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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	v1
This version publication date	05 Jul 2024
First version publication date	05 Jul 2024
Other versions	v2

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 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 ^[1] ^[2]

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
[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	3494	1741
Units: Participants	640	323

No statistical analyses for this end point

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 ^[3] ^[4]

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 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

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	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 ^[5] ^[6]

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
[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	19	4

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 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 ^[16]

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
[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	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 ^[17]

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
[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	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 ^[18]

End point description

An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND a 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 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

Secondary

End point timeframe

From birth to Day 366 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	38	22

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 ^[19]

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
[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	67	43

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 ^[20]

End point description

An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND 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 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 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
[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
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 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 a 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 endpoint. 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: RSV-A neutralizing antibody titers for maternal participants at Day 1, Day 31 and at delivery

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End point title

RSV-A neutralizing antibody titers for maternal participants at Day 1, Day 31 and at delivery ^[26]

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
[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	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: 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 ^[27]

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
[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	3557	1771
Units: Participants	3	6

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-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 ^[30]

End point description

End point type

Secondary

End point timeframe

At Day 121 post-birth

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 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 ^[31]

End point description

End point type

Secondary

End point timeframe

At Day 181 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	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: 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: 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 ^[32]

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
[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 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: 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 ^[33]

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
[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 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 ^[34]

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
[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 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

Top of page

End point title

Number of maternal participants with at least one SAE from Day 1 to Day 181 post-delivery ^[35]

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
[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	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 ^[36]

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
[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	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 ^[37]

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
[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	317	144

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 ^[38]

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
[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	1717	785

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 ^[39]

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
[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
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 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 ^[40]

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
[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
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 ^[41]

End point description

Neonatal/infant AESIs included congenital anomalies with functional defects, congenital anomalies with internal structural defects, congenital anomalies 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
[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 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

