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Clinical Trial Results:
A phase III, double blind (observer-blind), randomized, controlled multi-center study to evaluate, in infants and children, the efficacy of the RTS,S/AS01E candidate vaccine against malaria disease caused by P. falciparum infection, across diverse malaria transmission settings in Africa.

Summary
EudraCT number	2012-005716-26
Trial protocol	Outside EU/EEA
Global end of trial date	31 Jan 2014

Results information
Results version number	v2
This version publication date	06 Apr 2016
First version publication date	01 Aug 2015
Other versions	v1 , v3
Version creation reason	New data added to full data set Data for secondary endpoints have been added.

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

110021

ISRCTN number

US NCT number

NCT00866619

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline Biologicals

Sponsor organisation address

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

Public contact

Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com

Scientific contact

Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, 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?

Yes

Analysis stage

Final

Date of interim/final analysis

15 Jul 2014

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

31 Jan 2014

Was the trial ended prematurely?

Main objective of the trial

-To evaluate the protective efficacy of RTS,S/AS01E against clinical malaria disease caused by Plasmodium falciparum in African children whose age at first dose will be from 6-12 weeks and will receive vaccine in co-administration with DTPwHepB/Hib antigens (Tritanrix HepB/Hib) and OPV. Duration of follow up will be for a minimum of 12 months and a maximum of 18 months after completion of the primary course (Primary Analysis). -To evaluate the protective efficacy of RTS,S/AS01E against clinical malaria disease caused by Plasmodium falciparum in African children whose age at first dose will be from 5-17 months. Duration of follow up will be for a minimum of 12 months and a maximum of 18 months after completion of the primary course (Primary Analysis).

Protection of trial subjects

The vaccinees were observed closely for at least 30 minutes following the administration of all vaccines used in the study, with appropriate medical treatment readily available in case of an anaphylactic reaction. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines/products. Children and infants who received an incomplete primary vaccination schedule (not the 3 doses within the expected timings) did not receive the booster dose of RTS,S/AS01E or control vaccine.

Background therapy

Evidence for comparator

Actual start date of recruitment

27 Mar 2009

Long term follow-up planned

Yes

Long term follow-up rationale

Safety, Efficacy

Long term follow-up duration

12 Months

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Ghana: 2621

Country: Number of subjects enrolled

Tanzania, United Republic of: 3210

Country: Number of subjects enrolled

Mozambique: 1637

Country: Number of subjects enrolled

Malawi: 1626

Country: Number of subjects enrolled

Gabon: 930

Country: Number of subjects enrolled

Kenya: 4154

Country: Number of subjects enrolled

Burkina Faso: 1281

Worldwide total number of subjects

15459

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

15459

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

The study included 3 phases, a primary (PRI) phase (months [M] 0-3) and a booster (BST) phase at M20, each followed by a related PRI/BST efficacy, immunogenicity and safety (EIS) follow-up (FU) phase, and an EIS extension, from M32 to the median M48 time point for 5-17M subjects & the median M38 time point for 6-12W subjects.

Screening details

Screening included the following: check for inclusion/exclusion criteria, vaccination contraindications/precautions & subjects’ medical history, & signing informed consent forms.

Number of subjects started

15459

Number of subjects completed

15459

Period 1 title

Entire Study Period (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst

Are arms mutually exclusive

Yes

R3R (5-17M) Group

Arm description

Subjects in this group, aged 5 to 17 months at first vaccination, received a 3-dose primary vaccination course of the RTS,S/AS01 vaccine (also referred to as RTS,S or GSK 257049, vaccine) according to a Month 0, 1 and 2 followed by a booster dose of the same RTS,S/AS01 vaccine administered at Month 20. The RTS,S/AS01 vaccine was administered intramuscularly in the left deltoid.

Arm type

Experimental

Investigational medicinal product name

Candidate Plasmodium falciparum malaria vaccine

Investigational medicinal product code

RTS,S+AS01E

Other name

RTS,S, GSK 257049, RTS,S/AS01

Pharmaceutical forms

Powder and suspension for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

3 primary doses according to a Month 0, 1 and 2 followed by a booster dose at Month 20.

