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Clinical Trial Results:
A Phase III, randomized, double-blind, placebo controlled multi-country study to demonstrate efficacy of a single dose of unadjuvanted RSV Maternal vaccine, administered IM to pregnant women 18 to 49 years of age, for prevention of RSV associated LRTI in their infants up to 6 months of age

Summary
EudraCT number	2020-001355-40
Trial protocol	FI FR BE IT ES
Global end of trial date	14 Jun 2023

Results information
Results version number	v2(current)
This version publication date	19 Oct 2024
First version publication date	05 Jul 2024
Other versions	v1
Version creation reason

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

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Trial information

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Sponsor protocol code

212171

ISRCTN number

US NCT number

NCT04605159

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline

Sponsor organisation address

Rue de l’Institut 89, Rixensart, Belgium, B-1330

Public contact

GSK Response Center, GlaxoSmithKline, 44 8664357343, GSKClinicalSupportHD@gsk.com

Scientific contact

GSK Response Center, GlaxoSmithKline, 44 8664357343, GSKClinicalSupportHD@gsk.com

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

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

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

Analysis stage

Final

Date of interim/final analysis

20 Oct 2023

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

14 Jun 2023

Was the trial ended prematurely?

Yes

Main objective of the trial

• To assess the efficacy of a single dose of the RSV Maternal vaccine administered to maternal participants in preventing medically assessed, RSV-associated severe LRTIs in their infant participants up to 6 months of age. • To assess the efficacy of a single dose of the RSV Maternal vaccine administered to maternal participants in preventing medically assessed, RSV-associated LRTIs of any severity in their infant participants up to 6 months of age. • To evaluate the safety of the RSV Maternal vaccine in infants born to mothers who were vaccinated with a single intramuscular (IM) dose of study vaccine, up to 12 months after birth.

Protection of trial subjects

All maternal participants were observed closely for at least 30 minutes after the administration of the vaccine/product. Appropriate medical treatment was readily available during the observation period in case of anaphylaxis and/or syncope. Vaccines/products were administered by qualified and trained personnel. Vaccines/products were administered only to eligible participants that had no contraindications to any components of the vaccines/products.

Background therapy

Evidence for comparator

Actual start date of recruitment

20 Nov 2020

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 566

Country: Number of subjects enrolled

Australia: 83

Country: Number of subjects enrolled

Bangladesh: 642

Country: Number of subjects enrolled

Belgium: 118

Country: Number of subjects enrolled

Brazil: 155

Country: Number of subjects enrolled

Canada: 92

Country: Number of subjects enrolled

Colombia: 541

Country: Number of subjects enrolled

Dominican Republic: 59

Country: Number of subjects enrolled

Finland: 389

Country: Number of subjects enrolled

France: 68

Country: Number of subjects enrolled

Honduras: 60

Country: Number of subjects enrolled

India: 119

Country: Number of subjects enrolled

Italy: 128

Country: Number of subjects enrolled

Korea, Republic of: 28

Country: Number of subjects enrolled

Mexico: 88

Country: Number of subjects enrolled

New Zealand: 434

Country: Number of subjects enrolled

Panama: 1471

Country: Number of subjects enrolled

Philippines: 695

Country: Number of subjects enrolled

South Africa: 1307

Country: Number of subjects enrolled

Spain: 1526

Country: Number of subjects enrolled

Taiwan: 229

Country: Number of subjects enrolled

Thailand: 114

Country: Number of subjects enrolled

United Kingdom: 2

Country: Number of subjects enrolled

United States: 2280

Worldwide total number of subjects

11194

EEA total number of subjects

2229

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

323

Newborns (0-27 days)

4912

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

5959

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

A total of 11194 participants (5959 maternal participants and 5235 infants) completed the informed consent process, of which 5328 maternal participants were exposed to the study intervention, and 5235 infants were born to those exposed mothers (RSV MAT Group - Mother and Placebo Group - Mother). Therefore, 10563 participants started the study.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Blinding implementation details

The study was conducted in a double-blinded manner, but the study was unblinded following the decision to stop enrollment and vaccination in the study due to a safety signal.

Are arms mutually exclusive

Yes

RSV MAT Group - Mother

Arm description

Maternal participants received a single dose of the RSV MAT vaccine administered at Day 1 in this study.

Arm type

Experimental

Investigational medicinal product name

RSV MAT

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Single dose of the RSV MAT vaccine reconstituted with NaCl solution, administered intramuscularly in the non-dominant arm, at Day 1.

Placebo Group - Mother

Arm description

Maternal participants received a single dose of placebo administered at Day 1 in this study.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Single dose of Placebo (lyophilized sucrose reconstituted with NaCl solution), administered intramuscularly in the non-dominant arm, at Day 1.

RSV MAT Group - Infant

Arm description

This group consisted of infants born to mothers (from RSV MAT Group - Mother) who received a single dose of RSV MAT vaccine during pregnancy.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Placebo Group - Infant

Arm description

This group consisted of infants born to mothers (from Placebo Group - Mother) who received a single dose of placebo during pregnancy.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Number of subjects in period 1 ^[1]	RSV MAT Group - Mother	Placebo Group - Mother	RSV MAT Group - Infant	Placebo Group - Infant
Started	3557	1771	3494	1741
Completed	3374	1657	3236	1583
Not completed	183	114	258	158
Consent withdrawn by subject	66	37	68	50
Adverse event, non-fatal	6	3	21	4
Migrated / moved from the study area	32	22	41	21
Unspecified	1	2	7	3
Lost to follow-up	74	45	119	80
Protocol deviation	4	5	2	-

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: A total of 11194 participants (5959 maternal participants and 5235 infants) completed the informed consent process, of which 5328 maternal participants were exposed to the study intervention, and 5235 infants were born to those exposed mothers (RSV MAT Group - Mother and Placebo Group - Mother). Therefore, 10563 participants started the study.

Baseline characteristics

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Reporting group title

RSV MAT Group - Mother

Reporting group description

Maternal participants received a single dose of the RSV MAT vaccine administered at Day 1 in this study.

Reporting group title

Placebo Group - Mother

Reporting group description

Maternal participants received a single dose of placebo administered at Day 1 in this study.

Reporting group title

RSV MAT Group - Infant

Reporting group description

This group consisted of infants born to mothers (from RSV MAT Group - Mother) who received a single dose of RSV MAT vaccine during pregnancy.

Reporting group title

Placebo Group - Infant

Reporting group description

This group consisted of infants born to mothers (from Placebo Group - Mother) who received a single dose of placebo during pregnancy.

Reporting group values	RSV MAT Group - Mother	Placebo Group - Mother	RSV MAT Group - Infant	Placebo Group - Infant	Total
Number of subjects	3557	1771	3494	1741	10563
Age Categorical
Units: Participants
0 to 1 years of age	0	0	3494	1741	5235
18 to 34 years of age	2866	1408	0	0	4274
35 to 39 years of age	581	300	0	0	881
40 to 49 years of age	110	63	0	0	173
Sex/Gender, Customized
Units: Participants
Female	3557	1771	1739	867	7934
Male	0	0	1753	873	2626
Other, Unspecified	0	0	2	1	3
Race/Ethnicity, Customized
Units: Subjects
ASIAN	663	326	641	321	1951
BLACK OR AFRICAN AMERICAN	517	251	463	234	1465
WHITE	1669	838	1634	816	4957
OTHER, UNSPECIFIED	685	345	730	348	2108
OTHER, DEIDENTIFIED	23	11	26	22	82

End points

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Reporting group title

RSV MAT Group - Mother

Reporting group description

Maternal participants received a single dose of the RSV MAT vaccine administered at Day 1 in this study.

Reporting group title

Placebo Group - Mother

Reporting group description

Maternal participants received a single dose of placebo administered at Day 1 in this study.

Reporting group title

RSV MAT Group - Infant

Reporting group description

This group consisted of infants born to mothers (from RSV MAT Group - Mother) who received a single dose of RSV MAT vaccine during pregnancy.

Reporting group title

Placebo Group - Infant

Reporting group description

This group consisted of infants born to mothers (from Placebo Group - Mother) who received a single dose of placebo during pregnancy.

Subject analysis set title

RSV MAT Group

Subject analysis set type

Per protocol

Subject analysis set description

This group consisted of pairs of maternal participants from RSV MAT Group - Mother and infant participants from RSV MAT Group - Infant.

Subject analysis set title

Placebo Group

Subject analysis set type

Per protocol

Subject analysis set description

This group consisted of pairs of maternal participants from Placebo Group - Mother and infant participants from Placebo Group - Infant.

Primary: Number of infant participants with medically assessed, RSV-associated lower respiratory tract illnesses (LRTIs) of any severity and RSV-associated severe LRTIs from birth to Day 181 post-birth

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End point title

Number of infant participants with medically assessed, RSV-associated lower respiratory tract illnesses (LRTIs) of any severity and RSV-associated severe LRTIs from birth to Day 181 post-birth ^[1] ^[2]

End point description

An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND a blood oxygen saturation by pulse oximetry (SpO2) lower than (<) 95%, OR respiratory rate increase AND a confirmed RSV infection. An RSV-associated severe LRTI met the case definition of RSV-LRTI AND was additionally characterized by a SpO2 <93%, OR lower chest wall in-drawing, OR inability to feed, OR failure to respond/unconscious. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI. The analysis was performed on the Modified Full Analysis - Efficacy set for infants, which included all infant participants in the Exposed set who were born after at least 4 weeks of their maternal participants vaccination.

End point type

Primary

End point timeframe

From birth to Day 181 post-birth

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[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 is only reporting values for the infant participants.

End point values	RSV MAT Group - Infant	Placebo Group - Infant
Number of subjects analysed	3426	1711
Units: Participants
RSV-associated LRTIs of any severity	16	24
RSV-associated severe LRTIs	8	14

No statistical analyses for this end point

Primary: Number of infant participants with at least one adverse event (AE) leading to study withdrawal from birth to Day 181 post-birth

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End point title

Number of infant participants with at least one adverse event (AE) leading to study withdrawal from birth to Day 181 post-birth ^[3] ^[4]

End point description

A participant was considered a ‘withdrawal’ from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact. Participants who were withdrawn from the study because of AEs were clearly distinguished from participants who were withdrawn for other reasons. Investigators followed participants who were withdrawn from the study as a result of an AE until the event was resolved. At least one AE leading to study withdrawal = occurrence of at least one AE leading to study withdrawal regardless of intensity grade or relation to vaccination. The analysis was performed on the Exposed Set for infants, which included the infants live-born to exposed maternal participants, whose parents/legally acceptable representative(s) (LARs) completed the informed consent process and signed the informed consent form.

End point type

Primary

End point timeframe

From birth to Day 181 post-birth

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[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 is only reporting values for the infant participants.

End point values	RSV MAT Group - Infant	Placebo Group - Infant
Number of subjects analysed	3494	1741
Units: Participants	19	4

No statistical analyses for this end point

Primary: Number of infant participants with at least one serious adverse event (SAE) from birth to Day 181 post-birth

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End point title

Number of infant participants with at least one serious adverse event (SAE) from birth to Day 181 post-birth ^[5] ^[6]

End point description

An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. At least one SAE = occurrence of at least one SAE regardless of intensity grade or relation to vaccination. The analysis was performed on the Exposed Set for infants, which included the infants live-born to exposed maternal participants, whose parents/legally acceptable representative(s) (LARs) completed the informed consent process and signed the informed consent form.

End point type

Primary

End point timeframe

From birth to Day 181 post-birth

Notes
[5] - 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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[6] - 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 is only reporting values for the infant participants.

End point values	RSV MAT Group - Infant	Placebo Group - Infant
Number of subjects analysed	3494	1741
Units: Participants	640	323

No statistical analyses for this end point

Primary: Number of infant participants with at least one medically attended AE (MAE) from birth to Day 181 post-birth

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End point title

Number of infant participants with at least one medically attended AE (MAE) from birth to Day 181 post-birth ^[7] ^[8]

End point description

An MAE is defined as an unsolicited AE, such as a symptom or illness, which required hospitalization, or emergency room visit, or visit to/by a health care provider. At least one MAE = occurrence of at least one MAE regardless of intensity grade or relation to vaccination. The analysis was performed on the Exposed Set for infants, which included the infants live-born to exposed maternal participants, whose parents/legally acceptable representative(s) (LARs) completed the informed consent process and signed the informed consent form.

End point type

Primary

End point timeframe

From birth to Day 181 post-birth

Notes
[7] - 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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[8] - 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 is only reporting values for the infant participants.

End point values	RSV MAT Group - Infant	Placebo Group - Infant
Number of subjects analysed	3494	1741
Units: Participants	2321	1135

No statistical analyses for this end point

Primary: Number of infant participants with at least one SAE from birth to Day 366 post-birth

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End point title

Number of infant participants with at least one SAE from birth to Day 366 post-birth ^[9] ^[10]

End point description

An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. At least one SAE = occurrence of at least one SAE regardless of intensity grade or relation to vaccination. The analysis was performed on the Exposed Set for infants, which included the infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.

End point type

Primary

End point timeframe

From birth to Day 366 post-birth

Notes
[9] - 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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[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 is only reporting values for the infant participants.

End point values	RSV MAT Group - Infant	Placebo Group - Infant
Number of subjects analysed	3494	1741
Units: Participants	731	371

No statistical analyses for this end point

Primary: Number of infant participants with at least one AE leading to study withdrawal from birth to Day 366 post-birth

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End point title

Number of infant participants with at least one AE leading to study withdrawal from birth to Day 366 post-birth ^[11] ^[12]

End point description

A participant was considered a ‘withdrawal’ from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact. Participants who were withdrawn from the study because of AEs were clearly distinguished from participants who were withdrawn for other reasons. Investigators followed participants who were withdrawn from the study as a result of an AE until the event was resolved. At least one AE leading to study withdrawal = occurrence of at least one AE leading to study withdrawal regardless of intensity grade or relation to vaccination. The analysis was performed on the Exposed Set for infants, which included the infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.

End point type

Primary

End point timeframe

From birth to Day 366 post-birth

Notes
[11] - 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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[12] - 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 is only reporting values for the infant participants.

End point values	RSV MAT Group - Infant	Placebo Group - Infant
Number of subjects analysed	3494	1741
Units: Participants	21	4

No statistical analyses for this end point

Primary: Number of infant participants with at least one MAE from birth to Day 366 post-birth

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End point title

Number of infant participants with at least one MAE from birth to Day 366 post-birth ^[13] ^[14]

End point description

An MAE is defined as an unsolicited AE, such as a symptom or illness, which required hospitalization, or emergency room visit, or visit to/by a health care provider. At least one MAE = occurrence of at least one MAE regardless of intensity grade or relation to vaccination. The analysis was performed on the Exposed Set for infants, which included the infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.

End point type

Primary

End point timeframe

From birth to Day 366 post-birth

Notes
[13] - 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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[14] - 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 is only reporting values for the infant participants.

End point values	RSV MAT Group - Infant	Placebo Group - Infant
Number of subjects analysed	3494	1741
Units: Participants	2706	1330

No statistical analyses for this end point

Secondary: Number of infant participants with RSV-associated hospitalizations from birth to Day 181 post-birth

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End point title

Number of infant participants with RSV-associated hospitalizations from birth to Day 181 post-birth ^[15]

End point description

RSV-associated hospitalization is defined as a confirmed RSV infection and hospitalized for acute medical condition. Hospitalization is defined as admission for observation or treatment based on the judgment of a health care provider. The analysis was performed on the Modified Full Analysis - Efficacy set for infants, which included all infant participants in the Exposed Set who were born after at least 4 weeks of their maternal participants vaccination.

End point type

Secondary

End point timeframe

From birth to Day 181 post-birth

Notes
[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 is only reporting values for the infant participants.

End point values	RSV MAT Group - Infant	Placebo Group - Infant
Number of subjects analysed	3426	1711
Units: Participants	14	14

No statistical analyses for this end point

Secondary: Number of infant participants with medically assessed, RSV-associated severe LRTIs for RSV subtype A and RSV subtype B separately from birth to Day 181 post-birth

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End point title

Number of infant participants with medically assessed, RSV-associated severe LRTIs for RSV subtype A and RSV subtype B separately from birth to Day 181 post-birth ^[16]

End point description

An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 <95%, OR respiratory rate increase AND a confirmed RSV infection. An RSV-associated severe LRTI met the case definition of RSV-LRTI AND was additionally characterized by an SpO2 <93%, OR lower chest wall in-drawing, OR inability to feed, OR failure to respond/unconscious. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI. The RSV subtypes assessed for this analysis were RSV subtype A and RSV subtype B. The analysis was performed on the Modified Full Analysis - Efficacy set for infants which included all the infant participants in the Exposed Set who were born after at least 4 weeks of their maternal participants vaccination.

End point type

Secondary

End point timeframe

From birth to Day 181 post-birth

Notes
[16] - 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 is only reporting values for the infant participants.

End point values	RSV MAT Group - Infant	Placebo Group - Infant
Number of subjects analysed	3426	1711
Units: Participants
RSV A	2	3
RSV B	6	11

No statistical analyses for this end point

Secondary: Number of infant participants with medically assessed, RSV-associated LRTIs of any severity from birth to Day 366 post-birth

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End point title

Number of infant participants with medically assessed, RSV-associated LRTIs of any severity from birth to Day 366 post-birth ^[17]

End point description

An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 <95%, OR respiratory rate increase AND a confirmed RSV infection. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI. The analysis was performed on the Modified Full Analysis - Efficacy set for infants, which included all infant participants in the Exposed Set who were born after at least 4 weeks of their maternal participants vaccination.

End point type

Secondary

End point timeframe

From birth to Day 366 post-birth

Notes
[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 is only reporting values for the infant participants.

End point values	RSV MAT Group - Infant	Placebo Group - Infant
Number of subjects analysed	3426	1711
Units: Participants	67	43

No statistical analyses for this end point

Secondary: Number of infant participants with all-cause LRTIs from birth to Day 181 post-birth

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End point title

Number of infant participants with all-cause LRTIs from birth to Day 181 post-birth ^[18]

End point description

All-cause LRTI was characterized by history of cough OR difficulty in breathing, AND SpO2 < 95%, OR respiratory rate increase. The analysis was performed on the Modified Full Analysis - Efficacy set for infants, which included all the infant participants in the Exposed Set who were born after at least 4 weeks of their maternal participants vaccination.

End point type

Secondary

End point timeframe

From birth to Day 181 post-birth

Notes
[18] - 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 is only reporting values for the infant participants.

End point values	RSV MAT Group - Infant	Placebo Group - Infant
Number of subjects analysed	3426	1711
Units: Participants	162	103

No statistical analyses for this end point

Secondary: Number of infant participants with all-cause LRTIs with hospitalization from birth to Day 181 post-birth

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End point title

Number of infant participants with all-cause LRTIs with hospitalization from birth to Day 181 post-birth ^[19]

End point description

All-cause LRTI was characterized by history of cough OR difficulty in breathing, AND SpO2 < 95%, OR respiratory rate increase. Hospitalization is defined as admission for observation or treatment based on the judgment of a health care provider. The analysis was performed on the Modified Full Analysis - Efficacy set for infants, which included all infant participants in the Exposed Set who were born after at least 4 weeks of their maternal participants vaccination.

End point type

Secondary

End point timeframe

From birth to Day 181 post-birth

Notes
[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 is only reporting values for the infant participants.