Top of page

Timeframe for reporting adverse events

Maternal groups: Solicited AEs - from Day 1 to Day 7 and Unsolicited AEs - from Day 1 to Day 30 after vaccination. Deaths and SAEs - from Day 1 to Day 181 post-delivery. Infant groups: Deaths, SAEs and non SAEs - from birth to Day 366 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 received a single dose of the RSV MAT vaccine administered 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 received a single dose of placebo administered 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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Abortion spontaneous
alternative dictionary used: v26.1 26.1
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
Abnormal labour
alternative dictionary used: v26.1 26.1
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
Amniorrhoea
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Cephalo-pelvic disproportion
alternative dictionary used: v26.1 26.1
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
Cephalhaematoma
alternative dictionary used: v26.1 26.1
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
Cervix dystocia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Failed trial of labour
alternative dictionary used: v26.1 26.1
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
Face presentation
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
False labour
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 dystocia
alternative dictionary used: v26.1 26.1
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 growth restriction
alternative dictionary used: v26.1 26.1
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 distress syndrome
alternative dictionary used: v26.1 26.1
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 macrosomia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 malpresentation
alternative dictionary used: v26.1 26.1
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 malposition
alternative dictionary used: v26.1 26.1
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
Gestational diabetes
alternative dictionary used: v26.1 26.1
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
Gestational hypertension
alternative dictionary used: v26.1 26.1
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
HELLP syndrome
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Hydrops foetalis
alternative dictionary used: v26.1 26.1
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
High risk infant
alternative dictionary used: v26.1 26.1
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
High foetal head
alternative dictionary used: v26.1 26.1
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
Hypoxic ischaemic encephalopathy neonatal
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Jaundice neonatal
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Labour complication
alternative dictionary used: v26.1 26.1
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
Low birth weight baby
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Placental polyp
alternative dictionary used: v26.1 26.1
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
Placental insufficiency
alternative dictionary used: v26.1 26.1
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
Placenta praevia
alternative dictionary used: v26.1 26.1
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
Polyhydramnios
alternative dictionary used: v26.1 26.1
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 rupture of membranes
alternative dictionary used: v26.1 26.1
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 labour
alternative dictionary used: v26.1 26.1
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 baby
alternative dictionary used: v26.1 26.1
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
Precipitate labour
alternative dictionary used: v26.1 26.1
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
Postpartum haemorrhage
alternative dictionary used: v26.1 26.1
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
Pre-eclampsia
alternative dictionary used: v26.1 26.1
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
Prolonged labour
alternative dictionary used: v26.1 26.1
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
Preterm premature rupture of membranes
alternative dictionary used: v26.1 26.1
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
Premature separation of placenta
alternative dictionary used: v26.1 26.1
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 pregnancy
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Retained placenta or membranes
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Small for dates baby
alternative dictionary used: v26.1 26.1
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
Stillbirth
alternative dictionary used: v26.1 26.1
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
Threatened labour
alternative dictionary used: v26.1 26.1
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
Transverse presentation
alternative dictionary used: v26.1 26.1
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
Traumatic delivery
alternative dictionary used: v26.1 26.1
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
Umbilical cord around neck
alternative dictionary used: v26.1 26.1
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
Umbilical cord prolapse
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Uterine atony
alternative dictionary used: v26.1 26.1
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
Uterine contractions during pregnancy
alternative dictionary used: v26.1 26.1
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 hypertonus
alternative dictionary used: v26.1 26.1
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 hypotonus
alternative dictionary used: v26.1 26.1
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
Weight decrease neonatal
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Developmental delay
alternative dictionary used: v26.1 26.1
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
Death neonatal
alternative dictionary used: v26.1 26.1
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
Dysplasia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 death
alternative dictionary used: v26.1 26.1
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
Sudden infant death syndrome
alternative dictionary used: v26.1 26.1
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
Immune system disorders
ABO incompatibility
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Atelectasis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Asphyxia
alternative dictionary used: v26.1 26.1
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
Bronchial obstruction
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Brief resolved unexplained event
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Choking
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 asphyxia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 hypoxia
alternative dictionary used: v26.1 26.1
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 tachypnoea
alternative dictionary used: v26.1 26.1
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 respiratory depression
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 pulmonary hypertension
alternative dictionary used: v26.1 26.1
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
Pleural effusion
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 hypertension
alternative dictionary used: v26.1 26.1
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
Pulmonary venous hypertension
alternative dictionary used: v26.1 26.1
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 vein stenosis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 disorder neonatal
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 depression
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Cholestasis
alternative dictionary used: v26.1 26.1
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
Cholelithiasis
alternative dictionary used: v26.1 26.1
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
Cholecystitis acute
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Cholestasis of pregnancy
alternative dictionary used: v26.1 26.1
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
Gallbladder disorder
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Hepatitis neonatal
alternative dictionary used: v26.1 26.1
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 neonatal
alternative dictionary used: v26.1 26.1
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
Hyperbilirubinaemia
alternative dictionary used: v26.1 26.1
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
Investigations
Apgar score low
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Viral test positive
alternative dictionary used: v26.1 26.1
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 decreased
alternative dictionary used: v26.1 26.1
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
Injury, poisoning and procedural complications
Abdominal injury
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Face injury
alternative dictionary used: v26.1 26.1
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
Fall
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Thermal burn
alternative dictionary used: v26.1 26.1
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
Tongue injury
alternative dictionary used: v26.1 26.1
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
Traumatic haemorrhage
alternative dictionary used: v26.1 26.1
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 cervical laceration
alternative dictionary used: v26.1 26.1
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 rupture
alternative dictionary used: v26.1 26.1
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
Vulvovaginal injury
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Wound haematoma
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Aplasia cutis congenita
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Ankyloglossia congenital
alternative dictionary used: v26.1 26.1
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
Arteriovenous malformation
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Biotinidase deficiency
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Brachycephaly
alternative dictionary used: v26.1 26.1
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
Branchial cyst
alternative dictionary used: v26.1 26.1
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
Buried penis syndrome
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Cleft lip
alternative dictionary used: v26.1 26.1
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 cerebral cyst
alternative dictionary used: v26.1 26.1
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
Coarctation of the aorta
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 choroid plexus cyst
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 diaphragmatic hernia
alternative dictionary used: v26.1 26.1
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 ectopic bladder
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 great vessel anomaly
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 inguinal hernia
alternative dictionary used: v26.1 26.1
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 knee dislocation
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 melanosis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 skin dimples
alternative dictionary used: v26.1 26.1
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 toxoplasmosis
alternative dictionary used: v26.1 26.1
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 pneumonia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 syphilis
alternative dictionary used: v26.1 26.1
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 torticollis
alternative dictionary used: v26.1 26.1
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 nephrotic syndrome
alternative dictionary used: v26.1 26.1
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
Cryptorchism
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Hypertelorism
alternative dictionary used: v26.1 26.1
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
Hypospadias
alternative dictionary used: v26.1 26.1
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
Intestinal malrotation
alternative dictionary used: v26.1 26.1
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
Iris coloboma
alternative dictionary used: v26.1 26.1
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
Kidney duplex
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Micrognathia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Menkes' syndrome
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Multiple congenital abnormalities
alternative dictionary used: v26.1 26.1
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
Myotonic dystrophy
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Penoscrotal fusion
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Polydactyly
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Syndactyly
alternative dictionary used: v26.1 26.1
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
Syringomyelia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Cardiac failure
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Cardio-respiratory arrest
alternative dictionary used: v26.1 26.1
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
Cardiogenic shock
alternative dictionary used: v26.1 26.1
