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Clinical Trial Results:
A Phase 3, Randomized, Double-blinded, Placebo-controlled Trial to Evaluate the Efficacy and Safety of a Respiratory Syncytial Virus (RSV) Prefusion F Subunit Vaccine in Infants Born to Women Vaccinated During Pregnancy

Summary
EudraCT number	2019-002943-85
Trial protocol	DK FI NL
Global end of trial date	27 Oct 2023

Results information
Results version number	v1(current)
This version publication date	10 May 2024
First version publication date	10 May 2024
Other versions

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

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Trial information

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Sponsor protocol code

C3671008

ISRCTN number

US NCT number

NCT04424316

WHO universal trial number (UTN)

Sponsor organisation name

Pfizer Inc.

Sponsor organisation address

235E42nd Street, New York, United States, NY 10017

Public contact

PfizerClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

PfizerClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.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

10 Nov 2023

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

27 Oct 2023

Was the trial ended prematurely?

Main objective of the trial

For infant participants: the primary efficacy objective of this study was to evaluate the efficacy of respiratory syncytial virus stabilized prefusion F subunit vaccine (RSVpreF) in reducing the incidence of medically attended lower respiratory tract illness (MA-LRTI) and severe MA-LRTI due to RSV. The primary safety objective was to describe the safety of RSVpreF. For maternal participants: the primary objective was to describe the safety and tolerability of RSVpreF.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials participants were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

17 Jun 2020

Long term follow-up planned

Yes

Long term follow-up rationale

Safety

Long term follow-up duration

2 Years

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 1860

Country: Number of subjects enrolled

Australia: 48

Country: Number of subjects enrolled

Brazil: 145

Country: Number of subjects enrolled

Canada: 110

Country: Number of subjects enrolled

Chile: 342

Country: Number of subjects enrolled

Denmark: 123

Country: Number of subjects enrolled

Finland: 296

Country: Number of subjects enrolled

Gambia: 389

Country: Number of subjects enrolled

Japan: 926

Country: Number of subjects enrolled

Korea, Republic of: 24

Country: Number of subjects enrolled

Mexico: 149

Country: Number of subjects enrolled

Netherlands: 384

Country: Number of subjects enrolled

New Zealand: 197

Country: Number of subjects enrolled

Philippines: 156

Country: Number of subjects enrolled

South Africa: 1900

Country: Number of subjects enrolled

Spain: 484

Country: Number of subjects enrolled

Taiwan: 520

Country: Number of subjects enrolled

United States: 6637

Worldwide total number of subjects

14690

EEA total number of subjects

1287

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

379

Newborns (0-27 days)

6926

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

7367

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

A total of 14690 participants were enrolled at multiple sites (maternal - 7385 and infant - 7305 participants).

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Investigator, Monitor, Subject

Are arms mutually exclusive

Yes

Maternal Participants: RSVpreF

Arm description

Study-eligible pregnant women (maternal participants) were randomized to receive a single dose of 120 micrograms (mcg) RSVpreF, intramuscularly (IM) on Day 1 (day of vaccination). Participants were followed up to 6 months after delivery.

Arm type

Experimental

Investigational medicinal product name

RSVpreF

Investigational medicinal product code

PF-06928316

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Study-eligible pregnant women (maternal participants) upon randomization received a single dose of 120 mcg RSVpreF, intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 (day of vaccination).

Maternal Participants: Placebo

Arm description

Maternal participants were randomized to receive placebo matching to RSVpreF as a single dose on Day 1 (day of vaccination). Participants were followed up to 6 months after delivery.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Study-eligible pregnant women (maternal participants) upon randomization received a single dose of placebo (matched to RSVpreF but no active vaccine), intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 (day of vaccination).

Infant Participants: RSVpreF

Arm description

Infant participants born to maternal participants vaccinated with a single dose of 120 mcg RSVpreF were included. Infant participants were all followed up for 12 months after birth, and for infants born to maternal participants during the first year of the study, they were followed up for 24 months after birth.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Infant Participants: Placebo

Arm description

Infant participants born to maternal participants who received placebo (matching RSVpreF without active vaccine) were included. Infant participants were all followed up for 12 months after birth, and for infants born to maternal participants during the first year of the study, they were followed up for 24 months after birth.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Number of subjects in period 1	Maternal Participants: RSVpreF	Maternal Participants: Placebo	Infant Participants: RSVpreF	Infant Participants: Placebo
Started	3698	3687	3659	3646
Completed	3516	3509	3318	3294
Not completed	182	178	341	352
Physician decision	1	-	1	1
Consent withdrawn by subject	71	77	-	-
Adverse event, non-fatal	-	1	-	-
Death	1	-	8	14
No longer met eligibility criteria	1	-	-	-
Unspecified	15	11	34	45
Lost to follow-up	93	88	224	211
Withdrawal by parent/guardian	-	-	74	81
Protocol deviation	-	1	-	-

Baseline characteristics

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Reporting group title

Maternal Participants: RSVpreF

Reporting group description

Reporting group title

Maternal Participants: Placebo

Reporting group description

Maternal participants were randomized to receive placebo matching to RSVpreF as a single dose on Day 1 (day of vaccination). Participants were followed up to 6 months after delivery.

Reporting group title

Infant Participants: RSVpreF

Reporting group description

Reporting group title

Infant Participants: Placebo

Reporting group description

Reporting group values	Maternal Participants: RSVpreF	Maternal Participants: Placebo	Infant Participants: RSVpreF	Infant Participants: Placebo	Total
Number of subjects	3698	3687	3659	3646	14690
Age Categorical
Units: Participants
In utero	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	207	172	379
Newborns (0-27 days)	0	0	3452	3474	6926
Infants and toddlers (28 days-23 months)	0	0	0	0	0
Children (2-11 years)	0	0	0	0	0
Adolescents (12-17 years)	9	9	0	0	18
Adults (18-64 years)	3689	3678	0	0	7367
From 65-84 years	0	0	0	0	0
85 years and over	0	0	0	0	0
Age Continuous
Infants are born to the maternal participants that received RSVpreF or placebo. Timeline at birth is 0. This represents the mean age of maternal and infant participants respectively, at the time of enrolment.
Units: years
arithmetic mean (standard deviation)	29.0 ( 5.64 )	29.0 ( 5.75 )	0 ( 0 )	0 ( 0 )	-
Gender Categorical
Units: Participants
Female	3698	3687	1794	1815	10994
Male	0	0	1865	1831	3696
Race
Units: Subjects
American Indian or Alaska Native	38	37	42	36	153
Asian	456	464	446	456	1822
Native Hawaiian or Other Pacific Islander	9	12	13	11	45
Black or African American	720	725	706	706	2857
White	2397	2375	2340	2328	9440
More than one race	30	21	65	59	175
Unknown or Not Reported	48	53	47	50	198
Ethnicity
Units: Subjects
Hispanic or Latino	1063	1086	1079	1081	4309
Not Hispanic or Latino	2605	2568	2529	2519	10221
Unknown or Not Reported	30	33	51	46	160

End points

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Reporting group title

Maternal Participants: RSVpreF

Reporting group description

Reporting group title

Maternal Participants: Placebo

Reporting group description

Maternal participants were randomized to receive placebo matching to RSVpreF as a single dose on Day 1 (day of vaccination). Participants were followed up to 6 months after delivery.

Reporting group title

Infant Participants: RSVpreF

Reporting group description

Reporting group title

Infant Participants: Placebo

Reporting group description

Primary: Percentage of MA-LRTI Cases due to RSV in Infant Participants Occurring Within 90 Days After Birth (Efficacy)

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End point title

Percentage of MA-LRTI Cases due to RSV in Infant Participants Occurring Within 90 Days After Birth (Efficacy) ^[1]

End point description

Results are presented as confirmed by endpoint adjudication committee. MA-LRTI case: Infant with an MA-RTI visit with age related fast breathing (respiratory rate [RR] more than or equal to [=>]60 beats per minute [bpm] for less than [<]2 months of age [<60 days of age], =>50 bpm for =>2 months to <12 months of age, or =>40 bpm for =>12 months to 24 months of age) or oxygen saturation (SpO2) <95% or chest wall indrawing. The causative pathogen was to be determined but may meet endpoint definition if RSV-positivity was confirmed per study requirements. Evaluable efficacy - infant population= all infant participants who were born to maternal participants who did not have major protocol deviations prior to the delivery and who received the investigational product to which they were randomized at least 14 days prior to delivery, were eligible, had no major protocol deviations. “Number of Participants Analyzed”= number of participants included in evaluable efficacy - infant population.

End point type

Primary

End point timeframe

Within 90 Days after birth

Notes
[1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analysed only for infant participants.

End point values	Infant Participants: RSVpreF	Infant Participants: Placebo
Number of subjects analysed	3585	3563
Units: Percentage of cases
number (not applicable)	0.7	1.7

RSVpreF versus placebo

Statistical analysis description

Vaccine efficacy was calculated as 1-(P/[1-P]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.

Comparison groups

Infant Participants: RSVpreF v Infant Participants: Placebo

Number of subjects included in analysis

7148

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Vaccine Efficacy

Point estimate

57.6

Confidence interval

level

95%

sides

2-sided

lower limit

31.3

upper limit

74.6

Primary: Percentage of MA-LRTI Cases due to RSV in Infant Participants Occurring Within 120 Days After Birth (Efficacy)

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End point title

Percentage of MA-LRTI Cases due to RSV in Infant Participants Occurring Within 120 Days After Birth (Efficacy) ^[2]

End point description

Results are presented as confirmed by endpoint adjudication committee. MA-LRTI case: Infant with an MA-RTI visit with age related fast breathing (RR =>60 bpm for <2 months of age [<60 days of age], =>50 bpm for =>2 months to <12 months of age, or =>40 bpm for =>12 months to 24 months of age) or SpO2 <95% or chest wall indrawing. The causative pathogen was to be determined but may meet endpoint definition if RSV-positivity was confirmed per study requirements. Evaluable efficacy - infant population= all infant participants who were born to maternal participants who did not have major protocol deviations prior to the delivery and who received the investigational product to which they were randomized at least 14 days prior to delivery, were eligible, had no major protocol deviations. “Number of Participants Analyzed”= number of participants included in evaluable efficacy - infant population.

End point type

Primary

End point timeframe

Within 120 Days after birth

Notes
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analysed only for infant participants.

End point values	Infant Participants: RSVpreF	Infant Participants: Placebo
Number of subjects analysed	3585	3563
Units: Percentage of cases
number (not applicable)	1.1	2.5

RSVpreF vs placebo

Statistical analysis description

Vaccine efficacy was calculated as 1-(P/[1-P]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.

Comparison groups

Infant Participants: RSVpreF v Infant Participants: Placebo

Number of subjects included in analysis

7148

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Vaccine Efficacy

Point estimate

54.5

Confidence interval

level

95%

sides

2-sided

lower limit

33.2

upper limit

69.5

Primary: Percentage of MA-LRTI Cases due to RSV in Infant Participants Occurring Within 150 Days After Birth (Efficacy)

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End point title

Percentage of MA-LRTI Cases due to RSV in Infant Participants Occurring Within 150 Days After Birth (Efficacy) ^[3]

End point description

End point type

Primary

End point timeframe

Within 150 Days after birth

Notes
[3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analysed only for infant participants.

End point values	Infant Participants: RSVpreF	Infant Participants: Placebo
Number of subjects analysed	3585	3563
Units: Percentage of cases
number (not applicable)	1.5	3.1

RSVpreF vs placebo

Statistical analysis description

Vaccine efficacy was calculated as 1-(P/[1-P]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.

Comparison groups

Infant Participants: RSVpreF v Infant Participants: Placebo

Number of subjects included in analysis

7148

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Vaccine Efficacy

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

30.3

upper limit

64.5

Primary: Percentage of Severe MA-LRTI Cases due to RSV in Infant Participants Occurring Within 120 Days After Birth (Efficacy)

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End point title

Percentage of Severe MA-LRTI Cases due to RSV in Infant Participants Occurring Within 120 Days After Birth (Efficacy) ^[4]

End point description

Results are presented as confirmed by endpoint adjudication committee. Severe MA-LRTI cases were a subset of MA-LRTI cases, and all severe MA-LRTI cases were considered MA-LRTI cases. Severe MA-LRTI case was a RSV positively adjudicated event which met the following defined criteria: An infant with an MA-RTI visit and aged associated fast breathing (RR =>70 bpm for <2 months of age [<60 days of age], =>60 bpm for =>2 months to <12 months of age, or =>50 bpm for =>12 months to 24 months of age) or SpO2 <93% or high-flow nasal cannula or mechanical ventilation (i.e., invasive or noninvasive) or ICU admission for more than (>)4 hours or failure to respond/unconscious. Evaluable efficacy - infant population was used. Here, “Number of Participants Analyzed” signifies number of participants included in evaluable efficacy - infant population.

End point type

Primary

End point timeframe

Within 120 Days after birth

Notes
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analysed only for infant participants.