End point values	RSV MAT Group - Infant	Placebo Group - Infant
Number of subjects analysed	3426	1711
Units: Participants	30	22

No statistical analyses for this end point

Secondary: Number of infant participants with medically assessed, RSV-associated severe LRTIs from birth to Day 366 post-birth

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End point title

Number of infant participants with medically assessed, RSV-associated severe LRTIs from birth to Day 366 post-birth ^[20]

End point description

An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 <95%, OR respiratory rate increase AND a confirmed RSV infection. An RSV-associated severe LRTI met the case definition of RSV-LRTI AND was additionally characterized by an SpO2 <93%, OR lower chest wall in-drawing, OR inability to feed, OR failure to respond/unconscious. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI. The analysis was performed on the Modified Full Analysis - Efficacy set for infants, which included all infant participants in the Exposed Set who were born after at least 4 weeks of their maternal participants vaccination.

End point type

Secondary

End point timeframe

From birth to Day 366 post-birth

Notes
[20] - 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 is only reporting values for the infant participants.

End point values	RSV MAT Group - Infant	Placebo Group - Infant
Number of subjects analysed	3426	1711
Units: Participants	38	22

No statistical analyses for this end point

Secondary: Number of infant participants with medically assessed, RSV-associated LRTIs of any severity for RSV subtype A and RSV subtype B separately from birth to Day 181 post-birth

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End point title

Number of infant participants with medically assessed, RSV-associated LRTIs of any severity for RSV subtype A and RSV subtype B separately from birth to Day 181 post-birth ^[21]

End point description

An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 <95%, OR respiratory rate increase AND a confirmed RSV infection. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI. The RSV subtypes assessed for this analysis were RSV subtype A and RSV subtype B. The analysis was performed on the Modified Full Analysis - Efficacy set for infants, which included all infant participants in the Exposed Set who were born after at least 4 weeks of their maternal participants vaccination.

End point type

Secondary

End point timeframe

From birth to Day 181 post-birth

Notes
[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 is only reporting values for the infant participants.

End point values	RSV MAT Group - Infant	Placebo Group - Infant
Number of subjects analysed	3426	1711
Units: Participants
RSV A	6	8
RSV B	10	16

No statistical analyses for this end point

Secondary: Number of infant participants with medically assessed, RSV-associated severe LRTIs from birth to Day 121 post-birth

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End point title

Number of infant participants with medically assessed, RSV-associated severe LRTIs from birth to Day 121 post-birth ^[22]

End point description

An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 <95%, OR respiratory rate increase AND a confirmed RSV infection. An RSV-associated severe LRTI met the case definition of RSV-LRTI AND was additionally characterized by an SpO2 <93%, OR lower chest wall in-drawing, OR inability to feed, OR failure to respond/unconscious. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI. The analysis was performed on the Modified Full Analysis - Efficacy set for infants, which included all infant participants in the Exposed Set who were born after at least 4 weeks of their maternal participants vaccination.

End point type

Secondary

End point timeframe

From birth to Day 121 post-birth

Notes
[22] - 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 is only reporting values for the infant participants.

End point values	RSV MAT Group - Infant	Placebo Group - Infant
Number of subjects analysed	3426	1711
Units: Participants	6	9

No statistical analyses for this end point

Secondary: Number of infant participants with medically assessed, RSV-associated LRTIs of any severity from birth to Day 121 post-birth

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End point title

Number of infant participants with medically assessed, RSV-associated LRTIs of any severity from birth to Day 121 post-birth ^[23]

End point description

An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 <95%, OR respiratory rate increase AND a confirmed RSV infection. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI. The analysis was performed on the Modified Full Analysis - Efficacy set for infants, which included all infant participants in the Exposed Set who were born after at least 4 weeks of their maternal participants vaccination.

End point type

Secondary

End point timeframe

From birth to Day 121 post-birth

Notes
[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 is only reporting values for the infant participants.

End point values	RSV MAT Group - Infant	Placebo Group - Infant
Number of subjects analysed	3426	1711
Units: Participants	9	15

No statistical analyses for this end point

Secondary: Number of infant participants with all-cause pneumonia from birth to Day 181 post-birth

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End point title

Number of infant participants with all-cause pneumonia from birth to Day 181 post-birth ^[24]

End point description

The number of infant participants with all-cause pneumonia is presented in this outcome measure. The analysis was performed on the Modified Full Analysis - Efficacy set for infants, which included all infant participants in the Exposed Set who were born after at least 4 weeks of their maternal participants vaccination.

End point type

Secondary

End point timeframe

From birth to Day 181 post-birth

Notes
[24] - 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 is only reporting values for the infant participants.

End point values	RSV MAT Group - Infant	Placebo Group - Infant
Number of subjects analysed	3426	1711
Units: Participants	36	17

No statistical analyses for this end point

Secondary: Number of infant participants with RSV-associated hospitalizations from birth to Day 366 post-birth

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End point title

Number of infant participants with RSV-associated hospitalizations from birth to Day 366 post-birth ^[25]

End point description

End point type

Secondary

End point timeframe

From birth to Day 366 post-birth

Notes
[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 is only reporting values for the infant participants.

End point values	RSV MAT Group - Infant	Placebo Group - Infant
Number of subjects analysed	3426	1711
Units: Participants	41	26

No statistical analyses for this end point

Secondary: Number of maternal participants with RSV-associated medically attended RTIs (RSV-MA-RTIs) from study intervention administration (Day 1) to Day 181 post-delivery

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End point title

Number of maternal participants with RSV-associated medically attended RTIs (RSV-MA-RTIs) from study intervention administration (Day 1) to Day 181 post-delivery ^[26]

End point description

RSV-associated MA-RTI is defined as a medically attended visit for RTI symptoms and confirmed RSV infection. The analysis was performed on the Exposed Set for maternal participants, which included all maternal participants who received the study intervention.

End point type

Secondary

End point timeframe

From study intervention administration (Day 1) to Day 181 post-delivery

Notes
[26] - 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 is only reporting values for the maternal participants.

End point values	RSV MAT Group - Mother	Placebo Group - Mother
Number of subjects analysed	3557	1771
Units: Participants	3	6

No statistical analyses for this end point

Secondary: RSV-A neutralizing antibody titers for maternal participants at Day 1, at Day 31 and at delivery

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End point title

RSV-A neutralizing antibody titers for maternal participants at Day 1, at Day 31 and at delivery ^[27]

End point description

RSV-A neutralizing titers were determined by neutralization assay and expressed as geometric mean titers (GMTs). The analysis was performed on the Per Protocol - Immunogenicity set for maternal participants, which included all maternal participants who received the study intervention to which they were randomized and had post-vaccination immunogenicity data available for the specified analysis at each of the specified time points (i.e. Day 1, Day 31, delivery) minus those participants with protocol deviations that led to exclusion.

End point type

Secondary

End point timeframe

At Day 1 (before study intervention administration), at Day 31 and at delivery

Notes
[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 is only reporting values for the maternal participants.

End point values	RSV MAT Group - Mother	Placebo Group - Mother
Number of subjects analysed	404	196
Units: Titers
geometric mean (confidence interval 95%)
Day 1 (N=404;196)	637.2 (589.4 to 688.8)	594.9 (527.3 to 671.2)
Day 31 (N=317;148)	9196.9 (8310.8 to 10177.6)	673.5 (578.8 to 783.7)
Delivery (N=404;178)	5703.1 (5196.3 to 6259.3)	657.7 (575.4 to 751.8)

No statistical analyses for this end point

Secondary: RSV-A neutralizing antibody titers for infant participants at delivery or within 72 hours after birth

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End point title

RSV-A neutralizing antibody titers for infant participants at delivery or within 72 hours after birth ^[28]

End point description

RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. The titers were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 72 hours after birth (if no cord blood sample could be obtained). The analysis was performed on the Per Protocol - Immunogenicity set for infants, which included all infant participants in the Exposed set who had post-delivery/birth immunogenicity data available for the specified analysis at the specified time points (i.e. at delivery or within 72 hours after birth), minus those who (a) were born less than 4 weeks post- maternal participant vaccination and/ or (b) had protocol deviations that led to exclusion.

End point type

Secondary

End point timeframe

At delivery or within 72 hours after birth

Notes
[28] - 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 is only reporting values for the infant participants.

End point values	RSV MAT Group - Infant	Placebo Group - Infant
Number of subjects analysed	197	82
Units: Titers
geometric mean (confidence interval 95%)	9466.2 (8398.6 to 10669.5)	725.9 (593.1 to 888.5)

No statistical analyses for this end point

Secondary: RSV-A neutralizing antibody titers for infant participants at Day 43 post-birth

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End point title

RSV-A neutralizing antibody titers for infant participants at Day 43 post-birth ^[29]

End point description

RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. The analysis was performed on a sub-cohort from the Per Protocol - Immunogenicity set for infants, which included the infant participants for whom blood samples were collected for the specified analysis at Day 43 post-birth.

End point type

Secondary

End point timeframe

At Day 43 post-birth

Notes
[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 is only reporting values for the infant participants.

End point values	RSV MAT Group - Infant	Placebo Group - Infant
Number of subjects analysed	140	67
Units: Titers
geometric mean (confidence interval 95%)	4042.1 (3530.3 to 4628.2)	311.3 (250.3 to 387.2)

No statistical analyses for this end point

Secondary: RSV MAT immunoglobulin G (IgG)-specific antibody concentrations for maternal participants at delivery

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End point title

RSV MAT immunoglobulin G (IgG)-specific antibody concentrations for maternal participants at delivery ^[30]

End point description

RSV MAT IgG-specific antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (ELU/mL). The analysis was performed on the Per Protocol - Immunogenicity set for maternal participants, which included all maternal participants who received the study intervention to which they were randomized and had post-vaccination immunogenicity data available for the specified analysis at the specified time point (i.e. delivery) minus those participants with protocol deviations that led to exclusion.

End point type

Secondary

End point timeframe

At delivery

Notes
[30] - 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 is only reporting values for the maternal participants.

End point values	RSV MAT Group - Mother	Placebo Group - Mother
Number of subjects analysed	405	178
Units: ELU/mL
geometric mean (confidence interval 95%)	62880 (58517 to 67568)	5600 (4949 to 6338)

No statistical analyses for this end point

Secondary: RSV-A neutralizing antibody titers for infant participants at Day 121 post-birth

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End point title

RSV-A neutralizing antibody titers for infant participants at Day 121 post-birth ^[31]

End point description

End point type

Secondary

End point timeframe

At Day 121 post-birth

Notes
[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 is only reporting values for the infant participants.

End point values	RSV MAT Group - Infant	Placebo Group - Infant
Number of subjects analysed	50	23
Units: Titers
geometric mean (confidence interval 95%)	682.4 (520.2 to 895.3)	74.8 (46.5 to 120.2)

No statistical analyses for this end point

Secondary: RSV-A neutralizing antibody titers for infant participants at Day 181 post-birth

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End point title

RSV-A neutralizing antibody titers for infant participants at Day 181 post-birth ^[32]

End point description

End point type

Secondary

End point timeframe

At Day 181 post-birth

Notes
[32] - 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 is only reporting values for the infant participants.

End point values	RSV MAT Group - Infant	Placebo Group - Infant
Number of subjects analysed	44	9
Units: Titers
geometric mean (confidence interval 95%)	506.0 (432.4 to 592.3)	133.7 (52.4 to 341.2)

No statistical analyses for this end point

Secondary: Number of maternal participants with any solicited administration site events from Day 1 to Day 7 included

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End point title

Number of maternal participants with any solicited administration site events from Day 1 to Day 7 included ^[33]

End point description

Assessed solicited administration site events included erythema, pain and swelling at the injection site. Any pain = occurrence of the symptom regardless of intensity grade. Any erythema and swelling = symptom reported with a surface diameter greater than or equal to 20 millimeters. The analysis was performed on the Solicited Safety set for maternal participants, which included all maternal participants who received the study intervention and who had solicited safety data available during the specified period (i.e. from Day 1 to Day 7 included).

End point type

Secondary

End point timeframe

From Day 1 to Day 7 included

Notes
[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 is only reporting values for the maternal participants.

End point values	RSV MAT Group - Mother	Placebo Group - Mother
Number of subjects analysed	3090	1547
Units: Participants
Any Erythema	133	8
Any Pain	1294	230
Any Swelling	96	8

No statistical analyses for this end point

Secondary: Geometric mean ratio (GMR) between cord blood and maternal RSV MAT immunoglobulin G (IgG)-specific antibody concentrations

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End point title

Geometric mean ratio (GMR) between cord blood and maternal RSV MAT immunoglobulin G (IgG)-specific antibody concentrations

End point description

The placental transfer ratio of RSV-MAT IgG-specific antibody concentration was determined from cord blood over that of the blood sample from mother at delivery. If no cord blood could be obtained, an infant blood sample was collected 72 hours after birth. The analysis was performed on all pairs of maternal participants (from Per Protocol - Immunogenicity set for maternal participants) and their infants (from Per Protocol -Immunogenicity set for infants) with available results for this outcome measure at the specified time points.

End point type

Secondary

End point timeframe

At delivery (for maternal participants) or within 72 hours after birth (for infant participants, only if no cord blood could be obtained)

End point values	RSV MAT Group	Placebo Group
Number of subjects analysed	150	60
Units: Ratio
geometric mean (confidence interval 95%)	1.46 (1.35 to 1.58)	1.39 (1.22 to 1.59)

No statistical analyses for this end point

Secondary: RSV MAT IgG-specific antibody concentrations for infant participants at delivery or within 72 hours after birth

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End point title

RSV MAT IgG-specific antibody concentrations for infant participants at delivery or within 72 hours after birth ^[34]

End point description

RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL. The antibody concentrations were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 72 hours after birth (only if no cord blood sample could be obtained at delivery). The analysis was performed on the Per Protocol -Immunogenicity set for infants, which included all infant participants in the Exposed set who had post-delivery/birth immunogenicity data available for the specified analysis at the specified time points (i.e. at delivery or within 72 hours after birth), minus those who (a) were born less than 4 weeks post-maternal participant vaccination and/ or (b) had protocol deviations that led to exclusion.

End point type

Secondary

End point timeframe

At delivery or within 72 hours after birth (only if no cord blood sample could be obtained at delivery)

Notes
[34] - 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 is only reporting values for the infant participants.

End point values	RSV MAT Group - Infant	Placebo Group - Infant
Number of subjects analysed	230	97
Units: ELU/mL
geometric mean (confidence interval 95%)	94365 (86569 to 102864)	6610 (5688 to 7682)

No statistical analyses for this end point

Secondary: Number of maternal participants with any solicited systemic events from Day 1 to Day 7 included

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End point title

Number of maternal participants with any solicited systemic events from Day 1 to Day 7 included ^[35]

End point description

Assessed solicited systemic events included abdominal pain, diarrhea, fatigue, headache, nausea, fever [temperature equal to or above (>=) 38 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F), regardless of the location of measurement] and vomiting. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. The analysis was performed on the Solicited Safety set for maternal participants, which included all maternal participants who received the study intervention and who had solicited safety data available during the specified period (i.e. from Day 1 to Day 7 included).

End point type

Secondary

End point timeframe

From Day 1 to Day 7 included

Notes
[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 is only reporting values for the maternal participants.

End point values	RSV MAT Group - Mother	Placebo Group - Mother
Number of subjects analysed	3090	1547
Units: Participants
Any Abdominal pain	492	231
Any Diarrhea	351	180
Any Fatigue	1091	479
Any Headache	942	442
Any Nausea	599	306
Any Fever	26	7
Any Vomiting	276	149

No statistical analyses for this end point

Secondary: Number of maternal participants with any unsolicited AEs from Day 1 to Day 30 included

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End point title

Number of maternal participants with any unsolicited AEs from Day 1 to Day 30 included ^[36]

End point description

An unsolicited AE is defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Any = occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. The analysis was performed on the Exposed Set for maternal participants, which included all maternal participants who received the study intervention.

End point type

Secondary

End point timeframe

From Day 1 to Day 30 included

Notes
[36] - 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 is only reporting values for the maternal participants.

End point values	RSV MAT Group - Mother	Placebo Group - Mother
Number of subjects analysed	3557	1771
Units: Participants	629	297

No statistical analyses for this end point

Secondary: Number of maternal participants with at least one SAE from Day 1 to Day 181 post-delivery

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End point title

Number of maternal participants with at least one SAE from Day 1 to Day 181 post-delivery ^[37]

End point description

An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant or resulted in abnormal pregnancy outcomes or in other situations that were considered serious per medical or scientific judgment. At least one SAE = occurrence of at least one SAE regardless of intensity grade or relation to vaccination. The analysis was performed on the Exposed Set for maternal participants, which included all maternal participants who received the study intervention.

End point type

Secondary

End point timeframe

From Day 1 to Day 181 post-delivery

Notes
[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 is only reporting values for the maternal participants.

End point values	RSV MAT Group - Mother	Placebo Group - Mother
Number of subjects analysed	3557	1771
Units: Participants	827	395

No statistical analyses for this end point

Secondary: Number of maternal participants with at least one AE leading to study withdrawal from Day 1 to Day 181 post-delivery

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End point title

Number of maternal participants with at least one AE leading to study withdrawal from Day 1 to Day 181 post-delivery ^[38]

End point description

A participant was considered a ‘withdrawal’ from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact. Participants who were withdrawn from the study because of AEs were clearly distinguished from participants who were withdrawn for other reasons. Investigators followed participants who were withdrawn from the study as a result of an AE until the event was resolved. At least one AE leading to study withdrawal = occurrence of at least one AE leading to study withdrawal regardless of intensity grade or relation to vaccination. The analysis was performed on the Exposed Set for maternal participants, which included all maternal participants who received the study intervention.

End point type

Secondary

End point timeframe

From Day 1 to Day 181 post-delivery

Notes
[38] - 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 is only reporting values for the maternal participants.

End point values	RSV MAT Group - Mother	Placebo Group - Mother
Number of subjects analysed	3557	1771
Units: Participants	6	3

No statistical analyses for this end point

Secondary: Number of maternal participants with at least one all-cause MA-RTI from Day 1 to Day 181 post-delivery

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End point title

Number of maternal participants with at least one all-cause MA-RTI from Day 1 to Day 181 post-delivery ^[39]

End point description

All-cause MA-RTI occurred when the maternal participant visited a healthcare professional (e.g., a General Practitioner) for any respiratory symptom, including (but not limited to) cough, sore throat, sputum production and difficulty breathing. At least one all-cause MA-RTI = occurrence of at least one all-cause MA-RTI regardless of intensity grade or relation to vaccination. The analysis was performed on the Exposed Set for maternal participants, which included all maternal participants who received the study intervention.

End point type

Secondary

End point timeframe

From Day 1 to Day 181 post-delivery

Notes
[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 is only reporting values for the maternal participants.

End point values	RSV MAT Group - Mother	Placebo Group - Mother
Number of subjects analysed	3557	1771
Units: Participants	317	144

No statistical analyses for this end point

Secondary: Number of maternal participants with pregnancy outcomes from Day 1 to Day 42 post-delivery

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End point title

Number of maternal participants with pregnancy outcomes from Day 1 to Day 42 post-delivery ^[40]

End point description

Assessed pregnancy outcomes included live birth (LB) with no congenital anomalies, live birth (LB) with minor congenital anomaly(ies), live birth (LB) with at least 1 major congenital anomaly, fetal death (FD)/still birth (SB) with no congenital anomalies, fetal death (FD)/still birth (SB) with at least 1 major congenital anomaly and unknown outcome (includes participants withdrawn before/at delivery with no available data of pregnancy outcomes). The analysis was performed on the Exposed Set for maternal participants, which included all maternal participants who received the study intervention.