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
Foetal arrhythmia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Supraventricular tachycardia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Tachycardia foetal
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 ventricle dilatation
alternative dictionary used: v26.1 26.1
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
Cerebral cyst
alternative dictionary used: v26.1 26.1
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
Encephalopathy neonatal
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Infantile spasms
alternative dictionary used: v26.1 26.1
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
Infant irritability
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Intracranial aneurysm
alternative dictionary used: v26.1 26.1
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
Intraventricular haemorrhage neonatal
alternative dictionary used: v26.1 26.1
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
Lacunar stroke
alternative dictionary used: v26.1 26.1
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
Kernicterus
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Myoclonus
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 like phenomena
alternative dictionary used: v26.1 26.1
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
Seizure
alternative dictionary used: v26.1 26.1
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
Subarachnoid haemorrhage
alternative dictionary used: v26.1 26.1
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
Subependymal cyst
alternative dictionary used: v26.1 26.1
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
Syncope
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Thrombocytopenia neonatal
alternative dictionary used: v26.1 26.1
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 and labyrinth disorders
Deafness bilateral
alternative dictionary used: v26.1 26.1
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 unilateral
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 distension
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 pain upper
alternative dictionary used: v26.1 26.1
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
Abdominal pain lower
alternative dictionary used: v26.1 26.1
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
Anal fistula
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Diarrhoea
alternative dictionary used: v26.1 26.1
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
Dysphagia
alternative dictionary used: v26.1 26.1
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
Food poisoning
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Infantile colic
alternative dictionary used: v26.1 26.1
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
Ileus
alternative dictionary used: v26.1 26.1
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
Inguinal hernia
alternative dictionary used: v26.1 26.1
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
Intestinal obstruction
alternative dictionary used: v26.1 26.1
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
Intestinal pseudo-obstruction
alternative dictionary used: v26.1 26.1
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
Nausea
alternative dictionary used: v26.1 26.1
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
Necrotising colitis
alternative dictionary used: v26.1 26.1
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
Necrotising enterocolitis neonatal
alternative dictionary used: v26.1 26.1
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
Oesophageal stenosis
alternative dictionary used: v26.1 26.1
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
Obstructive pancreatitis
alternative dictionary used: v26.1 26.1
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
Pancreatitis
alternative dictionary used: v26.1 26.1
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 relapsing
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Volvulus
alternative dictionary used: v26.1 26.1
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
Vomiting
alternative dictionary used: v26.1 26.1
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
Skin and subcutaneous tissue disorders
Ecchymosis
alternative dictionary used: v26.1 26.1
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 multiforme
alternative dictionary used: v26.1 26.1
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 toxicum neonatorum
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 cyst
alternative dictionary used: v26.1 26.1
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 disorder in pregnancy
alternative dictionary used: v26.1 26.1
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
Ureteric stenosis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Rheumatoid arthritis
alternative dictionary used: v26.1 26.1
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
Retrognathia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Trigger finger
alternative dictionary used: v26.1 26.1
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
Abscess
alternative dictionary used: v26.1 26.1
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
Acarodermatitis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Adenovirus infection
alternative dictionary used: v26.1 26.1
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
Amoebic dysentery
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Anal abscess
alternative dictionary used: v26.1 26.1
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
Appendicitis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Bronchitis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Breast abscess
alternative dictionary used: v26.1 26.1
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 pneumonia
alternative dictionary used: v26.1 26.1
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
COVID-19
alternative dictionary used: v26.1 26.1
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
Bronchitis bacterial
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Cellulitis orbital
alternative dictionary used: v26.1 26.1
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
Conjunctivitis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Endocarditis bacterial
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Ear infection
alternative dictionary used: v26.1 26.1
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
Escherichia bacteraemia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Genital herpes
alternative dictionary used: v26.1 26.1
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
Gastroenteritis norovirus
alternative dictionary used: v26.1 26.1
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 salmonella
alternative dictionary used: v26.1 26.1
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
Gastrointestinal infection
alternative dictionary used: v26.1 26.1
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 viral
alternative dictionary used: v26.1 26.1
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
Groin abscess
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Lower respiratory tract infection
alternative dictionary used: v26.1 26.1
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
Leishmaniasis
alternative dictionary used: v26.1 26.1
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 viral
alternative dictionary used: v26.1 26.1
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
Mastitis
alternative dictionary used: v26.1 26.1
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
Mastoiditis
alternative dictionary used: v26.1 26.1
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
Mastitis bacterial
alternative dictionary used: v26.1 26.1
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
Measles
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Meningitis
alternative dictionary used: v26.1 26.1
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 neonatal
alternative dictionary used: v26.1 26.1
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
Meningitis viral
alternative dictionary used: v26.1 26.1
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
Metapneumovirus bronchiolitis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Nasopharyngitis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Neonatal infection
alternative dictionary used: v26.1 26.1
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
Norovirus infection
alternative dictionary used: v26.1 26.1
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
Omphalitis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Oral herpes
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Otitis externa
alternative dictionary used: v26.1 26.1
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
Osteomyelitis
alternative dictionary used: v26.1 26.1
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 acute
alternative dictionary used: v26.1 26.1
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
Papilloma viral infection
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Pharyngitis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Periorbital cellulitis
alternative dictionary used: v26.1 26.1
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
Pharyngotonsillitis
alternative dictionary used: v26.1 26.1
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 adenoviral
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Pilonidal disease
alternative dictionary used: v26.1 26.1
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 aspiration
alternative dictionary used: v26.1 26.1
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 influenzal
alternative dictionary used: v26.1 26.1
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
Pneumonia bacterial
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Post procedural pneumonia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Respiratory syncytial virus bronchitis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Salmonella bacteraemia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Rotavirus infection
alternative dictionary used: v26.1 26.1
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
Rhinitis
alternative dictionary used: v26.1 26.1
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
Sepsis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Streptococcal sepsis
alternative dictionary used: v26.1 26.1
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
Staphylococcal sepsis
alternative dictionary used: v26.1 26.1
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
Syphilis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Systemic viral infection
alternative dictionary used: v26.1 26.1
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
Thyroglossal cyst infection
alternative dictionary used: v26.1 26.1
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
Tonsillitis
alternative dictionary used: v26.1 26.1
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
Tracheobronchitis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Urachal sinus infection
alternative dictionary used: v26.1 26.1
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
Upper respiratory tract infection
alternative dictionary used: v26.1 26.1
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
Urosepsis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Varicella
alternative dictionary used: v26.1 26.1
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 rash
alternative dictionary used: v26.1 26.1
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 upper respiratory tract infection
alternative dictionary used: v26.1 26.1
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
Viral infection
alternative dictionary used: v26.1 26.1
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
Wound infection
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Hypoglycaemia neonatal
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Hypokalaemia
alternative dictionary used: v26.1 26.1
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
Hypomagnesaemia
alternative dictionary used: v26.1 26.1
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
Hyponatraemia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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	2262 / 3557 (63.59%)	1389 / 1741 (79.78%)	2802 / 3494 (80.19%)	1011 / 1771 (57.09%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
alternative dictionary used: v26.1 26.1
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
Anogenital warts
alternative dictionary used: v26.1 26.1
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 of skin
alternative dictionary used: v26.1 26.1
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
Haemangioma
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	4 / 1741 (0.23%)	7 / 3494 (0.20%)	0 / 1771 (0.00%)
occurrences all number	0	4	7	0
Infantile haemangioma
alternative dictionary used: v26.1 26.1
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
Lipoma
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Vascular disorders
Angiopathy
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Hypotension
alternative dictionary used: v26.1 26.1
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
Varicose vein
alternative dictionary used: v26.1 26.1
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	2	0	1	0
Vasodilatation
alternative dictionary used: v26.1 26.1
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
Surgical and medical procedures
Medically induced preterm birth