End point values	Infant Participants: RSVpreF	Infant Participants: Placebo
Number of subjects analysed	3585	3563
Units: Percentage of cases
number (not applicable)	0.4	1.4

RSVpreF vs placebo

Statistical analysis description

Vaccine efficacy was calculated as 1-(P/[1-P]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.

Comparison groups

Infant Participants: RSVpreF v Infant Participants: Placebo

Number of subjects included in analysis

7148

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Vaccine Efficacy

Point estimate

73.5

Confidence interval

level

95%

sides

2-sided

lower limit

50.3

upper limit

86.8

Primary: Percentage of Severe MA-LRTI Cases due to RSV in Infant Participants Occurring Within 90 Days After Birth (Efficacy)

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End point title

Percentage of Severe MA-LRTI Cases due to RSV in Infant Participants Occurring Within 90 Days After Birth (Efficacy) ^[5]

End point description

End point type

Primary

End point timeframe

Within 90 Days after birth

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

End point values	Infant Participants: RSVpreF	Infant Participants: Placebo
Number of subjects analysed	3585	3563
Units: Percentage of cases
number (not applicable)	0.2	1.0

RSVpreF vs placebo

Comparison groups

Infant Participants: RSVpreF v Infant Participants: Placebo

Number of subjects included in analysis

7148

Analysis specification

Pre-specified

Analysis type

superiority ^[6]

Method

Parameter type

Vaccine Efficacy

Point estimate

82.4

Confidence interval

level

95%

sides

2-sided

lower limit

57.5

upper limit

93.9

Notes
[6] - Vaccine efficacy was calculated as 1-(P/[1-P]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.

Primary: Percentage of MA-LRTI Cases due to RSV in Infant Participants Occurring Within 180 Days After Birth (Efficacy)

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End point title

Percentage of MA-LRTI Cases due to RSV in Infant Participants Occurring Within 180 Days After Birth (Efficacy) ^[7]

End point description

End point type

Primary

End point timeframe

Within 180 Days after birth

Notes
[7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analysed only for infant participants.

End point values	Infant Participants: RSVpreF	Infant Participants: Placebo
Number of subjects analysed	3585	3563
Units: Percentage of cases
number (not applicable)	1.9	3.7

RSVpreF vs placebo

Statistical analysis description

Vaccine efficacy was calculated as 1-(P/[1-P]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.

Comparison groups

Infant Participants: RSVpreF v Infant Participants: Placebo

Number of subjects included in analysis

7148

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Vaccine Efficacy

Point estimate

49.2

Confidence interval

level

95%

sides

2-sided

lower limit

31.4

upper limit

62.8

Primary: Percentage of Infant Participants With Adverse Events of Special Interest (AESI) (Safety)

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End point title

Percentage of Infant Participants With Adverse Events of Special Interest (AESI) (Safety) ^[8] ^[9]

End point description

AESI: Subset of targeted medical events based on review of known pharmacology, toxicology findings, possible class effects, published literature, and signals arising from safety data assessments, and on population under study. AESI's were based on targeted medical events associated with pregnant maternal participants and their infants prior to/during delivery and at birth. For infant participants AESI: Preterm birth (born at <37weeks gestation); birth weight 1001-2500 grams; developmental delay; positive viral (polymerase chain reaction [PCR] or antigen-based) testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), when not reported during MA-RTI visit, were reported as SARS-CoV-2 test positive. Extremely preterm birth (<28weeks), extremely low birth weight (=<1000 g) were reported AESI as SAE. Infant safety population: infant participants born to vaccinated maternal participants. “Number of Participants Analyzed”= participants included in infant safety population.

End point type

Primary

End point timeframe

Birth to 24 Months of age

Notes
[8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was analysed only for infant participants.
[9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analysed only for infant participants.

End point values	Infant Participants: RSVpreF	Infant Participants: Placebo
Number of subjects analysed	3659	3646
Units: Percentage of participants
number (confidence interval 95%)	11.9 (10.8 to 13.0)	10.3 (9.3 to 11.3)

No statistical analyses for this end point

Primary: Percentage of Severe MA-LRTI Cases due to RSV in Infant Participants Occurring Within 150 Days After Birth (Efficacy)

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End point title

Percentage of Severe MA-LRTI Cases due to RSV in Infant Participants Occurring Within 150 Days After Birth (Efficacy) ^[10]

End point description

End point type

Primary

End point timeframe

Within 150 Days after birth

Notes
[10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analysed only for infant participants.

End point values	Infant Participants: RSVpreF	Infant Participants: Placebo
Number of subjects analysed	3585	3563
Units: Percentage of cases
number (not applicable)	0.5	1.7

RSVpreF vs placebo

Statistical analysis description

Vaccine efficacy was calculated as 1-(P/[1-P]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.

Comparison groups

Infant Participants: RSVpreF v Infant Participants: Placebo

Number of subjects included in analysis

7148

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Vaccine Efficacy

Point estimate

70.5

Confidence interval

level

95%

sides

2-sided

lower limit

49.4

upper limit

83.6

Primary: Percentage of Severe MA-LRTI Cases due to RSV in Infant Participants Occurring Within 180 Days After Birth (Efficacy)

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End point title

Percentage of Severe MA-LRTI Cases due to RSV in Infant Participants Occurring Within 180 Days After Birth (Efficacy) ^[11]

End point description

End point type

Primary

End point timeframe

Within 180 Days after birth

Notes
[11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analysed only for infant participants.

End point values	Infant Participants: RSVpreF	Infant Participants: Placebo
Number of subjects analysed	3585	3563
Units: Percentage of cases
number (not applicable)	0.6	2.0

RSVpreF vs placebo

Statistical analysis description

Vaccine efficacy was calculated as 1-(P/[1-P]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.

Comparison groups

Infant Participants: RSVpreF v Infant Participants: Placebo

Number of subjects included in analysis

7148

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Vaccine Efficacy

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

50.6

upper limit

82.5

Primary: Percentage of Infant Participants According to Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute After Birth (Safety)

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End point title

Percentage of Infant Participants According to Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute After Birth (Safety) ^[12] ^[13]

End point description

APGAR was a fast evaluation technique used to evaluate a newborn baby's overall health immediately after birth, and at 5 or 10 minutes later. APGAR stands for (A) Appearance (skin coloration), (P) Pulse (heart rate), (G) Grimace (reflex response), (A) Activity (muscle tone) and (R) Respiration (breathing). Each component was given a score of 0, 1, or 2 for a total possible score of 0-10, where higher scores indicate better health. A score of 7 to 10 was good, 4 to <7 was moderate, and <4 is poor. Infant safety population included all infant participants who were born to vaccinated maternal participants. Here, “Number of Participants Analyzed” signifies number of participants included in infant safety population.

End point type

Primary

End point timeframe

1 Minute after birth

Notes
[12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was analysed only for infant participants.
[13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analysed only for infant participants.

End point values	Infant Participants: RSVpreF	Infant Participants: Placebo
Number of subjects analysed	3625	3606
Units: Percentage of participants
number (not applicable)
Score Less than (<)4	1.4	1.2
Score 4 to <7	3.7	3.4
Score 7 to 10	94.9	95.3

No statistical analyses for this end point

Primary: Percentage of Infant Participants With Neonatal Deaths (Safety)

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End point title

Percentage of Infant Participants With Neonatal Deaths (Safety) ^[14] ^[15]

End point description

Neonatal death was defined as the death of a live-born infant that occurred within a month after birth. Infant safety population included all infant participants who were born to vaccinated maternal participants. Here, “Number of Participants Analyzed” signifies number of participants included in infant safety population.

End point type

Primary

End point timeframe

Within 1 Month after birth

Notes
[14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was analysed only for infant participants.
[15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analysed only for infant participants.

End point values	Infant Participants: RSVpreF	Infant Participants: Placebo
Number of subjects analysed	3659	3646
Units: Percentage of participants
number (confidence interval 95%)	0.1 (0.0 to 0.2)	0.1 (0.0 to 0.3)

No statistical analyses for this end point

Primary: Percentage of Infant Participants With Congenital Malformations/Anomalies (Safety)

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End point title

Percentage of Infant Participants With Congenital Malformations/Anomalies (Safety) ^[16] ^[17]

End point description

Congenital malformations/ anomalies were defined as structural or functional anomalies that occurred during intrauterine life and could be identified prenatally, at birth or later in life. Infant safety population included all infant participants who were born to vaccinated maternal participants. Here, “Number of Participants Analyzed” signifies number of participants included in infant safety population.

End point type

Primary

End point timeframe

At birth

Notes
[16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was analysed only for infant participants.
[17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analysed only for infant participants.

End point values	Infant Participants: RSVpreF	Infant Participants: Placebo
Number of subjects analysed	3659	3646
Units: Percentage of participants
number (not applicable)	5.6	6.7

No statistical analyses for this end point

Primary: Percentage of Infant Participants With Other Neonatal Events (Safety)

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End point title

Percentage of Infant Participants With Other Neonatal Events (Safety) ^[18] ^[19]

End point description

Infant safety population included all infant participants who were born to vaccinated maternal participants. Here, “Number of Participants Analyzed” signifies number of participants included in infant safety population.

End point type

Primary

End point timeframe

Within 1 Month after birth

Notes
[18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was analysed only for infant participants.
[19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analysed only for infant participants.

End point values	Infant Participants: RSVpreF	Infant Participants: Placebo
Number of subjects analysed	3659	3646
Units: Percentage of participants
number (not applicable)	6.2	5.5

No statistical analyses for this end point

Primary: Percentage of Infant Participants According to APGAR Score at 5 Minutes After Birth (Safety)

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End point title

Percentage of Infant Participants According to APGAR Score at 5 Minutes After Birth (Safety) ^[20] ^[21]

End point description

End point type

Primary

End point timeframe

5 Minutes after birth

Notes
[20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was analysed only for infant participants.
[21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analysed only for infant participants.

End point values	Infant Participants: RSVpreF	Infant Participants: Placebo
Number of subjects analysed	3618	3602
Units: Percentage of participants
number (not applicable)
Score <4	0.2	0.1
Score 4 to <7	0.8	0.7
Score 7 to 10	99.0	99.1

No statistical analyses for this end point

Primary: Percentage of Infant Participants According to APGAR Score at 10 Minutes After Birth (Safety)

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End point title

Percentage of Infant Participants According to APGAR Score at 10 Minutes After Birth (Safety) ^[22] ^[23]

End point description

End point type

Primary

End point timeframe

10 Minutes after birth

Notes
[22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was analysed only for infant participants.
[23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analysed only for infant participants.

End point values	Infant Participants: RSVpreF	Infant Participants: Placebo
Number of subjects analysed	999	999
Units: Percentage of participants
number (not applicable)
Score <4	0	0
Score 4 to <7	0.6	0.4
Score 7 to 10	99.4	99.6

No statistical analyses for this end point

Primary: Percentage of Infant Participants With SAEs and NDCMCs From Birth Through 12 Months of Age (Safety)

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End point title

Percentage of Infant Participants With SAEs and NDCMCs From Birth Through 12 Months of Age (Safety) ^[24] ^[25]

End point description

An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or that was considered an important medical event. A NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Infant safety population included all infant participants who were born to vaccinated maternal participants. Here, “Number of Participants Analyzed” signifies participants included in infant safety population and evaluable for this endpoint.

End point type

Primary

End point timeframe

From birth to 12 Months of age

Notes
[24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was analysed only for infant participants.
[25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analysed only for infant participants.

End point values	Infant Participants: RSVpreF	Infant Participants: Placebo
Number of subjects analysed	3568	3558
Units: Percentage of participants
number (confidence interval 95%)
SAE	17.3 (16.1 to 18.6)	17.2 (15.9 to 18.5)
NDCMC	2.1 (1.7 to 2.6)	2.3 (1.9 to 2.9)

No statistical analyses for this end point

Primary: Percentage of Infant Participants With Adverse Events (AEs) From Birth to 1 Month of Age (Safety)

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End point title

Percentage of Infant Participants With Adverse Events (AEs) From Birth to 1 Month of Age (Safety) ^[26] ^[27]

End point description

An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Infant safety population included all infant participants who were born to vaccinated maternal participants. Here, “Number of Participants Analyzed” signifies number of participants included in infant safety population.

End point type

Primary

End point timeframe

From birth to 1 Month of age

Notes
[26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was analysed only for infant participants.
[27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analysed only for infant participants.

End point values	Infant Participants: RSVpreF	Infant Participants: Placebo
Number of subjects analysed	3659	3646
Units: Percentage of participants
number (confidence interval 95%)	38.0 (36.4 to 39.6)	35.4 (33.9 to 37.0)

No statistical analyses for this end point

Primary: Percentage of Infant Participants With Serious Adverse Events (SAEs) and Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Birth Through 6 Months of Age (Safety)

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End point title

Percentage of Infant Participants With Serious Adverse Events (SAEs) and Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Birth Through 6 Months of Age (Safety) ^[28] ^[29]

End point description

End point type

Primary

End point timeframe

From birth to 6 Months of age

Notes
[28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was analysed only for infant participants.
[29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analysed only for infant participants.