End point type

Secondary

End point timeframe

From Day 1 to Day 42 post-delivery, an average of 2 months

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 is only reporting values for the maternal participants.

End point values	RSV MAT Group - Mother	Placebo Group - Mother
Number of subjects analysed	3557	1771
Units: Participants
LB with no congenital anomalies	3118	1555
LB with only minor congenital anomaly(ies)	317	143
LB with at least 1 major congenital anomaly	61	43
FD/SB with no congenital anomalies	9	6
FD/SB with at least 1 major congenital anomaly	2	0
Unknown outcome	50	24

No statistical analyses for this end point

Secondary: Number of maternal participants with at least one MAE from Day 1 to Day 42 post-delivery

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End point title

Number of maternal participants with at least one MAE from Day 1 to Day 42 post-delivery ^[41]

End point description

An MAE is defined as an unsolicited AE, such as a symptom or illness, which required hospitalization, or emergency room visit, or visit to/by a health care provider. At least one MAE = occurrence of at least one MAE regardless of intensity grade or relation to vaccination. The analysis was performed on the Exposed Set for maternal participants, which included all maternal participants who received the study intervention.

End point type

Secondary

End point timeframe

From Day 1 to Day 42 post-delivery, an average of 2 months

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 is only reporting values for the maternal participants.

End point values	RSV MAT Group - Mother	Placebo Group - Mother
Number of subjects analysed	3557	1771
Units: Participants	1717	785

No statistical analyses for this end point

Secondary: Number of maternal participants with pregnancy-related adverse events of special interest (AESIs) from Day 1 to Day 42 post-delivery

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End point title

Number of maternal participants with pregnancy-related adverse events of special interest (AESIs) from Day 1 to Day 42 post-delivery ^[42]

End point description

Pregnancy-related AESIs included chorioamnionitis, fetal growth restriction, gestational diabetes mellitus, gestational hypertension, pre-eclampsia, pre-eclampsia with severe features including eclampsia, maternal death, premature preterm rupture of membranes, preterm labor, provider-initiated preterm birth. The analysis was performed on the Exposed Set for maternal participants, which included all maternal participants who received the study intervention.

End point type

Secondary

End point timeframe

From Day 1 to Day 42 post-delivery, an average of 2 months

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 is only reporting values for the maternal participants.

End point values	RSV MAT Group - Mother	Placebo Group - Mother
Number of subjects analysed	3557	1771
Units: Participants
Chorioamnionitis	30	14
Fetal Growth Restriction	30	26
Gestational Diabetes Mellitus	42	19
Gestational Hypertension	85	41
Pre-Eclampsia	74	36
Pre-Eclampsia With Severe Features	58	28
Maternal Death	2	1
Premature Preterm Rupture Of Membranes	53	20
Preterm Labor	141	57
Provider-Initiated Preterm Birth	54	16

No statistical analyses for this end point

Secondary: Number of infant participants with neonatal AESIs from birth to Day 42 post-birth

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End point title

Number of infant participants with neonatal AESIs from birth to Day 42 post-birth ^[43]

End point description

Neonatal/infant AESIs included congenital anomalies (CAs) with functional defects, congenital anomalies (CAs) with internal structural defects, congenital anomalies (CAs) with major external structural defects, extremely low birth weight (<1000 grams), low birth weight (<2500 grams), very low birth weight (<1500 grams), neonatal death in a preterm live birth (gestational age >=28 and <37 weeks), neonatal death in a term live birth (>=37 weeks of gestational age), neonatal death in an extremely pre-term birth (gestational age >=22 and <28 weeks), preterm birth (<37 weeks of gestational age), small for gestational age. The analysis was performed on the Exposed Set for infants, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.

End point type

Secondary

End point timeframe

From birth to Day 42 post-birth, an average of 2 months

Notes
[43] - 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 is only reporting values for the infant participants.

End point values	RSV MAT Group - Infant	Placebo Group - Infant
Number of subjects analysed	3494	1741
Units: Participants
CAs With Functional Defects	5	2
CAs With Internal Structural Defects	23	16
CAs With Major External Structural Defects	24	14
Extremely Low Birth Weight (<1000 grams)	3	0
Low Birth Weight (<2500 grams)	196	102
Very Low Birth Weight (<1500 grams)	5	0
Neonatal Death In A Preterm Live Birth	5	0
Neonatal Death In A Term Live Birth	6	3
Neonatal Death In An Extremely Pre-Term Birth	2	0
Preterm Birth	237	86
Small For Gestational Age	253	161

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Mothers: Solicited AEs: Day (D)1-D7&Unsolicited AEs:D1-D30 post-vaccination. AESIs&MAEs:D1-D42, deaths,(S)AEs leading to withdrawal,SAEs:D1-D181 post-delivery. Infants: AESIs: birth-D42, deaths,SAEs,(S)AEs leading to withdrawal,MAEs:birth-D366 post-birth.

Adverse event reporting additional description

All events presented in the SAEs & Non SAEs modules are reported for the Exposed set for maternal participants & Exposed set for infants during the specified timeframe. The solicited events presented for the RSV MAT Group – Mother & Placebo Group – Mother in the End Points module are reported for the Solicited safety set for maternal participants.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

26.1

Reporting group title

RSV MAT Group - Mother

Reporting group description

Maternal participants randomized to the RSV MAT Group received a single dose of the RSV MAT vaccine administered, between 24 to 34 weeks of gestation at Day 1 in this study.

Reporting group title

Placebo Group - Infant

Reporting group description

This group consisted of infants born to mothers (from Placebo Group - Mother) who received a single dose of placebo during pregnancy.

Reporting group title

RSV MAT Group - Infant

Reporting group description

This group consisted of infants born to mothers (from RSV MAT Group - Mother) who received a single dose of RSV MAT vaccine during pregnancy.

Reporting group title

Placebo Group - Mother

Reporting group description

Maternal participants randomized to the Placebo Group received a single dose of placebo administered, between 24 to 34 weeks of gestation, at Day 1 in this study.