alternative dictionary used: v26.1 26.1
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
Pregnancy, puerperium and perinatal conditions
Birth trauma
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Caput succedaneum
alternative dictionary used: v26.1 26.1
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
Cephalhaematoma
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	8 / 1741 (0.46%)	13 / 3494 (0.37%)	0 / 1771 (0.00%)
occurrences all number	0	8	13	0
Cephalo-pelvic disproportion
alternative dictionary used: v26.1 26.1
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
Complication of delivery
alternative dictionary used: v26.1 26.1
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
Complication of pregnancy
alternative dictionary used: v26.1 26.1
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	5 / 1771 (0.28%)
occurrences all number	1	0	0	5
False labour
alternative dictionary used: v26.1 26.1
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
Foetal acidosis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Foetal growth restriction
alternative dictionary used: v26.1 26.1
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
Foetal hypokinesia
alternative dictionary used: v26.1 26.1
subjects affected / exposed	6 / 3557 (0.17%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	7	0	0	1
Foetal macrosomia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Gestational diabetes
alternative dictionary used: v26.1 26.1
subjects affected / exposed	23 / 3557 (0.65%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	18 / 1771 (1.02%)
occurrences all number	23	0	0	18
Gestational hypertension
alternative dictionary used: v26.1 26.1
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
Haemorrhage in pregnancy
alternative dictionary used: v26.1 26.1
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
Hypothermia neonatal
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	95 / 1741 (5.46%)	251 / 3494 (7.18%)	0 / 1771 (0.00%)
occurrences all number	0	95	252	0
Large for dates baby
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	20 / 1741 (1.15%)	27 / 3494 (0.77%)	0 / 1771 (0.00%)
occurrences all number	0	20	27	0
Low birth weight baby
alternative dictionary used: v26.1 26.1
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 stain
alternative dictionary used: v26.1 26.1
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
Maternal condition affecting foetus
alternative dictionary used: v26.1 26.1
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 in amniotic fluid
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Neonatal disorder
alternative dictionary used: v26.1 26.1
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
Oligohydramnios
alternative dictionary used: v26.1 26.1
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
Omphalorrhexis
alternative dictionary used: v26.1 26.1
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
Placenta praevia
alternative dictionary used: v26.1 26.1
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 disorder
alternative dictionary used: v26.1 26.1
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
Premature rupture of membranes
alternative dictionary used: v26.1 26.1
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
Poor weight gain neonatal
alternative dictionary used: v26.1 26.1
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
Postpartum haemorrhage
alternative dictionary used: v26.1 26.1
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
Pre-eclampsia
alternative dictionary used: v26.1 26.1
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
Premature baby
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	18 / 3557 (0.51%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	8 / 1771 (0.45%)
occurrences all number	18	0	0	8
Polyhydramnios
alternative dictionary used: v26.1 26.1
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
Prolonged labour
alternative dictionary used: v26.1 26.1
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
Preterm premature rupture of membranes
alternative dictionary used: v26.1 26.1
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
Retained placenta or membranes
alternative dictionary used: v26.1 26.1
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
Shoulder dystocia
alternative dictionary used: v26.1 26.1
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
Small for dates baby
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Umbilical cord around neck
alternative dictionary used: v26.1 26.1
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
Umbilical cord abnormality
alternative dictionary used: v26.1 26.1
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 granuloma
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	6 / 1741 (0.34%)	12 / 3494 (0.34%)	0 / 1771 (0.00%)
occurrences all number	0	6	12	0
Umbilical cord haemorrhage
alternative dictionary used: v26.1 26.1
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 hypotonus
alternative dictionary used: v26.1 26.1
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 irritability
alternative dictionary used: v26.1 26.1
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 contractions during pregnancy
alternative dictionary used: v26.1 26.1
subjects affected / exposed	8 / 3557 (0.22%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	6 / 1771 (0.34%)
occurrences all number	8	0	0	7
Weight decrease neonatal
alternative dictionary used: v26.1 26.1
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
General disorders and administration site conditions
Administration site erythema
alternative dictionary used: v26.1 26.1
subjects affected / exposed	133 / 3557 (3.74%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	8 / 1771 (0.45%)
occurrences all number	133	0	0	8
Administration site pain
alternative dictionary used: v26.1 26.1
subjects affected / exposed	1294 / 3557 (36.38%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	231 / 1771 (13.04%)
occurrences all number	1294	0	0	231
Administration site swelling
alternative dictionary used: v26.1 26.1
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
Adverse food reaction
alternative dictionary used: v26.1 26.1
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
Asthenia
alternative dictionary used: v26.1 26.1
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
Chills
alternative dictionary used: v26.1 26.1
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
Crepitations
alternative dictionary used: v26.1 26.1
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
Crying
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Feeling hot
alternative dictionary used: v26.1 26.1
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
Feeling jittery
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Fatigue
alternative dictionary used: v26.1 26.1
subjects affected / exposed	1093 / 3557 (30.73%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	479 / 1771 (27.05%)
occurrences all number	1093	0	0	480
High-pitched crying
alternative dictionary used: v26.1 26.1
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
Hypertrophy
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Hypothermia
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	0	1	2	0
Illness
alternative dictionary used: v26.1 26.1
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
Ill-defined disorder
alternative dictionary used: v26.1 26.1
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
Injection site swelling
alternative dictionary used: v26.1 26.1
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
Injection site pruritus
alternative dictionary used: v26.1 26.1
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 pain
alternative dictionary used: v26.1 26.1
subjects affected / exposed	4 / 3557 (0.11%)	2 / 1741 (0.11%)	3 / 3494 (0.09%)	1 / 1771 (0.06%)
occurrences all number	4	3	5	1
Injection site oedema
alternative dictionary used: v26.1 26.1
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 erythema
alternative dictionary used: v26.1 26.1
subjects affected / exposed	3 / 3557 (0.08%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	3	0	1	0
Injection site bruising
alternative dictionary used: v26.1 26.1
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
Influenza like illness
alternative dictionary used: v26.1 26.1
subjects affected / exposed	1 / 3557 (0.03%)	12 / 1741 (0.69%)	19 / 3494 (0.54%)	2 / 1771 (0.11%)
occurrences all number	1	27	44	2
Irritability postvaccinal
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	9 / 1741 (0.52%)	9 / 3494 (0.26%)	0 / 1771 (0.00%)
occurrences all number	0	14	13	0
Injury associated with device
alternative dictionary used: v26.1 26.1
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
Macrosomia
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	15 / 1741 (0.86%)	17 / 3494 (0.49%)	0 / 1771 (0.00%)
occurrences all number	0	15	17	0
Malaise
alternative dictionary used: v26.1 26.1
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
Oedema
alternative dictionary used: v26.1 26.1
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
Oedema peripheral
alternative dictionary used: v26.1 26.1
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
Pain
alternative dictionary used: v26.1 26.1
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
Peripheral swelling
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	27 / 3557 (0.76%)	81 / 1741 (4.65%)	191 / 3494 (5.47%)	9 / 1771 (0.51%)
occurrences all number	27	98	219	9
Swelling
alternative dictionary used: v26.1 26.1
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
Swelling face
alternative dictionary used: v26.1 26.1
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
Thirst
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	1 / 3557 (0.03%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	2 / 1771 (0.11%)
occurrences all number	1	1	1	2
Vessel puncture site bruise
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Allergy to arthropod bite
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 allergy
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	7 / 1741 (0.40%)	16 / 3494 (0.46%)	0 / 1771 (0.00%)
occurrences all number	0	7	16	0
Hypersensitivity
alternative dictionary used: v26.1 26.1
subjects affected / exposed	1 / 3557 (0.03%)	3 / 1741 (0.17%)	7 / 3494 (0.20%)	0 / 1771 (0.00%)
occurrences all number	1	3	7	0
Milk allergy
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	7 / 1741 (0.40%)	18 / 3494 (0.52%)	0 / 1771 (0.00%)
occurrences all number	0	7	18	0
Multiple allergies
alternative dictionary used: v26.1 26.1
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
Nutritional supplement allergy
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	1 / 3557 (0.03%)	1 / 1741 (0.06%)	5 / 3494 (0.14%)	0 / 1771 (0.00%)
occurrences all number	1	1	5	0
Reproductive system and breast disorders
Acquired phimosis
alternative dictionary used: v26.1 26.1
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
Adnexa uteri cyst
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Coital bleeding
alternative dictionary used: v26.1 26.1
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
Galactostasis
alternative dictionary used: v26.1 26.1
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 blister
alternative dictionary used: v26.1 26.1
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 discomfort
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	9 / 3494 (0.26%)	0 / 1771 (0.00%)
occurrences all number	0	3	9	0
Genital macule
alternative dictionary used: v26.1 26.1
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 prolapse
alternative dictionary used: v26.1 26.1
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 ulceration
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Penile adhesion
alternative dictionary used: v26.1 26.1
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
Pelvic pain
alternative dictionary used: v26.1 26.1
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
Pruritus genital
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Testicular retraction
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	8 / 3557 (0.22%)	2 / 1741 (0.11%)	1 / 3494 (0.03%)	3 / 1771 (0.17%)
occurrences all number	8	2	1	3
Vaginal disorder
alternative dictionary used: v26.1 26.1
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	1 / 1771 (0.06%)
occurrences all number	2	0	1	1
Vaginal haemorrhage
alternative dictionary used: v26.1 26.1
subjects affected / exposed	6 / 3557 (0.17%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	6	0	1	0
Vulvovaginal erythema
alternative dictionary used: v26.1 26.1
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
Vulval oedema
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	1 / 3557 (0.03%)	6 / 1741 (0.34%)	8 / 3494 (0.23%)	0 / 1771 (0.00%)
occurrences all number	1	6	8	0
Atelectasis
alternative dictionary used: v26.1 26.1
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
Asthmatic crisis
alternative dictionary used: v26.1 26.1
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
Brief resolved unexplained event
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Bronchiolitis obliterans syndrome
alternative dictionary used: v26.1 26.1
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
Bronchitis chronic
alternative dictionary used: v26.1 26.1
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
Bronchospasm
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	10 / 1741 (0.57%)	13 / 3494 (0.37%)	0 / 1771 (0.00%)
occurrences all number	0	12	15	0
Catarrh