R3C (5-17M) Group

Arm description

Subjects in this group, aged 5 to 17 months at first vaccination, received a 3-dose primary vaccination course of the RTS,S/AS01 vaccine (also referred to as RTS,S or GSK 257049, vaccine) according to a Month 0, 1 and 2 followed by a booster dose of Menjugate (or MenC vaccine) administered at Month 20. The RTS,S/AS01 and MenC vaccines were administered intramuscularly in the left deltoid.

Arm type

Experimental

Investigational medicinal product name

Candidate Plasmodium falciparum malaria vaccine

Investigational medicinal product code

RTS,S+AS01E

Other name

RTS,S, GSK 257049, RTS,S/AS01

Pharmaceutical forms

Powder and suspension for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

3 primary doses according to a Month 0, 1 and 2

Investigational medicinal product name

MENJUGATE KIT

Investigational medicinal product code

Other name

Menjugate, MenC

Pharmaceutical forms

Powder and solvent for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose at Month 20

C3C (5-17M) Group

Arm description

Subjects in this group, aged 5 to 17 months at first vaccination, received a 3-dose primary vaccination course of Verorab (also referred to as Rabies vaccine) according to a Month 0, 1 and 2 followed by a booster dose of the Menjugate vaccine (MenC) administered at Month 20. The Rabies and MenC vaccines were administered intramuscularly in the left deltoid.

Arm type

Active comparator

Investigational medicinal product name

Verorab

Investigational medicinal product code

Other name

Rabies

Pharmaceutical forms

Powder and suspension for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

3-dose primary vaccination course according to a Month 0, 1 and 2

Investigational medicinal product name

MENJUGATE KIT

Investigational medicinal product code

Other name

Menjugate, MenC

Pharmaceutical forms

Powder and solvent for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose at Month 20

R3R (6-12W) Group

Arm description

Subjects in this group, aged 6 to 12 weeks at first vaccination, received a 3-dose primary vaccination course of the RTS,S/AS01 vaccine (also referred to as RTS,S or GSK 257049, vaccine) co-administered with Polio Sabin (or OPV vaccine) and Tritanrix HepB/Hib (or DTPwHepB/Hib vaccine) (reconstituted from Tritanrix HepB and Hiberix vaccines) according to a Month 0, 1 and 2 followed by a booster dose of the same RTS,S/AS01 vaccine co-administered with OPV at Month 20. All vaccines were administered intramuscularly, except the OPV vaccine given orally; the primary RTS,S/AS01 vaccine doses were injected in the anterolateral left thigh and the booster dose into the left deltoid; the DTPwHepB/Hib vaccine was injected in the anterolateral right thigh.

Arm type

Experimental

Investigational medicinal product name

Candidate Plasmodium falciparum malaria vaccine

Investigational medicinal product code

RTS,S+AS01E

Other name

RTS,S, GSK 257049, RTS,S/AS01

Pharmaceutical forms

Powder and suspension for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

3 primary doses according to a Month 0, 1 and 2 followed by a booster dose at Month 20.

Investigational medicinal product name

Tritanrix-HepB

Investigational medicinal product code

DTPw-HBV

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

3 doses in the anterolateral right thigh according to a Month 0, 1 and 2 of Tritanrix-HepB (DTPw-HBV /Hib) reconstituted into Tritanrix HepB/Hib by combining with Hiberix (Hib) vaccine

Investigational medicinal product name

Hiberix

Investigational medicinal product code

Hib

Other name

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

3 doses in the anterolateral right thigh according to a Month 0, 1 and 2 as part of 3 dose of Tritanrix-HepB (DTPw-HBV /Hib) reconstituted into Tritanrix HepB/Hib by combining with Hiberix (Hib) vaccine

Investigational medicinal product name

Polio Sabin (Oral)

Investigational medicinal product code

OPV

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

3 primary doses according to a Month 0, 1 and 2 followed by a booster dose at Month 20.