Serious adverse events	RSV MAT Group - Mother	Placebo Group - Infant	RSV MAT Group - Infant	Placebo Group - Mother
Total subjects affected by serious adverse events
subjects affected / exposed	827 / 3557 (23.25%)	371 / 1741 (21.31%)	731 / 3494 (20.92%)	395 / 1771 (22.30%)
number of deaths (all causes)	2	4	20	1
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Granulosa cell tumour of the testis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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 haemangioma
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Lymphoproliferative disorder
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Malignant peritoneal neoplasm
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Ovarian epithelial cancer
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Retinoblastoma
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Aortic stenosis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Deep vein thrombosis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
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
Haemodynamic instability
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Hypertensive crisis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Hypotension
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 hypotension
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Renovascular hypertension
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Shock
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Subgaleal haematoma
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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 / 1	0 / 0
Venous thrombosis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
Surgical and medical procedures
Medically induced preterm birth
subjects affected / exposed	37 / 3557 (1.04%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	12 / 1771 (0.68%)
occurrences causally related to treatment / all	1 / 37	0 / 0	0 / 0	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Abnormal labour
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Abortion spontaneous
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Amniorrhoea
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Arrested labour
subjects affected / exposed	21 / 3557 (0.59%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	9 / 1771 (0.51%)
occurrences causally related to treatment / all	0 / 21	0 / 0	0 / 0	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Breech presentation
subjects affected / exposed	20 / 3557 (0.56%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	5 / 1771 (0.28%)
occurrences causally related to treatment / all	0 / 20	0 / 0	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Caput succedaneum
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Cephalhaematoma
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	1 / 3494 (0.03%)	0 / 1771 (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
Cephalo-pelvic disproportion
subjects affected / exposed	23 / 3557 (0.65%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	16 / 1771 (0.90%)
occurrences causally related to treatment / all	0 / 23	0 / 0	0 / 0	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cervix dystocia
subjects affected / exposed	7 / 3557 (0.20%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	4 / 1771 (0.23%)
occurrences causally related to treatment / all	0 / 7	0 / 0	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Eclampsia
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
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
Face presentation
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Failed induction of labour
subjects affected / exposed	27 / 3557 (0.76%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	12 / 1771 (0.68%)
occurrences causally related to treatment / all	0 / 27	0 / 0	0 / 0	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Failed trial of labour
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
False labour
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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 damage
subjects affected / exposed	5 / 3557 (0.14%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	5 / 1771 (0.28%)
occurrences causally related to treatment / all	0 / 5	0 / 0	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foetal disorder
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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 distress syndrome
subjects affected / exposed	125 / 3557 (3.51%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	69 / 1771 (3.90%)
occurrences causally related to treatment / all	0 / 125	0 / 0	0 / 0	0 / 69
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foetal dystocia
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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 macrosomia
subjects affected / exposed	9 / 3557 (0.25%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	3 / 1771 (0.17%)
occurrences causally related to treatment / all	0 / 9	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foetal hypokinesia
subjects affected / exposed	9 / 3557 (0.25%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences causally related to treatment / all	1 / 9	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foetal growth restriction
subjects affected / exposed	17 / 3557 (0.48%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	13 / 1771 (0.73%)
occurrences causally related to treatment / all	0 / 17	0 / 0	0 / 0	1 / 13
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foetal malposition
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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 malpresentation
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Gestational hypertension
subjects affected / exposed	46 / 3557 (1.29%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	22 / 1771 (1.24%)
occurrences causally related to treatment / all	0 / 46	0 / 0	0 / 0	0 / 22
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gestational diabetes
subjects affected / exposed	10 / 3557 (0.28%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences causally related to treatment / all	0 / 10	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
HELLP syndrome
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
Haemorrhage in pregnancy
subjects affected / exposed	6 / 3557 (0.17%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences causally related to treatment / all	0 / 6	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
High foetal head
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
High risk infant
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Hypoxic ischaemic encephalopathy neonatal
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	3 / 3494 (0.09%)	0 / 1771 (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
Hypothermia neonatal
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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
Labour complication
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Jaundice neonatal
subjects affected / exposed	0 / 3557 (0.00%)	51 / 1741 (2.93%)	89 / 3494 (2.55%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 51	0 / 91	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Large for dates baby
subjects affected / exposed	1 / 3557 (0.03%)	3 / 1741 (0.17%)	3 / 3494 (0.09%)	0 / 1771 (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
Low birth weight baby
subjects affected / exposed	0 / 3557 (0.00%)	21 / 1741 (1.21%)	53 / 3494 (1.52%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 21	1 / 53	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 5	0 / 0
Maternal death
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 1
Meconium in amniotic fluid
subjects affected / exposed	15 / 3557 (0.42%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	6 / 1771 (0.34%)
occurrences causally related to treatment / all	0 / 15	0 / 0	0 / 0	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Morning sickness
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Obstructed labour
subjects affected / exposed	9 / 3557 (0.25%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences causally related to treatment / all	0 / 9	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Oligohydramnios
subjects affected / exposed	19 / 3557 (0.53%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	14 / 1771 (0.79%)
occurrences causally related to treatment / all	1 / 19	0 / 0	0 / 0	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pelvic haematoma obstetric
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Peripartum cardiomyopathy
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Placenta praevia
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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 / 1
Placental insufficiency
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
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
Placental polyp
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Pre-eclampsia
subjects affected / exposed	105 / 3557 (2.95%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	51 / 1771 (2.88%)
occurrences causally related to treatment / all	0 / 106	0 / 0	0 / 0	0 / 52
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
Postpartum haemorrhage
subjects affected / exposed	46 / 3557 (1.29%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	26 / 1771 (1.47%)
occurrences causally related to treatment / all	0 / 47	0 / 0	0 / 0	0 / 27
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Precipitate labour
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Premature baby
subjects affected / exposed	0 / 3557 (0.00%)	30 / 1741 (1.72%)	84 / 3494 (2.40%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 30	1 / 84	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 4	0 / 0
Premature labour
subjects affected / exposed	56 / 3557 (1.57%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	15 / 1771 (0.85%)
occurrences causally related to treatment / all	2 / 56	0 / 0	0 / 0	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Premature rupture of membranes
subjects affected / exposed	11 / 3557 (0.31%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	5 / 1771 (0.28%)
occurrences causally related to treatment / all	0 / 11	0 / 0	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Premature separation of placenta
subjects affected / exposed	9 / 3557 (0.25%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	8 / 1771 (0.45%)
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
Prolonged labour
subjects affected / exposed	66 / 3557 (1.86%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	43 / 1771 (2.43%)
occurrences causally related to treatment / all	0 / 66	0 / 0	0 / 0	0 / 43
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Prolonged pregnancy
subjects affected / exposed	8 / 3557 (0.22%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	7 / 1771 (0.40%)
occurrences causally related to treatment / all	0 / 8	0 / 0	0 / 0	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Prolonged rupture of membranes
subjects affected / exposed	11 / 3557 (0.31%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	3 / 1771 (0.17%)
occurrences causally related to treatment / all	0 / 11	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Preterm premature rupture of membranes
subjects affected / exposed	37 / 3557 (1.04%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	14 / 1771 (0.79%)
occurrences causally related to treatment / all	0 / 37	0 / 0	0 / 0	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Retained placenta or membranes
subjects affected / exposed	9 / 3557 (0.25%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	3 / 1771 (0.17%)
occurrences causally related to treatment / all	0 / 9	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Retained products of conception
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Shoulder dystocia
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Stillbirth
subjects affected / exposed	11 / 3557 (0.31%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	6 / 1771 (0.34%)
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
Small for dates baby
subjects affected / exposed	0 / 3557 (0.00%)	15 / 1741 (0.86%)	21 / 3494 (0.60%)	0 / 1771 (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 / 2	0 / 0	0 / 0
Threatened labour
subjects affected / exposed	28 / 3557 (0.79%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	15 / 1771 (0.85%)
occurrences causally related to treatment / all	0 / 30	0 / 0	0 / 0	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Umbilical cord around neck
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	1 / 3494 (0.03%)	0 / 1771 (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
Traumatic delivery
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Transverse presentation
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Umbilical cord compression
subjects affected / exposed	6 / 3557 (0.17%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 6	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Umbilical cord prolapse
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Uterine hypotonus
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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 hypertonus
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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 contractions during pregnancy
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Uterine atony
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
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
Weight decrease neonatal
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
General disorders and administration site conditions
Chest pain
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Crying
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (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
Death neonatal
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	13 / 3494 (0.37%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 13	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 3	0 / 13	0 / 0
Developmental delay
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Dysplasia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Fatigue
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Feeling jittery
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Generalised oedema
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Hyperthermia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (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
Hypothermia
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	5 / 3494 (0.14%)	0 / 1771 (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
Inflammation
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Macrosomia
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	0 / 3494 (0.00%)	0 / 1771 (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
Multiple organ dysfunction syndrome
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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 / 1
Pyrexia
subjects affected / exposed	0 / 3557 (0.00%)	6 / 1741 (0.34%)	10 / 3494 (0.29%)	3 / 1771 (0.17%)
occurrences causally related to treatment / all	0 / 0	0 / 6	0 / 10	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Sudden infant death syndrome
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 death
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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 / 1	0 / 1	0 / 0
Immune system disorders
ABO incompatibility
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	7 / 3494 (0.20%)	0 / 1771 (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 / 1	0 / 0
Anaphylactic reaction
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Blood type incompatibility
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	1 / 3494 (0.03%)	0 / 1771 (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
Milk allergy
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (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
Rhesus incompatibility
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	0 / 3494 (0.00%)	0 / 1771 (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
Reproductive system and breast disorders
Abnormal uterine bleeding
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Cervical dysplasia
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Enlarged clitoris
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Genital labial adhesions
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Pelvic haematoma
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Shortened cervix
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Vaginal haemorrhage
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Vaginal discharge
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Acute respiratory failure
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	1 / 1771 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Apnoea
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	3 / 3494 (0.09%)	0 / 1771 (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
Asphyxia
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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 / 1	0 / 0
Atelectasis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Asthmatic crisis
subjects affected / exposed	1 / 3557 (0.03%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Asthma
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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 / 3557 (0.00%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (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
Brief resolved unexplained event
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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
Bronchopulmonary dysplasia
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	0 / 3494 (0.00%)	0 / 1771 (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
Bronchial obstruction
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	3 / 3494 (0.09%)	0 / 1771 (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
Bronchial hyperreactivity
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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
Choking
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Chronic respiratory disease
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Cough
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Cyanosis neonatal
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Dyspnoea
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	0 / 3494 (0.00%)	0 / 1771 (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
Epistaxis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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	1 / 3557 (0.03%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (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
Infantile apnoea
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	3 / 3494 (0.09%)	0 / 1771 (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
Laryngeal stenosis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 aspiration syndrome
subjects affected / exposed	0 / 3557 (0.00%)	8 / 1741 (0.46%)	10 / 3494 (0.29%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 8	0 / 10	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
Neonatal aspiration
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Neonatal dyspnoea
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (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
Neonatal hypoxia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	3 / 3494 (0.09%)	0 / 1771 (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
Neonatal asphyxia
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
Neonatal pneumothorax
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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 pulmonary hypertension
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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 respiratory depression
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 respiratory distress
subjects affected / exposed	0 / 3557 (0.00%)	31 / 1741 (1.78%)	66 / 3494 (1.89%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 31	2 / 66	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Neonatal respiratory distress syndrome
subjects affected / exposed	0 / 3557 (0.00%)	7 / 1741 (0.40%)	23 / 3494 (0.66%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 7	0 / 23	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
Neonatal tachypnoea
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	3 / 3494 (0.09%)	0 / 1771 (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
Pleural effusion
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	1 / 1771 (0.06%)
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
Pneumothorax
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Pulmonary artery stenosis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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 embolism
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Pulmonary vein stenosis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 venous hypertension
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 hypertension
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	4 / 3494 (0.11%)	1 / 1771 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
Respiratory depression
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Respiratory arrest
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Respiratory depth decreased
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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 disorder neonatal
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Stridor
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Tachypnoea
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (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
Transient tachypnoea of the newborn
subjects affected / exposed	0 / 3557 (0.00%)	16 / 1741 (0.92%)	37 / 3494 (1.06%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 16	0 / 37	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Wheezing
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Psychiatric disorders
Confusional state
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Biliary colic
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Biliary dilatation
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Cholecystitis acute
subjects affected / exposed	4 / 3557 (0.11%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Cholelithiasis
subjects affected / exposed	4 / 3557 (0.11%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
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
Cholestasis of pregnancy
subjects affected / exposed	4 / 3557 (0.11%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	3 / 1771 (0.17%)
occurrences causally related to treatment / all	0 / 4	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cholestasis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 rupture
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Gallbladder disorder
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Hepatitis neonatal
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Hyperbilirubinaemia
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Hyperbilirubinaemia neonatal
subjects affected / exposed	0 / 3557 (0.00%)	14 / 1741 (0.80%)	26 / 3494 (0.74%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 14	0 / 26	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
Apgar score low
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Blood pressure increased
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
C-reactive protein increased
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Foetal heart rate abnormal
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foetal heart rate decreased
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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 monitoring abnormal
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Gynaecological examination abnormal
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
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
Haemoglobin decreased
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Hepatitis B surface antigen positive
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Male genital examination abnormal
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Medical observation
subjects affected / exposed	1 / 3557 (0.03%)	3 / 1741 (0.17%)	6 / 3494 (0.17%)	2 / 1771 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Oxygen saturation decreased
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (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
Weight decreased
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	0 / 3494 (0.00%)	0 / 1771 (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
Viral test positive
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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, poisoning and procedural complications
Abdominal injury
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Ankle fracture
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Brachial plexus injury
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	3 / 3494 (0.09%)	0 / 1771 (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 / 1	0 / 0
Clavicle fracture
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Contusion
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Exposure to SARS-CoV-2
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Extradural haematoma
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Face injury
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Failed forceps delivery
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Fall
subjects affected / exposed	1 / 3557 (0.03%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Foetal exposure during delivery
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (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
Fracture of clavicle due to birth trauma
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Fractured skull depressed
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Head injury
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Humerus fracture
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Joint dislocation
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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
Multiple fractures
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Perineal injury
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Post lumbar puncture syndrome
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Procedural haemorrhage
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Skull fracture
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	3 / 3494 (0.09%)	0 / 1771 (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
Subdural haemorrhage
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Tongue injury
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Thermal burn
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Traumatic haemorrhage
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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 cervical laceration
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Wound dehiscence
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Vulvovaginal injury
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Wound haematoma
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Congenital, familial and genetic disorders
Adrenogenital syndrome
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Ankyloglossia congenital
subjects affected / exposed	0 / 3557 (0.00%)	7 / 1741 (0.40%)	9 / 3494 (0.26%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 7	0 / 9	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Aplasia cutis congenita
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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
Anomalous pulmonary venous connection
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Arteriovenous malformation
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 / 3557 (0.00%)	10 / 1741 (0.57%)	22 / 3494 (0.63%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 11	0 / 22	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Atrioventricular septal defect
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Bicuspid aortic valve
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (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
Biotinidase deficiency
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Branchial cyst
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Brachycephaly
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Buried penis syndrome
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (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 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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
Choanal atresia
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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 lip and palate
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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 lip
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Coarctation of the aorta
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Chordee
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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 cerebral cyst
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (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
Congenital choroid plexus cyst
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 cystic kidney disease
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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 inguinal hernia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 ectopic bladder
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 facial diplegia
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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 great vessel anomaly
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 hydronephrosis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital diaphragmatic hernia
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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 knee dislocation
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 laryngeal stridor
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 melanosis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 of skull
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 syphilis
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	3 / 3494 (0.09%)	0 / 1771 (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
Congenital nephrotic syndrome
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 pneumonia
subjects affected / exposed	0 / 3557 (0.00%)	5 / 1741 (0.29%)	4 / 3494 (0.11%)	0 / 1771 (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 / 1	0 / 0	0 / 0
Congenital pyelocaliectasis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (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
Congenital skin dimples
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 myasthenic syndrome
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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 torticollis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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 toxoplasmosis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Cryptorchism
subjects affected / exposed	0 / 3557 (0.00%)	5 / 1741 (0.29%)	16 / 3494 (0.46%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 16	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Craniosynostosis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cystic fibrosis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Cytogenetic abnormality
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 / 3557 (0.00%)	9 / 1741 (0.52%)	12 / 3494 (0.34%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 10	0 / 12	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Dextrocardia
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Disseminated neonatal herpes simplex
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Dysmorphism
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Ectopic kidney
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Erythroblastosis foetalis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Epispadias
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Fibromatosis colli of infancy
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Genitalia external ambiguous
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (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
Glucose-6-phosphate dehydrogenase deficiency
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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
Haemangioma congenital
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	2 / 3494 (0.06%)	0 / 1771 (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
Heart disease congenital
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	5 / 3494 (0.14%)	0 / 1771 (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 / 1	0 / 0
Heterotaxia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Hypospadias
subjects affected / exposed	0 / 3557 (0.00%)	6 / 1741 (0.34%)	9 / 3494 (0.26%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 6	0 / 9	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypertelorism
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Intestinal malrotation
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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
Kidney duplex
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Iris coloboma
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 / 3557 (0.00%)	2 / 1741 (0.11%)	0 / 3494 (0.00%)	0 / 1771 (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
Macrocephaly
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	0 / 3494 (0.00%)	0 / 1771 (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
Macrostomia
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Menkes' syndrome
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Microtia
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Micropenis
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	1 / 3494 (0.03%)	0 / 1771 (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
Micrognathia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Myotonic dystrophy
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Multiple congenital abnormalities
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Oesophageal atresia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Osteochondrodysplasia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Osteogenesis imperfecta
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Penoscrotal fusion
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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
Penile torsion
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Pectus excavatum
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	7 / 3494 (0.20%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Patent ductus arteriosus
subjects affected / exposed	0 / 3557 (0.00%)	8 / 1741 (0.46%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 8	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Polydactyly
subjects affected / exposed	0 / 3557 (0.00%)	4 / 1741 (0.23%)	5 / 3494 (0.14%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary artery stenosis congenital
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pyloric stenosis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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
Renal hypoplasia
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Shone complex
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 hypoplasia
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Syringomyelia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Thalassaemia alpha
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Talipes
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	7 / 3494 (0.20%)	0 / 1771 (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
Trisomy 21
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (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
Urachal abnormality
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	1 / 3494 (0.03%)	0 / 1771 (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
Vascular malformation
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 septal defect
subjects affected / exposed	1 / 3557 (0.03%)	5 / 1741 (0.29%)	12 / 3494 (0.34%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 5	0 / 12	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Cardiac disorders
Acute left ventricular failure
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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
Arrhythmia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Bradycardia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Bradycardia foetal
subjects affected / exposed	10 / 3557 (0.28%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	4 / 1771 (0.23%)
occurrences causally related to treatment / all	0 / 10	0 / 0	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bradycardia neonatal
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (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 / 1	0 / 0
Cardiogenic shock
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Cardio-respiratory arrest
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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 / 1	0 / 0
Cardiac failure
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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 / 1	0 / 0
Cardiac arrest
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
Foetal arrhythmia
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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 heart rate deceleration abnormality
subjects affected / exposed	11 / 3557 (0.31%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	5 / 1771 (0.28%)
occurrences causally related to treatment / all	0 / 11	0 / 0	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Left ventricular failure
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Left ventricular hypertrophy
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Nonreassuring foetal heart rate pattern
subjects affected / exposed	19 / 3557 (0.53%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	7 / 1771 (0.40%)
occurrences causally related to treatment / all	0 / 19	0 / 0	0 / 0	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary valve stenosis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (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
Right ventricular hypertrophy
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Supraventricular tachycardia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Supravalvular aortic stenosis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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	5 / 3557 (0.14%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	3 / 1771 (0.17%)
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
Ventricular dysfunction
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Wolff-Parkinson-White syndrome
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Nervous system disorders
Brain hypoxia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Cerebral cyst
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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
Cerebral ventricle dilatation
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Encephalopathy neonatal
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	1 / 3494 (0.03%)	0 / 1771 (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
Extrapyramidal disorder
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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 / 3557 (0.00%)	2 / 1741 (0.11%)	7 / 3494 (0.20%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Fontanelle bulging
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Generalised tonic-clonic seizure
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Headache
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Infant irritability
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Hypoxic-ischaemic encephalopathy
subjects affected / exposed	1 / 3557 (0.03%)	3 / 1741 (0.17%)	2 / 3494 (0.06%)	0 / 1771 (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
Infantile spasms
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Kernicterus
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Intraventricular haemorrhage neonatal
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	3 / 3494 (0.09%)	0 / 1771 (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
Intracranial aneurysm
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Lacunar stroke
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Myoclonus
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Migraine
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Monoplegia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 seizure
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Poor sucking reflex
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	0 / 3494 (0.00%)	0 / 1771 (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
Seizure
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	4 / 3494 (0.11%)	1 / 1771 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Seizure like phenomena
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 / 3557 (0.00%)	0 / 1741 (0.00%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Subarachnoid haemorrhage
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 / 1	0 / 0
Syncope
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Tethered cord syndrome
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Unresponsive to stimuli
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Blood and lymphatic system disorders
Anaemia neonatal
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Anaemia macrocytic
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Anaemia
subjects affected / exposed	11 / 3557 (0.31%)	1 / 1741 (0.06%)	6 / 3494 (0.17%)	3 / 1771 (0.17%)
occurrences causally related to treatment / all	0 / 11	0 / 1	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Blood loss anaemia
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Coagulopathy
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Disseminated intravascular coagulation
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
Febrile neutropenia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Foetal anaemia
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Haemorrhagic disorder
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Hypersplenism
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Leukocytosis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Lymphadenopathy
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Polycythaemia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Thrombocytopenia neonatal
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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 / 3557 (0.03%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	1 / 1771 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
Deafness unilateral
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Deafness bilateral
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Vertigo
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Eye disorders
Retinopathy of prematurity
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Abdominal pain lower
subjects affected / exposed	5 / 3557 (0.14%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	3 / 1771 (0.17%)
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
Abdominal pain
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Abdominal distension
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	1 / 1771 (0.06%)
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
Abdominal pain upper
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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 fistula
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Constipation
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (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
Dysphagia
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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
Diarrhoea
subjects affected / exposed	1 / 3557 (0.03%)	5 / 1741 (0.29%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 5	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Food poisoning
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Gastritis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 pain
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 / 3557 (0.00%)	1 / 1741 (0.06%)	3 / 3494 (0.09%)	0 / 1771 (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
Haematemesis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Haematochezia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Haemorrhoids
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Ileus
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Intestinal pseudo-obstruction
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Intestinal obstruction
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (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
Inguinal hernia
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	2 / 3494 (0.06%)	0 / 1771 (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
Infantile colic
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Necrotising enterocolitis neonatal
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Necrotising colitis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (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 / 1	0 / 0
Nausea
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Obstructive pancreatitis
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Oesophageal stenosis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Pancreatitis relapsing
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Pancreatitis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Peptic ulcer
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Vomiting
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	3 / 3494 (0.09%)	0 / 1771 (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
Volvulus
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 and subcutaneous tissue disorders
Ecchymosis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Erythema toxicum neonatorum
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Erythema multiforme
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Henoch-Schonlein purpura
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Melanoderma
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Umbilical haemorrhage
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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	1 / 3557 (0.03%)	1 / 1741 (0.06%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
Bladder perforation
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Hydronephrosis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Nephrolithiasis
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Pelvi-ureteric obstruction
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Pyelocaliectasis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	4 / 3494 (0.11%)	0 / 1771 (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
Renal disorder in pregnancy
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Renal cyst
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 stenosis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Urinary retention
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Urinary tract obstruction
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Endocrine disorders
Adrenal insufficiency
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Goitre
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Musculoskeletal and connective tissue disorders
Retrognathia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Rheumatoid arthritis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Trigger finger
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Torticollis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Infections and infestations
Acarodermatitis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Abscess neck
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Abscess
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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 / 3557 (0.00%)	2 / 1741 (0.11%)	1 / 3494 (0.03%)	0 / 1771 (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
Anal abscess
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 cavity infection
subjects affected / exposed	12 / 3557 (0.34%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	11 / 1771 (0.62%)
occurrences causally related to treatment / all	0 / 12	0 / 0	0 / 1	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	4 / 3557 (0.11%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences causally related to treatment / all	0 / 4	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bacterial infection
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Bacteraemia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Breast abscess
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
COVID-19
subjects affected / exposed	8 / 3557 (0.22%)	10 / 1741 (0.57%)	22 / 3494 (0.63%)	2 / 1771 (0.11%)
occurrences causally related to treatment / all	0 / 8	0 / 11	0 / 22	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
COVID-19 pneumonia
subjects affected / exposed	4 / 3557 (0.11%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	5 / 3494 (0.14%)	0 / 1771 (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
Bronchiolitis
subjects affected / exposed	0 / 3557 (0.00%)	24 / 1741 (1.38%)	56 / 3494 (1.60%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 25	0 / 61	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bronchitis bacterial
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Cellulitis orbital
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Cellulitis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	3 / 3494 (0.09%)	0 / 1771 (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
Croup infectious
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	0 / 3494 (0.00%)	0 / 1771 (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
Dacryocystitis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Dengue fever
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Device related infection
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Dysentery
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Ear infection
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (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
Endocarditis bacterial
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 / 3557 (0.14%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	3 / 1771 (0.17%)
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
Escherichia bacteraemia
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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 pyelonephritis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 / 3557 (0.00%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	1 / 1771 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Exanthema subitum
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (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
Eye infection
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Gastroenteritis
subjects affected / exposed	3 / 3557 (0.08%)	7 / 1741 (0.40%)	9 / 3494 (0.26%)	1 / 1771 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 7	0 / 9	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis adenovirus
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Gastroenteritis bacterial
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Gastroenteritis salmonella
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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 viral
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	1 / 3494 (0.03%)	0 / 1771 (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
Gastrointestinal infection
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Gastroenteritis norovirus
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Genital herpes
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Groin abscess
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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
Herpes simplex
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Impetigo
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	1 / 3494 (0.03%)	0 / 1771 (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
Infection
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	1 / 1771 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Influenza
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	1 / 1771 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Intestinal sepsis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Laryngitis
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	1 / 3494 (0.03%)	0 / 1771 (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
Leishmaniasis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Lower respiratory tract infection
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	5 / 3494 (0.14%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Mastitis bacterial
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Mastitis
subjects affected / exposed	6 / 3557 (0.17%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences causally related to treatment / all	0 / 6	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Lower respiratory tract infection viral
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 aseptic
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Measles
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Mastoiditis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 viral
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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 neonatal
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Metapneumovirus bronchiolitis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Metapneumovirus infection
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Myiasis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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 / 3557 (0.00%)	3 / 1741 (0.17%)	2 / 3494 (0.06%)	0 / 1771 (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
Nasopharyngitis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neonatal pneumonia
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	5 / 3494 (0.14%)	0 / 1771 (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 / 1	0 / 0
Norovirus infection
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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
Oral herpes
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Omphalitis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Ophthalmia neonatorum
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (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
Oral candidiasis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Osteomyelitis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Otitis externa
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Otitis media
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Papilloma viral infection
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Parainfluenzae virus infection
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	0 / 3494 (0.00%)	0 / 1771 (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
Periorbital cellulitis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Pertussis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (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
Pharyngitis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Pharyngotonsillitis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Pneumonia
subjects affected / exposed	4 / 3557 (0.11%)	21 / 1741 (1.21%)	46 / 3494 (1.32%)	1 / 1771 (0.06%)
occurrences causally related to treatment / all	0 / 4	0 / 22	0 / 53	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 2	0 / 0
Pneumonia adenoviral
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Pneumonia aspiration
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	0 / 3494 (0.00%)	0 / 1771 (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
Pneumonia bacterial
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	2 / 3494 (0.06%)	0 / 1771 (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
Pneumonia parainfluenzae viral
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Pneumonia pneumococcal
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Pneumonia respiratory syncytial viral
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	9 / 3494 (0.26%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 9	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia viral
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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
Pneumonia influenzal
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (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
Post procedural pneumonia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Postoperative wound infection
subjects affected / exposed	7 / 3557 (0.20%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences causally related to treatment / all	0 / 7	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Postpartum sepsis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
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
Puerperal infection
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Puerperal pyrexia
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Pyelonephritis
subjects affected / exposed	4 / 3557 (0.11%)	3 / 1741 (0.17%)	1 / 3494 (0.03%)	1 / 1771 (0.06%)
occurrences causally related to treatment / all	0 / 4	0 / 3	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	3 / 1771 (0.17%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Rash pustular
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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 syncytial virus bronchiolitis
subjects affected / exposed	0 / 3557 (0.00%)	15 / 1741 (0.86%)	19 / 3494 (0.54%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 15	0 / 19	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory syncytial virus bronchitis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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 tract infection
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	0 / 3494 (0.00%)	0 / 1771 (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
Respiratory syncytial virus infection
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	3 / 3494 (0.09%)	1 / 1771 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Rhinitis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Rotavirus infection
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Salmonella bacteraemia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Rhinovirus infection
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	3 / 3494 (0.09%)	0 / 1771 (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
Sepsis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (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 / 1	0 / 0
Sepsis neonatal
subjects affected / exposed	0 / 3557 (0.00%)	18 / 1741 (1.03%)	46 / 3494 (1.32%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 19	0 / 46	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 4	0 / 0
Septic shock
subjects affected / exposed	1 / 3557 (0.03%)	1 / 1741 (0.06%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 3	0 / 0
Staphylococcal sepsis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
Streptococcal sepsis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Systemic viral infection
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Syphilis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Suspected COVID-19
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Thyroglossal cyst infection
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tracheobronchitis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Tonsillitis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Umbilical sepsis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Upper respiratory tract infection
subjects affected / exposed	1 / 3557 (0.03%)	4 / 1741 (0.23%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 4	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Urachal sinus infection
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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
Urosepsis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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 tract infection neonatal
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Urinary tract infection
subjects affected / exposed	14 / 3557 (0.39%)	5 / 1741 (0.29%)	25 / 3494 (0.72%)	11 / 1771 (0.62%)
occurrences causally related to treatment / all	0 / 14	0 / 5	0 / 28	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Viral rash
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Varicella
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Viral infection
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	4 / 3494 (0.11%)	0 / 1771 (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
Viral upper respiratory tract infection
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (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
Wound infection
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Wound sepsis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Metabolism and nutrition disorders
Carnitine deficiency
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 / 3557 (0.00%)	8 / 1741 (0.46%)	10 / 3494 (0.29%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 8	0 / 10	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Failure to thrive
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	3 / 3494 (0.09%)	0 / 1771 (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
Feeding disorder
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	1 / 3494 (0.03%)	0 / 1771 (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
Food intolerance
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Hyperglycaemia
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (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
Hypomagnesaemia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Hypokalaemia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Hypoglycaemia neonatal
subjects affected / exposed	0 / 3557 (0.00%)	9 / 1741 (0.52%)	27 / 3494 (0.77%)	0 / 1771 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 9	0 / 27	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	0 / 3557 (0.00%)	5 / 1741 (0.29%)	2 / 3494 (0.06%)	0 / 1771 (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
Hypervolaemia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
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
Hyponatraemia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Malnutrition
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (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
Metabolic acidosis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (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 hypocalcaemia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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
Underweight
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (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

