lung abscess
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lymph gland infection
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lymph node tuberculosis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lymphadenitis bacterial
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Malaria
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	2 / 6487 (0.03%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Meningitis aseptic
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Meningitis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Measles
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Mastoiditis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Meningitis tuberculous
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Muscle abscess
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nasopharyngitis
subjects affected / exposed	3 / 6687 (0.04%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Obstetric infection
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Oral herpes
subjects affected / exposed	2 / 6687 (0.03%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Orchitis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Osteomyelitis chronic
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Otitis externa
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Otitis media acute
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Paranasal sinus abscess
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Parasite allergy
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Parasitic gastroenteritis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 2	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Parotitis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pelvic abscess
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pelvic inflammatory disease
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	3 / 12961 (0.02%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 3	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Periorbital abscess
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Periorbital cellulitis
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Peritonsillar abscess
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	3 / 13380 (0.02%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	3 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pharyngotonsillitis
subjects affected / exposed	2 / 6687 (0.03%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	3 / 13380 (0.02%)	2 / 13033 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 1	0 / 2	0 / 0	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pilonidal disease
subjects affected / exposed	2 / 6687 (0.03%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	8 / 6687 (0.12%)	7 / 6519 (0.11%)	2 / 5990 (0.03%)	8 / 6487 (0.12%)	20 / 12961 (0.15%)	0 / 2985 (0.00%)	10 / 13380 (0.07%)	6 / 13033 (0.05%)
occurrences causally related to treatment / all	0 / 8	0 / 7	0 / 2	0 / 9	0 / 20	0 / 0	0 / 10	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pharyngitis bacterial
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pharyngitis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	3 / 6487 (0.05%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	3 / 13033 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 3	0 / 2	0 / 0	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia viral
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Post procedural infection
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia bacterial
subjects affected / exposed	2 / 6687 (0.03%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	1 / 2985 (0.03%)	2 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1	0 / 0	0 / 1	0 / 1	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia influenzal
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia mycoplasmal
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pseudomembranous colitis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Puerperal infection
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Postoperative wound infection
subjects affected / exposed	1 / 6687 (0.01%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	2 / 6487 (0.03%)	4 / 12961 (0.03%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 2	0 / 4	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Postpartum sepsis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	4 / 6487 (0.06%)	2 / 12961 (0.02%)	2 / 2985 (0.07%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 4	0 / 3	0 / 2	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyoderma
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary tuberculosis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	1 / 6487 (0.02%)	4 / 12961 (0.03%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 4	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pustule
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Salpingitis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rickettsiosis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
SARS-CoV-2 sepsis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory tract infection
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rhinitis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Septic shock
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	2 / 6487 (0.03%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 2	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Septic phlebitis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sinusitis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Scarlet fever
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sepsis
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	1 / 5990 (0.02%)	4 / 6487 (0.06%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 4	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Subcutaneous abscess
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	4 / 12961 (0.03%)	0 / 2985 (0.00%)	2 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 4	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Staphylococcal infection
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Staphylococcal sepsis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sinusitis bacterial
subjects affected / exposed	0 / 6687 (0.00%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Staphylococcal abscess
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Systemic viral infection
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Syphilis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Superinfection
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Suspected COVID-19
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tinea capitis
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tooth abscess
subjects affected / exposed	2 / 6687 (0.03%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	5 / 13380 (0.04%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 1	0 / 2	0 / 0	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Typhoid fever
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	2 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tonsillitis
subjects affected / exposed	1 / 6687 (0.01%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	3 / 6487 (0.05%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	3 / 13380 (0.02%)	2 / 13033 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 4	0 / 2	0 / 0	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tonsillitis bacterial
subjects affected / exposed	2 / 6687 (0.03%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	2 / 6487 (0.03%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	4 / 13380 (0.03%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urethritis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	1 / 2985 (0.03%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	5 / 6687 (0.07%)	2 / 6519 (0.03%)	3 / 5990 (0.05%)	15 / 6487 (0.23%)	20 / 12961 (0.15%)	0 / 2985 (0.00%)	9 / 13380 (0.07%)	4 / 13033 (0.03%)
occurrences causally related to treatment / all	0 / 6	0 / 2	0 / 5	0 / 15	0 / 24	0 / 0	0 / 9	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vaginal infection
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	5 / 6687 (0.07%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	4 / 6487 (0.06%)	9 / 12961 (0.07%)	0 / 2985 (0.00%)	3 / 13380 (0.02%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 1	0 / 0	0 / 4	0 / 9	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Upper respiratory tract infection bacterial
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Viral upper respiratory tract infection
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	4 / 13380 (0.03%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Viral myocarditis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	1 / 2985 (0.03%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Viral infection
subjects affected / exposed	19 / 6687 (0.28%)	4 / 6519 (0.06%)	1 / 5990 (0.02%)	17 / 6487 (0.26%)	16 / 12961 (0.12%)	3 / 2985 (0.10%)	23 / 13380 (0.17%)	3 / 13033 (0.02%)
occurrences causally related to treatment / all	0 / 20	0 / 4	0 / 1	0 / 17	0 / 16	0 / 3	0 / 23	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Varicella
subjects affected / exposed	2 / 6687 (0.03%)	1 / 6519 (0.02%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Viral rash
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Wound infection
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	1 / 5990 (0.02%)	0 / 6487 (0.00%)	3 / 12961 (0.02%)	1 / 2985 (0.03%)	1 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 3	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Abnormal weight gain
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Diabetic ketoacidosis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	3 / 12961 (0.02%)	0 / 2985 (0.00%)	2 / 13380 (0.01%)	1 / 13033 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 3	0 / 4	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dehydration
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	3 / 6487 (0.05%)	3 / 12961 (0.02%)	0 / 2985 (0.00%)	2 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 3	0 / 3	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Obesity
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	2 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolic syndrome
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	1 / 12961 (0.01%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolic acidosis
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	1 / 6487 (0.02%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	0 / 6687 (0.00%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	0 / 2985 (0.00%)	1 / 13380 (0.01%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Type 1 diabetes mellitus
subjects affected / exposed	1 / 6687 (0.01%)	0 / 6519 (0.00%)	0 / 5990 (0.00%)	0 / 6487 (0.00%)	3 / 12961 (0.02%)	0 / 2985 (0.00%)	0 / 13380 (0.00%)	0 / 13033 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	Placebo (Part 1)	Placebo (Part 2)	TDV (Part 4)	Placebo (Part 3)	TDV (Part 3)	Placebo (Part 4)	TDV (Part 1)	TDV (Part 2)
Total subjects affected by non serious adverse events
subjects affected / exposed	527 / 6687 (7.88%)	0 / 6519 (0.00%)	409 / 5990 (6.83%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	149 / 2985 (4.99%)	1260 / 13380 (9.42%)	0 / 13033 (0.00%)
Nervous system disorders
Headache
subjects affected / exposed	337 / 6687 (5.04%)	0 / 6519 (0.00%)	206 / 5990 (3.44%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	82 / 2985 (2.75%)	736 / 13380 (5.50%)	0 / 13033 (0.00%)
occurrences all number	1145	0	561	0	0	250	2475	0
General disorders and administration site conditions
Pain
subjects affected / exposed	363 / 6687 (5.43%)	0 / 6519 (0.00%)	340 / 5990 (5.68%)	0 / 6487 (0.00%)	0 / 12961 (0.00%)	113 / 2985 (3.79%)	1011 / 13380 (7.56%)	0 / 13033 (0.00%)
occurrences all number	779	0	758	0	0	243	2745	0