End point values	Infant Participants: RSVpreF	Infant Participants: Placebo
Number of subjects analysed	3568	3558
Units: Percentage of participants
number (confidence interval 95%)
SAE	16.7 (15.5 to 17.9)	16.4 (15.2 to 17.7)
NDCMC	1.3 (0.9 to 1.7)	1.6 (1.2 to 2.1)

No statistical analyses for this end point

Primary: Percentage of Maternal Participants With Prespecified Local Reactions (LR) Within 7 Days After Vaccination (Safety)

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End point title

Percentage of Maternal Participants With Prespecified Local Reactions (LR) Within 7 Days After Vaccination (Safety) ^[30] ^[31]

End point description

Local reactions included redness, swelling, and pain at injection site and were recorded in electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit= 0.5 centimetre (cm). Redness and swelling were graded as mild (greater than [>]2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and grade 4 (necrosis or exfoliative dermatitis). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization for the severe pain at the injection site). Maternal safety population included all randomised maternal participants who received investigational product. Here, “Number of Participants Analyzed” = number of participants included in maternal safety population and evaluable for this endpoint.

End point type

Primary

End point timeframe

Within 7 Day follow-up period after vaccination

Notes
[30] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was analysed only for maternal participants.
[31] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analysed only for maternal participants.

End point values	Maternal Participants: RSVpreF	Maternal Participants: Placebo
Number of subjects analysed	3678	3651
Units: Percentage of participants
number (confidence interval 95%)
Redness: Any	7.2 (6.4 to 8.1)	0.2 (0.1 to 0.4)
Redness: Mild	5.0 (4.3 to 5.7)	0.1 (0.0 to 0.3)
Redness: Moderate	2.1 (1.7 to 2.6)	0.1 (0.0 to 0.3)
Redness: Severe	0.1 (0.0 to 0.3)	0 (0.0 to 0.1)
Redness: Grade 4	0 (0.0 to 0.1)	0 (0.0 to 0.1)
Swelling: Any	6.2 (5.4 to 7.0)	0.2 (0.1 to 0.4)
Swelling: Mild	4.1 (3.5 to 4.8)	0.1 (0.0 to 0.3)
Swelling: Moderate	2.0 (1.6 to 2.5)	0.1 (0.0 to 0.2)
Swelling: Severe	0.1 (0.0 to 0.2)	0 (0.0 to 0.1)
Swelling: Grade 4	0 (0.0 to 0.1)	0 (0.0 to 0.1)
Pain at injection site: Any	40.7 (39.1 to 42.3)	10.2 (9.2 to 11.2)
Pain at injection site: Mild	36.1 (34.6 to 37.7)	9.3 (8.4 to 10.3)
Pain at injection site: Moderate	4.5 (3.8 to 5.2)	0.9 (0.6 to 1.2)
Pain at injection site: Severe	0.1 (0.0 to 0.3)	0 (0.0 to 0.1)
Pain at injection site: Grade 4	0 (0.0 to 0.1)	0 (0.0 to 0.1)

No statistical analyses for this end point

Primary: Percentage of Infant Participants With SAEs and NDCMCs From Birth Through 24 Months of Age (Safety)

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End point title

Percentage of Infant Participants With SAEs and NDCMCs From Birth Through 24 Months of Age (Safety) ^[32] ^[33]

End point description

End point type

Primary

End point timeframe

From birth to 24 Months of age

Notes
[32] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was analysed only for infant participants.
[33] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analysed only for infant participants.

End point values	Infant Participants: RSVpreF	Infant Participants: Placebo
Number of subjects analysed	3659	3646
Units: Percentage of participants
number (confidence interval 95%)
SAE	19.0 (17.8 to 20.4)	18.9 (17.6 to 20.2)
NDCMC	3.9 (3.3 to 4.6)	4.5 (3.8 to 5.2)

No statistical analyses for this end point

Primary: Percentage of Maternal Participants With Prespecified Systemic Events (SE) Within 7 Days after Vaccination (Safety)

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End point title

Percentage of Maternal Participants With Prespecified Systemic Events (SE) Within 7 Days after Vaccination (Safety) ^[34] ^[35]

End point description

Systemic events included: fever, fatigue, headache, nausea, muscle pain, joint pain, vomiting, and diarrhoea. Fever was classified as: =>38.0 degree Celsius [C]), 38.0-38.4, 38.5-38.9, 39.0 40.0 and >40.0 degree C. Headache, nausea, fatigue, muscle pain and joint pain were graded as mild (didn’t interfere with activity), moderate (some interference with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Vomiting: mild (1-2 times in 24 hours [H]), moderate (>2 times in 24 H), severe (required intravenous [IV] hydration) and grade 4 (emergency room visit or hospitalization). Diarrhoea: mild (2-3 loose stools in 24 H), moderate (4-5 loose stools in 24 H), severe (>=6 in 24 H) and grade 4 (emergency room visit or hospitalization). Maternal safety population evaluated. Here, “Number of Participants Analyzed”= participants included in maternal safety population and evaluable for this endpoint.

End point type

Primary

End point timeframe

Within 7 Day follow-up period after vaccination

Notes
[34] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was analysed only for maternal participants.
[35] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analysed only for maternal participants.

End point values	Maternal Participants: RSVpreF	Maternal Participants: Placebo
Number of subjects analysed	3678	3651
Units: Percentage of participants
number (confidence interval 95%)
Fever: >=38.0 degree C	2.6 (2.1 to 3.1)	2.9 (2.4 to 3.5)
Fever: 38.0 to 38.4 degree C	1.7 (1.3 to 2.1)	1.5 (1.1 to 2.0)
Fever: 38.5 to 38.9 degree C	0.8 (0.5 to 1.1)	1.2 (0.8 to 1.6)
Fever: 39.0 to 40.0 degree C	0.1 (0.0 to 0.2)	0.1 (0.0 to 0.3)
Fever: >40.0 degree C	0.1 (0.0 to 0.2)	0.1 (0.0 to 0.3)
Fatigue: Any	46.1 (44.5 to 47.7)	43.8 (42.2 to 45.4)
Fatigue: Mild	23.5 (22.1 to 24.9)	22.7 (21.4 to 24.1)
Fatigue: Moderate	21.3 (20.0 to 22.7)	19.6 (18.4 to 21.0)
Fatigue: Severe	1.3 (1.0 to 1.8)	1.4 (1.1 to 1.9)
Fatigue: Grade 4	0 (0.0 to 0.1)	0 (0.0 to 0.1)
Headache: Any	31.0 (29.5 to 32.5)	27.6 (26.2 to 29.1)
Headache: Mild	20.2 (18.9 to 21.5)	17.9 (16.7 to 19.2)
Headache: Moderate	10.4 (9.4 to 11.4)	9.4 (8.5 to 10.4)
Headache: Severe	0.4 (0.2 to 0.7)	0.4 (0.2 to 0.6)
Headache: Grade 4	0 (0.0 to 0.1)	0 (0.0 to 0.1)
Nausea: Any	20.0 (18.7 to 21.3)	19.3 (18.0 to 20.6)
Nausea: Mild	14.4 (13.3 to 15.6)	13.9 (12.8 to 15.0)
Nausea: Moderate	5.4 (4.7 to 6.1)	5.2 (4.5 to 6.0)
Nausea: Severe	0.2 (0.1 to 0.4)	0.2 (0.1 to 0.4)
Nausea: Grade 4	0 (0.0 to 0.1)	0 (0.0 to 0.1)
Muscle pain: Any	26.6 (25.1 to 28.0)	17.1 (15.9 to 18.4)
Muscle pain: Mild	17.6 (16.4 to 18.9)	10.0 (9.0 to 11.0)
Muscle pain: Moderate	8.6 (7.7 to 9.5)	6.8 (6.0 to 7.7)
Muscle pain: Severe	0.4 (0.2 to 0.6)	0.3 (0.2 to 0.6)
Muscle pain: Grade 4	0 (0.0 to 0.1)	0 (0.0 to 0.1)
Joint pain: Any	11.6 (10.6 to 12.7)	10.5 (9.5 to 11.6)
Joint pain: Mild	6.5 (5.7 to 7.3)	6.0 (5.2 to 6.8)
Joint pain: Moderate	4.9 (4.2 to 5.7)	4.4 (3.8 to 5.2)
Joint pain: Severe	0.2 (0.1 to 0.4)	0.1 (0.0 to 0.2)
Joint pain: Grade 4	0 (0.0 to 0.1)	0 (0.0 to 0.1)
Vomiting: Any	7.9 (7.0 to 8.8)	7.0 (6.2 to 7.8)
Vomiting: Mild	6.4 (5.6 to 7.2)	5.4 (4.7 to 6.1)
Vomiting: Moderate	1.3 (0.9 to 1.7)	1.5 (1.2 to 2.0)
Vomiting: Severe	0.2 (0.1 to 0.4)	0.1 (0.0 to 0.2)
Vomiting: Grade 4	0 (0.0 to 0.1)	0 (0.0 to 0.1)
Diarrhoea: Any	11.3 (10.3 to 12.3)	11.4 (10.4 to 12.5)
Diarrhoea: Mild	9.1 (8.2 to 10.1)	9.4 (8.4 to 10.4)
Diarrhoea: Moderate	2.0 (1.6 to 2.5)	1.9 (1.4 to 2.4)
Diarrhoea: Severe	0.1 (0.0 to 0.3)	0.2 (0.1 to 0.4)
Diarrhoea: Grade 4	0 (0.0 to 0.1)	0 (0.0 to 0.1)

No statistical analyses for this end point

Primary: Percentage of Maternal Participants With SAEs Throughout the Study Period (Safety)

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End point title

Percentage of Maternal Participants With SAEs Throughout the Study Period (Safety) ^[36] ^[37]

End point description

SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or that was considered an important medical event. Maternal safety population included all randomised maternal participants who received investigational product. Here, “Number of Participants Analyzed” signifies participants included in maternal safety population.

End point type

Primary

End point timeframe

Up to 6 Months

Notes
[36] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was analysed only for maternal participants.
[37] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analysed only for maternal participants.

End point values	Maternal Participants: RSVpreF	Maternal Participants: Placebo
Number of subjects analysed	3698	3687
Units: Percentage of participants
number (confidence interval 95%)	16.6 (15.4 to 17.8)	15.8 (14.6 to 17.0)

No statistical analyses for this end point

Primary: Percentage of Maternal Participants With AEs From the Time of Vaccination Through 1 Month After Vaccination (Safety)

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End point title

Percentage of Maternal Participants With AEs From the Time of Vaccination Through 1 Month After Vaccination (Safety) ^[38] ^[39]

End point description

An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Maternal safety population included all randomised maternal participants who received investigational product. Here, “Number of Participants Analyzed” signifies participants included in maternal safety population.

End point type

Primary

End point timeframe

1 Month after vaccination

Notes
[38] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was analysed only for maternal participants.
[39] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analysed only for maternal participants.

End point values	Maternal Participants: RSVpreF	Maternal Participants: Placebo
Number of subjects analysed	3698	3687
Units: Percentage of participants
number (confidence interval 95%)	14.0 (12.9 to 15.1)	13.2 (12.2 to 14.4)

No statistical analyses for this end point

Secondary: Percentage of Hospitalizations due to RSV in Infant Participants Occurring Within 90, 120, 150, 180 and 360 Days After Birth (Efficacy)

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End point title

Percentage of Hospitalizations due to RSV in Infant Participants Occurring Within 90, 120, 150, 180 and 360 Days After Birth (Efficacy) ^[40]

End point description

Results are reported as confirmed by endpoint adjudication committee. The evaluable efficacy – infant population included all infant participants who are born to maternal participants who did not have major protocol deviations prior to the delivery and who received the investigational product to which they were randomized at least 14 days prior to delivery, were eligible, and had no major protocol deviations. Here, “Number of Participants Analyzed” signifies participants included in evaluable efficacy – infant population and evaluable for this endpoint.

End point type

Secondary

End point timeframe

Within 90, 120, 150, 180 and 360 Days after birth

Notes
[40] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analysed only for infant participants.