R3C (6-12W) Group

Arm description

Subjects in this group, aged 6 to 12 weeks at first vaccination, received a 3-dose primary vaccination course of the RTS,S/AS01 vaccine (also referred to as RTS,S or GSK 257049, vaccine) co-administered with Polio Sabin (or OPV vaccine) and Tritanrix HepB/Hib (or DTPwHepB/Hib vaccine) (reconstituted from Tritanrix HepB and Hiberix vaccines) according to a Month 0, 1 and 2 followed by a booster dose of dose of Menjugate (or MenC vaccine) co-administered with OPV vaccine at Month 20. All vaccines were administered intramuscularly, except the OPV vaccine given orally; the primary RTS,S/AS01 vaccine doses were injected in the anterolateral left thigh; the MenC vaccine was injected in the left thigh for children < 1 year of age and into the left deltoid in children > 1 year of age; the DTPwHepB/Hib vaccine was injected in the anterolateral right thigh.

Arm type

Experimental

Investigational medicinal product name

Candidate Plasmodium falciparum malaria vaccine

Investigational medicinal product code

RTS,S+AS01E

Other name

RTS,S, GSK 257049, RTS,S/AS01

Pharmaceutical forms

Powder and suspension for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

3 primary doses according to a Month 0, 1 and 2

Investigational medicinal product name

MENJUGATE KIT

Investigational medicinal product code

Other name

Menjugate, MenC

Pharmaceutical forms

Powder and solvent for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose at Month 20

Investigational medicinal product name

Tritanrix-HepB

Investigational medicinal product code

DTPw-HBV

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

3 doses in the anterolateral right thigh according to a Month 0, 1 and 2 of Tritanrix-HepB (DTPw-HBV /Hib) reconstituted into Tritanrix HepB/Hib by combining with Hiberix (Hib) vaccine

Investigational medicinal product name

Hiberix

Investigational medicinal product code

Hib

Other name

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Investigational medicinal product name

Polio Sabin (Oral)

Investigational medicinal product code

OPV

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

3 primary doses according to a Month 0, 1 and 2 followed by a booster dose at Month 20.

C3C (6-12W) Group

Arm description

Subjects in this group, aged 6 to 12 weeks at first vaccination, received a 3-dose primary vaccination course of Menjugate (or MenC vaccine) co-administered with Polio Sabin (or OPV vaccine) and Tritanrix HepB/Hib (or DTPwHepB/Hib vaccine) (reconstituted from Tritanrix HepB and Hiberix vaccines) according to a Month 0, 1 and 2 followed by a booster dose of dose of MenC vaccine co-administered with OPV vaccine at Month 20. All vaccines were administered intramuscularly, except the OPV vaccine given orally; the MenC vaccine was injected in the left thigh for children < 1 year of age and into the left deltoid in children > 1 year of age; the DTPwHepB/Hib vaccine was injected in the anterolateral right thigh.

Arm type

Active comparator

Investigational medicinal product name

MENJUGATE KIT

Investigational medicinal product code

Other name

Menjugate, MenC

Pharmaceutical forms

Powder and solvent for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

3 primary doses according to a Month 0, 1 and 2 followed by a booster dose at Month 20.

Investigational medicinal product name

Tritanrix-HepB

Investigational medicinal product code

DTPw-HBV

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

3 doses in the anterolateral right thigh according to a Month 0, 1 and 2 of Tritanrix-HepB (DTPw-HBV /Hib) reconstituted into Tritanrix HepB/Hib by combining with Hiberix (Hib) vaccine

Investigational medicinal product name

Hiberix

Investigational medicinal product code

Hib

Other name

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Investigational medicinal product name

Polio Sabin (Oral)

Investigational medicinal product code

OPV

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

3 primary doses according to a Month 0, 1 and 2 followed by a booster dose at Month 20.