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

Non-serious adverse events	RSV MAT Group - Mother	Placebo Group - Infant	RSV MAT Group - Infant	Placebo Group - Mother
Total subjects affected by non serious adverse events
subjects affected / exposed	2561 / 3557 (72.00%)	1293 / 1741 (74.27%)	2615 / 3494 (74.84%)	1175 / 1771 (66.35%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences all number	0	0	3	0
Anogenital warts
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Haemangioma
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	5 / 3494 (0.14%)	0 / 1771 (0.00%)
occurrences all number	0	2	5	0
Haemangioma of skin
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Infantile haemangioma
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	2	0	0
Lipoma
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Melanocytic naevus
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	3	1	0
Ocular neoplasm
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Pyogenic granuloma
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Skin papilloma
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Ulcerated haemangioma
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	1	1	0
Xanthogranuloma
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Uterine leiomyoma
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Vascular disorders
Angiopathy
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Cyanosis
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences all number	0	2	3	0
Haematoma
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Hot flush
subjects affected / exposed	1 / 3557 (0.03%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	1	0	0
Hypertension
subjects affected / exposed	13 / 3557 (0.37%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	11 / 1771 (0.62%)
occurrences all number	13	0	0	11
Hypotension
subjects affected / exposed	7 / 3557 (0.20%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	3 / 1771 (0.17%)
occurrences all number	7	1	0	3
Varicose vein
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	2	0	0	1
Vasodilatation
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Blood pressure fluctuation
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Essential hypertension
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Haemorrhage
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Hypertensive crisis
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	2	0	0	0
Inferior vena cava syndrome
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Raynaud's phenomenon
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Superficial vein thrombosis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Thrombosis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Surgical and medical procedures
Medically induced preterm birth
subjects affected / exposed	17 / 3557 (0.48%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	4 / 1771 (0.23%)
occurrences all number	17	0	0	4
Episiotomy
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Pregnancy, puerperium and perinatal conditions
Birth trauma
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Breech presentation
subjects affected / exposed	9 / 3557 (0.25%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	3 / 1771 (0.17%)
occurrences all number	10	0	0	3
Caput succedaneum
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	7 / 3494 (0.20%)	0 / 1771 (0.00%)
occurrences all number	0	3	7	0
Cephalhaematoma
subjects affected / exposed	0 / 3557 (0.00%)	4 / 1741 (0.23%)	10 / 3494 (0.29%)	0 / 1771 (0.00%)
occurrences all number	0	4	10	0
Cephalo-pelvic disproportion
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	3	0	0	2
Complication of delivery
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	1 / 1771 (0.06%)
occurrences all number	0	0	1	1
Complication of pregnancy
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	6 / 1771 (0.34%)
occurrences all number	2	0	0	6
False labour
subjects affected / exposed	5 / 3557 (0.14%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	4 / 1771 (0.23%)
occurrences all number	6	0	0	4
Foetal acidosis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Foetal distress syndrome
subjects affected / exposed	18 / 3557 (0.51%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	6 / 1771 (0.34%)
occurrences all number	18	0	0	7
Foetal growth restriction
subjects affected / exposed	16 / 3557 (0.45%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	15 / 1771 (0.85%)
occurrences all number	16	0	0	15
Foetal hypokinesia
subjects affected / exposed	18 / 3557 (0.51%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	7 / 1771 (0.40%)
occurrences all number	19	0	0	7
Foetal macrosomia
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	1	1	0
Foetal malpresentation
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	0	1	0	2
Gestational diabetes
subjects affected / exposed	35 / 3557 (0.98%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	18 / 1771 (1.02%)
occurrences all number	35	0	0	18
Gestational hypertension
subjects affected / exposed	42 / 3557 (1.18%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	20 / 1771 (1.13%)
occurrences all number	42	0	0	20
Haemorrhage in pregnancy
subjects affected / exposed	4 / 3557 (0.11%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	3 / 1771 (0.17%)
occurrences all number	4	0	0	3
Hypothermia neonatal
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Jaundice neonatal
subjects affected / exposed	0 / 3557 (0.00%)	70 / 1741 (4.02%)	207 / 3494 (5.92%)	0 / 1771 (0.00%)
occurrences all number	0	70	207	0
Large for dates baby
subjects affected / exposed	0 / 3557 (0.00%)	9 / 1741 (0.52%)	9 / 3494 (0.26%)	2 / 1771 (0.11%)
occurrences all number	0	9	9	2
Low birth weight baby
subjects affected / exposed	0 / 3557 (0.00%)	82 / 1741 (4.71%)	151 / 3494 (4.32%)	0 / 1771 (0.00%)
occurrences all number	0	82	151	0
Meconium in amniotic fluid
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	3 / 3494 (0.09%)	5 / 1771 (0.28%)
occurrences all number	3	0	3	5
Meconium stain
subjects affected / exposed	1 / 3557 (0.03%)	1 / 1741 (0.06%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	1	1	4	0
Morning sickness
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	2	0	0	2
Neonatal disorder
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Oligohydramnios
subjects affected / exposed	25 / 3557 (0.70%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	10 / 1771 (0.56%)
occurrences all number	25	0	0	10
Placenta praevia
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	2	0	0	0
Placental disorder
subjects affected / exposed	4 / 3557 (0.11%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	4	0	0	0
Polyhydramnios
subjects affected / exposed	7 / 3557 (0.20%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	4 / 1771 (0.23%)
occurrences all number	8	0	0	4
Poor weight gain neonatal
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Postpartum haemorrhage
subjects affected / exposed	32 / 3557 (0.90%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	22 / 1771 (1.24%)
occurrences all number	32	0	0	22
Pre-eclampsia
subjects affected / exposed	25 / 3557 (0.70%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	11 / 1771 (0.62%)
occurrences all number	25	0	0	11
Premature baby
subjects affected / exposed	0 / 3557 (0.00%)	56 / 1741 (3.22%)	153 / 3494 (4.38%)	0 / 1771 (0.00%)
occurrences all number	0	56	153	0
Premature labour
subjects affected / exposed	84 / 3557 (2.36%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	43 / 1771 (2.43%)
occurrences all number	84	0	0	43
Premature rupture of membranes
subjects affected / exposed	6 / 3557 (0.17%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	4 / 1771 (0.23%)
occurrences all number	6	0	0	4
Preterm premature rupture of membranes
subjects affected / exposed	17 / 3557 (0.48%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	6 / 1771 (0.34%)
occurrences all number	17	0	0	6
Prolonged labour
subjects affected / exposed	14 / 3557 (0.39%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	6 / 1771 (0.34%)
occurrences all number	14	0	0	6
Retained placenta or membranes
subjects affected / exposed	10 / 3557 (0.28%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	3 / 1771 (0.17%)
occurrences all number	10	0	0	3
Shoulder dystocia
subjects affected / exposed	7 / 3557 (0.20%)	2 / 1741 (0.11%)	4 / 3494 (0.11%)	3 / 1771 (0.17%)
occurrences all number	7	2	4	3
Small for dates baby
subjects affected / exposed	0 / 3557 (0.00%)	147 / 1741 (8.44%)	233 / 3494 (6.67%)	1 / 1771 (0.06%)
occurrences all number	0	147	233	1
Threatened labour
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	4 / 1771 (0.23%)
occurrences all number	3	0	0	4
Umbilical cord abnormality
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	1 / 1771 (0.06%)
occurrences all number	3	0	2	1
Umbilical cord around neck
subjects affected / exposed	5 / 3557 (0.14%)	1 / 1741 (0.06%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences all number	5	1	3	0
Umbilical cord haemorrhage
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Umbilical granuloma
subjects affected / exposed	0 / 3557 (0.00%)	4 / 1741 (0.23%)	12 / 3494 (0.34%)	0 / 1771 (0.00%)
occurrences all number	0	4	12	0
Uterine contractions during pregnancy
subjects affected / exposed	14 / 3557 (0.39%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	10 / 1771 (0.56%)
occurrences all number	14	0	0	11
Uterine hypotonus
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	3	0	0	1
Uterine irritability
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	2	0	0	0
Weight decrease neonatal
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	2	2	0
Abnormal cord insertion
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Abnormal labour
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	2	0	0	0
Afterbirth pain
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Amniorrhexis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Amniorrhoea
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Arrested labour
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	3	0	0	0
Face presentation
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Failed induction of labour
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	1	0	0	2
Foetal damage
subjects affected / exposed	5 / 3557 (0.14%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	5	0	0	1
Foetal dystocia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Hyperemesis gravidarum
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Intrapartum haemorrhage
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	2	0	0	1
Labour complication
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Labour pain
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	1	0	0	2
Meconium abnormal
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Obstructed labour
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	1	0	0	2
Placental calcification
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Placental polyp
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Postpartum uterine subinvolution
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Precipitate labour
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	2	0	0	0
Premature separation of placenta
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	3	0	0	2
Prolonged pregnancy
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Prolonged rupture of membranes
subjects affected / exposed	4 / 3557 (0.11%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	4 / 1771 (0.23%)
occurrences all number	4	0	0	4
Retained products of conception
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Subchorionic haemorrhage
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Transverse presentation
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Umbilical cord compression
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Uterine atony
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	3 / 1771 (0.17%)
occurrences all number	3	0	0	3
Uterine hypertonus
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Uterine inversion
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
General disorders and administration site conditions
Adverse food reaction
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Administration site swelling
subjects affected / exposed	96 / 3557 (2.70%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	8 / 1771 (0.45%)
occurrences all number	96	0	0	8
Administration site pain
subjects affected / exposed	1294 / 3557 (36.38%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	231 / 1771 (13.04%)
occurrences all number	1297	0	0	231
Administration site erythema
subjects affected / exposed	133 / 3557 (3.74%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	8 / 1771 (0.45%)
occurrences all number	136	0	0	8
Asthenia
subjects affected / exposed	6 / 3557 (0.17%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	5 / 1771 (0.28%)
occurrences all number	7	0	0	5
Chills
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	5 / 3494 (0.14%)	0 / 1771 (0.00%)
occurrences all number	0	2	5	0
Crying
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	3	1	0
Cyst
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Developmental delay
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	2	2	0
Discomfort
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	2	0	0	0
Fatigue
subjects affected / exposed	1094 / 3557 (30.76%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	479 / 1771 (27.05%)
occurrences all number	1104	0	0	480
Feeling jittery
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Fever neonatal
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
High-pitched crying
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Hyperthermia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences all number	0	0	3	0
Hypertrophy
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Hypothermia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Ill-defined disorder
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	1	1	0
Illness
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	2	0	0	1
Influenza like illness
subjects affected / exposed	2 / 3557 (0.06%)	4 / 1741 (0.23%)	9 / 3494 (0.26%)	3 / 1771 (0.17%)
occurrences all number	3	5	14	3
Injection site bruising
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Injection site erythema
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	3	0	0	0
Injection site oedema
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Injection site pain
subjects affected / exposed	4 / 3557 (0.11%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	1 / 1771 (0.06%)
occurrences all number	4	0	2	1
Injection site pruritus
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	1	0	0	1
Injection site swelling
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Irritability postvaccinal
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Macrosomia
subjects affected / exposed	0 / 3557 (0.00%)	5 / 1741 (0.29%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	0	5	4	0
Malaise
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Oedema
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	2	0	0	0
Oedema peripheral
subjects affected / exposed	7 / 3557 (0.20%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	4 / 1771 (0.23%)
occurrences all number	7	0	0	4
Pain
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Peripheral swelling
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	1 / 1771 (0.06%)
occurrences all number	0	1	1	1
Puncture site pain
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Pyrexia
subjects affected / exposed	43 / 3557 (1.21%)	53 / 1741 (3.04%)	129 / 3494 (3.69%)	15 / 1771 (0.85%)
occurrences all number	44	60	134	15
Swelling
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	3	2	0
Swelling face
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	1 / 1771 (0.06%)
occurrences all number	0	0	1	1
Thirst
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Vaccination site induration
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Vaccination site pain
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	1	0	0	2
Vessel puncture site bruise
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Vessel puncture site pain
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Chest pain
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	2	0	0	0
Non-cardiac chest pain
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Scar inflammation
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Immune system disorders
ABO incompatibility
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences all number	0	0	3	0
Allergy to arthropod bite
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Allergy to arthropod sting
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Allergy to chemicals
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Allergy to vaccine
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Alloimmunisation
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Atopy
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Drug hypersensitivity
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Food allergy
subjects affected / exposed	1 / 3557 (0.03%)	6 / 1741 (0.34%)	14 / 3494 (0.40%)	0 / 1771 (0.00%)
occurrences all number	1	6	14	0
Hypersensitivity
subjects affected / exposed	3 / 3557 (0.08%)	3 / 1741 (0.17%)	7 / 3494 (0.20%)	0 / 1771 (0.00%)
occurrences all number	3	3	7	0
Milk allergy
subjects affected / exposed	0 / 3557 (0.00%)	6 / 1741 (0.34%)	18 / 3494 (0.52%)	0 / 1771 (0.00%)
occurrences all number	0	6	18	0
Multiple allergies
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Rhesus incompatibility
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Seasonal allergy
subjects affected / exposed	1 / 3557 (0.03%)	1 / 1741 (0.06%)	4 / 3494 (0.11%)	1 / 1771 (0.06%)
occurrences all number	1	1	4	1
Reproductive system and breast disorders
Adnexa uteri cyst
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Balanoposthitis
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	2	1	0
Bilateral breast buds
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Coital bleeding
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Genital blister
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Genital discomfort
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Genital labial adhesions
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	8 / 3494 (0.23%)	0 / 1771 (0.00%)
occurrences all number	0	3	8	0
Genital macule
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Genital ulceration
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Gynaecomastia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Ovarian cyst
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Pelvic pain
subjects affected / exposed	4 / 3557 (0.11%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	4 / 1771 (0.23%)
occurrences all number	4	0	0	4
Penile adhesion
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	1	1	0
Pruritus genital
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	0	0	0	2
Scrotal swelling
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Testicular retraction
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	2	1	0
Vaginal discharge
subjects affected / exposed	14 / 3557 (0.39%)	2 / 1741 (0.11%)	1 / 3494 (0.03%)	7 / 1771 (0.40%)
occurrences all number	15	2	1	8
Vaginal disorder
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	1 / 1771 (0.06%)
occurrences all number	3	0	1	1
Vaginal haemorrhage
subjects affected / exposed	17 / 3557 (0.48%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	1 / 1771 (0.06%)
occurrences all number	17	0	1	1
Vulval oedema
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Vulvovaginal pain
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Vulvovaginal pruritus
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	2	0	0	1
Abnormal uterine bleeding
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	1	0	0	1
Bartholin's cyst
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Breast engorgement
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	2	0	0	1
Breast inflammation
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	2
Breast mass
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	2	0	0	0
Breast pain
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Cystocele
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Endometrial hyperplasia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Female genital tract fistula
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Genital haemorrhage
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Heavy menstrual bleeding
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Intermenstrual bleeding
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	1	0	0	2
Lactation disorder
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	3 / 1771 (0.17%)
occurrences all number	2	0	0	3
Lactation insufficiency
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	5 / 1771 (0.28%)
occurrences all number	3	0	0	5
Nipple disorder
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	2	0	0	0
Perineal pain
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Shortened cervix
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Threatened uterine rupture
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Uterine haemorrhage
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Uterine prolapse
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Uterine scar
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	1	2	0
Apnoea
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Apnoeic attack
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Asthma
subjects affected / exposed	2 / 3557 (0.06%)	6 / 1741 (0.34%)	8 / 3494 (0.23%)	1 / 1771 (0.06%)
occurrences all number	2	6	8	1
Asthmatic crisis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Atelectasis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Bronchospasm
subjects affected / exposed	0 / 3557 (0.00%)	10 / 1741 (0.57%)	12 / 3494 (0.34%)	0 / 1771 (0.00%)
occurrences all number	0	12	14	0
Bronchitis chronic
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Bronchiolitis obliterans syndrome
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Brief resolved unexplained event
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Bronchial hyperreactivity
subjects affected / exposed	0 / 3557 (0.00%)	4 / 1741 (0.23%)	8 / 3494 (0.23%)	0 / 1771 (0.00%)
occurrences all number	0	4	9	0
Bronchial obstruction
subjects affected / exposed	0 / 3557 (0.00%)	5 / 1741 (0.29%)	20 / 3494 (0.57%)	0 / 1771 (0.00%)
occurrences all number	0	6	31	0
Catarrh
subjects affected / exposed	0 / 3557 (0.00%)	6 / 1741 (0.34%)	7 / 3494 (0.20%)	0 / 1771 (0.00%)
occurrences all number	0	9	11	0
Childhood asthma
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Choking
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	2	2	0
Cough
subjects affected / exposed	10 / 3557 (0.28%)	82 / 1741 (4.71%)	180 / 3494 (5.15%)	4 / 1771 (0.23%)
occurrences all number	10	109	251	4
Dysphonia
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	1	1	0
Dyspnoea
subjects affected / exposed	3 / 3557 (0.08%)	13 / 1741 (0.75%)	18 / 3494 (0.52%)	0 / 1771 (0.00%)
occurrences all number	4	15	21	0
Epistaxis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Hyperventilation
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Hypoxia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Increased bronchial secretion
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Infantile apnoea
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	1	1	0
Lower respiratory tract congestion
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Meconium aspiration syndrome
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	2	1	0
Nasal congestion
subjects affected / exposed	4 / 3557 (0.11%)	57 / 1741 (3.27%)	142 / 3494 (4.06%)	3 / 1771 (0.17%)
occurrences all number	4	64	160	3
Nasal discomfort
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Nasal disorder
subjects affected / exposed	0 / 3557 (0.00%)	4 / 1741 (0.23%)	6 / 3494 (0.17%)	0 / 1771 (0.00%)
occurrences all number	0	4	7	0
Nasal dryness
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Nasal inflammation
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Nasal obstruction
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	6 / 3494 (0.17%)	0 / 1771 (0.00%)
occurrences all number	0	2	8	0
Neonatal respiratory depression
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	3	0	0
Neonatal respiratory distress
subjects affected / exposed	0 / 3557 (0.00%)	7 / 1741 (0.40%)	12 / 3494 (0.34%)	0 / 1771 (0.00%)
occurrences all number	0	7	12	0
Neonatal tachypnoea
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	1	2	0
Oropharyngeal pain
subjects affected / exposed	5 / 3557 (0.14%)	2 / 1741 (0.11%)	0 / 3494 (0.00%)	4 / 1771 (0.23%)
occurrences all number	5	2	0	4
Pharyngeal erythema
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Pneumothorax
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Productive cough
subjects affected / exposed	3 / 3557 (0.08%)	1 / 1741 (0.06%)	4 / 3494 (0.11%)	2 / 1771 (0.11%)
occurrences all number	3	1	5	2
Pulmonary artery stenosis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Pulmonary congestion
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	1	0	1	0
Pulmonary hypertension
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences all number	0	0	3	0
Respiration abnormal
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Respiratory depression
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	1	1	0
Respiratory disorder
subjects affected / exposed	6 / 3557 (0.17%)	72 / 1741 (4.14%)	141 / 3494 (4.04%)	5 / 1771 (0.28%)
occurrences all number	6	162	343	5
Respiratory distress
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Respiratory symptom
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Rhinitis allergic
subjects affected / exposed	2 / 3557 (0.06%)	7 / 1741 (0.40%)	19 / 3494 (0.54%)	3 / 1771 (0.17%)
occurrences all number	2	8	21	3
Rhinorrhoea
subjects affected / exposed	3 / 3557 (0.08%)	51 / 1741 (2.93%)	120 / 3494 (3.43%)	1 / 1771 (0.06%)
occurrences all number	3	80	191	1
Rhonchi
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Sinonasal obstruction
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	0	1	4	0
Sinus congestion
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	1	0	1	0
Sneezing
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Stridor
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences all number	0	0	3	0
Tachypnoea
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	5 / 3494 (0.14%)	0 / 1771 (0.00%)
occurrences all number	0	1	5	0
Tracheomalacia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Transient tachypnoea of the newborn
subjects affected / exposed	0 / 3557 (0.00%)	8 / 1741 (0.46%)	12 / 3494 (0.34%)	0 / 1771 (0.00%)
occurrences all number	0	8	12	0
Upper respiratory tract congestion
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	1	2	0
Vasomotor rhinitis
subjects affected / exposed	0 / 3557 (0.00%)	7 / 1741 (0.40%)	7 / 3494 (0.20%)	0 / 1771 (0.00%)
occurrences all number	0	11	8	0
Wheezing
subjects affected / exposed	1 / 3557 (0.03%)	15 / 1741 (0.86%)	23 / 3494 (0.66%)	0 / 1771 (0.00%)
occurrences all number	1	16	24	0
Immature respiratory system
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Nasal turbinate hypertrophy
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Nasal ulcer
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Pleural effusion
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Psychiatric disorders
Anxiety
subjects affected / exposed	7 / 3557 (0.20%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	3 / 1771 (0.17%)
occurrences all number	7	0	0	3
Brief psychotic disorder, with postpartum onset
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Initial insomnia
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Insomnia
subjects affected / exposed	4 / 3557 (0.11%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	4	0	0	0
Irritability
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	5 / 3494 (0.14%)	0 / 1771 (0.00%)
occurrences all number	0	1	5	0
Panic attack
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Psychomotor retardation
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Selective eating disorder
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	2	2	0
Sleep disorder
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	1 / 1771 (0.06%)
occurrences all number	0	0	2	1
Tearfulness
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Depression
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	3 / 1771 (0.17%)
occurrences all number	0	0	0	3
Perinatal depression
subjects affected / exposed	6 / 3557 (0.17%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	6	0	0	2
Postpartum anxiety
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Hepatobiliary disorders
Cholelithiasis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	1	0	0	1
Cholestasis of pregnancy
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	4 / 1771 (0.23%)
occurrences all number	2	0	0	4
Hyperbilirubinaemia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Hyperbilirubinaemia neonatal
subjects affected / exposed	0 / 3557 (0.00%)	14 / 1741 (0.80%)	27 / 3494 (0.77%)	0 / 1771 (0.00%)
occurrences all number	0	14	27	0
Hypertransaminasaemia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Jaundice
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	2	1	0
Biliary colic
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Cholecystitis chronic
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	2	0	0	0
Investigations
Acoustic stimulation tests abnormal
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	5 / 3494 (0.14%)	0 / 1771 (0.00%)
occurrences all number	0	1	5	0
Alanine aminotransferase increased
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Apgar score low
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Audiogram abnormal
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Blood alkaline phosphatase increased
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Blood bilirubin increased
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Blood glucose decreased
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	0	3	4	0
Blood glucose increased
subjects affected / exposed	3 / 3557 (0.08%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	3	1	0	0
Blood iron decreased
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	3	0	0	2
Blood potassium increased
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Blood pressure increased
subjects affected / exposed	5 / 3557 (0.14%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	6 / 1771 (0.34%)
occurrences all number	5	0	0	6
Breath sounds abnormal
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	1	2	0
Blood thyroid stimulating hormone abnormal
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Body temperature increased
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
C-reactive protein increased
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Cardiac murmur
subjects affected / exposed	0 / 3557 (0.00%)	11 / 1741 (0.63%)	28 / 3494 (0.80%)	0 / 1771 (0.00%)