End point values	Infant Participants: RSVpreF	Infant Participants: Placebo
Number of subjects analysed	3585	3563
Units: Percentage of participants
number (not applicable)
90 days after birth	0.3	0.9
120 days after birth	0.4	1.1
150 days after birth	0.5	1.2
180 days after birth	0.6	1.3
360 days after birth	1.4	1.9

RSVpreF vs placebo

Statistical analysis description

Comparison groups

Infant Participants: RSVpreF v Infant Participants: Placebo

Number of subjects included in analysis

7148

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Vaccine efficacy

Point estimate

69.7

Confidence interval

level

95%

sides

2-sided

lower limit

37.1

upper limit

86.7

RSVpreF vs placebo

Statistical analysis description

Comparison groups

Infant Participants: RSVpreF v Infant Participants: Placebo

Number of subjects included in analysis

7148

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Vaccine efficacy

Point estimate

61.5

Confidence interval

level

95%

sides

2-sided

lower limit

28.6

upper limit

80.3

RSVpreF vs placebo

Statistical analysis description

Comparison groups

Infant Participants: RSVpreF v Infant Participants: Placebo

Number of subjects included in analysis

7148

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Vaccine efficacy

Point estimate

57.1

Confidence interval

level

95%

sides

2-sided

lower limit

23.9

upper limit

76.8

RSVpreF vs placebo

Statistical analysis description

Comparison groups

Infant Participants: RSVpreF v Infant Participants: Placebo

Number of subjects included in analysis

7148

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Vaccine efficacy

Point estimate

55.3

Confidence interval

level

95%

sides

2-sided

lower limit

23.8

upper limit

74.6

RSVpreF vs placebo

Statistical analysis description

Comparison groups

Infant Participants: RSVpreF v Infant Participants: Placebo

Number of subjects included in analysis

7148

Analysis specification

Post-hoc

Analysis type

superiority

Method

Parameter type

Vaccine efficacy

Point estimate

24.2

Confidence interval

level

95%

sides

2-sided

lower limit

-11.1

upper limit

48.6

Secondary: Percentage of MA-LRTI Cases due to any Cause With Protocol Defined Criteria in Infant Participants Occurring Within 90, 120, 150, 180 and 360 Days After Birth (Efficacy)

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End point title

Percentage of MA-LRTI Cases due to any Cause With Protocol Defined Criteria in Infant Participants Occurring Within 90, 120, 150, 180 and 360 Days After Birth (Efficacy) ^[41]

End point description

MA-LRTI cases due to any cause occurring within 90 days, 120 days, 150 days, 180 days, and 360 days after birth was defined as an infant with an MA-RTI visit with age related fast breathing (RR =>60 bpm for <2 months of age [<60 days of age], =>50 bpm for =>2 months to <12 months of age, or =>40 bpm for =>12 months to 24 months of age) or SpO2 <95% or chest wall indrawing. The evaluable efficacy - infant population included all infant participants who were born to maternal participants who did not have major protocol deviations prior to the delivery and who received the investigational product to which they were randomized at least 14 days prior to delivery, were eligible, and had no major protocol deviations. Here, “Number of Participants Analyzed” signifies number of participants included in evaluable efficacy - infant population and evaluable for this endpoint.

End point type

Secondary

End point timeframe

Within 90, 120, 150, 180 and 360 Days after birth

Notes
[41] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analysed only for infant participants.

End point values	Infant Participants: RSVpreF	Infant Participants: Placebo
Number of subjects analysed	3495	3480
Units: Percentage of cases
number (not applicable)
90 days after birth	5.3	5.7
120 days after birth	7.5	8.0
150 days after birth	9.5	10.0
180 days after birth	11.2	11.6
360 days after birth	14.4	15.3

RSVpreF vs placebo

Statistical analysis description

Vaccine efficacy within 90 days after birth. Vaccine efficacy was calculated as 1-(P/[1-P]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.

Comparison groups

Infant Participants: RSVpreF v Infant Participants: Placebo

Number of subjects included in analysis

6975

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Vaccine efficacy

Point estimate

Confidence interval

level

99.17%

sides

2-sided

lower limit

-22.3

upper limit

29.3

RSVpreF vs placebo

Statistical analysis description

Vaccine efficacy within 120 days after birth. Vaccine efficacy was calculated as 1-(P/[1-P]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.

Comparison groups

Infant Participants: RSVpreF v Infant Participants: Placebo

Number of subjects included in analysis

6975

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Vaccine efficacy

Point estimate

6.1

Confidence interval

level

99.17%

sides

2-sided

lower limit

-18.3

upper limit

25.5

RSVpreF vs placebo

Statistical analysis description

Vaccine efficacy within 360 days after birth. Vaccine efficacy was calculated as 1-(P/[1-P]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.

Comparison groups

Infant Participants: RSVpreF v Infant Participants: Placebo

Number of subjects included in analysis

6975

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Vaccine efficacy

Point estimate

5.1

Confidence interval

level

99.17%

sides

2-sided

lower limit

-12.1

upper limit

19.6

RSVpreF vs placebo

Statistical analysis description

Vaccine efficacy within 180 days after birth. Vaccine efficacy was calculated as 1-(P/[1-P]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.

Comparison groups

Infant Participants: RSVpreF v Infant Participants: Placebo

Number of subjects included in analysis

6975

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Vaccine efficacy

Point estimate

2.5

Confidence interval

level

99.17%

sides

2-sided

lower limit

-17.9

upper limit

19.4

RSVpreF vs placebo

Statistical analysis description

Vaccine efficacy within 150 days after birth. Vaccine efficacy was calculated as 1-(P/[1-P]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.

Comparison groups

Infant Participants: RSVpreF v Infant Participants: Placebo

Number of subjects included in analysis

6975

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Vaccine efficacy

Point estimate

5.2

Confidence interval

level

99.17%

sides

2-sided

lower limit

-16.5

upper limit

22.8

Secondary: Percentage of MA-LRTI Cases due to RSV in Infant Participants Occurring Within 210, 240, 270 and 360 Days After Birth (Efficacy)

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End point title

Percentage of MA-LRTI Cases due to RSV in Infant Participants Occurring Within 210, 240, 270 and 360 Days After Birth (Efficacy) ^[42]

End point description

End point type

Secondary

End point timeframe

Within 210, 240, 270 and 360 Days after birth

Notes
[42] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was analysed only for infant participants.

End point values	Infant Participants: RSVpreF	Infant Participants: Placebo
Number of subjects analysed	3495	3480
Units: Percentage of cases
number (not applicable)
210 days after birth	2.0	3.6
240 days after birth	2.2	3.8
270 days after birth	2.3	3.9
360 days after birth	2.6	4.5

RSVpreF vs placebo

Statistical analysis description

Vaccine efficacy at 210 days after birth. Vaccine efficacy was calculated as 1-(P/[1-P]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.

Comparison groups

Infant Participants: RSVpreF v Infant Participants: Placebo

Number of subjects included in analysis

6975

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Vaccine efficacy

Point estimate

44.9

Confidence interval

level

99.17%

sides

2-sided

lower limit

17.9

upper limit

63.5

RSVpreF vs placebo

Statistical analysis description

Vaccine efficacy at 360 days after birth. Vaccine efficacy was calculated as 1-(P/[1-P]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.

Comparison groups

Infant Participants: RSVpreF v Infant Participants: Placebo

Number of subjects included in analysis

6975

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Vaccine efficacy

Point estimate

Confidence interval

level

99.17%

sides

2-sided

lower limit

16.2

upper limit

58.9

RSVpreF vs placebo

Statistical analysis description

Vaccine efficacy at 270 days after birth. Vaccine efficacy was calculated as 1-(P/[1-P]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.

Comparison groups

Infant Participants: RSVpreF v Infant Participants: Placebo

Number of subjects included in analysis

6975

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Vaccine efficacy

Point estimate

40.1

Confidence interval

level

99.17%

sides

2-sided

lower limit

upper limit

59.2

RSVpreF vs placebo

Statistical analysis description

Vaccine efficacy at 240 days after birth. Vaccine efficacy was calculated as 1-(P/[1-P]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.

Comparison groups

Infant Participants: RSVpreF v Infant Participants: Placebo

Number of subjects included in analysis

6975

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Vaccine efficacy

Point estimate

42.9

Confidence interval

level

99.17%

sides

2-sided

lower limit

16.1

upper limit

61.6

Adverse events

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Timeframe for reporting adverse events

Maternal participants: AEs: Consent until 28 days after vaccination. SAEs & other AEs: Consent until end of study visit. Infant participants: AEs: Birth until 28 days after birth. SAEs, NDCMCs & other AEs: Consent until end of study visit

Adverse event reporting additional description

LR & SE were assessed by systematic assessment (SA) & AEs by non-SA. Same event may appear as both an AE & SAE. But, what is presented are distinct events. An event may be categorized as serious in one participant & as non-serious in another, or a participant may have experienced both SAE & non-SAE Maternal & infant safety population was evaluated.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

26.1

Reporting group title

Maternal Participants: RSVpreF

Reporting group description

Study-eligible pregnant women (maternal participants) were randomized to receive a single dose of 120 mcg RSVpreF, IM on Day 1 (day of vaccination). Participants were followed up to 6 months after delivery.

Reporting group title

Infant Participants: RSVpreF

Reporting group description

Reporting group title

Infant Participants: Placebo

Reporting group description

Reporting group title

Maternal Participants: Placebo

Reporting group description

Maternal participants were randomized to receive placebo matching to RSVpreF as a single dose on Day 1 (day of vaccination). Participants were followed up to 6 months after delivery.