Number of subjects in period 1	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Started	2976	2972	2974	2180	2178	2179
Completed	2064	2038	2085	1555	1533	1549
Not completed	912	934	889	625	645	630
Consent withdrawn by subject	297	290	272	157	138	144
Adverse event, non-fatal	61	51	47	51	55	44
Lost to follow-up	552	593	568	395	435	425
Protocol deviation	2	-	2	22	17	17

Baseline characteristics

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Reporting group title

R3R (5-17M) Group

Reporting group description

Reporting group title

R3C (5-17M) Group

Reporting group description

Subjects in this group, aged 5 to 17 months at first vaccination, received a 3-dose primary vaccination course of the RTS,S/AS01 vaccine (also referred to as RTS,S or GSK 257049, vaccine) according to a Month 0, 1 and 2 followed by a booster dose of Menjugate (or MenC vaccine) administered at Month 20. The RTS,S/AS01 and MenC vaccines were administered intramuscularly in the left deltoid.

Reporting group title

C3C (5-17M) Group

Reporting group description

Reporting group title

R3R (6-12W) Group

Reporting group description

Reporting group title

R3C (6-12W) Group

Reporting group description

Subjects in this group, aged 6 to 12 weeks at first vaccination, received a 3-dose primary vaccination course of the RTS,S/AS01 vaccine (also referred to as RTS,S or GSK 257049, vaccine) co-administered with Polio Sabin (or OPV vaccine) and Tritanrix HepB/Hib (or DTPwHepB/Hib vaccine) (reconstituted from Tritanrix HepB and Hiberix vaccines) according to a Month 0, 1 and 2 followed by a booster dose of dose of Menjugate (or MenC vaccine) co-administered with OPV vaccine at Month 20. All vaccines were administered intramuscularly, except the OPV vaccine given orally; the primary RTS,S/AS01 vaccine doses were injected in the anterolateral left thigh; the MenC vaccine was injected in the left thigh for children < 1 year of age and into the left deltoid in children > 1 year of age; the DTPwHepB/Hib vaccine was injected in the anterolateral right thigh.

Reporting group title

C3C (6-12W) Group

Reporting group description

Reporting group values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group	Total
Number of subjects	2976	2972	2974	2180	2178	2179	15459
Age categorical
Units: Subjects
Infants and toddlers (28 days-23 months)	2976	2972	2974	2180	2178	2179	15459
Age continuous
Units: months
arithmetic mean (standard deviation)	10.7 ( 3.79 )	10.6 ( 3.82 )	10.6 ( 3.75 )	7.2 ( 1.45 )	7.1 ( 1.39 )	7.1 ( 1.43 )	-
Gender categorical
Units: Subjects
Female	1467	1500	1503	1064	1060	1100	7694
Male	1509	1472	1471	1116	1118	1079	7765

End points

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Reporting group title

R3R (5-17M) Group

Reporting group description

Reporting group title

R3C (5-17M) Group

Reporting group description

Subjects in this group, aged 5 to 17 months at first vaccination, received a 3-dose primary vaccination course of the RTS,S/AS01 vaccine (also referred to as RTS,S or GSK 257049, vaccine) according to a Month 0, 1 and 2 followed by a booster dose of Menjugate (or MenC vaccine) administered at Month 20. The RTS,S/AS01 and MenC vaccines were administered intramuscularly in the left deltoid.

Reporting group title

C3C (5-17M) Group

Reporting group description

Reporting group title

R3R (6-12W) Group

Reporting group description

Reporting group title

R3C (6-12W) Group

Reporting group description

Subjects in this group, aged 6 to 12 weeks at first vaccination, received a 3-dose primary vaccination course of the RTS,S/AS01 vaccine (also referred to as RTS,S or GSK 257049, vaccine) co-administered with Polio Sabin (or OPV vaccine) and Tritanrix HepB/Hib (or DTPwHepB/Hib vaccine) (reconstituted from Tritanrix HepB and Hiberix vaccines) according to a Month 0, 1 and 2 followed by a booster dose of dose of Menjugate (or MenC vaccine) co-administered with OPV vaccine at Month 20. All vaccines were administered intramuscularly, except the OPV vaccine given orally; the primary RTS,S/AS01 vaccine doses were injected in the anterolateral left thigh; the MenC vaccine was injected in the left thigh for children < 1 year of age and into the left deltoid in children > 1 year of age; the DTPwHepB/Hib vaccine was injected in the anterolateral right thigh.