More information

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Were there any global substantial amendments to the protocol? Yes

17 Nov 2015

Following changes were implemented with Protocol Amendment 2: -The protocol was primarily amended to change the dosing regimen and to modify the long-term febrile surveillance methodology (during Part 3). -Updated the role of Data Monitoring Committee and addition of involvement of Adjudication Committee. -Added second trial vaccination on Day 90 (Month 3). -Updated time window between trial visits and specification of trial procedures for each year of follow-up during Part 3. -Updated trial objectives and endpoints. -Removed conditional booster. -Replacement of enhanced passive hospital-based surveillance by modified active surveillance. -Six-month cap on pre-vaccination surveillance for dengue replaced by 10 months. -Addition of febrile illness surveillance during dry-run. -Updated the section on collection of serious adverse events. -Specifications added on use of interactive web/voice response system (IWRS/IVRS) for subject enrollment/randomisation. -Updates to certain study procedures, statistical analysis, and eligibility criteria.

18 May 2020

Following changes were implemented with Protocol Amendment 4: -Added a booster phase to the ongoing DEN-301 trial. -Subheadings were generated to differentiate between Parts 1, 2, and 3 of the trial and the new booster phase of the trial (Parts 4 and 5). -Microneutralization test (MNT) was replaced with MNT50 for consistency. -The term ‘Legally Authorized Representative (LAR)’ was replaced by parent/guardian for consistency. -The administrative trial information was updated and minor grammatical and editorial changes were included.

20 Apr 2021

Following changes were implemented with Protocol Amendment 4: - EudraCT Number was added. -Updated the status of the Interim Clinical Study Reports planned for the trial. -Corrected and updated list of References.