Serious adverse events	Maternal Participants: RSVpreF	Infant Participants: RSVpreF	Infant Participants: Placebo	Maternal Participants: Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	613 / 3698 (16.58%)	697 / 3659 (19.05%)	689 / 3646 (18.90%)	581 / 3687 (15.76%)
number of deaths (all causes)	1	8	14	0
number of deaths resulting from adverse events	1	8	14	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skull base tumour
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
Acute myeloid leukaemia
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Spinal cord lipoma
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ovarian neoplasm
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neuroblastoma
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Eye haemangioma
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neoplasm skin
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Haemangioma
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	5 / 3646 (0.14%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Haemangioma of skin
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infantile haemangioma
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Juvenile xanthogranuloma
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Eyelid haemangioma
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ulcerated haemangioma
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Kawasaki's disease
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypotension
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypovolaemic shock
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood pressure fluctuation
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cyanosis
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	5 / 3646 (0.14%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Deep vein thrombosis
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	3 / 3687 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Haemorrhage
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypertension
subjects affected / exposed	13 / 3698 (0.35%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	6 / 3687 (0.16%)
occurrences causally related to treatment / all	0 / 13	0 / 0	0 / 0	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypertensive crisis
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Superficial vein thrombosis
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Scalp haematoma
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Subgaleal haematoma
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Surgical and medical procedures
Extradural haematoma evacuation
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Low birth weight baby
subjects affected / exposed	0 / 3698 (0.00%)	29 / 3659 (0.79%)	31 / 3646 (0.85%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 29	0 / 31	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
Postpartum haemorrhage
subjects affected / exposed	29 / 3698 (0.78%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	33 / 3687 (0.90%)
occurrences causally related to treatment / all	0 / 29	0 / 0	0 / 0	0 / 33
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
Premature baby
subjects affected / exposed	0 / 3698 (0.00%)	49 / 3659 (1.34%)	42 / 3646 (1.15%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 49	0 / 42	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
Abnormal labour
subjects affected / exposed	5 / 3698 (0.14%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	7 / 3687 (0.19%)
occurrences causally related to treatment / all	0 / 5	0 / 0	0 / 0	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Abortion spontaneous
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	2 / 3687 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Arrested labour
subjects affected / exposed	37 / 3698 (1.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	43 / 3687 (1.17%)
occurrences causally related to treatment / all	0 / 37	0 / 0	0 / 0	0 / 43
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Birth trauma
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Breech presentation
subjects affected / exposed	6 / 3698 (0.16%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	5 / 3687 (0.14%)
occurrences causally related to treatment / all	0 / 6	0 / 0	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cephalhaematoma
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cephalo-pelvic disproportion
subjects affected / exposed	14 / 3698 (0.38%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	19 / 3687 (0.52%)
occurrences causally related to treatment / all	0 / 14	0 / 0	0 / 0	0 / 19
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foetal disorder
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	2 / 3687 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foetal death
subjects affected / exposed	6 / 3698 (0.16%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	8 / 3687 (0.22%)
occurrences causally related to treatment / all	0 / 6	0 / 0	0 / 0	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foetal distress syndrome
subjects affected / exposed	67 / 3698 (1.81%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	65 / 3687 (1.76%)
occurrences causally related to treatment / all	0 / 67	0 / 1	0 / 0	0 / 65
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Delayed delivery
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Eclampsia
subjects affected / exposed	7 / 3698 (0.19%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	3 / 3687 (0.08%)
occurrences causally related to treatment / all	1 / 7	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ectopic pregnancy
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Face presentation
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	4 / 3687 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Failed induction of labour
subjects affected / exposed	9 / 3698 (0.24%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	8 / 3687 (0.22%)
occurrences causally related to treatment / all	0 / 9	0 / 0	0 / 0	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Failed trial of labour
subjects affected / exposed	2 / 3698 (0.05%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
False labour
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	5 / 3687 (0.14%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foetal growth restriction
subjects affected / exposed	15 / 3698 (0.41%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	11 / 3687 (0.30%)
occurrences causally related to treatment / all	0 / 15	0 / 0	0 / 0	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gestational hypertension
subjects affected / exposed	43 / 3698 (1.16%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	41 / 3687 (1.11%)
occurrences causally related to treatment / all	0 / 44	0 / 0	0 / 0	0 / 41
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gestational diabetes
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foetal-maternal haemorrhage
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
HELLP syndrome
subjects affected / exposed	2 / 3698 (0.05%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	3 / 3687 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foetal malpresentation
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foetal malposition
subjects affected / exposed	3 / 3698 (0.08%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foetal macrosomia
subjects affected / exposed	6 / 3698 (0.16%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	7 / 3687 (0.19%)
occurrences causally related to treatment / all	0 / 6	0 / 0	0 / 0	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foetal hypokinesia
subjects affected / exposed	5 / 3698 (0.14%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	4 / 3687 (0.11%)
occurrences causally related to treatment / all	0 / 5	0 / 0	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foetal vascular malperfusion
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Meconium in amniotic fluid
subjects affected / exposed	3 / 3698 (0.08%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Large for dates baby
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Labour complication
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	2 / 3687 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Jaundice neonatal
subjects affected / exposed	0 / 3698 (0.00%)	77 / 3659 (2.10%)	69 / 3646 (1.89%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 79	0 / 69	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Intrapartum haemorrhage
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	3 / 3687 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypoxic ischaemic encephalopathy neonatal
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypothermia neonatal
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hydrops foetalis
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Haemorrhage in pregnancy
subjects affected / exposed	7 / 3698 (0.19%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	3 / 3687 (0.08%)
occurrences causally related to treatment / all	0 / 7	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Meconium stain
subjects affected / exposed	5 / 3698 (0.14%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	5 / 3687 (0.14%)
occurrences causally related to treatment / all	0 / 5	0 / 0	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Peripartum cardiomyopathy
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Oligohydramnios
subjects affected / exposed	16 / 3698 (0.43%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	21 / 3687 (0.57%)
occurrences causally related to treatment / all	0 / 16	0 / 0	0 / 0	0 / 21
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Obstructed labour
subjects affected / exposed	15 / 3698 (0.41%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	12 / 3687 (0.33%)
occurrences causally related to treatment / all	0 / 15	0 / 0	0 / 0	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neonatal disorder
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Precipitate labour
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Placental calcification
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Placental insufficiency
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Polyhydramnios
subjects affected / exposed	2 / 3698 (0.05%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	4 / 3687 (0.11%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pre-eclampsia
subjects affected / exposed	67 / 3698 (1.81%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	53 / 3687 (1.44%)
occurrences causally related to treatment / all	0 / 67	0 / 0	0 / 0	0 / 53
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Placenta accreta
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Premature separation of placenta
subjects affected / exposed	19 / 3698 (0.51%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	13 / 3687 (0.35%)
occurrences causally related to treatment / all	0 / 20	0 / 0	0 / 0	1 / 13
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Premature rupture of membranes
subjects affected / exposed	14 / 3698 (0.38%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	16 / 3687 (0.43%)
occurrences causally related to treatment / all	0 / 14	0 / 0	0 / 0	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Premature labour
subjects affected / exposed	15 / 3698 (0.41%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	9 / 3687 (0.24%)
occurrences causally related to treatment / all	1 / 15	0 / 0	0 / 0	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Premature delivery
subjects affected / exposed	30 / 3698 (0.81%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	24 / 3687 (0.65%)
occurrences causally related to treatment / all	0 / 30	0 / 0	0 / 0	0 / 24
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Preterm premature rupture of membranes
subjects affected / exposed	15 / 3698 (0.41%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	11 / 3687 (0.30%)
occurrences causally related to treatment / all	0 / 15	0 / 0	0 / 0	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Retained products of conception
subjects affected / exposed	3 / 3698 (0.08%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Retained placenta or membranes
subjects affected / exposed	8 / 3698 (0.22%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	5 / 3687 (0.14%)
occurrences causally related to treatment / all	0 / 8	0 / 0	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Prolonged rupture of membranes
subjects affected / exposed	10 / 3698 (0.27%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	10 / 3687 (0.27%)
occurrences causally related to treatment / all	0 / 10	0 / 0	0 / 0	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Prolonged pregnancy
subjects affected / exposed	9 / 3698 (0.24%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	7 / 3687 (0.19%)
occurrences causally related to treatment / all	0 / 9	0 / 0	0 / 0	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Prolonged labour
subjects affected / exposed	23 / 3698 (0.62%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	21 / 3687 (0.57%)
occurrences causally related to treatment / all	0 / 23	0 / 0	0 / 0	0 / 21
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Shoulder dystocia
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Small for dates baby
subjects affected / exposed	0 / 3698 (0.00%)	6 / 3659 (0.16%)	10 / 3646 (0.27%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 6	0 / 10	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Spontaneous rupture of membranes
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	2 / 3687 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Stillbirth
subjects affected / exposed	4 / 3698 (0.11%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Umbilical cord prolapse
subjects affected / exposed	3 / 3698 (0.08%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	4 / 3687 (0.11%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Umbilical cord abnormality
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Transverse presentation
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Threatened labour
subjects affected / exposed	15 / 3698 (0.41%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	14 / 3687 (0.38%)
occurrences causally related to treatment / all	0 / 18	0 / 0	0 / 0	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Superimposed pre-eclampsia
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	2 / 3687 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Umbilical cord around neck
subjects affected / exposed	1 / 3698 (0.03%)	3 / 3659 (0.08%)	3 / 3646 (0.08%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Weight decrease neonatal
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Uterine atony
subjects affected / exposed	5 / 3698 (0.14%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	3 / 3687 (0.08%)
occurrences causally related to treatment / all	0 / 5	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Uterine contractions during pregnancy
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	3 / 3687 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Uterine hypotonus
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Uterine tachysystole
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Death
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
Multiple organ dysfunction syndrome
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Sudden infant death syndrome
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	3 / 3646 (0.08%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 3	0 / 0
Chills
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Developmental delay
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Drug withdrawal syndrome neonatal
subjects affected / exposed	0 / 3698 (0.00%)	3 / 3659 (0.08%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Fever neonatal
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypothermia
subjects affected / exposed	0 / 3698 (0.00%)	4 / 3659 (0.11%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Localised oedema
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypertrophy
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Mass
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	2 / 3698 (0.05%)	2 / 3659 (0.05%)	8 / 3646 (0.22%)	3 / 3687 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 8	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Macrosomia
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	2 / 3646 (0.05%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Immune system disorders
ABO incompatibility
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	4 / 3646 (0.11%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Anaphylactic reaction
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood type incompatibility
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypogammaglobulinaemia
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Milk allergy
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Rhesus incompatibility
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Social circumstances
Disease risk factor
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Intermenstrual bleeding
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Female genital tract fistula
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ovarian cyst
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ovarian cyst torsion
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Perineal disorder
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Uterine prolapse
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Uterine haemorrhage
subjects affected / exposed	2 / 3698 (0.05%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Uterine disorder
subjects affected / exposed	2 / 3698 (0.05%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Uterine cervix hyperplasia
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Threatened uterine rupture
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	2 / 3687 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Testicular torsion
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Testicular retraction
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Testicular disorder
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vulval haematoma
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Uterovaginal prolapse
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vaginal discharge
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vaginal haemorrhage
subjects affected / exposed	2 / 3698 (0.05%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Dyspnoea
subjects affected / exposed	0 / 3698 (0.00%)	4 / 3659 (0.11%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
Meconium aspiration syndrome
subjects affected / exposed	0 / 3698 (0.00%)	9 / 3659 (0.25%)	7 / 3646 (0.19%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 9	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
Neonatal asphyxia
subjects affected / exposed	0 / 3698 (0.00%)	8 / 3659 (0.22%)	7 / 3646 (0.19%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 8	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
Pulmonary hypertension
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	3 / 3646 (0.08%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Acute respiratory distress syndrome
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Asphyxia
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Apnoea
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	3 / 3646 (0.08%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Adenoidal hypertrophy
subjects affected / exposed	0 / 3698 (0.00%)	3 / 3659 (0.08%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Acute respiratory failure
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Aspiration
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypoxia
subjects affected / exposed	0 / 3698 (0.00%)	6 / 3659 (0.16%)	3 / 3646 (0.08%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 6	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Choking
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Brief resolved unexplained event
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	5 / 3646 (0.14%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Asthma
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infantile apnoea
subjects affected / exposed	0 / 3698 (0.00%)	10 / 3659 (0.27%)	3 / 3646 (0.08%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 10	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Lung disorder
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nasal flaring
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neonatal aspiration
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neonatal respiratory distress syndrome
subjects affected / exposed	0 / 3698 (0.00%)	11 / 3659 (0.30%)	14 / 3646 (0.38%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 11	0 / 14	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neonatal respiratory distress
subjects affected / exposed	0 / 3698 (0.00%)	11 / 3659 (0.30%)	14 / 3646 (0.38%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 11	0 / 14	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neonatal respiratory depression
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neonatal pneumothorax
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neonatal hypoxia
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neonatal dyspnoea
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neonatal respiratory failure
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	3 / 3646 (0.08%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	2 / 3687 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary artery stenosis
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary arterial hypertension
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumothorax spontaneous
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	0 / 3698 (0.00%)	5 / 3659 (0.14%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonitis aspiration
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumomediastinum
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Obstructive sleep apnoea syndrome
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neonatal tachypnoea
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary haemorrhage
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiration abnormal
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Transient tachypnoea of the newborn
subjects affected / exposed	0 / 3698 (0.00%)	33 / 3659 (0.90%)	29 / 3646 (0.80%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 33	0 / 29	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tachypnoea
subjects affected / exposed	0 / 3698 (0.00%)	6 / 3659 (0.16%)	8 / 3646 (0.22%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 6	0 / 8	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Sleep apnoea syndrome
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory failure
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory distress
subjects affected / exposed	0 / 3698 (0.00%)	49 / 3659 (1.34%)	46 / 3646 (1.26%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 49	0 / 46	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory disorder neonatal
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory depression
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory acidosis
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Attention deficit hyperactivity disorder
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bipolar disorder
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Brief psychotic disorder, with postpartum onset
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Depression
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Anxiety disorder
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Intentional self-injury
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Panic attack
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Selective eating disorder
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Perinatal depression
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Panic disorder
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Product issues
Device occlusion
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Chronic hepatic failure
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
Hepatic haematoma
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Hepatic function abnormal
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gallbladder polyp
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cholestasis of pregnancy
subjects affected / exposed	11 / 3698 (0.30%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	6 / 3687 (0.16%)
occurrences causally related to treatment / all	0 / 11	0 / 0	0 / 0	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cholestasis
subjects affected / exposed	2 / 3698 (0.05%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	2 / 3687 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	2 / 3698 (0.05%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	3 / 3687 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	2 / 3698 (0.05%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	2 / 3687 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Biliary obstruction
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Biliary colic
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bile duct stone
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	4 / 3687 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neonatal cholestasis
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Jaundice
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypertransaminasaemia
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hyperbilirubinaemia neonatal
subjects affected / exposed	0 / 3698 (0.00%)	51 / 3659 (1.39%)	42 / 3646 (1.15%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 51	0 / 43	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hyperbilirubinaemia
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hepatitis
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Intrahepatic portal hepatic venous fistula
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
Blood glucose decreased
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood glucose
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood bilirubin increased
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Base excess decreased
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Apgar score low
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Amniotic fluid volume decreased
subjects affected / exposed	2 / 3698 (0.05%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Body temperature fluctuation
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Body temperature increased
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cytomegalovirus test positive
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cholangiogram abnormal
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiovascular function test abnormal
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac murmur
subjects affected / exposed	1 / 3698 (0.03%)	4 / 3659 (0.11%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 4	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Oxygen saturation abnormal
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foetal heart rate indeterminate
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foetal monitoring abnormal
subjects affected / exposed	3 / 3698 (0.08%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	6 / 3687 (0.16%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
HIV test positive
subjects affected / exposed	1 / 3698 (0.03%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nutritional condition abnormal
subjects affected / exposed	0 / 3698 (0.00%)	3 / 3659 (0.08%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foetal heart rate abnormal
subjects affected / exposed	7 / 3698 (0.19%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	2 / 3687 (0.05%)
occurrences causally related to treatment / all	0 / 7	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Streptococcus test positive
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
SARS-CoV-2 test positive
subjects affected / exposed	5 / 3698 (0.14%)	0 / 3659 (0.00%)	3 / 3646 (0.08%)	2 / 3687 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 0	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Platelet count decreased
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Oxygen saturation decreased
subjects affected / exposed	0 / 3698 (0.00%)	3 / 3659 (0.08%)	3 / 3646 (0.08%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ultrasound antenatal screen abnormal
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	2 / 3687 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
White blood cell count increased
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Weight decreased
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ultrasound foetal abnormal
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	3 / 3687 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Accidental exposure to product
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Abdominal injury
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ankle fracture
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bladder injury
subjects affected / exposed	2 / 3698 (0.05%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Burns second degree
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Clavicle fracture
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Fall
subjects affected / exposed	1 / 3698 (0.03%)	2 / 3659 (0.05%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Craniocerebral injury
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Electrical burn
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Exposure to SARS-CoV-2
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Extradural haematoma
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Concussion
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foetal exposure during pregnancy
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Forearm fracture
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foreign body in respiratory tract
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foreign body ingestion
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Fractured skull depressed
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hand fracture
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Head injury
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Injury to brachial plexus due to birth trauma
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Joint injury
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Maternal drugs affecting foetus
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Skull fractured base
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Skull fracture
subjects affected / exposed	0 / 3698 (0.00%)	4 / 3659 (0.11%)	4 / 3646 (0.11%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Perineal injury
subjects affected / exposed	3 / 3698 (0.08%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	3 / 3687 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Procedural headache
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Postoperative ileus
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Post procedural fever
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Post lumbar puncture syndrome
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	2 / 3698 (0.05%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vulvovaginal injury
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	2 / 3687 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Wound dehiscence
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular procedure complication
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Uterine rupture
subjects affected / exposed	3 / 3698 (0.08%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	3 / 3687 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Traumatic intracranial haematoma
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Thermal burn
subjects affected / exposed	0 / 3698 (0.00%)	4 / 3659 (0.11%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tendon rupture
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Subdural haemorrhage
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital, familial and genetic disorders
Inborn error of metabolism
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
Ventricular hypoplasia
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Aberrant aortic arch
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Accessory spleen
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Autosomal chromosome anomaly
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Atrioventricular septal defect
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Atrial septal defect
subjects affected / exposed	0 / 3698 (0.00%)	37 / 3659 (1.01%)	46 / 3646 (1.26%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 39	0 / 49	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bicuspid aortic valve
subjects affected / exposed	0 / 3698 (0.00%)	3 / 3659 (0.08%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Anorchism
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Anomaly of external ear congenital
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Anisomelia
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Anal atresia
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Anorectal malformation
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bifid ureter
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Brachycephaly
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Branchial cyst
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Buried penis syndrome
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cleft uvula
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Chordee
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	3 / 3646 (0.08%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Chromosomal deletion
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cleft lip and palate
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cleft palate
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cataract congenital
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Coarctation of the aorta
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Coloboma
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital absence of bile ducts
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital aortic anomaly
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital foot malformation
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital coronary artery malformation
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital cytomegalovirus infection
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital diaphragmatic eventration
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital eye disorder