occurrences all number	0	11	28	0
Cardiac murmur functional
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Coombs direct test positive
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Coombs test positive
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences all number	0	0	3	0
Drug screen positive
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	1	0	1	0
Electroencephalogram normal
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
HIV test positive
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Haemoglobin decreased
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	1	0	1	0
Head circumference abnormal
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	1	2	0
Heart rate increased
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Human rhinovirus test positive
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Immunoreactive trypsinogen increased
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Influenza A virus test positive
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Medical observation
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Otoacoustic emissions test abnormal
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Oxygen saturation decreased
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Platelet count decreased
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Serum ferritin decreased
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Vitamin B12 decreased
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Weight decreased
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	5 / 3494 (0.14%)	0 / 1771 (0.00%)
occurrences all number	0	1	5	0
Weight increased
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
White blood cell count increased
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Foetal heart rate abnormal
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	3	0	0	0
Foetal heart rate increased
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Foetal heart rate indeterminate
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	3	0	0	0
Foetal monitoring
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Foetal monitoring abnormal
subjects affected / exposed	5 / 3557 (0.14%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	5	0	0	1
Foetal non-stress test abnormal
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Inhibin A increased
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Kleihauer-Betke test positive
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Streptococcus test positive
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Injury, poisoning and procedural complications
Accidental exposure to product packaging
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Anal injury
subjects affected / exposed	1 / 3557 (0.03%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	1	1	1	0
Arthropod bite
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	0	4	4	0
Animal scratch
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	2	0	0	0
Animal bite
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	1	0	2	0
Bone fissure
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Burns first degree
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Chemical burn
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Clavicle fracture
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	5 / 3494 (0.14%)	0 / 1771 (0.00%)
occurrences all number	0	0	5	0
Contusion
subjects affected / exposed	1 / 3557 (0.03%)	2 / 1741 (0.11%)	5 / 3494 (0.14%)	0 / 1771 (0.00%)
occurrences all number	1	2	5	0
Craniocerebral injury
subjects affected / exposed	0 / 3557 (0.00%)	4 / 1741 (0.23%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences all number	0	4	3	0
Eye injury
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Face injury
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	1	1	0
Fall
subjects affected / exposed	6 / 3557 (0.17%)	5 / 1741 (0.29%)	7 / 3494 (0.20%)	1 / 1771 (0.06%)
occurrences all number	6	5	7	1
Femur fracture
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	1	2	0
Foreign body ingestion
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Fracture of clavicle due to birth trauma
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	2	0	0
Head injury
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	9 / 3494 (0.26%)	0 / 1771 (0.00%)
occurrences all number	0	2	9	0
Humerus fracture
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Immunisation reaction
subjects affected / exposed	1 / 3557 (0.03%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	1	1	2	0
Incision site rash
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Injury
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	2	0	0
Joint dislocation
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Joint injury
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	1 / 1771 (0.06%)
occurrences all number	0	0	1	1
Ligament sprain
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	3	0	0	2
Limb injury
subjects affected / exposed	1 / 3557 (0.03%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	1	1	2	0
Lip injury
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Mouth injury
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Muscle strain
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	3	0	0	1
Nasal injury
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	1 / 1771 (0.06%)
occurrences all number	0	0	1	1
Perineal injury
subjects affected / exposed	71 / 3557 (2.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	37 / 1771 (2.09%)
occurrences all number	71	0	0	37
Post vaccination fever
subjects affected / exposed	1 / 3557 (0.03%)	3 / 1741 (0.17%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences all number	1	3	3	0
Procedural complication
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Radial head dislocation
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Road traffic accident
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	3	0	2	0
Scar
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Skin abrasion
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Skin injury
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	1	1	0
Skin laceration
subjects affected / exposed	2 / 3557 (0.06%)	1 / 1741 (0.06%)	3 / 3494 (0.09%)	4 / 1771 (0.23%)
occurrences all number	2	1	3	4
Skin wound
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Soft tissue injury
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Thermal burn
subjects affected / exposed	1 / 3557 (0.03%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	1	1	2	0
Ulnar nerve injury
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Abdominal injury
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Anaemia postoperative
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	3	0	0	0
Arthropod sting
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Foot fracture
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Incision site dermatitis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Incision site haemorrhage
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	0	0	0	2
Incision site pain
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Post procedural complication
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Post procedural fever
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Post procedural haemorrhage
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Postoperative wound complication
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Procedural headache
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	2	0	0	0
Seroma
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	2	0	0	2
Tooth fracture
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Urethral injury
subjects affected / exposed	5 / 3557 (0.14%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	3 / 1771 (0.17%)
occurrences all number	5	0	0	3
Uterine cervical laceration
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Vulvovaginal injury
subjects affected / exposed	45 / 3557 (1.27%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	18 / 1771 (1.02%)
occurrences all number	45	0	0	18
Wound dehiscence
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	1	0	0	1
Congenital, familial and genetic disorders
Accessory auricle
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Albinism
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Anorectal malformation
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Anomaly of external ear congenital
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Ankyloglossia congenital
subjects affected / exposed	0 / 3557 (0.00%)	23 / 1741 (1.32%)	51 / 3494 (1.46%)	0 / 1771 (0.00%)
occurrences all number	0	23	51	0
Atrial septal defect
subjects affected / exposed	1 / 3557 (0.03%)	1 / 1741 (0.06%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences all number	1	1	3	0
Birth mark
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Carnitine-acylcarnitine translocase deficiency
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Cleft uvula
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Congenital hypothyroidism
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Congenital melanosis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Congenital musculoskeletal disorder of skull
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Congenital naevus
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	1	2	0
Congenital skin dimples
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	7 / 3494 (0.20%)	0 / 1771 (0.00%)
occurrences all number	0	3	7	0
Congenital syphilis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Congenital thymus absence
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Congenital umbilical hernia
subjects affected / exposed	0 / 3557 (0.00%)	21 / 1741 (1.21%)	42 / 3494 (1.20%)	0 / 1771 (0.00%)
occurrences all number	0	21	42	0
Craniosynostosis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Cryptorchism
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	6 / 3494 (0.17%)	0 / 1771 (0.00%)
occurrences all number	0	0	6	0
Cystic fibrosis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Dacryostenosis congenital
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Dermoid cyst
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	1	1	0
Ear malformation
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Fibromatosis colli of infancy
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	1	1	0
Glucose-6-phosphate dehydrogenase deficiency
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	2	2	0
Haemangioma congenital
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	11 / 3494 (0.31%)	0 / 1771 (0.00%)
occurrences all number	0	1	11	0
Heart disease congenital
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Hydrocele
subjects affected / exposed	0 / 3557 (0.00%)	5 / 1741 (0.29%)	11 / 3494 (0.31%)	0 / 1771 (0.00%)
occurrences all number	0	5	11	0
Labial tie
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences all number	0	1	3	0
Laryngomalacia
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	6 / 3494 (0.17%)	0 / 1771 (0.00%)
occurrences all number	0	2	6	0
Low set ears
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Lymphatic malformation
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Naevus flammeus
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	7 / 3494 (0.20%)	0 / 1771 (0.00%)
occurrences all number	0	1	7	0
Patent ductus arteriosus
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Phimosis
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	7 / 3494 (0.20%)	0 / 1771 (0.00%)
occurrences all number	0	2	7	0
Polydactyly
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	1	2	0
Preauricular cyst
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	0	1	4	0
Pulmonary artery stenosis congenital
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Sickle cell anaemia
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences all number	0	1	3	0
Sickle cell disease
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Stahl's ear
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Thalassaemia alpha
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Ventricular septal defect
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Congenital hydronephrosis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Congenital renal cyst
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Cardiac disorders
Bradycardia neonatal
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	1	1	0
Bradycardia foetal
subjects affected / exposed	7 / 3557 (0.20%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	4 / 1771 (0.23%)
occurrences all number	7	0	2	4
Bradycardia
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences all number	0	1	3	0
Extrasystoles
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	1	0	1	0
Foetal arrhythmia
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Foetal heart rate deceleration abnormality
subjects affected / exposed	7 / 3557 (0.20%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	4 / 1771 (0.23%)
occurrences all number	7	1	0	4
Left ventricular dilatation
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Mitral valve incompetence
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Neonatal tachycardia
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Palpitations
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	3 / 1771 (0.17%)
occurrences all number	1	0	0	3
Tachycardia
subjects affected / exposed	6 / 3557 (0.17%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	6	1	0	2
Tachycardia foetal
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	2 / 1771 (0.11%)
occurrences all number	3	0	1	2
Ventricular hypertrophy
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Nonreassuring foetal heart rate pattern
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	2	0	0	1
Sinus tachycardia
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Ventricular extrasystoles
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Nervous system disorders
Agitation neonatal
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Brain oedema
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	1	1	0
Burning sensation
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Carpal tunnel syndrome
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	3	0	0	2
Cerebral haemorrhage
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Dizziness
subjects affected / exposed	5 / 3557 (0.14%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	5	0	0	2
Drooling
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	1	1	0
Facial paralysis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	1 / 1771 (0.06%)
occurrences all number	0	0	1	1
Febrile convulsion
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	4	1	0
Fontanelle depressed
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Gross motor delay
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Haemorrhage intracranial
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Headache
subjects affected / exposed	962 / 3557 (27.05%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	452 / 1771 (25.52%)
occurrences all number	993	0	0	465
Hypertonia
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	8 / 3494 (0.23%)	0 / 1771 (0.00%)
occurrences all number	0	2	8	0
Hypotonia
subjects affected / exposed	0 / 3557 (0.00%)	4 / 1741 (0.23%)	8 / 3494 (0.23%)	0 / 1771 (0.00%)
occurrences all number	0	4	9	0
IVth nerve paralysis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Infant irritability
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Language disorder
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Lethargy
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	2	1	0
Migraine
subjects affected / exposed	5 / 3557 (0.14%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	6	0	0	0
Motor developmental delay
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences all number	0	0	3	0
Movement disorder
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Myoclonus
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Nerve compression
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Neurodevelopmental delay
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Nystagmus
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	2	2	0
Paraesthesia
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	2	0	0	0
Presyncope
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	2	0	0	0
Sciatica
subjects affected / exposed	4 / 3557 (0.11%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	4	0	0	2
Seizure
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Seizure like phenomena
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Subependymal cyst
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Syncope
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Tethered cord syndrome
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Tremor neonatal
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Hypoaesthesia
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	2	0	0	0
Lumbar radiculopathy
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Neuralgia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Restless legs syndrome
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Sensory loss
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Tension headache
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Blood and lymphatic system disorders
Anaemia of pregnancy
subjects affected / exposed	14 / 3557 (0.39%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	5 / 1771 (0.28%)
occurrences all number	14	0	0	5
Anaemia neonatal
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	2	1	0
Anaemia
subjects affected / exposed	62 / 3557 (1.74%)	12 / 1741 (0.69%)	33 / 3494 (0.94%)	24 / 1771 (1.36%)
occurrences all number	62	12	34	24
Bandaemia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	1 / 1771 (0.06%)
occurrences all number	0	0	2	1
Haemorrhagic disease of newborn
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Hypochromic anaemia
subjects affected / exposed	1 / 3557 (0.03%)	5 / 1741 (0.29%)	14 / 3494 (0.40%)	0 / 1771 (0.00%)
occurrences all number	1	5	14	0
Iron deficiency anaemia
subjects affected / exposed	4 / 3557 (0.11%)	2 / 1741 (0.11%)	6 / 3494 (0.17%)	2 / 1771 (0.11%)
occurrences all number	4	2	6	2
Leukopenia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Lymph node pain
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Lymphadenopathy
subjects affected / exposed	4 / 3557 (0.11%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	4	0	1	0
Microcytic anaemia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	0	0	4	0
Neutropenia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Polycythaemia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Thrombocytopenia
subjects affected / exposed	1 / 3557 (0.03%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	3 / 1771 (0.17%)
occurrences all number	1	1	2	3
Thrombocytopenia neonatal
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Blood loss anaemia
subjects affected / exposed	5 / 3557 (0.14%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	5 / 1771 (0.28%)
occurrences all number	5	0	0	5
Coagulopathy
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Leukocytosis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Normochromic normocytic anaemia
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Normocytic anaemia
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	2	0	0	1
Ear and labyrinth disorders
Cerumen impaction
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Ear pain
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	4 / 3494 (0.11%)	1 / 1771 (0.06%)
occurrences all number	1	0	5	1
Eustachian tube dysfunction
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Excessive cerumen production
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Middle ear inflammation
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Otorrhoea
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	2	2	0
Tympanic membrane disorder
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Tympanic membrane hyperaemia
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Vertigo
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	3	0	0	0
Tinnitus
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Eye disorders
Amblyopia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Blepharitis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Chalazion
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Conjunctival haemorrhage
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	6 / 3494 (0.17%)	0 / 1771 (0.00%)
occurrences all number	0	2	6	0
Conjunctival hyperaemia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Conjunctivitis allergic
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	1	1	0
Corneal erosion
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Dacryostenosis acquired
subjects affected / exposed	0 / 3557 (0.00%)	12 / 1741 (0.69%)	10 / 3494 (0.29%)	0 / 1771 (0.00%)
occurrences all number	0	13	10	0
Dry eye
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Eye discharge
subjects affected / exposed	0 / 3557 (0.00%)	8 / 1741 (0.46%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	0	8	4	0
Eye inflammation
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Eye swelling
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	1	2	0
Eyelid ptosis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences all number	0	0	3	0
Orbital oedema
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Periorbital oedema
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Strabismus
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	3	2	0
Swelling of eyelid
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Trichiasis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Vision blurred
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Eczema eyelids
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Visual impairment
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Gastrointestinal disorders
Abdominal discomfort
subjects affected / exposed	3 / 3557 (0.08%)	2 / 1741 (0.11%)	2 / 3494 (0.06%)	3 / 1771 (0.17%)
occurrences all number	3	2	2	3
Abdominal pain upper
subjects affected / exposed	7 / 3557 (0.20%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	3 / 1771 (0.17%)
occurrences all number	7	1	1	3
Abdominal pain lower
subjects affected / exposed	20 / 3557 (0.56%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	7 / 1771 (0.40%)
occurrences all number	22	0	0	8
Abdominal pain
subjects affected / exposed	508 / 3557 (14.28%)	11 / 1741 (0.63%)	22 / 3494 (0.63%)	235 / 1771 (13.27%)
occurrences all number	512	11	22	241
Abdominal hernia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Abdominal distension
subjects affected / exposed	1 / 3557 (0.03%)	4 / 1741 (0.23%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	1	4	2	0
Allergic colitis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Anal rash
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Anal fissure
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	1	0	2	0
Anal erythema
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	1	1	0
Anal eczema
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Aphthous ulcer
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Colitis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Constipation
subjects affected / exposed	11 / 3557 (0.31%)	23 / 1741 (1.32%)	64 / 3494 (1.83%)	5 / 1771 (0.28%)
occurrences all number	12	24	66	5
Constipation neonatal
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Diarrhoea
subjects affected / exposed	357 / 3557 (10.04%)	41 / 1741 (2.35%)	97 / 3494 (2.78%)	187 / 1771 (10.56%)
occurrences all number	361	44	107	187
Diarrhoea haemorrhagic
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Dyschezia
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	1	2	0
Dyspepsia
subjects affected / exposed	15 / 3557 (0.42%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	5 / 1771 (0.28%)
occurrences all number	15	0	1	6
Dysphagia
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Enlarged uvula
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Enteritis
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	2	2	0
Enterocolitis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Eosinophilic colitis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Flatulence
subjects affected / exposed	2 / 3557 (0.06%)	6 / 1741 (0.34%)	11 / 3494 (0.31%)	0 / 1771 (0.00%)
occurrences all number	2	6	12	0
Food poisoning
subjects affected / exposed	1 / 3557 (0.03%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	1 / 1771 (0.06%)
occurrences all number	1	1	1	1
Frequent bowel movements
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Gastritis
subjects affected / exposed	3 / 3557 (0.08%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	1 / 1771 (0.06%)
occurrences all number	3	1	1	1
Gastrointestinal disorder
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Gastrooesophageal reflux disease
subjects affected / exposed	8 / 3557 (0.22%)	46 / 1741 (2.64%)	76 / 3494 (2.18%)	12 / 1771 (0.68%)
occurrences all number	9	48	78	12
Gastrooesophageal reflux in neonate
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	1	2	0
Gingival cyst
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Haematemesis
subjects affected / exposed	1 / 3557 (0.03%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	1	1	0	1
Haematochezia
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	0	3	4	0
Haemorrhoids
subjects affected / exposed	21 / 3557 (0.59%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	8 / 1771 (0.45%)
occurrences all number	22	0	0	9
Haemorrhoids thrombosed
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Hyperchlorhydria
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	1	0	0	1
Infantile colic
subjects affected / exposed	0 / 3557 (0.00%)	12 / 1741 (0.69%)	15 / 3494 (0.43%)	0 / 1771 (0.00%)
occurrences all number	0	12	15	0
Infantile spitting up
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	3	0	0
Inguinal hernia
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	0	2	4	0
Meconium plug syndrome
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Mouth ulceration
subjects affected / exposed	1 / 3557 (0.03%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	1	1	0	2
Nausea
subjects affected / exposed	606 / 3557 (17.04%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	307 / 1771 (17.33%)
occurrences all number	613	1	0	313
Oesophagitis
subjects affected / exposed	1 / 3557 (0.03%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	1	0	0
Oral disorder
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Peptic ulcer
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	3 / 1771 (0.17%)
occurrences all number	3	0	0	3
Proctitis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Rectal prolapse
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Regurgitation
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	5 / 3494 (0.14%)	0 / 1771 (0.00%)
occurrences all number	0	1	5	0
Stomatitis
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	0	3	4	0
Teething
subjects affected / exposed	0 / 3557 (0.00%)	6 / 1741 (0.34%)	11 / 3494 (0.31%)	0 / 1771 (0.00%)
occurrences all number	0	6	11	0
Tooth demineralisation
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Tooth development disorder
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	1	1	0
Toothache
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Umbilical hernia
subjects affected / exposed	0 / 3557 (0.00%)	8 / 1741 (0.46%)	15 / 3494 (0.43%)	0 / 1771 (0.00%)
occurrences all number	0	8	15	0
Vomiting
subjects affected / exposed	287 / 3557 (8.07%)	26 / 1741 (1.49%)	49 / 3494 (1.40%)	153 / 1771 (8.64%)
occurrences all number	291	26	51	153
Vomiting projectile
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Anal incontinence
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Ileus
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Odynophagia
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Pelvic floor dysfunction
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Skin and subcutaneous tissue disorders
Acne infantile
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	7 / 3494 (0.20%)	0 / 1771 (0.00%)
occurrences all number	0	1	7	0
Alopecia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Blister
subjects affected / exposed	1 / 3557 (0.03%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	1	1	2	0
Cafe au lait spots
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Cellulite
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Decubitus ulcer
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Dermal cyst
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	2	2	0
Dermatitis
subjects affected / exposed	2 / 3557 (0.06%)	15 / 1741 (0.86%)	35 / 3494 (1.00%)	0 / 1771 (0.00%)
occurrences all number	2	15	35	0
Dermatitis allergic
subjects affected / exposed	1 / 3557 (0.03%)	1 / 1741 (0.06%)	3 / 3494 (0.09%)	1 / 1771 (0.06%)
occurrences all number	1	1	3	1
Dermatitis atopic
subjects affected / exposed	0 / 3557 (0.00%)	42 / 1741 (2.41%)	56 / 3494 (1.60%)	0 / 1771 (0.00%)
occurrences all number	0	44	58	0
Dermatitis contact
subjects affected / exposed	1 / 3557 (0.03%)	2 / 1741 (0.11%)	10 / 3494 (0.29%)	1 / 1771 (0.06%)
occurrences all number	1	2	10	1
Dermatitis diaper
subjects affected / exposed	0 / 3557 (0.00%)	55 / 1741 (3.16%)	113 / 3494 (3.23%)	0 / 1771 (0.00%)
occurrences all number	0	58	124	0
Drug eruption
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Dry skin
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	6 / 3494 (0.17%)	0 / 1771 (0.00%)
occurrences all number	0	1	6	0
Eczema
subjects affected / exposed	4 / 3557 (0.11%)	34 / 1741 (1.95%)	76 / 3494 (2.18%)	2 / 1771 (0.11%)
occurrences all number	4	37	76	2
Eczema asteatotic
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Eczema infantile
subjects affected / exposed	0 / 3557 (0.00%)	4 / 1741 (0.23%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	4	2	0
Eczema nummular
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Erythema
subjects affected / exposed	1 / 3557 (0.03%)	3 / 1741 (0.17%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	1	4	2	0
Erythema toxicum neonatorum
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	5 / 3494 (0.14%)	0 / 1771 (0.00%)
occurrences all number	0	2	5	0
Hand dermatitis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Herpes gestationis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Hyperhidrosis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Ingrowing nail
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	5 / 3494 (0.14%)	0 / 1771 (0.00%)
occurrences all number	0	0	5	0
Intertrigo
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	1	1	0
Macule
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	1	1	0
Melanoderma
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Milia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Miliaria
subjects affected / exposed	0 / 3557 (0.00%)	15 / 1741 (0.86%)	33 / 3494 (0.94%)	0 / 1771 (0.00%)
occurrences all number	0	15	35	0
Nail fold inflammation