Reporting group title

C3C (6-12W) Group

Reporting group description

Subject analysis set title

RTS,S/AS01 (5-17M)

Subject analysis set type

Sub-group analysis

Subject analysis set description

This group results from the pooling of the R3R (5-17M) and R3C (5-17M) groups and include subjects who received a 3-dose primary vaccination course of the RTS,S/AS01 vaccine (also referred to as RTS,S or GSK 257049) according to a Month 0, 1 and 2 schedule followed by, at Month 20, either a booster dose of the RTS,S/AS01 vaccine or a dose of Menjugate (or MenC). Refer to the respective descriptions for the R3R (5-17M) and R3C (5-17M) groups for details on routes of vaccination.

Subject analysis set title

RTS,S/AS01 (6-12W) Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

This group results from the pooling of the R3R (6-12W) and R3C (6-12W) groups and include subjects who received a 3-dose primary vaccination course of the RTS,S/AS01 vaccine (also referred to as RTS,S or GSK 257049) co-administered with Polio Sabin (or OPV) and Tritanrix HepB/Hib (or DTPwHepB/Hib) according to a Month 0, 1 and 2 schedule followed by, at Month 20, either a booster dose of the RTS,S/AS01 and OPV vaccines or a booster dose of Menjugate (or MenC) and OPV vaccines. Refer to the respective descriptions for the R3R (6-12W) and R3C (6-12W) groups for details on routes of vaccination

Subject analysis set title

RTS,S/AS01 Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

This group results from the pooling of the R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups. Subjects aged 5 to 17 months at first vaccination received a 3-dose primary vaccination course of the RTS,S/AS01 vaccine (also referred to as RTS,S or GSK 257049 vaccine) according to a Month 0, 1 and 2 schedule, followed by, at Month 20, either a booster dose of the RTS,S/AS01 vaccine or a dose of Menjugate (or MenC). Subjects aged 6 to 12 weeks at first vaccination received a 3-dose primary vaccination course of RTS,S/AS01 vaccine co-administered with Polio Sabin (or OPV) and Tritanrix HepB/Hib (or DTPwHepB/Hib) according to a Month 0, 1 and 2 schedule followed by, at Month 20, either a booster dose of RTS,S/AS01 and OPV vaccines or a booster dose of Menjugate (or MenC) and OPV vaccines. Refer to the respective descriptions for the R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups for details on routes of vaccination.

Subject analysis set title

R3R Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

This group results from the pooling of the R3R (5-17M) and R3R (6-12W) groups and include subjects who received a 3-dose primary vaccination course of the RTS,S/AS01 vaccine (also referred to as RTS,S or GSK 257049) according to a Month 0, 1 and 2 schedule, followed by, at Month 20, either a booster dose of the RTS,S/AS01 vaccine. Refer to the respective descriptions for the R3R (5-17M) and R3R (6-12W) groups for details on other vaccines administered depending on age of subjects and routes of vaccination.

Subject analysis set title

R3C Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

This group results from the pooling of the R3C (5-17M) and R3C (6-12W) groups and include subjects who received a 3-dose primary vaccination course of the RTS,S/AS01 vaccine (also referred to as RTS,S or GSK 257049) according to a Month 0, 1 and 2 schedule, followed by, at Month 20, either a booster dose of Menjugate (or MenC). Refer to the respective descriptions for the R3C (5-17M) and R3C (6-12W) groups for details on other vaccines administered depending on age of subjects and routes of vaccination.