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital central nervous system anomaly
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital hydronephrosis
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	3 / 3646 (0.08%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital hypothyroidism
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital knee deformity
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital megacolon
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital retinoblastoma
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital musculoskeletal disorder
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital musculoskeletal disorder of spine
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital naevus
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital pulmonary artery anomaly
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital melanocytic naevus
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital skin dimples
subjects affected / exposed	0 / 3698 (0.00%)	3 / 3659 (0.08%)	5 / 3646 (0.14%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital syphilis
subjects affected / exposed	0 / 3698 (0.00%)	3 / 3659 (0.08%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital torticollis
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital urethral anomaly
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Developmental hip dysplasia
subjects affected / exposed	0 / 3698 (0.00%)	11 / 3659 (0.30%)	15 / 3646 (0.41%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 11	0 / 15	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Craniosynostosis
subjects affected / exposed	0 / 3698 (0.00%)	3 / 3659 (0.08%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cryptorchism
subjects affected / exposed	0 / 3698 (0.00%)	12 / 3659 (0.33%)	18 / 3646 (0.49%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 12	0 / 18	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cystic fibrosis
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Deafness congenital
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Craniofacial deformity
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Dextrocardia
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Dolichocephaly
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Duane's syndrome
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Dysmorphism
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Genitalia external ambiguous
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Eyelid ptosis congenital
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	3 / 3646 (0.08%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Galactosaemia
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gallbladder anomaly congenital
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ear malformation
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Haemangioma congenital
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypoplastic left heart syndrome
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypospadias
subjects affected / exposed	0 / 3698 (0.00%)	6 / 3659 (0.16%)	11 / 3646 (0.30%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 6	0 / 11	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Intestinal malrotation
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Left-to-right cardiac shunt
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Kidney duplex
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Laryngeal cleft
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Laryngomalacia
subjects affected / exposed	0 / 3698 (0.00%)	3 / 3659 (0.08%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Iris coloboma
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Microphthalmos
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Mitochondrial encephalomyopathy
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Naevus flammeus
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neurofibromatosis
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Micropenis
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Macrocephaly
subjects affected / exposed	0 / 3698 (0.00%)	5 / 3659 (0.14%)	3 / 3646 (0.08%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Meningocele
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Microcephaly
subjects affected / exposed	0 / 3698 (0.00%)	7 / 3659 (0.19%)	7 / 3646 (0.19%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 7	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Micrognathia
subjects affected / exposed	0 / 3698 (0.00%)	5 / 3659 (0.14%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Limb reduction defect
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Newborn persistent pulmonary hypertension
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	3 / 3646 (0.08%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Oesophageal atresia
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Optic nerve hypoplasia
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Osteochondrodysplasia
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Patent ductus arteriosus
subjects affected / exposed	0 / 3698 (0.00%)	13 / 3659 (0.36%)	14 / 3646 (0.38%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 13	0 / 14	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pectus excavatum
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Penile torsion
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	3 / 3646 (0.08%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Penoscrotal fusion
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	4 / 3646 (0.11%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Phenylketonuria
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Phimosis
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Plagiocephaly
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	3 / 3646 (0.08%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Poland's syndrome
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Polycystic liver disease
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Polydactyly
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	7 / 3646 (0.19%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal aplasia
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Preternatural anus
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary artery stenosis congenital
subjects affected / exposed	0 / 3698 (0.00%)	7 / 3659 (0.19%)	6 / 3646 (0.16%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 7	0 / 6	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pyloric stenosis
subjects affected / exposed	0 / 3698 (0.00%)	3 / 3659 (0.08%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pyruvate carboxylase deficiency
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Posterior segment of eye anomaly congenital
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal dysplasia
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive tract hypoplasia, male
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Scaphocephaly
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Septo-optic dysplasia
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Thalassaemia alpha
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Supernumerary nipple
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Syndactyly
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Talipes
subjects affected / exposed	0 / 3698 (0.00%)	5 / 3659 (0.14%)	4 / 3646 (0.11%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tethered oral tissue
subjects affected / exposed	0 / 3698 (0.00%)	18 / 3659 (0.49%)	16 / 3646 (0.44%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 18	0 / 16	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Spina bifida occulta
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Trisomy 21
subjects affected / exposed	0 / 3698 (0.00%)	3 / 3659 (0.08%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vallecular cyst
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular malformation
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ventricular septal defect
subjects affected / exposed	0 / 3698 (0.00%)	15 / 3659 (0.41%)	21 / 3646 (0.58%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 15	0 / 21	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Cardio-respiratory arrest
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
Left ventricular failure
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Atrioventricular block first degree
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Atrioventricular block complete
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bradycardia
subjects affected / exposed	0 / 3698 (0.00%)	3 / 3659 (0.08%)	1 / 3646 (0.03%)	2 / 3687 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bradycardia foetal
subjects affected / exposed	8 / 3698 (0.22%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	13 / 3687 (0.35%)
occurrences causally related to treatment / all	0 / 8	0 / 0	0 / 0	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bradycardia neonatal
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foetal arrhythmia
subjects affected / exposed	2 / 3698 (0.05%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foetal heart rate deceleration abnormality
subjects affected / exposed	6 / 3698 (0.16%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	12 / 3687 (0.33%)
occurrences causally related to treatment / all	0 / 6	0 / 0	0 / 0	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Chronic left ventricular failure
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac ventricular disorder
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Coronary artery dissection
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pericardial effusion
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary valve stenosis
subjects affected / exposed	0 / 3698 (0.00%)	3 / 3659 (0.08%)	5 / 3646 (0.14%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary valve thickening
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Right atrial enlargement
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Sinus arrhythmia
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Sinus bradycardia
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Left ventricular hypertrophy
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Mitral valve incompetence
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neonatal bradyarrhythmia
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nonreassuring foetal heart rate pattern
subjects affected / exposed	37 / 3698 (1.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	30 / 3687 (0.81%)
occurrences causally related to treatment / all	0 / 37	0 / 0	0 / 0	0 / 30
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Sinus tachycardia
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Supraventricular extrasystoles
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ventricular tachycardia
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ventricular extrasystoles
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tricuspid valve incompetence
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	3 / 3646 (0.08%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tricuspid valve disease
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tachycardia foetal
subjects affected / exposed	2 / 3698 (0.05%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	3 / 3687 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tachycardia
subjects affected / exposed	4 / 3698 (0.11%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	2 / 3687 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Supraventricular tachycardia
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Hypoxic-ischaemic encephalopathy
subjects affected / exposed	0 / 3698 (0.00%)	6 / 3659 (0.16%)	3 / 3646 (0.08%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 6	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
Cerebral cyst
subjects affected / exposed	0 / 3698 (0.00%)	3 / 3659 (0.08%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Atypical migraine
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Benign enlargement of the subarachnoid spaces
subjects affected / exposed	0 / 3698 (0.00%)	3 / 3659 (0.08%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cerebral infarction
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cerebral ventricle dilatation
subjects affected / exposed	0 / 3698 (0.00%)	5 / 3659 (0.14%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cerebrovascular disorder
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Depressed level of consciousness
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Febrile convulsion
subjects affected / exposed	0 / 3698 (0.00%)	9 / 3659 (0.25%)	13 / 3646 (0.36%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 9	0 / 13	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Encephalopathy neonatal
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	3 / 3646 (0.08%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
External hydrocephalus
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Encephalomalacia
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hemiparesis
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hydrocephalus
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hyporeflexia
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypotonia
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Headache
subjects affected / exposed	2 / 3698 (0.05%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	2 / 3687 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Intraventricular haemorrhage
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Intraventricular haemorrhage neonatal
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Lenticulostriatal vasculopathy
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Intracranial haemorrhage neonatal
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Lumbar radiculopathy
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Motor developmental delay
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Moyamoya disease
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Myoclonus
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Quadriparesis
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Non-epileptic paroxysmal event
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nystagmus
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Paraplegia
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neurodevelopmental delay
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Seizure
subjects affected / exposed	0 / 3698 (0.00%)	3 / 3659 (0.08%)	6 / 3646 (0.16%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Speech disorder developmental
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Spinal cord compression
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Status epilepticus
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tethered cord syndrome
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Subdural haemorrhage neonatal
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Subependymal cyst
subjects affected / exposed	0 / 3698 (0.00%)	3 / 3659 (0.08%)	3 / 3646 (0.08%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Syncope
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	2 / 3687 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Subarachnoid haemorrhage
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tremor
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Hypochromic anaemia
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Anaemia neonatal
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Anaemia of pregnancy
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood loss anaemia
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Haemolysis neonatal
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Anaemia
subjects affected / exposed	4 / 3698 (0.11%)	1 / 3659 (0.03%)	4 / 3646 (0.11%)	5 / 3687 (0.14%)
occurrences causally related to treatment / all	0 / 4	0 / 1	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Idiopathic neutropenia
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Iron deficiency anaemia
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	3 / 3687 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neutropenia
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Polycythaemia
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Splenic cyst
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	2 / 3646 (0.05%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Polycythaemia neonatorum
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
Deafness unilateral
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Eustachian tube dysfunction
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypoacusis
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tympanic membrane perforation
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Deafness
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Eye disorders
Pupillary disorder
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Eyelid ptosis
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Eye haemorrhage
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Food protein-induced enterocolitis syndrome
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	3 / 3687 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Abdominal pain lower
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Colitis
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastritis
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Crohn's disease
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Diaphragmatic hernia
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	3 / 3646 (0.08%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Enterocolitis
subjects affected / exposed	1 / 3698 (0.03%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Constipation
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ileus
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infantile colic
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infantile vomiting
subjects affected / exposed	0 / 3698 (0.00%)	4 / 3659 (0.11%)	3 / 3646 (0.08%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	0 / 3698 (0.00%)	6 / 3659 (0.16%)	8 / 3646 (0.22%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 6	0 / 8	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	5 / 3646 (0.14%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Haematemesis
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Haemorrhoidal haemorrhage
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ileal ulcer
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Intra-abdominal fluid collection
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Intussusception
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	3 / 3646 (0.08%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Irritable bowel syndrome
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Meconium ileus
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Obstructive pancreatitis
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nausea
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Necrotising colitis
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Obstruction gastric
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Meconium plug syndrome
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tongue disorder
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Upper gastrointestinal haemorrhage
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vomiting
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	5 / 3646 (0.14%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	2 / 3698 (0.05%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	2 / 3687 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Terminal ileitis
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Petechiae
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Eczema
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	3 / 3646 (0.08%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Dermal cyst
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pruritus
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Seborrhoeic dermatitis
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Scar pain
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Rash vesicular
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Rash neonatal
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Rash
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Calculus bladder
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Haematuria
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal colic
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pyelocaliectasis
subjects affected / exposed	0 / 3698 (0.00%)	6 / 3659 (0.16%)	8 / 3646 (0.22%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 6	0 / 8	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal cyst
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hydronephrosis
subjects affected / exposed	1 / 3698 (0.03%)	6 / 3659 (0.16%)	9 / 3646 (0.25%)	2 / 3687 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 6	0 / 9	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hydroureter
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Kidney small
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neonatal anuria
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nephrectasia
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nephrolithiasis
subjects affected / exposed	3 / 3698 (0.08%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Prerenal failure
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vesicoureteric reflux
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	4 / 3646 (0.11%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ureterocele
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ureteric dilatation
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal impairment
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Urinary retention
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	2 / 3687 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Endocrine disorders
Hypopituitarism
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Diastasis recti abdominis
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Arthralgia
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ankle deformity
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Acquired plagiocephaly
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Facial asymmetry
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Joint instability
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Head deformity
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foot deformity
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Flank pain
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pain in extremity
subjects affected / exposed	2 / 3698 (0.05%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Knee deformity
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Kyphosis
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Limb deformity
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Muscle spasms
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Joint noise
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Seronegative arthritis
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Sacroiliitis
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Retrognathia
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Posture abnormal
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Systemic lupus erythematosus
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Torticollis
subjects affected / exposed	0 / 3698 (0.00%)	6 / 3659 (0.16%)	7 / 3646 (0.19%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 6	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Escherichia sepsis
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	5 / 3698 (0.14%)	23 / 3659 (0.63%)	18 / 3646 (0.49%)	3 / 3687 (0.08%)
occurrences causally related to treatment / all	0 / 5	0 / 25	0 / 20	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
Sepsis neonatal
subjects affected / exposed	0 / 3698 (0.00%)	19 / 3659 (0.52%)	21 / 3646 (0.58%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 19	0 / 21	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
Pneumonia
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Amniotic cavity infection
subjects affected / exposed	10 / 3698 (0.27%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	5 / 3687 (0.14%)
occurrences causally related to treatment / all	0 / 10	0 / 0	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Abscess limb
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Abscess oral
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Adenovirus infection
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Amoebic dysentery
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Arthritis bacterial
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bacterial infection
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Breast abscess
subjects affected / exposed	1 / 3698 (0.03%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	4 / 3687 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bacterial sepsis
subjects affected / exposed	0 / 3698 (0.00%)	3 / 3659 (0.08%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bacteriuria
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Botulism
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bacterial pyelonephritis
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
COVID-19
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	4 / 3646 (0.11%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	1 / 3698 (0.03%)	3 / 3659 (0.08%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cellulitis staphylococcal
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Chest wall abscess
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Conjunctivitis bacterial
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Endometritis
subjects affected / exposed	5 / 3698 (0.14%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	2 / 3687 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Dengue fever
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ear infection
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Encephalitis
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Dacryocystitis
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Epididymitis
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Escherichia bacteraemia
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Escherichia urinary tract infection
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Exanthema subitum
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hand-foot-and-mouth disease
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis adenovirus
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis rotavirus
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis salmonella
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Groin abscess
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis Escherichia coli
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Impetigo
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infection
subjects affected / exposed	0 / 3698 (0.00%)	14 / 3659 (0.38%)	15 / 3646 (0.41%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 15	0 / 15	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infectious mononucleosis
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Influenza
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Meningitis
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Kidney infection
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Klebsiella sepsis
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Klebsiella urinary tract infection
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Mastitis
subjects affected / exposed	5 / 3698 (0.14%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 5	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Intervertebral discitis
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Meningitis bacterial
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Meningitis cronobacter
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Meningitis enteroviral
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Meningitis streptococcal
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ophthalmia neonatorum
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neonatal infection
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	3 / 3646 (0.08%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neonatal infective mastitis
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neonatal pneumonia
subjects affected / exposed	0 / 3698 (0.00%)	3 / 3659 (0.08%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Omphalitis
subjects affected / exposed	0 / 3698 (0.00%)	4 / 3659 (0.11%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Meningitis viral
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Otitis media
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Otitis media acute
subjects affected / exposed	0 / 3698 (0.00%)	3 / 3659 (0.08%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Otitis media chronic
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pilonidal disease
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pelvic abscess
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Periorbital cellulitis
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Perirectal abscess
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pathogen resistance
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Postpartum sepsis
subjects affected / exposed	2 / 3698 (0.05%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Puerperal infection
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	3 / 3687 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Puerperal pyrexia
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	2 / 3687 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	1 / 3698 (0.03%)	2 / 3659 (0.05%)	3 / 3646 (0.08%)	4 / 3687 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Postoperative wound infection
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	5 / 3687 (0.14%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pyomyositis
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumococcal bacteraemia
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Post procedural infection
subjects affected / exposed	2 / 3698 (0.05%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Postoperative abscess
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	0 / 3698 (0.00%)	3 / 3659 (0.08%)	1 / 3646 (0.03%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pyuria
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Salmonellosis
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Secondary syphilis
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Sepsis
subjects affected / exposed	1 / 3698 (0.03%)	9 / 3659 (0.25%)	4 / 3646 (0.11%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 9	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Staphylococcal skin infection
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Skin infection
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Staphylococcal bacteraemia
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Staphylococcal scalded skin syndrome
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Staphylococcal sepsis
subjects affected / exposed	1 / 3698 (0.03%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Septic coagulopathy
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tinea versicolour
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tonsillitis
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tooth abscess
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tooth infection
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Viral infection
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Wound sepsis
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	7 / 3698 (0.19%)	15 / 3659 (0.41%)	14 / 3646 (0.38%)	6 / 3687 (0.16%)
occurrences causally related to treatment / all	0 / 7	0 / 15	0 / 15	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Acidosis
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Dehydration
subjects affected / exposed	0 / 3698 (0.00%)	9 / 3659 (0.25%)	13 / 3646 (0.36%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 9	0 / 13	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Diabetes mellitus
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Diabetic ketoacidosis
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Electrolyte imbalance
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hyperkalaemia
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Food aversion
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Fluid intake reduced
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Feeding intolerance
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Feeding disorder
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Failure to thrive
subjects affected / exposed	0 / 3698 (0.00%)	6 / 3659 (0.16%)	5 / 3646 (0.14%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 6	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypoglycaemia neonatal
subjects affected / exposed	0 / 3698 (0.00%)	13 / 3659 (0.36%)	10 / 3646 (0.27%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 13	0 / 10	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	1 / 3698 (0.03%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypovolaemia
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Lactose intolerance
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypernatraemia
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hyperphosphataemia
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypervolaemia
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1 / 3687 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypoalbuminaemia
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypocalcaemia
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	0 / 3698 (0.00%)	20 / 3659 (0.55%)	17 / 3646 (0.47%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 20	0 / 17	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Malnutrition
subjects affected / exposed	0 / 3698 (0.00%)	2 / 3659 (0.05%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metabolic acidosis
subjects affected / exposed	0 / 3698 (0.00%)	3 / 3659 (0.08%)	2 / 3646 (0.05%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neonatal hyponatraemia
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Poor feeding infant
subjects affected / exposed	0 / 3698 (0.00%)	0 / 3659 (0.00%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Weight gain poor
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	1 / 3646 (0.03%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Underweight
subjects affected / exposed	0 / 3698 (0.00%)	1 / 3659 (0.03%)	0 / 3646 (0.00%)	0 / 3687 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 1%