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	6 / 1741 (0.34%)	8 / 3494 (0.23%)	0 / 1771 (0.00%)
occurrences all number	0	9	12	0
Choking
alternative dictionary used: v26.1 26.1
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
Childhood asthma
alternative dictionary used: v26.1 26.1
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
Cough
alternative dictionary used: v26.1 26.1
subjects affected / exposed	4 / 3557 (0.11%)	124 / 1741 (7.12%)	243 / 3494 (6.95%)	3 / 1771 (0.17%)
occurrences all number	4	167	356	3
Dyspnoea
alternative dictionary used: v26.1 26.1
subjects affected / exposed	3 / 3557 (0.08%)	19 / 1741 (1.09%)	20 / 3494 (0.57%)	0 / 1771 (0.00%)
occurrences all number	4	21	25	0
Dysphonia
alternative dictionary used: v26.1 26.1
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
Epistaxis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 apnoea
alternative dictionary used: v26.1 26.1
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
Increased bronchial secretion
alternative dictionary used: v26.1 26.1
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
Lower respiratory tract congestion
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	4 / 3557 (0.11%)	93 / 1741 (5.34%)	223 / 3494 (6.38%)	1 / 1771 (0.06%)
occurrences all number	4	112	269	1
Nasal discomfort
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	6 / 1741 (0.34%)	7 / 3494 (0.20%)	0 / 1771 (0.00%)
occurrences all number	0	6	9	0
Nasal dryness
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	4 / 1741 (0.23%)	8 / 3494 (0.23%)	0 / 1771 (0.00%)
occurrences all number	0	4	10	0
Nasal inflammation
alternative dictionary used: v26.1 26.1
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 respiratory distress
alternative dictionary used: v26.1 26.1
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
Neonatal tachypnoea
alternative dictionary used: v26.1 26.1
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
Neonatal respiratory depression
alternative dictionary used: v26.1 26.1
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
Oropharyngeal pain
alternative dictionary used: v26.1 26.1
subjects affected / exposed	2 / 3557 (0.06%)	2 / 1741 (0.11%)	1 / 3494 (0.03%)	2 / 1771 (0.11%)
occurrences all number	2	2	1	2
Pharyngeal erythema
alternative dictionary used: v26.1 26.1
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
Pneumothorax
alternative dictionary used: v26.1 26.1
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
Pulmonary artery stenosis
alternative dictionary used: v26.1 26.1
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
Productive cough
alternative dictionary used: v26.1 26.1
subjects affected / exposed	1 / 3557 (0.03%)	1 / 1741 (0.06%)	5 / 3494 (0.14%)	2 / 1771 (0.11%)
occurrences all number	1	1	6	2
Pulmonary congestion
alternative dictionary used: v26.1 26.1
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
Pulmonary hypertension
alternative dictionary used: v26.1 26.1
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
Respiratory depression
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	4 / 3557 (0.11%)	72 / 1741 (4.14%)	142 / 3494 (4.06%)	3 / 1771 (0.17%)
occurrences all number	4	164	344	3
Respiratory distress
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Respiration abnormal
alternative dictionary used: v26.1 26.1
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
Rhinitis allergic
alternative dictionary used: v26.1 26.1
subjects affected / exposed	1 / 3557 (0.03%)	7 / 1741 (0.40%)	21 / 3494 (0.60%)	3 / 1771 (0.17%)
occurrences all number	1	8	23	3
Rhinorrhoea
alternative dictionary used: v26.1 26.1
subjects affected / exposed	1 / 3557 (0.03%)	95 / 1741 (5.46%)	186 / 3494 (5.32%)	1 / 1771 (0.06%)
occurrences all number	1	156	304	1
Rhonchi
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Sneezing
alternative dictionary used: v26.1 26.1
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
Stridor
alternative dictionary used: v26.1 26.1
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
Tachypnoea
alternative dictionary used: v26.1 26.1
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
Tracheomalacia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	8 / 1741 (0.46%)	13 / 3494 (0.37%)	0 / 1771 (0.00%)
occurrences all number	0	8	13	0
Upper respiratory tract congestion
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	7 / 1741 (0.40%)	11 / 3494 (0.31%)	0 / 1771 (0.00%)
occurrences all number	0	12	15	0
Wheezing
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	19 / 1741 (1.09%)	28 / 3494 (0.80%)	0 / 1771 (0.00%)
occurrences all number	0	20	31	0
Psychiatric disorders
Anxiety
alternative dictionary used: v26.1 26.1
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
Brief psychotic disorder, with postpartum onset
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Irritability
alternative dictionary used: v26.1 26.1
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
Panic attack
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Tearfulness
alternative dictionary used: v26.1 26.1
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
Hepatobiliary disorders
Cholelithiasis
alternative dictionary used: v26.1 26.1
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
Cholestasis of pregnancy
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	4 / 1771 (0.23%)
occurrences all number	0	0	0	4
Hypertransaminasaemia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	16 / 1741 (0.92%)	31 / 3494 (0.89%)	0 / 1771 (0.00%)
occurrences all number	0	16	31	0
Jaundice
alternative dictionary used: v26.1 26.1
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
Ocular icterus
alternative dictionary used: v26.1 26.1
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
Investigations
Acoustic stimulation tests abnormal
alternative dictionary used: v26.1 26.1
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
Alanine aminotransferase increased
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Blood glucose increased
alternative dictionary used: v26.1 26.1
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
Blood iron decreased
alternative dictionary used: v26.1 26.1
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
Blood potassium increased
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Blood thyroid stimulating hormone abnormal
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Breath sounds abnormal
alternative dictionary used: v26.1 26.1
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
C-reactive protein increased
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	11 / 1741 (0.63%)	38 / 3494 (1.09%)	0 / 1771 (0.00%)
occurrences all number	0	11	38	0
Cardiac murmur functional
alternative dictionary used: v26.1 26.1
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
Coombs direct test positive
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Drug screen positive
alternative dictionary used: v26.1 26.1
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
Electroencephalogram normal
alternative dictionary used: v26.1 26.1
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
Foetal heart rate decreased
alternative dictionary used: v26.1 26.1
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
Haemoglobin decreased
alternative dictionary used: v26.1 26.1
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
HIV test positive
alternative dictionary used: v26.1 26.1
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
Heart rate increased
alternative dictionary used: v26.1 26.1
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
Head circumference abnormal
alternative dictionary used: v26.1 26.1
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
Human rhinovirus test positive
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Male genital examination abnormal
alternative dictionary used: v26.1 26.1
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
Medical observation
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Respiratory rate increased
alternative dictionary used: v26.1 26.1
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
Serum ferritin decreased
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
White blood cell count increased
alternative dictionary used: v26.1 26.1
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 increased
alternative dictionary used: v26.1 26.1
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
Weight decreased
alternative dictionary used: v26.1 26.1
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
Injury, poisoning and procedural complications
Accidental exposure to product packaging
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Animal bite
alternative dictionary used: v26.1 26.1
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
Animal scratch
alternative dictionary used: v26.1 26.1
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
Arthropod bite
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	4 / 1741 (0.23%)	7 / 3494 (0.20%)	0 / 1771 (0.00%)
occurrences all number	0	5	8	0
Bone fissure
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Chemical burn
alternative dictionary used: v26.1 26.1
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
Contusion
alternative dictionary used: v26.1 26.1
subjects affected / exposed	1 / 3557 (0.03%)	4 / 1741 (0.23%)	8 / 3494 (0.23%)	0 / 1771 (0.00%)
occurrences all number	1	4	8	0
Craniocerebral injury
alternative dictionary used: v26.1 26.1
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
Exposure to communicable disease
alternative dictionary used: v26.1 26.1
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 injury
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	3 / 3557 (0.08%)	5 / 1741 (0.29%)	7 / 3494 (0.20%)	1 / 1771 (0.06%)
occurrences all number	3	5	7	1
Femur fracture
alternative dictionary used: v26.1 26.1
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
Foetal exposure during pregnancy
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Foreign body ingestion
alternative dictionary used: v26.1 26.1
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
Head injury
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	11 / 3494 (0.31%)	0 / 1771 (0.00%)
occurrences all number	0	2	11	0
Humerus fracture
alternative dictionary used: v26.1 26.1
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
Incision site rash
alternative dictionary used: v26.1 26.1
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
Immunisation reaction
alternative dictionary used: v26.1 26.1
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
Injury
alternative dictionary used: v26.1 26.1
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 injury
alternative dictionary used: v26.1 26.1
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
Joint dislocation
alternative dictionary used: v26.1 26.1
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
Ligament sprain
alternative dictionary used: v26.1 26.1
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
Lip injury
alternative dictionary used: v26.1 26.1
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
Limb injury
alternative dictionary used: v26.1 26.1
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
Mouth injury
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Nasal injury
alternative dictionary used: v26.1 26.1
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
Perineal injury
alternative dictionary used: v26.1 26.1
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
Post vaccination fever
alternative dictionary used: v26.1 26.1
subjects affected / exposed	1 / 3557 (0.03%)	12 / 1741 (0.69%)	18 / 3494 (0.52%)	0 / 1771 (0.00%)
occurrences all number	1	13	24	0
Procedural complication
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 injury
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Skin wound
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Ulnar nerve injury
alternative dictionary used: v26.1 26.1
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
Vaccination complication
alternative dictionary used: v26.1 26.1
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, familial and genetic disorders
Accessory auricle
alternative dictionary used: v26.1 26.1
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
Albinism
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	28 / 1741 (1.61%)	55 / 3494 (1.57%)	0 / 1771 (0.00%)
occurrences all number	0	28	55	0
Anorectal malformation
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Atrial septal defect
alternative dictionary used: v26.1 26.1
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
Birth mark
alternative dictionary used: v26.1 26.1
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
Carnitine-acylcarnitine translocase deficiency
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 syphilis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Congenital musculoskeletal disorder of skull
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	6 / 1741 (0.34%)	10 / 3494 (0.29%)	0 / 1771 (0.00%)
occurrences all number	0	6	10	0
Congenital nystagmus
alternative dictionary used: v26.1 26.1
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 skin dimples
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	5 / 1741 (0.29%)	8 / 3494 (0.23%)	0 / 1771 (0.00%)
occurrences all number	0	5	8	0
Congenital hypothyroidism
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	27 / 1741 (1.55%)	55 / 3494 (1.57%)	0 / 1771 (0.00%)
occurrences all number	0	27	55	0
Craniosynostosis
alternative dictionary used: v26.1 26.1
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 congenital