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Papule
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Perioral dermatitis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Petechiae
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Pigmentation disorder
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Pityriasis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Pityriasis alba
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences all number	0	1	3	0
Pityriasis rosea
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Prurigo
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	1	1	0
Pruritus
subjects affected / exposed	8 / 3557 (0.22%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	5 / 1771 (0.28%)
occurrences all number	9	0	0	5
Rash
subjects affected / exposed	2 / 3557 (0.06%)	24 / 1741 (1.38%)	53 / 3494 (1.52%)	0 / 1771 (0.00%)
occurrences all number	2	27	53	0
Rash erythematous
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Rash macular
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Rash maculo-papular
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	1	2	0
Rash neonatal
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Rash papular
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	6 / 3494 (0.17%)	0 / 1771 (0.00%)
occurrences all number	0	0	6	0
Rash pruritic
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	2	0	0	0
Seborrhoea
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Seborrhoeic dermatitis
subjects affected / exposed	0 / 3557 (0.00%)	27 / 1741 (1.55%)	72 / 3494 (2.06%)	0 / 1771 (0.00%)
occurrences all number	0	27	72	0
Skin exfoliation
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	3	0	0
Skin hyperpigmentation
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Skin hypopigmentation
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	1	2	0
Skin irritation
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Skin lesion
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	0	1	4	0
Skin mass
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Skin ulcer
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Solar dermatitis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Toxic skin eruption
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	2	2	0
Transient neonatal pustular melanosis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Umbilical discharge
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Urticaria
subjects affected / exposed	4 / 3557 (0.11%)	2 / 1741 (0.11%)	6 / 3494 (0.17%)	0 / 1771 (0.00%)
occurrences all number	5	2	6	0
Urticaria papular
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Vitiligo
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Acne
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Excessive granulation tissue
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Polymorphic eruption of pregnancy
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	2	0	0	0
Prurigo of pregnancy
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Scar pain
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	3	0	0	1
Skin reaction
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Renal and urinary disorders
Anuria
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Dysuria
subjects affected / exposed	4 / 3557 (0.11%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	1 / 1771 (0.06%)
occurrences all number	4	0	1	1
Haematuria
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Hydronephrosis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	1	2	0
Oliguria
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Pollakiuria
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	3 / 1771 (0.17%)
occurrences all number	1	0	0	3
Proteinuria
subjects affected / exposed	4 / 3557 (0.11%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	4	0	0	0
Pyelocaliectasis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences all number	0	1	3	0
Renal colic
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Urinary hesitation
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Vesicoureteric reflux
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Atonic urinary bladder
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Bladder spasm
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Urinary retention
subjects affected / exposed	5 / 3557 (0.14%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	5	0	0	0
Endocrine disorders
Hypothyroidism
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Precocious puberty
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Thyroid dysfunction in pregnancy
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	2	0	0	0
Transient neonatal hyperthyrotropinaemia
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Musculoskeletal and connective tissue disorders
Acquired plagiocephaly
subjects affected / exposed	0 / 3557 (0.00%)	10 / 1741 (0.57%)	21 / 3494 (0.60%)	0 / 1771 (0.00%)
occurrences all number	0	10	21	0
Arthralgia
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	2	0	0	2
Asymmetric gluteal fold
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	2	1	0
Asymmetric thigh fold
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Axillary mass
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Back pain
subjects affected / exposed	21 / 3557 (0.59%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	11 / 1771 (0.62%)
occurrences all number	22	0	0	11
Bone hypertrophy
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Bone disorder
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Foot deformity
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	1	2	0
Head deformity
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	0	2	4	0
Hypertonia neonatal
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Hypotonia neonatal
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Joint laxity
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Joint noise
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Ligament laxity
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Ligament pain
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Muscle spasms
subjects affected / exposed	8 / 3557 (0.22%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	4 / 1771 (0.23%)
occurrences all number	8	1	0	4
Muscle twitching
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	1	1	0
Muscular weakness
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Musculoskeletal chest pain
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Musculoskeletal disorder
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Myalgia
subjects affected / exposed	4 / 3557 (0.11%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	4	0	1	0
Newborn head moulding
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Nose deformity
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Pain in extremity
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	3	0	0	0
Posture abnormal
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Pubic pain
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	3	0	0	2
Short stature
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Snapping hip syndrome
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Tendon disorder
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Torticollis
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	10 / 3494 (0.29%)	0 / 1771 (0.00%)
occurrences all number	0	2	10	0
Coccydynia
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Costochondritis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Musculoskeletal pain
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	2	0	0	0
Neck pain
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	3	0	0	1
Plantar fasciitis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Tendonitis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Infections and infestations
Acarodermatitis
subjects affected / exposed	1 / 3557 (0.03%)	13 / 1741 (0.75%)	29 / 3494 (0.83%)	2 / 1771 (0.11%)
occurrences all number	1	15	34	2
Abscess limb
subjects affected / exposed	1 / 3557 (0.03%)	1 / 1741 (0.06%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	1	1	4	0
Abscess
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Acute sinusitis
subjects affected / exposed	2 / 3557 (0.06%)	4 / 1741 (0.23%)	5 / 3494 (0.14%)	1 / 1771 (0.06%)
occurrences all number	2	4	6	1
Adenovirus infection
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	0	2	4	0
Adenoviral upper respiratory infection
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Anal candidiasis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Anal abscess
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Amoebic dysentery
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	2	3	0
Amniotic cavity infection
subjects affected / exposed	18 / 3557 (0.51%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	3 / 1771 (0.17%)
occurrences all number	18	0	0	3
Ascariasis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Balanitis candida
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Asymptomatic bacteriuria
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	4 / 1771 (0.23%)
occurrences all number	3	0	1	4
Bacterial disease carrier
subjects affected / exposed	27 / 3557 (0.76%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	7 / 1771 (0.40%)
occurrences all number	27	0	0	7
Bacterial vaginosis
subjects affected / exposed	12 / 3557 (0.34%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	12	0	0	2
Bartholin's abscess
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Beta haemolytic streptococcal infection
subjects affected / exposed	5 / 3557 (0.14%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	5 / 1771 (0.28%)
occurrences all number	5	1	1	5
Breast abscess
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	2	0	0	1
Body tinea
subjects affected / exposed	0 / 3557 (0.00%)	6 / 1741 (0.34%)	5 / 3494 (0.14%)	0 / 1771 (0.00%)
occurrences all number	0	6	5	0
Candida infection
subjects affected / exposed	4 / 3557 (0.11%)	10 / 1741 (0.57%)	16 / 3494 (0.46%)	3 / 1771 (0.17%)
occurrences all number	4	11	17	3
Candida nappy rash
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	9 / 3494 (0.26%)	0 / 1771 (0.00%)
occurrences all number	0	2	10	0
COVID-19
subjects affected / exposed	117 / 3557 (3.29%)	90 / 1741 (5.17%)	159 / 3494 (4.55%)	50 / 1771 (2.82%)
occurrences all number	118	90	161	50
Bullous impetigo
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	2	1	0
Bronchitis
subjects affected / exposed	2 / 3557 (0.06%)	38 / 1741 (2.18%)	82 / 3494 (2.35%)	0 / 1771 (0.00%)
occurrences all number	2	43	97	0
Bronchiolitis
subjects affected / exposed	0 / 3557 (0.00%)	152 / 1741 (8.73%)	298 / 3494 (8.53%)	0 / 1771 (0.00%)
occurrences all number	0	175	387	0
Cellulitis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	1 / 1771 (0.06%)
occurrences all number	1	0	1	2
Cellulitis orbital
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Conjunctivitis
subjects affected / exposed	4 / 3557 (0.11%)	61 / 1741 (3.50%)	141 / 3494 (4.04%)	0 / 1771 (0.00%)
occurrences all number	4	71	148	0
Conjunctivitis bacterial
subjects affected / exposed	0 / 3557 (0.00%)	6 / 1741 (0.34%)	11 / 3494 (0.31%)	0 / 1771 (0.00%)
occurrences all number	0	6	11	0
Conjunctivitis viral
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	0	2	4	0
Croup infectious
subjects affected / exposed	0 / 3557 (0.00%)	12 / 1741 (0.69%)	24 / 3494 (0.69%)	0 / 1771 (0.00%)
occurrences all number	0	13	28	0
Cystitis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Dacryocystitis
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences all number	0	2	3	0
Dengue fever
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Dermatitis infected
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	3	0
Dermatophytosis of nail
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Diarrhoea infectious
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Dysentery
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	1	2	0
Ear infection
subjects affected / exposed	2 / 3557 (0.06%)	63 / 1741 (3.62%)	120 / 3494 (3.43%)	1 / 1771 (0.06%)
occurrences all number	2	83	148	1
Ear infection viral
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Eczema impetiginous
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Eczema infected
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	1	1	0
Enterobiasis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Enterovirus infection
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	0	2	4	0
Erysipelas
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Erythema infectiosum
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Escherichia infection
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Escherichia urinary tract infection
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Exanthema subitum
subjects affected / exposed	0 / 3557 (0.00%)	12 / 1741 (0.69%)	16 / 3494 (0.46%)	0 / 1771 (0.00%)
occurrences all number	0	12	16	0
Eye infection
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	5 / 3494 (0.14%)	0 / 1771 (0.00%)
occurrences all number	0	1	5	0
Eye infection staphylococcal
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Eye infection viral
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Eyelid infection
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Folliculitis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Fungal infection
subjects affected / exposed	4 / 3557 (0.11%)	3 / 1741 (0.17%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	4	3	2	0
Fungal skin infection
subjects affected / exposed	2 / 3557 (0.06%)	8 / 1741 (0.46%)	16 / 3494 (0.46%)	0 / 1771 (0.00%)
occurrences all number	2	9	16	0
Furuncle
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	1	2	0
Gastroenteritis
subjects affected / exposed	13 / 3557 (0.37%)	60 / 1741 (3.45%)	104 / 3494 (2.98%)	3 / 1771 (0.17%)
occurrences all number	13	68	119	3
Gastroenteritis adenovirus
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Gastroenteritis bacterial
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Gastroenteritis norovirus
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Gastroenteritis viral
subjects affected / exposed	6 / 3557 (0.17%)	5 / 1741 (0.29%)	14 / 3494 (0.40%)	0 / 1771 (0.00%)
occurrences all number	6	5	15	0
Gastrointestinal infection
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Gastrointestinal viral infection
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Genital candidiasis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Genital herpes
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Groin abscess
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Groin infection
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Hand-foot-and-mouth disease
subjects affected / exposed	1 / 3557 (0.03%)	12 / 1741 (0.69%)	38 / 3494 (1.09%)	0 / 1771 (0.00%)
occurrences all number	1	12	38	0
Herpangina
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	6 / 3494 (0.17%)	0 / 1771 (0.00%)
occurrences all number	0	1	6	0
Herpes simplex
subjects affected / exposed	2 / 3557 (0.06%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	2	1	0	2
Herpes virus infection
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Herpes zoster
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	2	0	0	0
Hordeolum
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	1 / 1771 (0.06%)
occurrences all number	0	0	1	1
Human herpesvirus 6 infection
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Impetigo
subjects affected / exposed	0 / 3557 (0.00%)	11 / 1741 (0.63%)	27 / 3494 (0.77%)	0 / 1771 (0.00%)
occurrences all number	0	11	27	0
Infected bite
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Infection
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Influenza
subjects affected / exposed	7 / 3557 (0.20%)	14 / 1741 (0.80%)	24 / 3494 (0.69%)	3 / 1771 (0.17%)
occurrences all number	7	14	24	3
Klebsiella urinary tract infection
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Labyrinthitis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Laryngitis
subjects affected / exposed	0 / 3557 (0.00%)	16 / 1741 (0.92%)	45 / 3494 (1.29%)	1 / 1771 (0.06%)
occurrences all number	0	17	51	1
Laryngotracheitis obstructive
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Localised infection
subjects affected / exposed	1 / 3557 (0.03%)	2 / 1741 (0.11%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	2	0	0
Lower respiratory tract infection
subjects affected / exposed	4 / 3557 (0.11%)	60 / 1741 (3.45%)	124 / 3494 (3.55%)	0 / 1771 (0.00%)
occurrences all number	4	72	144	0
Lower respiratory tract infection viral
subjects affected / exposed	0 / 3557 (0.00%)	7 / 1741 (0.40%)	8 / 3494 (0.23%)	0 / 1771 (0.00%)
occurrences all number	0	7	8	0
Mastitis
subjects affected / exposed	42 / 3557 (1.18%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	15 / 1771 (0.85%)
occurrences all number	42	0	0	17
Metapneumovirus bronchiolitis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Metapneumovirus infection
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences all number	0	0	3	0
Myringitis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Nail bed infection
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Nasopharyngitis
subjects affected / exposed	38 / 3557 (1.07%)	306 / 1741 (17.58%)	590 / 3494 (16.89%)	19 / 1771 (1.07%)
occurrences all number	41	557	1121	20
Neonatal infection
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Neonatal pneumonia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Norovirus infection
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Omphalitis
subjects affected / exposed	0 / 3557 (0.00%)	4 / 1741 (0.23%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	0	4	4	0
Ophthalmia neonatorum
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	6 / 3494 (0.17%)	0 / 1771 (0.00%)
occurrences all number	0	2	6	0
Oral candidiasis
subjects affected / exposed	0 / 3557 (0.00%)	30 / 1741 (1.72%)	51 / 3494 (1.46%)	1 / 1771 (0.06%)
occurrences all number	0	34	57	1
Oral fungal infection
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	1	1	0
Oral herpes
subjects affected / exposed	5 / 3557 (0.14%)	2 / 1741 (0.11%)	2 / 3494 (0.06%)	1 / 1771 (0.06%)
occurrences all number	5	2	2	1
Oral viral infection
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Otitis externa
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	2	0	4	0
Otitis externa fungal
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Otitis media
subjects affected / exposed	1 / 3557 (0.03%)	59 / 1741 (3.39%)	114 / 3494 (3.26%)	1 / 1771 (0.06%)
occurrences all number	1	79	141	1
Otitis media acute
subjects affected / exposed	0 / 3557 (0.00%)	45 / 1741 (2.58%)	98 / 3494 (2.80%)	0 / 1771 (0.00%)
occurrences all number	0	55	113	0
Otitis media chronic
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	2	1	0
Parainfluenzae virus infection
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	5 / 3494 (0.14%)	0 / 1771 (0.00%)
occurrences all number	0	1	5	0
Parasitic gastroenteritis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Paronychia
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	4 / 3494 (0.11%)	1 / 1771 (0.06%)
occurrences all number	0	1	4	1
Periodontitis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Pertussis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Pharyngitis
subjects affected / exposed	5 / 3557 (0.14%)	14 / 1741 (0.80%)	39 / 3494 (1.12%)	1 / 1771 (0.06%)
occurrences all number	5	14	40	1
Pharyngitis streptococcal
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	2	1	0
Pharyngotonsillitis
subjects affected / exposed	0 / 3557 (0.00%)	4 / 1741 (0.23%)	9 / 3494 (0.26%)	0 / 1771 (0.00%)
occurrences all number	0	4	10	0
Pneumonia
subjects affected / exposed	0 / 3557 (0.00%)	10 / 1741 (0.57%)	31 / 3494 (0.89%)	1 / 1771 (0.06%)
occurrences all number	0	10	31	1
Pneumonia bacterial
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	1	1	0
Pneumonia mycoplasmal
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Pneumonia respiratory syncytial viral
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Pneumonia viral
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Pustule
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Pyoderma
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	0	3	6	0
Respiratory syncytial virus bronchiolitis
subjects affected / exposed	0 / 3557 (0.00%)	25 / 1741 (1.44%)	22 / 3494 (0.63%)	0 / 1771 (0.00%)
occurrences all number	0	25	23	0
Respiratory syncytial virus bronchitis
subjects affected / exposed	0 / 3557 (0.00%)	4 / 1741 (0.23%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	0	4	4	0
Respiratory syncytial virus infection
subjects affected / exposed	0 / 3557 (0.00%)	18 / 1741 (1.03%)	34 / 3494 (0.97%)	0 / 1771 (0.00%)
occurrences all number	0	18	34	0
Respiratory tract infection
subjects affected / exposed	51 / 3557 (1.43%)	65 / 1741 (3.73%)	140 / 3494 (4.01%)	18 / 1771 (1.02%)
occurrences all number	55	131	243	20
Respiratory tract infection viral
subjects affected / exposed	0 / 3557 (0.00%)	6 / 1741 (0.34%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	0	7	4	0
Rhinitis
subjects affected / exposed	0 / 3557 (0.00%)	46 / 1741 (2.64%)	86 / 3494 (2.46%)	1 / 1771 (0.06%)
occurrences all number	0	50	96	1
Rhinovirus infection
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	10 / 3494 (0.29%)	0 / 1771 (0.00%)
occurrences all number	0	3	12	0
Roseola
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Scarlet fever
subjects affected / exposed	1 / 3557 (0.03%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	1	0	0
Sepsis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Sepsis neonatal
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	2	0	0
Sinusitis
subjects affected / exposed	7 / 3557 (0.20%)	6 / 1741 (0.34%)	9 / 3494 (0.26%)	4 / 1771 (0.23%)
occurrences all number	8	8	9	4
Skin candida
subjects affected / exposed	0 / 3557 (0.00%)	8 / 1741 (0.46%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	0	8	4	0
Skin infection
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	4 / 3494 (0.11%)	1 / 1771 (0.06%)
occurrences all number	0	1	4	1
Staphylococcal infection
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Subcutaneous abscess
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	5 / 3494 (0.14%)	0 / 1771 (0.00%)
occurrences all number	0	4	5	0
Subglottic laryngitis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	1	1	0
Suspected COVID-19
subjects affected / exposed	10 / 3557 (0.28%)	18 / 1741 (1.03%)	59 / 3494 (1.69%)	4 / 1771 (0.23%)
occurrences all number	10	19	61	4
Systemic viral infection
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	6 / 3494 (0.17%)	0 / 1771 (0.00%)
occurrences all number	0	3	6	0
Thyroglossal cyst infection
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Tinea capitis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Tinea infection
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	5 / 3494 (0.14%)	0 / 1771 (0.00%)
occurrences all number	0	2	5	0
Tinea pedis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Tinea versicolour
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences all number	0	3	3	0
Tonsillitis
subjects affected / exposed	2 / 3557 (0.06%)	8 / 1741 (0.46%)	14 / 3494 (0.40%)	1 / 1771 (0.06%)
occurrences all number	2	8	14	1
Toxoplasmosis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Tracheitis
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	1	1	0
Tracheobronchitis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Upper respiratory tract infection
subjects affected / exposed	71 / 3557 (2.00%)	396 / 1741 (22.75%)	848 / 3494 (24.27%)	37 / 1771 (2.09%)
occurrences all number	86	779	1703	43
Upper respiratory tract infection bacterial
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	1 / 1771 (0.06%)
occurrences all number	0	0	2	1
Urinary tract infection
subjects affected / exposed	104 / 3557 (2.92%)	9 / 1741 (0.52%)	29 / 3494 (0.83%)	49 / 1771 (2.77%)
occurrences all number	107	9	32	50
Urogenital infection fungal
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Vaccination site abscess
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Vaginal infection
subjects affected / exposed	9 / 3557 (0.25%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	3 / 1771 (0.17%)
occurrences all number	9	0	1	3
Varicella
subjects affected / exposed	0 / 3557 (0.00%)	4 / 1741 (0.23%)	8 / 3494 (0.23%)	0 / 1771 (0.00%)
occurrences all number	0	4	8	0
Viral diarrhoea
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	0	2	0
Viral infection
subjects affected / exposed	0 / 3557 (0.00%)	12 / 1741 (0.69%)	36 / 3494 (1.03%)	0 / 1771 (0.00%)
occurrences all number	0	12	37	0
Viral pharyngitis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	1	0	2	0
Viral rash
subjects affected / exposed	0 / 3557 (0.00%)	11 / 1741 (0.63%)	22 / 3494 (0.63%)	0 / 1771 (0.00%)
occurrences all number	0	11	22	0
Viral rhinitis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Viral tonsillitis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Viral upper respiratory tract infection
subjects affected / exposed	2 / 3557 (0.06%)	24 / 1741 (1.38%)	43 / 3494 (1.23%)	1 / 1771 (0.06%)
occurrences all number	2	37	55	1
Vulvitis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Vulvovaginal candidiasis
subjects affected / exposed	13 / 3557 (0.37%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	9 / 1771 (0.51%)
occurrences all number	13	1	0	9
Vulvovaginal mycotic infection
subjects affected / exposed	6 / 3557 (0.17%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	5 / 1771 (0.28%)
occurrences all number	6	0	0	5
Wound infection
subjects affected / exposed	2 / 3557 (0.06%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	3 / 1771 (0.17%)
occurrences all number	2	1	0	3
Bacterial vulvovaginitis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Bacteriuria
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	1	0	0	1
COVID-19 pneumonia
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Cervicitis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Endometritis
subjects affected / exposed	5 / 3557 (0.14%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	5	0	0	0
Enterococcal infection
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Genital herpes simplex
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Genital infection female
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Gingivitis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Gonococcal infection
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Hepatitis B
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Kidney infection
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Mastitis postpartum
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	3	0	0	1
Otosalpingitis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Perineal infection
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Postoperative wound infection
subjects affected / exposed	10 / 3557 (0.28%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	3 / 1771 (0.17%)
occurrences all number	10	0	0	3
Puerperal infection
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Puerperal pyrexia
subjects affected / exposed	6 / 3557 (0.17%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	3 / 1771 (0.17%)
occurrences all number	6	0	0	3
Syphilis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	1	0	0	2
Tooth abscess
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	2	0	0	1
Tooth infection
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Uterine infection
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	0	0	0	2
Vulval abscess
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Vulvovaginitis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	1	0	0	1
Vulvovaginitis trichomonal
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Wound cellulitis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Wound sepsis
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Metabolism and nutrition disorders
Abnormal loss of weight
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Breast milk substitute intolerance
subjects affected / exposed	0 / 3557 (0.00%)	6 / 1741 (0.34%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	0	6	4	0
Cachexia
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Dairy intolerance
subjects affected / exposed	0 / 3557 (0.00%)	5 / 1741 (0.29%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences all number	0	5	3	0
Decreased appetite
subjects affected / exposed	2 / 3557 (0.06%)	3 / 1741 (0.17%)	2 / 3494 (0.06%)	2 / 1771 (0.11%)
occurrences all number	2	3	2	2
Dehydration
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	5 / 3494 (0.14%)	0 / 1771 (0.00%)
occurrences all number	1	0	5	0
Failure to thrive
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	0	1	4	0
Fluid retention
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Food intolerance
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Hyperglycaemia
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Hypocalcaemia
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Hypoglycaemia
subjects affected / exposed	1 / 3557 (0.03%)	10 / 1741 (0.57%)	17 / 3494 (0.49%)	0 / 1771 (0.00%)
occurrences all number	1	10	17	0
Hypoglycaemia neonatal
subjects affected / exposed	0 / 3557 (0.00%)	4 / 1741 (0.23%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences all number	0	4	3	0
Hypokalaemia
subjects affected / exposed	2 / 3557 (0.06%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	2	1	0	1
Iron deficiency
subjects affected / exposed	9 / 3557 (0.25%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	4 / 1771 (0.23%)
occurrences all number	9	0	1	4
Lactose intolerance
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	0	2	2	0
Malnutrition
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences all number	0	1	3	0
Metabolic acidosis
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Metabolic disorder
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	0	1	0	0
Milk soy protein intolerance
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Obesity
subjects affected / exposed	1 / 3557 (0.03%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	1	1	1	0
Overweight
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	6 / 3494 (0.17%)	0 / 1771 (0.00%)
occurrences all number	0	3	6	0
Poor feeding infant
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	12 / 3494 (0.34%)	0 / 1771 (0.00%)
occurrences all number	0	4	13	0
Underweight
subjects affected / exposed	1 / 3557 (0.03%)	6 / 1741 (0.34%)	3 / 3494 (0.09%)	0 / 1771 (0.00%)
occurrences all number	1	6	3	0
Vitamin B12 deficiency
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	2	0	0	0
Vitamin D deficiency
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	1	0	1	0
Vitamin K deficiency
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	0	1	0
Weight gain poor
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	7 / 3494 (0.20%)	0 / 1771 (0.00%)
occurrences all number	0	2	7	0
Diabetes mellitus
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	0	0	1
Hyperlipidaemia
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0
Hypomagnesaemia
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	1	0	0	0