Non-serious adverse events	Maternal Participants: RSVpreF	Infant Participants: RSVpreF	Infant Participants: Placebo	Maternal Participants: Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	2755 / 3698 (74.50%)	674 / 3659 (18.42%)	598 / 3646 (16.40%)	2339 / 3687 (63.44%)
Investigations
SARS-CoV-2 test positive
subjects affected / exposed	148 / 3698 (4.00%)	119 / 3659 (3.25%)	108 / 3646 (2.96%)	114 / 3687 (3.09%)
occurrences all number	148	122	111	116
Congenital, familial and genetic disorders
Congenital naevus
subjects affected / exposed	0 / 3698 (0.00%)	49 / 3659 (1.34%)	30 / 3646 (0.82%)	0 / 3687 (0.00%)
occurrences all number	0	49	30	0
Tethered oral tissue
subjects affected / exposed	0 / 3698 (0.00%)	41 / 3659 (1.12%)	32 / 3646 (0.88%)	0 / 3687 (0.00%)
occurrences all number	0	41	32	0
Nervous system disorders
Headache (HEADACHE)
Additional description: “99999” represents ‘all occurrences’ field data which is not applicable for reactogenicity events. Number of participants exposed: number of participants at risk for reactogenicity event and is different from the total safety population.
alternative assessment type: Systematic
subjects affected / exposed ^[1]	1141 / 3678 (31.02%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1009 / 3651 (27.64%)
occurrences all number	99999	0	0	99999
Pregnancy, puerperium and perinatal conditions
Premature delivery
subjects affected / exposed	182 / 3698 (4.92%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	153 / 3687 (4.15%)
occurrences all number	182	0	0	153
Premature baby
subjects affected / exposed	0 / 3698 (0.00%)	158 / 3659 (4.32%)	130 / 3646 (3.57%)	0 / 3687 (0.00%)
occurrences all number	0	158	130	0
Low birth weight baby
subjects affected / exposed	0 / 3698 (0.00%)	157 / 3659 (4.29%)	127 / 3646 (3.48%)	0 / 3687 (0.00%)
occurrences all number	0	157	127	0
Jaundice neonatal
subjects affected / exposed	0 / 3698 (0.00%)	191 / 3659 (5.22%)	183 / 3646 (5.02%)	0 / 3687 (0.00%)
occurrences all number	0	193	185	0
General disorders and administration site conditions
Swelling (SWELLING)
Additional description: “99999” represents ‘all occurrences’ field data which is not applicable for reactogenicity events. Number of participants exposed: number of participants at risk for reactogenicity event and is different from the total safety population.
alternative assessment type: Systematic
subjects affected / exposed ^[2]	228 / 3678 (6.20%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	8 / 3651 (0.22%)
occurrences all number	99999	0	0	99999
Pyrexia (FEVER)
Additional description: “99999” represents ‘all occurrences’ field data which is not applicable for reactogenicity events. Number of participants exposed: number of participants at risk for reactogenicity event and is different from the total safety population.
alternative assessment type: Systematic
subjects affected / exposed ^[3]	94 / 3678 (2.56%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	107 / 3651 (2.93%)
occurrences all number	99999	0	0	99999
Injection site pain (PAIN AT INJECTION SITE)
Additional description: “99999” represents ‘all occurrences’ field data which is not applicable for reactogenicity events. Number of participants exposed: number of participants at risk for reactogenicity event and is different from the total safety population.
alternative assessment type: Systematic
subjects affected / exposed ^[4]	1496 / 3678 (40.67%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	371 / 3651 (10.16%)
occurrences all number	99999	0	0	99999
Fatigue (FATIGUE)
Additional description: “99999” represents ‘all occurrences’ field data which is not applicable for reactogenicity events. Number of participants exposed: number of participants at risk for reactogenicity event and is different from the total safety population.
alternative assessment type: Systematic
subjects affected / exposed ^[5]	1696 / 3678 (46.11%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	1599 / 3651 (43.80%)
occurrences all number	99999	0	0	99999
Gastrointestinal disorders
Vomiting (VOMITING)
Additional description: “99999” represents ‘all occurrences’ field data which is not applicable for reactogenicity events. Number of participants exposed: number of participants at risk for reactogenicity event and is different from the total safety population.
alternative assessment type: Systematic
subjects affected / exposed ^[6]	289 / 3678 (7.86%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	254 / 3651 (6.96%)
occurrences all number	99999	0	0	99999
Diarrhoea (DIARRHEA)
Additional description: “99999” represents ‘all occurrences’ field data which is not applicable for reactogenicity events. Number of participants exposed: number of participants at risk for reactogenicity event and is different from the total safety population.
alternative assessment type: Systematic
subjects affected / exposed ^[7]	414 / 3678 (11.26%)	0 / 3569 (0.00%)	0 / 3646 (0.00%)	416 / 3651 (11.39%)
occurrences all number	99999	0	0	99999
Nausea (NAUSEA)
Additional description: “99999” represents ‘all occurrences’ field data which is not applicable for reactogenicity events. Number of participants exposed: number of participants at risk for reactogenicity event and is different from the total safety population.
alternative assessment type: Systematic
subjects affected / exposed ^[8]	734 / 3678 (19.96%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	705 / 3651 (19.31%)
occurrences all number	99999	0	0	99999
Hepatobiliary disorders
Hyperbilirubinaemia neonatal
subjects affected / exposed	0 / 3698 (0.00%)	59 / 3659 (1.61%)	65 / 3646 (1.78%)	0 / 3687 (0.00%)
occurrences all number	0	59	65	0
Skin and subcutaneous tissue disorders
Erythema (REDNESS)
Additional description: “99999” represents ‘all occurrences’ field data which is not applicable for reactogenicity events. Number of participants exposed: number of participants at risk for reactogenicity event and is different from the total safety population.
alternative assessment type: Systematic
subjects affected / exposed ^[9]	265 / 3678 (7.21%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	8 / 3651 (0.22%)
occurrences all number	99999	0	0	99999
Dermatitis diaper
subjects affected / exposed	0 / 3698 (0.00%)	31 / 3659 (0.85%)	39 / 3646 (1.07%)	0 / 3687 (0.00%)
occurrences all number	0	31	39	0
Musculoskeletal and connective tissue disorders
Myalgia (MUSCLE PAIN)
Additional description: “99999” represents ‘all occurrences’ field data which is not applicable for reactogenicity events. Number of participants exposed: number of participants at risk for reactogenicity event and is different from the total safety population.
alternative assessment type: Systematic
subjects affected / exposed ^[10]	977 / 3678 (26.56%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	626 / 3651 (17.15%)
occurrences all number	99999	0	0	99999
Arthralgia (JOINT PAIN)
Additional description: “99999” represents ‘all occurrences’ field data which is not applicable for reactogenicity events. Number of participants exposed: number of participants at risk for reactogenicity event and is different from the total safety population.
alternative assessment type: Systematic
subjects affected / exposed ^[11]	426 / 3678 (11.58%)	0 / 3659 (0.00%)	0 / 3646 (0.00%)	384 / 3651 (10.52%)
occurrences all number	99999	0	0	99999