alternative dictionary used: v26.1 26.1
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
Cystic fibrosis
alternative dictionary used: v26.1 26.1
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
Cryptorchism
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	9 / 3494 (0.26%)	0 / 1771 (0.00%)
occurrences all number	0	0	9	0
Dermoid cyst
alternative dictionary used: v26.1 26.1
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
Double heterozygous sickling disorders
alternative dictionary used: v26.1 26.1
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
Ear malformation
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Haemangioma congenital
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	19 / 3494 (0.54%)	0 / 1771 (0.00%)
occurrences all number	0	1	19	0
Glucose-6-phosphate dehydrogenase deficiency
alternative dictionary used: v26.1 26.1
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
Heart disease congenital
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	8 / 1741 (0.46%)	13 / 3494 (0.37%)	0 / 1771 (0.00%)
occurrences all number	0	8	13	0
Laryngomalacia
alternative dictionary used: v26.1 26.1
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
Labial tie
alternative dictionary used: v26.1 26.1
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
Low set ears
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	6 / 1741 (0.34%)	13 / 3494 (0.37%)	0 / 1771 (0.00%)
occurrences all number	0	6	13	0
Patent ductus arteriosus
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Preauricular cyst
alternative dictionary used: v26.1 26.1
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
Pulmonary artery stenosis congenital
alternative dictionary used: v26.1 26.1
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
Protuberant ear
alternative dictionary used: v26.1 26.1
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
Sickle cell anaemia
alternative dictionary used: v26.1 26.1
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
Sickle cell disease
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Vascular malformation
alternative dictionary used: v26.1 26.1
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
Ventricular septal defect
alternative dictionary used: v26.1 26.1
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
Cardiac disorders
Bradycardia
alternative dictionary used: v26.1 26.1
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
Bradycardia foetal
alternative dictionary used: v26.1 26.1
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	2 / 3494 (0.06%)	1 / 1771 (0.06%)
occurrences all number	2	0	2	1
Bradycardia neonatal
alternative dictionary used: v26.1 26.1
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
Extrasystoles
alternative dictionary used: v26.1 26.1
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 arrhythmia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Left ventricular dilatation
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Tachycardia
alternative dictionary used: v26.1 26.1
subjects affected / exposed	2 / 3557 (0.06%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	2	1	0	0
Tachycardia foetal
alternative dictionary used: v26.1 26.1
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
Ventricular hypertrophy
alternative dictionary used: v26.1 26.1
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
Nervous system disorders
Agitation neonatal
alternative dictionary used: v26.1 26.1
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
Benign enlargement of the subarachnoid spaces
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Cerebral haemorrhage
alternative dictionary used: v26.1 26.1
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
Cerebral ventricle dilatation
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Drooling
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Febrile convulsion
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	953 / 3557 (26.79%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	448 / 1771 (25.30%)
occurrences all number	963	0	0	453
Hypertonia
alternative dictionary used: v26.1 26.1
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
Hypersomnia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	5 / 1741 (0.29%)	9 / 3494 (0.26%)	0 / 1771 (0.00%)
occurrences all number	0	5	10	0
Infant irritability
alternative dictionary used: v26.1 26.1
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
IVth nerve paralysis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Language disorder
alternative dictionary used: v26.1 26.1
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
Migraine
alternative dictionary used: v26.1 26.1
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
Motor developmental delay
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Resting tremor
alternative dictionary used: v26.1 26.1
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
Sciatica
alternative dictionary used: v26.1 26.1
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
Seizure
alternative dictionary used: v26.1 26.1
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
Seizure like phenomena
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Tethered cord syndrome
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Tremor
alternative dictionary used: v26.1 26.1
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
Tremor neonatal
alternative dictionary used: v26.1 26.1
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 and lymphatic system disorders
Anaemia
alternative dictionary used: v26.1 26.1
subjects affected / exposed	22 / 3557 (0.62%)	13 / 1741 (0.75%)	35 / 3494 (1.00%)	9 / 1771 (0.51%)
occurrences all number	22	13	36	9
Anaemia neonatal
alternative dictionary used: v26.1 26.1
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 of pregnancy
alternative dictionary used: v26.1 26.1
subjects affected / exposed	4 / 3557 (0.11%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	4	0	0	1
Bandaemia
alternative dictionary used: v26.1 26.1
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
Haemorrhagic disease of newborn
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	5 / 1741 (0.29%)	16 / 3494 (0.46%)	0 / 1771 (0.00%)
occurrences all number	0	5	16	0
Iron deficiency anaemia
alternative dictionary used: v26.1 26.1
subjects affected / exposed	1 / 3557 (0.03%)	2 / 1741 (0.11%)	6 / 3494 (0.17%)	1 / 1771 (0.06%)
occurrences all number	1	2	6	1
Leukopenia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	4 / 3557 (0.11%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	4	1	1	0
Microcytic anaemia
alternative dictionary used: v26.1 26.1
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
Neutropenia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Splenomegaly
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	1 / 1771 (0.06%)
occurrences all number	0	1	2	1
Thrombocytopenia neonatal
alternative dictionary used: v26.1 26.1
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
Ear and labyrinth disorders
Cerumen impaction
alternative dictionary used: v26.1 26.1
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 discomfort
alternative dictionary used: v26.1 26.1
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
Ear pain
alternative dictionary used: v26.1 26.1
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	6 / 3494 (0.17%)	0 / 1771 (0.00%)
occurrences all number	1	0	7	0
Eustachian tube dysfunction
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 effusion
alternative dictionary used: v26.1 26.1
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
Middle ear inflammation
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Vertigo
alternative dictionary used: v26.1 26.1
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
Eye disorders
Amblyopia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Conjunctival hyperaemia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Corneal erosion
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	12 / 1741 (0.69%)	15 / 3494 (0.43%)	0 / 1771 (0.00%)
occurrences all number	0	13	15	0
Dry eye
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	8 / 1741 (0.46%)	5 / 3494 (0.14%)	0 / 1771 (0.00%)
occurrences all number	0	8	5	0
Eye inflammation
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Eyelid skin dryness
alternative dictionary used: v26.1 26.1
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
Orbital oedema
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Swelling of eyelid
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Gastrointestinal disorders
Abdominal distension
alternative dictionary used: v26.1 26.1
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
Abdominal discomfort
alternative dictionary used: v26.1 26.1
subjects affected / exposed	2 / 3557 (0.06%)	2 / 1741 (0.11%)	4 / 3494 (0.11%)	1 / 1771 (0.06%)
occurrences all number	2	2	4	1
Abdominal hernia
alternative dictionary used: v26.1 26.1
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
Abdominal pain upper
alternative dictionary used: v26.1 26.1
subjects affected / exposed	4 / 3557 (0.11%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	1 / 1771 (0.06%)
occurrences all number	4	1	1	1
Abdominal pain lower
alternative dictionary used: v26.1 26.1
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
Abdominal pain
alternative dictionary used: v26.1 26.1
subjects affected / exposed	499 / 3557 (14.03%)	19 / 1741 (1.09%)	33 / 3494 (0.94%)	235 / 1771 (13.27%)
occurrences all number	500	19	33	236
Allergic colitis
alternative dictionary used: v26.1 26.1
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
Anal eczema
alternative dictionary used: v26.1 26.1
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 erythema
alternative dictionary used: v26.1 26.1
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
Anal fissure
alternative dictionary used: v26.1 26.1
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
Anal inflammation
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Buccal polyp
alternative dictionary used: v26.1 26.1
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
Colitis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	3 / 3557 (0.08%)	31 / 1741 (1.78%)	73 / 3494 (2.09%)	3 / 1771 (0.17%)
occurrences all number	3	32	75	3
Constipation neonatal
alternative dictionary used: v26.1 26.1
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
Dental discomfort
alternative dictionary used: v26.1 26.1
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
Diarrhoea haemorrhagic
alternative dictionary used: v26.1 26.1
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
Diarrhoea
alternative dictionary used: v26.1 26.1
subjects affected / exposed	354 / 3557 (9.95%)	54 / 1741 (3.10%)	117 / 3494 (3.35%)	182 / 1771 (10.28%)
occurrences all number	356	62	137	182
Dyschezia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	10 / 3557 (0.28%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	3 / 1771 (0.17%)
occurrences all number	10	1	1	3
Dysphagia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	11 / 1741 (0.63%)	16 / 3494 (0.46%)	0 / 1771 (0.00%)
occurrences all number	0	11	17	0
Food poisoning
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	3 / 3494 (0.09%)	1 / 1771 (0.06%)
occurrences all number	0	1	3	1
Frequent bowel movements
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	2 / 3557 (0.06%)	1 / 1741 (0.06%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	2	1	2	0
Gastrointestinal disorder
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	6 / 3557 (0.17%)	51 / 1741 (2.93%)	89 / 3494 (2.55%)	11 / 1771 (0.62%)
occurrences all number	6	53	91	11
Gastrooesophageal reflux in neonate
alternative dictionary used: v26.1 26.1
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 blister
alternative dictionary used: v26.1 26.1
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
Gingival cyst
alternative dictionary used: v26.1 26.1
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
Haematochezia
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	5 / 3494 (0.14%)	0 / 1771 (0.00%)
occurrences all number	0	3	5	0
Haematemesis
alternative dictionary used: v26.1 26.1
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
Haemorrhoids
alternative dictionary used: v26.1 26.1
subjects affected / exposed	9 / 3557 (0.25%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	3 / 1771 (0.17%)
occurrences all number	9	0	0	3
Haemorrhoids thrombosed
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Infantile colic
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	15 / 1741 (0.86%)	25 / 3494 (0.72%)	0 / 1771 (0.00%)
occurrences all number	0	15	25	0
Infant dyschezia
alternative dictionary used: v26.1 26.1
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 spitting up
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Meconium plug syndrome
alternative dictionary used: v26.1 26.1
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 cyst
alternative dictionary used: v26.1 26.1
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
Mouth ulceration
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	0	2	0	2
Nausea
alternative dictionary used: v26.1 26.1
subjects affected / exposed	603 / 3557 (16.95%)	1 / 1741 (0.06%)	1 / 3494 (0.03%)	307 / 1771 (17.33%)
occurrences all number	606	1	1	310
Oesophagitis
alternative dictionary used: v26.1 26.1
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
Oral disorder
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Proctitis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	7 / 1741 (0.40%)	6 / 3494 (0.17%)	0 / 1771 (0.00%)