More information

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Were there any global substantial amendments to the protocol? Yes

05 Oct 2020

The following points have been amended: Case definitions for lower respiratory tract illness have been modified to include the phrase “medically assessed." In addition, the success criteria for the primary objective on any RSV-associated lower respiratory tract infection has been changed. Previously the lower bound of this primary endpoint was 10%; it has been increased to 20%. The timing of interim analyses have been modified to make overall interim analyses operationally pragmatic. In addition, the corresponding study design operational characteristics have been updated.

23 Jun 2021

This protocol has been amended to: • implement the changes discussed and agreed with Center for Biologics Evaluation and Research (CBER). • extend the infant respiratory tract illness (RTI) surveillance to 12 months to ensure that this period will cover at least 1 full RSV season. • remove the collection of hematocrit samples due to challenges (mostly due to the COVID-19 pandemic) faced in several countries preventing the samples from reaching the central lab in adequate time for testing. • define an additional population for analysis: Modified Full Analysis - Efficacy Set.

10 Feb 2022

This protocol has been amended to: • change the trigger point for interim analyses which could lead to claim vaccine efficacy (2, 3 and 4) as there is a high chance of claiming vaccine efficacy (VE) earlier than initially anticipated. • add 2 new secondary descriptive efficacy objectives to assess VE against severe medically assessed LRTIs and any medically assessed LRTIs associated to RSV subtypes A and B separately in the infant participants from birth up to 6 months of age. • acquire further information on how the VE can be sustained up to 12 months post-birth. • remove the distribution of antibody titers/concentrations and the scatter plots showing the individual post-vaccination versus pre-vaccination results as well as scatter plots showing relationship between maternal and infants antibody titers. These analyses have already been described as part of previous completed RSV MAT studies and performing them in RSV MAT-009 (i.e. a larger sample size), is not expected to provide any additional critical information with regards to the study vaccine immunogenicity. • remove the section about predicted VE based on surrogate endpoint due to the limitation of data from internal epidemiological studies. Hence, the surrogate endpoint model cannot be robustly established and validated.

15 Mar 2022

Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study. Ongoing study participants at that time continued to be monitored as part of the study. The Protocol was updated to reflect the change to study’s safety assessment plan.

23 Feb 2023

The following points have been amended: • The Benefit/Risk assessment has been updated to clarify the status of the safety signals after GSK’s signal validation process. • The objectives and outcome measures section was updated. • RSV IgG antibody concentrations would be assessed only in maternal blood samples collected at delivery and cord blood* [ *or an infant blood sample collected within 72 hours after birth (if no cord blood sample can be obtained)]. • RSV-B neutralizing antibody titers were removed from the secondary immunogenicity analysis. • Populations for analysis were updated to reflect the changes to the statistical analysis plan of the study, following the of decision to stop further enrolment and vaccination. • Country-specific requirements have been added for Spain and Argentina.

Were there any global interruptions to the trial? No

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

None reported

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of infant participants with medically assessed, RSV-associated lower respiratory tract illnesses (LRTIs) of any severity and RSV-associated severe LRTIs from birth to Day 181 post-birth

Primary: Number of infant participants with medically assessed, RSV-associated lower respiratory tract illnesses (LRTIs) of any severity and RSV-associated severe LRTIs from birth to Day 181 post-birth

Primary: Number of infant participants with at least one adverse event (AE) leading to study withdrawal from birth to Day 181 post-birth

Primary: Number of infant participants with at least one adverse event (AE) leading to study withdrawal from birth to Day 181 post-birth

Primary: Number of infant participants with at least one serious adverse event (SAE) from birth to Day 181 post-birth

Primary: Number of infant participants with at least one serious adverse event (SAE) from birth to Day 181 post-birth

Primary: Number of infant participants with at least one medically attended AE (MAE) from birth to Day 181 post-birth

Primary: Number of infant participants with at least one medically attended AE (MAE) from birth to Day 181 post-birth

Primary: Number of infant participants with at least one SAE from birth to Day 366 post-birth

Primary: Number of infant participants with at least one SAE from birth to Day 366 post-birth

Primary: Number of infant participants with at least one AE leading to study withdrawal from birth to Day 366 post-birth

Primary: Number of infant participants with at least one AE leading to study withdrawal from birth to Day 366 post-birth

Primary: Number of infant participants with at least one MAE from birth to Day 366 post-birth

Primary: Number of infant participants with at least one MAE from birth to Day 366 post-birth

Secondary: Number of infant participants with RSV-associated hospitalizations from birth to Day 181 post-birth

Secondary: Number of infant participants with RSV-associated hospitalizations from birth to Day 181 post-birth

Secondary: Number of infant participants with medically assessed, RSV-associated severe LRTIs for RSV subtype A and RSV subtype B separately from birth to Day 181 post-birth

Secondary: Number of infant participants with medically assessed, RSV-associated severe LRTIs for RSV subtype A and RSV subtype B separately from birth to Day 181 post-birth

Secondary: Number of infant participants with medically assessed, RSV-associated LRTIs of any severity from birth to Day 366 post-birth

Secondary: Number of infant participants with medically assessed, RSV-associated LRTIs of any severity from birth to Day 366 post-birth

Secondary: Number of infant participants with all-cause LRTIs from birth to Day 181 post-birth

Secondary: Number of infant participants with all-cause LRTIs from birth to Day 181 post-birth

Secondary: Number of infant participants with all-cause LRTIs with hospitalization from birth to Day 181 post-birth

Secondary: Number of infant participants with all-cause LRTIs with hospitalization from birth to Day 181 post-birth

Secondary: Number of infant participants with medically assessed, RSV-associated severe LRTIs from birth to Day 366 post-birth

Secondary: Number of infant participants with medically assessed, RSV-associated severe LRTIs from birth to Day 366 post-birth

Secondary: Number of infant participants with medically assessed, RSV-associated LRTIs of any severity for RSV subtype A and RSV subtype B separately from birth to Day 181 post-birth

Secondary: Number of infant participants with medically assessed, RSV-associated LRTIs of any severity for RSV subtype A and RSV subtype B separately from birth to Day 181 post-birth

Secondary: Number of infant participants with medically assessed, RSV-associated severe LRTIs from birth to Day 121 post-birth

Secondary: Number of infant participants with medically assessed, RSV-associated severe LRTIs from birth to Day 121 post-birth

Secondary: Number of infant participants with medically assessed, RSV-associated LRTIs of any severity from birth to Day 121 post-birth

Secondary: Number of infant participants with medically assessed, RSV-associated LRTIs of any severity from birth to Day 121 post-birth

Secondary: Number of infant participants with all-cause pneumonia from birth to Day 181 post-birth

Secondary: Number of infant participants with all-cause pneumonia from birth to Day 181 post-birth

Secondary: Number of infant participants with RSV-associated hospitalizations from birth to Day 366 post-birth

Secondary: Number of infant participants with RSV-associated hospitalizations from birth to Day 366 post-birth

Secondary: Number of maternal participants with RSV-associated medically attended RTIs (RSV-MA-RTIs) from study intervention administration (Day 1) to Day 181 post-delivery

Secondary: Number of maternal participants with RSV-associated medically attended RTIs (RSV-MA-RTIs) from study intervention administration (Day 1) to Day 181 post-delivery

Secondary: RSV-A neutralizing antibody titers for maternal participants at Day 1, at Day 31 and at delivery

Secondary: RSV-A neutralizing antibody titers for maternal participants at Day 1, at Day 31 and at delivery

Secondary: RSV-A neutralizing antibody titers for infant participants at delivery or within 72 hours after birth

Secondary: RSV-A neutralizing antibody titers for infant participants at delivery or within 72 hours after birth

Secondary: RSV-A neutralizing antibody titers for infant participants at Day 43 post-birth

Secondary: RSV-A neutralizing antibody titers for infant participants at Day 43 post-birth

Secondary: RSV MAT immunoglobulin G (IgG)-specific antibody concentrations for maternal participants at delivery

Secondary: RSV MAT immunoglobulin G (IgG)-specific antibody concentrations for maternal participants at delivery

Secondary: RSV-A neutralizing antibody titers for infant participants at Day 121 post-birth

Secondary: RSV-A neutralizing antibody titers for infant participants at Day 121 post-birth

Secondary: RSV-A neutralizing antibody titers for infant participants at Day 181 post-birth

Secondary: RSV-A neutralizing antibody titers for infant participants at Day 181 post-birth

Secondary: Number of maternal participants with any solicited administration site events from Day 1 to Day 7 included

Secondary: Number of maternal participants with any solicited administration site events from Day 1 to Day 7 included

Secondary: Geometric mean ratio (GMR) between cord blood and maternal RSV MAT immunoglobulin G (IgG)-specific antibody concentrations

Secondary: Geometric mean ratio (GMR) between cord blood and maternal RSV MAT immunoglobulin G (IgG)-specific antibody concentrations

Secondary: RSV MAT IgG-specific antibody concentrations for infant participants at delivery or within 72 hours after birth

Secondary: RSV MAT IgG-specific antibody concentrations for infant participants at delivery or within 72 hours after birth

Secondary: Number of maternal participants with any solicited systemic events from Day 1 to Day 7 included

Secondary: Number of maternal participants with any solicited systemic events from Day 1 to Day 7 included

Secondary: Number of maternal participants with any unsolicited AEs from Day 1 to Day 30 included

Secondary: Number of maternal participants with any unsolicited AEs from Day 1 to Day 30 included

Secondary: Number of maternal participants with at least one SAE from Day 1 to Day 181 post-delivery

Secondary: Number of maternal participants with at least one SAE from Day 1 to Day 181 post-delivery

Secondary: Number of maternal participants with at least one AE leading to study withdrawal from Day 1 to Day 181 post-delivery

Secondary: Number of maternal participants with at least one AE leading to study withdrawal from Day 1 to Day 181 post-delivery

Secondary: Number of maternal participants with at least one all-cause MA-RTI from Day 1 to Day 181 post-delivery

Secondary: Number of maternal participants with at least one all-cause MA-RTI from Day 1 to Day 181 post-delivery

Secondary: Number of maternal participants with pregnancy outcomes from Day 1 to Day 42 post-delivery

Secondary: Number of maternal participants with pregnancy outcomes from Day 1 to Day 42 post-delivery

Secondary: Number of maternal participants with at least one MAE from Day 1 to Day 42 post-delivery

Secondary: Number of maternal participants with at least one MAE from Day 1 to Day 42 post-delivery

Secondary: Number of maternal participants with pregnancy-related adverse events of special interest (AESIs) from Day 1 to Day 42 post-delivery