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Number of participants exposed is the number of participants at risk for this reactogenicity event and is different from the total safety population for this reporting group.
[2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Number of participants exposed is the number of participants at risk for this reactogenicity event and is different from the total safety population for this reporting group.
[3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Number of participants exposed is the number of participants at risk for this reactogenicity event and is different from the total safety population for this reporting group.
[4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Number of participants exposed is the number of participants at risk for this reactogenicity event and is different from the total safety population for this reporting group.
[5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Number of participants exposed is the number of participants at risk for this reactogenicity event and is different from the total safety population for this reporting group.
[6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Number of participants exposed is the number of participants at risk for this reactogenicity event and is different from the total safety population for this reporting group.
[7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Number of participants exposed is the number of participants at risk for this reactogenicity event and is different from the total safety population for this reporting group.
[8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Number of participants exposed is the number of participants at risk for this reactogenicity event and is different from the total safety population for this reporting group.
[9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Number of participants exposed is the number of participants at risk for this reactogenicity event and is different from the total safety population for this reporting group.
[10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Number of participants exposed is the number of participants at risk for this reactogenicity event and is different from the total safety population for this reporting group.
[11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Number of participants exposed is the number of participants at risk for this reactogenicity event and is different from the total safety population for this reporting group.

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Were there any global substantial amendments to the protocol? Yes

24 Mar 2020

Protocol Amendment 1: The study title updated to reflect the revised study design and the final dose and formulation of RSVpreF selected for maternal participants in this study (120mcg) based on recent results from the C3671003 maternal phase 2b trial; alignment of study procedures for maternal participants prior to vaccination; the sentence regarding intrapartum antibiotic prophylaxis (IAP) details for maternal participants with a group B streptococcal (GBS) status refined. Further clarification provided regarding the collection and safety reporting requirements for medically attended respiratory tract illness (MA-RTI) associated with maternal and infant participants. Schedule of Activities for Infant Subjects: Visit flexibility was increased to prioritize subject safety and adherence to local guidance in the event of a COVID-19 outbreak or other outbreaks. The protocol safety reporting criteria and period for AEs, SAEs, and NDCMCs were streamlined. The protocol’s safety, device deficiencies and endpoint reporting requirements were revised to ensure consistency with Pfizer’s updated safety reporting requirements for Pfizer studies. Clarification text was added to support the safety and pregnancy reporting requirements for subjects who may experience exposure during pregnancy while in the study.

26 Aug 2020

Protocol Amendment 3: Exploratory endpoint objective refined - the planned statistical analysis period of “after 6 months of age” to “all-cause MA-RTIs and hospitalizations due to RSV. Incorporated revisions to align endpoints with study duration, and incorporated analysis plans for the healthcare utilization endpoints. Clarified RSV seasonality, enrolment across gestational ages with regards to eligibility and RSV surveillance periods during the study. Clarifications to the eligibility criteria, and refined the Tdap vaccine administration requirements text to describe the timing of vaccinations based on recent data from the C3671004 study. Due to COVID and other potential pandemic situations, some revisions were made to the conduct of the study including safety-related updates for study participants and investigational sites; Additional procedures were outlined for the investigational sites to increase efficiency and completeness in capturing study endpoints during the RSV surveillance periods. The benefit-risk text was updated to include Phase 2 safety data. Several Pfizer text revisions were incorporated regarding the safety reporting requirements for this study; the “SAE Reporting to Pfizer Safety via an Electronic Data Collection Tool” section was removed.

22 Mar 2021

Protocol Amendment 4: Increased study participant enrolment and included adolescent participants in the study. Statistical methods were updated and refined for both secondary and exploratory endpoints. Clarifications to the eligibility criteria including the gestational age determination, consent process for minors and foetal anomaly ultrasounds. Due to the COVID pandemic situations, additional revisions were made to the conduct of the study including, safety-related updates for maternal and infant participants pertaining to a positive test result for SARS-CoV-2 during the study, the use of licensed COVID-19 vaccines recommended during pregnancy, and acceptable standard of care assessments during study visits. Additional procedures were outlined for the investigational sites to increase efficiency and completeness in capturing study endpoints during COVID restrictive measures including nasal swab collection requirements from infant subjects during a confirmed MA-RTI episode. This was to provide flexibility and prioritize subject and site safety during the study.

12 Jan 2022

Protocol Amendment 5: Statistical update to the third secondary efficacy endpoint due to a typographical error. The administration requirements for maternal participants refined for licensed pertussis containing vaccines, licensed COVID-19 vaccines and COVID-19 vaccines authorized for temporary or emergency use.

01 Jun 2022

Protocol Amendment 6: Eligibility requirements pertaining to COVID concomitant vaccination requirements for study participants updated, revised the procedural assessment windows during the ongoing pandemic, and several Pfizer protocol template text revisions were incorporated pertaining to the dissemination of clinical study data. Statistical plans updated and refined in line with revised enrolment strategy and endpoint case -accrual plan based on RSV seasonality monitoring activities.

08 Aug 2022

Protocol Amendment 7: Based on regulatory feedback associated with protocol amendment 5, the statistical analysis was refined.

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.

Infant participants were not vaccinated and therefore not exposed, no reactogenicity events. Database does not accept “0”. Due to this limitation, exposed numbers are reported as total safety population for each infant group, which is not factual.

http://www.ncbi.nlm.nih.gov/pubmed/37018474

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Clinical trials

Clinical Trial Results: A Phase 3, Randomized, Double-blinded, Placebo-controlled Trial to Evaluate the Efficacy and Safety of a Respiratory Syncytial Virus (RSV) Prefusion F Subunit Vaccine in Infants Born to Women Vaccinated During Pregnancy

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End points

End points

Primary: Percentage of MA-LRTI Cases due to RSV in Infant Participants Occurring Within 90 Days After Birth (Efficacy)

Primary: Percentage of MA-LRTI Cases due to RSV in Infant Participants Occurring Within 90 Days After Birth (Efficacy)

Primary: Percentage of MA-LRTI Cases due to RSV in Infant Participants Occurring Within 120 Days After Birth (Efficacy)

Primary: Percentage of MA-LRTI Cases due to RSV in Infant Participants Occurring Within 120 Days After Birth (Efficacy)

Primary: Percentage of MA-LRTI Cases due to RSV in Infant Participants Occurring Within 150 Days After Birth (Efficacy)

Primary: Percentage of MA-LRTI Cases due to RSV in Infant Participants Occurring Within 150 Days After Birth (Efficacy)

Primary: Percentage of Severe MA-LRTI Cases due to RSV in Infant Participants Occurring Within 120 Days After Birth (Efficacy)

Primary: Percentage of Severe MA-LRTI Cases due to RSV in Infant Participants Occurring Within 120 Days After Birth (Efficacy)

Primary: Percentage of Severe MA-LRTI Cases due to RSV in Infant Participants Occurring Within 90 Days After Birth (Efficacy)

Primary: Percentage of Severe MA-LRTI Cases due to RSV in Infant Participants Occurring Within 90 Days After Birth (Efficacy)

Primary: Percentage of MA-LRTI Cases due to RSV in Infant Participants Occurring Within 180 Days After Birth (Efficacy)

Primary: Percentage of MA-LRTI Cases due to RSV in Infant Participants Occurring Within 180 Days After Birth (Efficacy)

Primary: Percentage of Infant Participants With Adverse Events of Special Interest (AESI) (Safety)

Primary: Percentage of Infant Participants With Adverse Events of Special Interest (AESI) (Safety)

Primary: Percentage of Severe MA-LRTI Cases due to RSV in Infant Participants Occurring Within 150 Days After Birth (Efficacy)

Primary: Percentage of Severe MA-LRTI Cases due to RSV in Infant Participants Occurring Within 150 Days After Birth (Efficacy)

Primary: Percentage of Severe MA-LRTI Cases due to RSV in Infant Participants Occurring Within 180 Days After Birth (Efficacy)

Primary: Percentage of Severe MA-LRTI Cases due to RSV in Infant Participants Occurring Within 180 Days After Birth (Efficacy)

Primary: Percentage of Infant Participants According to Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute After Birth (Safety)

Primary: Percentage of Infant Participants According to Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute After Birth (Safety)

Primary: Percentage of Infant Participants With Neonatal Deaths (Safety)

Primary: Percentage of Infant Participants With Neonatal Deaths (Safety)

Primary: Percentage of Infant Participants With Congenital Malformations/Anomalies (Safety)

Primary: Percentage of Infant Participants With Congenital Malformations/Anomalies (Safety)

Primary: Percentage of Infant Participants With Other Neonatal Events (Safety)

Primary: Percentage of Infant Participants With Other Neonatal Events (Safety)

Primary: Percentage of Infant Participants According to APGAR Score at 5 Minutes After Birth (Safety)

Primary: Percentage of Infant Participants According to APGAR Score at 5 Minutes After Birth (Safety)

Primary: Percentage of Infant Participants According to APGAR Score at 10 Minutes After Birth (Safety)

Primary: Percentage of Infant Participants According to APGAR Score at 10 Minutes After Birth (Safety)

Primary: Percentage of Infant Participants With SAEs and NDCMCs From Birth Through 12 Months of Age (Safety)

Primary: Percentage of Infant Participants With SAEs and NDCMCs From Birth Through 12 Months of Age (Safety)

Primary: Percentage of Infant Participants With Adverse Events (AEs) From Birth to 1 Month of Age (Safety)

Primary: Percentage of Infant Participants With Adverse Events (AEs) From Birth to 1 Month of Age (Safety)

Primary: Percentage of Infant Participants With Serious Adverse Events (SAEs) and Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Birth Through 6 Months of Age (Safety)

Primary: Percentage of Infant Participants With Serious Adverse Events (SAEs) and Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Birth Through 6 Months of Age (Safety)

Primary: Percentage of Maternal Participants With Prespecified Local Reactions (LR) Within 7 Days After Vaccination (Safety)

Primary: Percentage of Maternal Participants With Prespecified Local Reactions (LR) Within 7 Days After Vaccination (Safety)

Primary: Percentage of Infant Participants With SAEs and NDCMCs From Birth Through 24 Months of Age (Safety)

Primary: Percentage of Infant Participants With SAEs and NDCMCs From Birth Through 24 Months of Age (Safety)

Primary: Percentage of Maternal Participants With Prespecified Systemic Events (SE) Within 7 Days after Vaccination (Safety)

Primary: Percentage of Maternal Participants With Prespecified Systemic Events (SE) Within 7 Days after Vaccination (Safety)

Primary: Percentage of Maternal Participants With SAEs Throughout the Study Period (Safety)

Primary: Percentage of Maternal Participants With SAEs Throughout the Study Period (Safety)

Primary: Percentage of Maternal Participants With AEs From the Time of Vaccination Through 1 Month After Vaccination (Safety)

Primary: Percentage of Maternal Participants With AEs From the Time of Vaccination Through 1 Month After Vaccination (Safety)

Secondary: Percentage of Hospitalizations due to RSV in Infant Participants Occurring Within 90, 120, 150, 180 and 360 Days After Birth (Efficacy)

Secondary: Percentage of Hospitalizations due to RSV in Infant Participants Occurring Within 90, 120, 150, 180 and 360 Days After Birth (Efficacy)

Secondary: Percentage of MA-LRTI Cases due to any Cause With Protocol Defined Criteria in Infant Participants Occurring Within 90, 120, 150, 180 and 360 Days After Birth (Efficacy)

Secondary: Percentage of MA-LRTI Cases due to any Cause With Protocol Defined Criteria in Infant Participants Occurring Within 90, 120, 150, 180 and 360 Days After Birth (Efficacy)

Secondary: Percentage of MA-LRTI Cases due to RSV in Infant Participants Occurring Within 210, 240, 270 and 360 Days After Birth (Efficacy)

Secondary: Percentage of MA-LRTI Cases due to RSV in Infant Participants Occurring Within 210, 240, 270 and 360 Days After Birth (Efficacy)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

Clinical Trial Results:
A Phase 3, Randomized, Double-blinded, Placebo-controlled Trial to Evaluate the Efficacy and Safety of a Respiratory Syncytial Virus (RSV) Prefusion F Subunit Vaccine in Infants Born to Women Vaccinated During Pregnancy