occurrences all number	0	7	6	0
Rectal prolapse
alternative dictionary used: v26.1 26.1
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
Stomatitis
alternative dictionary used: v26.1 26.1
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
Teething
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	12 / 1741 (0.69%)	36 / 3494 (1.03%)	0 / 1771 (0.00%)
occurrences all number	0	13	47	0
Tooth demineralisation
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Umbilical hernia
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	14 / 1741 (0.80%)	24 / 3494 (0.69%)	0 / 1771 (0.00%)
occurrences all number	0	14	24	0
Upper gastrointestinal haemorrhage
alternative dictionary used: v26.1 26.1
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
Vomiting projectile
alternative dictionary used: v26.1 26.1
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
Vomiting
alternative dictionary used: v26.1 26.1
subjects affected / exposed	285 / 3557 (8.01%)	32 / 1741 (1.84%)	57 / 3494 (1.63%)	150 / 1771 (8.47%)
occurrences all number	286	32	60	150
Skin and subcutaneous tissue disorders
Acne infantile
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	13 / 3494 (0.37%)	0 / 1771 (0.00%)
occurrences all number	0	3	13	0
Alopecia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Cafe au lait spots
alternative dictionary used: v26.1 26.1
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
Cellulite
alternative dictionary used: v26.1 26.1
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 allergic
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	5 / 3494 (0.14%)	1 / 1771 (0.06%)
occurrences all number	0	1	5	1
Decubitus ulcer
alternative dictionary used: v26.1 26.1
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
Dermatitis
alternative dictionary used: v26.1 26.1
subjects affected / exposed	2 / 3557 (0.06%)	19 / 1741 (1.09%)	40 / 3494 (1.14%)	0 / 1771 (0.00%)
occurrences all number	2	19	40	0
Dermal cyst
alternative dictionary used: v26.1 26.1
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 atopic
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	47 / 1741 (2.70%)	72 / 3494 (2.06%)	0 / 1771 (0.00%)
occurrences all number	0	50	74	0
Dermatitis contact
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	5 / 1741 (0.29%)	12 / 3494 (0.34%)	1 / 1771 (0.06%)
occurrences all number	0	5	12	1
Dermatitis diaper
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	73 / 1741 (4.19%)	146 / 3494 (4.18%)	0 / 1771 (0.00%)
occurrences all number	0	81	164	0
Drug eruption
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	4 / 1741 (0.23%)	11 / 3494 (0.31%)	0 / 1771 (0.00%)
occurrences all number	0	4	11	0
Eczema
alternative dictionary used: v26.1 26.1
subjects affected / exposed	1 / 3557 (0.03%)	44 / 1741 (2.53%)	91 / 3494 (2.60%)	0 / 1771 (0.00%)
occurrences all number	1	47	92	0
Eczema asteatotic
alternative dictionary used: v26.1 26.1
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
Eczema infantile
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	1 / 3557 (0.03%)	3 / 1741 (0.17%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	1	4	4	0
Erythema toxicum neonatorum
alternative dictionary used: v26.1 26.1
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
Hand dermatitis
alternative dictionary used: v26.1 26.1
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
Herpes gestationis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Melanoderma
alternative dictionary used: v26.1 26.1
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
Milia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	19 / 1741 (1.09%)	42 / 3494 (1.20%)	0 / 1771 (0.00%)
occurrences all number	0	19	44	0
Nail fold inflammation
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Perioral dermatitis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Pigmentation disorder
alternative dictionary used: v26.1 26.1
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 alba
alternative dictionary used: v26.1 26.1
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
Pityriasis rosea
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Post inflammatory pigmentation change
alternative dictionary used: v26.1 26.1
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
Prurigo
alternative dictionary used: v26.1 26.1
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
Pruritus
alternative dictionary used: v26.1 26.1
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
Rash macular
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Rash morbilliform
alternative dictionary used: v26.1 26.1
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
Rash erythematous
alternative dictionary used: v26.1 26.1
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
Rash
alternative dictionary used: v26.1 26.1
subjects affected / exposed	2 / 3557 (0.06%)	34 / 1741 (1.95%)	82 / 3494 (2.35%)	0 / 1771 (0.00%)
occurrences all number	2	37	84	0
Rash neonatal
alternative dictionary used: v26.1 26.1
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
Rash papular
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	0 / 1741 (0.00%)	8 / 3494 (0.23%)	0 / 1771 (0.00%)
occurrences all number	0	0	8	0
Rash pruritic
alternative dictionary used: v26.1 26.1
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
Seborrhoea
alternative dictionary used: v26.1 26.1
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
Seborrhoeic dermatitis
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	39 / 1741 (2.24%)	91 / 3494 (2.60%)	0 / 1771 (0.00%)
occurrences all number	0	39	91	0
Skin hyperpigmentation
alternative dictionary used: v26.1 26.1
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 exfoliation
alternative dictionary used: v26.1 26.1
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 hypopigmentation
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 lesion
alternative dictionary used: v26.1 26.1
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
Skin ulcer
alternative dictionary used: v26.1 26.1
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 mass
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Urticaria
alternative dictionary used: v26.1 26.1
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
Umbilical discharge
alternative dictionary used: v26.1 26.1
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 haemorrhage
alternative dictionary used: v26.1 26.1
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
Urticaria papular
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Renal and urinary disorders
Anuria
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Haematuria
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Proteinuria
alternative dictionary used: v26.1 26.1
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
Pyelocaliectasis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Endocrine disorders
Hypothyroidism
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Transient neonatal hyperthyrotropinaemia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	15 / 1741 (0.86%)	30 / 3494 (0.86%)	0 / 1771 (0.00%)
occurrences all number	0	15	30	0
Arthralgia
alternative dictionary used: v26.1 26.1
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
Asymmetric gluteal fold
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	15 / 3557 (0.42%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	8 / 1771 (0.45%)
occurrences all number	16	0	0	8
Bone disorder
alternative dictionary used: v26.1 26.1
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 hypertrophy
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 hyperextension
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Joint laxity
alternative dictionary used: v26.1 26.1
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
Ligament laxity
alternative dictionary used: v26.1 26.1
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 range of motion decreased
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Limb asymmetry
alternative dictionary used: v26.1 26.1
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
Muscle spasms
alternative dictionary used: v26.1 26.1
subjects affected / exposed	4 / 3557 (0.11%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	2 / 1771 (0.11%)
occurrences all number	4	1	0	2
Muscle twitching
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Myalgia
alternative dictionary used: v26.1 26.1
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	2	0	1	0
Musculoskeletal disorder
alternative dictionary used: v26.1 26.1
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
Newborn head moulding
alternative dictionary used: v26.1 26.1
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
Nose deformity
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Posture abnormal
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Short stature
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Soft tissue mass
alternative dictionary used: v26.1 26.1
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
Tendon disorder
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Infections and infestations
Abscess
alternative dictionary used: v26.1 26.1
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
Abscess limb
alternative dictionary used: v26.1 26.1
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
Acarodermatitis
alternative dictionary used: v26.1 26.1
subjects affected / exposed	1 / 3557 (0.03%)	14 / 1741 (0.80%)	31 / 3494 (0.89%)	2 / 1771 (0.11%)
occurrences all number	1	16	39	2
Acute sinusitis
alternative dictionary used: v26.1 26.1
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
Adenoviral upper respiratory infection
alternative dictionary used: v26.1 26.1
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
Adenovirus infection
alternative dictionary used: v26.1 26.1
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
Amniotic cavity infection
alternative dictionary used: v26.1 26.1
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
Amoebic dysentery
alternative dictionary used: v26.1 26.1
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
Anal candidiasis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Ascariasis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	2 / 3557 (0.06%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	2 / 1771 (0.11%)
occurrences all number	2	0	1	2
Balanitis candida
alternative dictionary used: v26.1 26.1
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
Bartholin's abscess
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Bacterial disease carrier
alternative dictionary used: v26.1 26.1
subjects affected / exposed	4 / 3557 (0.11%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	4	0	0	1
Bacterial vaginosis
alternative dictionary used: v26.1 26.1
subjects affected / exposed	7 / 3557 (0.20%)	0 / 1741 (0.00%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	7	0	0	0
Body tinea
alternative dictionary used: v26.1 26.1
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
Breast abscess
alternative dictionary used: v26.1 26.1
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
Bronchiolitis
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	152 / 1741 (8.73%)	298 / 3494 (8.53%)	0 / 1771 (0.00%)
occurrences all number	0	176	387	0
Bronchitis
alternative dictionary used: v26.1 26.1
subjects affected / exposed	1 / 3557 (0.03%)	39 / 1741 (2.24%)	82 / 3494 (2.35%)	0 / 1771 (0.00%)
occurrences all number	1	44	98	0
COVID-19
alternative dictionary used: v26.1 26.1
subjects affected / exposed	54 / 3557 (1.52%)	130 / 1741 (7.47%)	259 / 3494 (7.41%)	23 / 1771 (1.30%)
occurrences all number	54	132	263	23
Burkholderia mallei infection
alternative dictionary used: v26.1 26.1
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
Bullous impetigo
alternative dictionary used: v26.1 26.1
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
Candida infection
alternative dictionary used: v26.1 26.1
subjects affected / exposed	1 / 3557 (0.03%)	13 / 1741 (0.75%)	17 / 3494 (0.49%)	1 / 1771 (0.06%)
occurrences all number	1	14	19	1
Candida nappy rash
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	11 / 3494 (0.31%)	0 / 1771 (0.00%)
occurrences all number	0	2	12	0
Cellulitis orbital
alternative dictionary used: v26.1 26.1
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
Cellulitis
alternative dictionary used: v26.1 26.1
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
Clostridium difficile infection
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	2 / 3557 (0.06%)	63 / 1741 (3.62%)	153 / 3494 (4.38%)	0 / 1771 (0.00%)
occurrences all number	2	73	171	0
Conjunctivitis viral
alternative dictionary used: v26.1 26.1
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
Conjunctivitis bacterial
alternative dictionary used: v26.1 26.1
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
Croup infectious
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	12 / 1741 (0.69%)	24 / 3494 (0.69%)	0 / 1771 (0.00%)
occurrences all number	0	13	29	0
Cystitis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 viral
alternative dictionary used: v26.1 26.1
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
Ear infection
alternative dictionary used: v26.1 26.1
subjects affected / exposed	2 / 3557 (0.06%)	63 / 1741 (3.62%)	122 / 3494 (3.49%)	0 / 1771 (0.00%)
occurrences all number	2	86	151	0
Eczema impetiginous
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Enterobiasis
alternative dictionary used: v26.1 26.1
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
Eczema infected
alternative dictionary used: v26.1 26.1
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