Were there any global interruptions to the trial? No

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

None reported

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Clinical trials

Clinical Trial Results: Phase III, Double-Blind, Randomized, Placebo-Controlled Trial to Investigate the Efficacy, Safety and Immunogenicity of a Tetravalent Dengue Vaccine (TDV) Administered Subcutaneously in Healthy Children Aged 4 - 16 Years Old

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Vaccine Efficacy (VE) of Two Doses of Tetravalent Dengue Vaccine (TDV) in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

Primary: Vaccine Efficacy (VE) of Two Doses of Tetravalent Dengue Vaccine (TDV) in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

Secondary: VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

Secondary: VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

Secondary: VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Each Dengue Serotype

Secondary: VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Each Dengue Serotype

Secondary: VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seronegative at Baseline

Secondary: VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seronegative at Baseline

Secondary: VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seropositive at Baseline

Secondary: VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seropositive at Baseline

Secondary: VE of Two Doses of TDV in Preventing Virologically-Confirmed Severe Dengue Fever Induced by Any Dengue Serotype

Secondary: VE of Two Doses of TDV in Preventing Virologically-Confirmed Severe Dengue Fever Induced by Any Dengue Serotype

Secondary: Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset

Secondary: Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset

Secondary: Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset

Secondary: Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset

Secondary: Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Set Immunogenicity Subset

Secondary: Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Set Immunogenicity Subset

Secondary: Percentage of Participants With Serious Adverse Events (SAEs) During Parts 1 and 2

Secondary: Percentage of Participants With Serious Adverse Events (SAEs) During Parts 1 and 2

Secondary: Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During the First and Second Half of Part 3

Secondary: Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During the First and Second Half of Part 3

Secondary: Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset

Secondary: Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset

Secondary: Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset

Secondary: Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset

Secondary: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset

Secondary: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset

Other pre-specified: VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

Other pre-specified: VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

Other pre-specified: VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

Other pre-specified: VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

Other pre-specified: VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

Other pre-specified: VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

Other pre-specified: VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

Other pre-specified: VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

Other pre-specified: VE of a TDV Booster Dose in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30 Booster [b] (Month 1b)) Until the End of Part 4

Other pre-specified: VE of a TDV Booster Dose in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30 Booster [b] (Month 1b)) Until the End of Part 4

Other pre-specified: VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype From 30 days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4

Other pre-specified: VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype From 30 days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4

Other pre-specified: VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4

Other pre-specified: VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4

Other pre-specified: VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4

Other pre-specified: VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4

Other pre-specified: VE of a TDV Booster Dose in Preventing Hospitalization Due to Virologically Confirmed Dengue Fever Induced by Any Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4

Other pre-specified: VE of a TDV Booster Dose in Preventing Hospitalization Due to Virologically Confirmed Dengue Fever Induced by Any Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4

Other pre-specified: VE of a TDV Booster Dose in Preventing Virologically Confirmed Severe Dengue Fever Induced by Any Dengue Serotype From 30 days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4

Other pre-specified: VE of a TDV Booster Dose in Preventing Virologically Confirmed Severe Dengue Fever Induced by Any Dengue Serotype From 30 days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4

Other pre-specified: Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4

Other pre-specified: Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4

Other pre-specified: Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4

Other pre-specified: Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4

Other pre-specified: Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Set-Booster-Immunogenicity Subset During Part 4

Other pre-specified: Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Set-Booster-Immunogenicity Subset During Part 4

Other pre-specified: Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During Part 4

Other pre-specified: Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During Part 4

Other pre-specified: Percentage of Participants With Serious Adverse Events (SAEs) During Part 4

Other pre-specified: Percentage of Participants With Serious Adverse Events (SAEs) During Part 4

Other pre-specified: Seropositivity Rate for Each of the 4 Dengue Serotypes During Part 4

Other pre-specified: Seropositivity Rate for Each of the 4 Dengue Serotypes During Part 4

Other pre-specified: Seropositivity Rate for Multiple Dengue Serotypes During Part 4

Other pre-specified: Seropositivity Rate for Multiple Dengue Serotypes During Part 4

Other pre-specified: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Part 4

Other pre-specified: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Part 4

Other pre-specified: Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each Dengue Serotype

Other pre-specified: Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each Dengue Serotype

Other pre-specified: GMR of Neutralizing Antibodies for Each Dengue Serotype

Other pre-specified: GMR of Neutralizing Antibodies for Each Dengue Serotype

Other pre-specified: GMR of Neutralizing Antibodies for Each Dengue Serotype

Other pre-specified: GMR of Neutralizing Antibodies for Each Dengue Serotype

Clinical Trial Results:
Phase III, Double-Blind, Randomized, Placebo-Controlled Trial to Investigate the Efficacy, Safety and Immunogenicity of a Tetravalent Dengue Vaccine (TDV) Administered Subcutaneously in Healthy Children Aged 4 - 16 Years Old