Erysipelas
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 urinary tract infection
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	12 / 1741 (0.69%)	23 / 3494 (0.66%)	0 / 1771 (0.00%)
occurrences all number	0	12	23	0
Escherichia infection
alternative dictionary used: v26.1 26.1
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 infection
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	8 / 3494 (0.23%)	0 / 1771 (0.00%)
occurrences all number	0	1	8	0
Eye infection staphylococcal
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Fungal skin infection
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	10 / 1741 (0.57%)	16 / 3494 (0.46%)	0 / 1771 (0.00%)
occurrences all number	0	11	16	0
Furuncle
alternative dictionary used: v26.1 26.1
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
Gastrointestinal viral infection
alternative dictionary used: v26.1 26.1
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
Gastroenteritis adenovirus
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	3 / 3557 (0.08%)	5 / 1741 (0.29%)	17 / 3494 (0.49%)	0 / 1771 (0.00%)
occurrences all number	3	5	19	0
Gastrointestinal infection
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	6 / 3557 (0.17%)	75 / 1741 (4.31%)	118 / 3494 (3.38%)	2 / 1771 (0.11%)
occurrences all number	6	90	143	2
Genital candidiasis
alternative dictionary used: v26.1 26.1
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
Genital herpes
alternative dictionary used: v26.1 26.1
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 infection
alternative dictionary used: v26.1 26.1
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
Groin abscess
alternative dictionary used: v26.1 26.1
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
Hand-foot-and-mouth disease
alternative dictionary used: v26.1 26.1
subjects affected / exposed	1 / 3557 (0.03%)	17 / 1741 (0.98%)	48 / 3494 (1.37%)	0 / 1771 (0.00%)
occurrences all number	1	17	49	0
Herpangina
alternative dictionary used: v26.1 26.1
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
Herpes simplex
alternative dictionary used: v26.1 26.1
subjects affected / exposed	2 / 3557 (0.06%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	0 / 1771 (0.00%)
occurrences all number	2	1	0	0
Herpes virus infection
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	13 / 1741 (0.75%)	29 / 3494 (0.83%)	0 / 1771 (0.00%)
occurrences all number	0	13	29	0
Infected bite
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	4 / 3557 (0.11%)	15 / 1741 (0.86%)	26 / 3494 (0.74%)	2 / 1771 (0.11%)
occurrences all number	4	15	26	2
Infection
alternative dictionary used: v26.1 26.1
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
Laryngotracheitis obstructive
alternative dictionary used: v26.1 26.1
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
Klebsiella urinary tract infection
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	17 / 1741 (0.98%)	48 / 3494 (1.37%)	0 / 1771 (0.00%)
occurrences all number	0	18	55	0
Localised infection
alternative dictionary used: v26.1 26.1
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
Lower respiratory tract infection
alternative dictionary used: v26.1 26.1
subjects affected / exposed	1 / 3557 (0.03%)	63 / 1741 (3.62%)	130 / 3494 (3.72%)	0 / 1771 (0.00%)
occurrences all number	1	76	150	0
Lower respiratory tract infection viral
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Metapneumovirus bronchiolitis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Nail bed infection
alternative dictionary used: v26.1 26.1
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
Myringitis
alternative dictionary used: v26.1 26.1
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
Neonatal infection
alternative dictionary used: v26.1 26.1
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
Nasopharyngitis
alternative dictionary used: v26.1 26.1
subjects affected / exposed	17 / 3557 (0.48%)	339 / 1741 (19.47%)	666 / 3494 (19.06%)	9 / 1771 (0.51%)
occurrences all number	17	724	1435	9
Neonatal pneumonia
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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 viral infection
alternative dictionary used: v26.1 26.1
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
Ophthalmia neonatorum
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	33 / 1741 (1.90%)	58 / 3494 (1.66%)	0 / 1771 (0.00%)
occurrences all number	0	37	65	0
Oral fungal infection
alternative dictionary used: v26.1 26.1
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
Oral herpes
alternative dictionary used: v26.1 26.1
subjects affected / exposed	3 / 3557 (0.08%)	2 / 1741 (0.11%)	2 / 3494 (0.06%)	0 / 1771 (0.00%)
occurrences all number	3	2	2	0
Omphalitis
alternative dictionary used: v26.1 26.1
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
Otitis externa
alternative dictionary used: v26.1 26.1
subjects affected / exposed	1 / 3557 (0.03%)	0 / 1741 (0.00%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	1	0	4	0
Otitis externa fungal
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	59 / 1741 (3.39%)	117 / 3494 (3.35%)	0 / 1771 (0.00%)
occurrences all number	0	80	145	0
Otitis media acute
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	45 / 1741 (2.58%)	99 / 3494 (2.83%)	0 / 1771 (0.00%)
occurrences all number	0	55	115	0
Otitis media chronic
alternative dictionary used: v26.1 26.1
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
Parasitic gastroenteritis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Parainfluenzae virus infection
alternative dictionary used: v26.1 26.1
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
Periodontitis
alternative dictionary used: v26.1 26.1
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
Pharyngitis
alternative dictionary used: v26.1 26.1
subjects affected / exposed	3 / 3557 (0.08%)	15 / 1741 (0.86%)	41 / 3494 (1.17%)	0 / 1771 (0.00%)
occurrences all number	3	15	42	0
Pharyngitis streptococcal
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Pertussis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	10 / 1741 (0.57%)	31 / 3494 (0.89%)	0 / 1771 (0.00%)
occurrences all number	0	10	31	0
Pneumonia bacterial
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Post procedural cellulitis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	6 / 3494 (0.17%)	0 / 1771 (0.00%)
occurrences all number	0	4	8	0
Pustule
alternative dictionary used: v26.1 26.1
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
Respiratory syncytial virus bronchiolitis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	24 / 3557 (0.67%)	70 / 1741 (4.02%)	151 / 3494 (4.32%)	5 / 1771 (0.28%)
occurrences all number	24	138	262	6
Respiratory tract infection viral
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	76 / 1741 (4.37%)	154 / 3494 (4.41%)	0 / 1771 (0.00%)
occurrences all number	0	102	203	0
Rhinovirus infection
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	6 / 3557 (0.17%)	6 / 1741 (0.34%)	10 / 3494 (0.29%)	1 / 1771 (0.06%)
occurrences all number	6	8	10	1
Skin candida
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	5 / 3494 (0.14%)	1 / 1771 (0.06%)
occurrences all number	0	1	5	1
Subcutaneous abscess
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	2 / 1741 (0.11%)	5 / 3494 (0.14%)	0 / 1771 (0.00%)
occurrences all number	0	5	5	0
Subglottic laryngitis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	5 / 3557 (0.14%)	57 / 1741 (3.27%)	147 / 3494 (4.21%)	3 / 1771 (0.17%)
occurrences all number	5	58	151	3
Staphylococcal infection
alternative dictionary used: v26.1 26.1
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
Systemic viral infection
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	6 / 3494 (0.17%)	0 / 1771 (0.00%)
occurrences all number	0	4	6	0
Toxoplasmosis
alternative dictionary used: v26.1 26.1
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
Thyroglossal cyst infection
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Tinea infection
alternative dictionary used: v26.1 26.1
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
Tinea pedis
alternative dictionary used: v26.1 26.1
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 versicolour
alternative dictionary used: v26.1 26.1
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
Tonsillitis
alternative dictionary used: v26.1 26.1
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
Tracheitis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	38 / 3557 (1.07%)	437 / 1741 (25.10%)	932 / 3494 (26.67%)	15 / 1771 (0.85%)
occurrences all number	40	861	1888	15
Upper respiratory tract infection bacterial
alternative dictionary used: v26.1 26.1
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
Urinary tract infection
alternative dictionary used: v26.1 26.1
subjects affected / exposed	61 / 3557 (1.71%)	9 / 1741 (0.52%)	30 / 3494 (0.86%)	21 / 1771 (1.19%)
occurrences all number	61	9	33	21
Urogenital infection fungal
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Vaginal infection
alternative dictionary used: v26.1 26.1
subjects affected / exposed	6 / 3557 (0.17%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	1 / 1771 (0.06%)
occurrences all number	6	0	1	1
Varicella
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	6 / 1741 (0.34%)	13 / 3494 (0.37%)	0 / 1771 (0.00%)
occurrences all number	0	6	13	0
Viral upper respiratory tract infection
alternative dictionary used: v26.1 26.1
subjects affected / exposed	2 / 3557 (0.06%)	27 / 1741 (1.55%)	47 / 3494 (1.35%)	1 / 1771 (0.06%)
occurrences all number	2	43	66	1
Viral diarrhoea
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	13 / 1741 (0.75%)	41 / 3494 (1.17%)	0 / 1771 (0.00%)
occurrences all number	0	13	42	0
Viral pharyngitis
alternative dictionary used: v26.1 26.1
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 rash
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	13 / 1741 (0.75%)	24 / 3494 (0.69%)	0 / 1771 (0.00%)
occurrences all number	0	13	24	0
Viral rhinitis
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	3 / 3557 (0.08%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	5 / 1771 (0.28%)
occurrences all number	3	1	0	5
Vulvitis
alternative dictionary used: v26.1 26.1
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 mycotic infection
alternative dictionary used: v26.1 26.1
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
Wound infection
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	1	0	1
Metabolism and nutrition disorders
Abnormal loss of weight
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	1 / 3557 (0.03%)	3 / 1741 (0.17%)	3 / 3494 (0.09%)	1 / 1771 (0.06%)
occurrences all number	1	3	3	1
Dehydration
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	3 / 1741 (0.17%)	5 / 3494 (0.14%)	0 / 1771 (0.00%)
occurrences all number	0	3	5	0
Fluid retention
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
Hypervitaminosis D
alternative dictionary used: v26.1 26.1
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
Hypokalaemia
alternative dictionary used: v26.1 26.1
subjects affected / exposed	0 / 3557 (0.00%)	1 / 1741 (0.06%)	0 / 3494 (0.00%)	1 / 1771 (0.06%)
occurrences all number	0	1	0	1
Hypoglycaemia neonatal
alternative dictionary used: v26.1 26.1
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
Hypoglycaemia
alternative dictionary used: v26.1 26.1
subjects affected / exposed	1 / 3557 (0.03%)	11 / 1741 (0.63%)	20 / 3494 (0.57%)	0 / 1771 (0.00%)
occurrences all number	1	11	20	0
Hypocalcaemia
alternative dictionary used: v26.1 26.1
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
Iron deficiency
alternative dictionary used: v26.1 26.1
subjects affected / exposed	4 / 3557 (0.11%)	0 / 1741 (0.00%)	1 / 3494 (0.03%)	3 / 1771 (0.17%)
occurrences all number	4	0	1	3
Lactose intolerance
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	1 / 3557 (0.03%)	4 / 1741 (0.23%)	1 / 3494 (0.03%)	0 / 1771 (0.00%)
occurrences all number	1	4	1	0
Overweight
alternative dictionary used: v26.1 26.1
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
Poor feeding infant
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
subjects affected / exposed	1 / 3557 (0.03%)	7 / 1741 (0.40%)	4 / 3494 (0.11%)	0 / 1771 (0.00%)
occurrences all number	1	7	4	0
Vitamin B12 deficiency
alternative dictionary used: v26.1 26.1
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
Vitamin D deficiency
alternative dictionary used: v26.1 26.1
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
Vitamin K deficiency
alternative dictionary used: v26.1 26.1
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
alternative dictionary used: v26.1 26.1
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

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

Secondary: RSV-A neutralizing antibody titers for maternal participants at Day 1, Day 31 and at 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: 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 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-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: 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: 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: 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 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 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 pregnancy-related adverse events of special interest (AESIs) 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

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

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

Adverse events