Subject analysis set title

C3C Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

This group results from the pooling of the C3C (5-17M) and C3C (6-12W) groups and include subjects who received a 3-dose primary vaccination course of either Verorab (also referred to as Rabies vaccine (subjects aged 5-17 months at first vaccination) or Menjugate (or MenC) (subjects aged 6-12 weeks at first vaccination according to a Month 0, 1 and 2 schedule, followed by, at Month 20, either a booster dose of the MenC vaccine. Refer to the respective descriptions for the C3C (5-17M) and C3C (6-12W) groups for details on other vaccines administered depending on age of subjects and routes of vaccination.

Primary: Time to first or only clinical episode of Plasmodium falciparum (P. falciparum) malaria infection (CPFMI), or clinical malaria episode, of Primary Case Definition (CPFMI-PCD) - In subjects enrolled aged 5-17 months

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End point title

Time to first or only clinical episode of Plasmodium falciparum (P. falciparum) malaria infection (CPFMI), or clinical malaria episode, of Primary Case Definition (CPFMI-PCD) - In subjects enrolled aged 5-17 months ^[1]

End point description

A CPFMI-PCD was defined as an episode of malaria for which P. falciparum asexual parasitemia > 5000 parasites/µL accompanied by presence of fever (axillary temperature ≥ 37.5°C at the time of presentation AND occurring in a child who is unwell and brought for treatment to a healthcare facility OR a case of malaria meeting the primary case definition of severe malaria disease. The time to first or only CPFMI-PCD is expressed in terms of rate of first or only CPFMI (RfoCPFMI), that is, the number of CPFMI events reported (n) over the period elapsed until the CPFMI event occurred for each group (T in year = sum of follow-up period expressed in years censored at the first occurrence of event in each group). Analysis for this outcome was solely performed on subjects in the 5-17 months age category

End point type

Primary

End point timeframe

From Month 2.5 to Month 14

Notes
[1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	C3C (5-17M) Group	RTS,S/AS01 (5-17M)
Number of subjects analysed	1466	2830
Units: n/T
number (not applicable)
RfoCPFMI-PCD 5-17M M2.5-14	0.833	0.435

Vaccine efficacy (VE) RTS,S/AS01 vs control

Statistical analysis description

The analysis aimed to compare RfoCPFMI between groups over the Months 2.5-14 time period. Using RfoCFPMI, a Cox regression model was used to evaluate vaccine efficacy (VE) allowing for adjustment by factors . VE was calculated as 1 minus [Hazard Ratio (HR) in RTS,S/AS01 (5-17M) Group (HR1) divided by HR in control C3C (5-17M) Group (HR2)], i. e. 1 - (HR1/HR2).

Comparison groups

C3C (5-17M) Group v RTS,S/AS01 (5-17M)

Number of subjects included in analysis

4296

Analysis specification

Pre-specified

Analysis type

superiority ^[2]

P-value

< 0.0001 ^[3]

Method

Regression, Cox

Parameter type

VE (see above)

Point estimate

55.8

Confidence interval

level

97.5%

sides

2-sided

lower limit

50.6

upper limit

60.4

Notes
[2] - Point estimate of efficacy was adjusted for study site as stratification factor for the analysis. This efficacy was calculated with the first 6000 subjects enrolled in the 5-17 months (5-17M) age category. Results were uncorrected for the double enrolment of one subject receiving the RTS,S/AS01 vaccine in the 5-17Ms age category. Criterion for success = lower limit (LL) of 97.5% confidence interval (CI) of VE > 0.
[3] - The p-value presented was calculated using the likelihood ratio test.

Primary: Time to first or only clinical episode of Plasmodium falciparum (P. falciparum) malaria infection (CPFMI), or clinical malaria episode, of Primary Case Definition (CPFMI-PCD) – In subjects enrolled aged 6-12 weeks

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End point title

End point description

End point type

Primary

End point timeframe

From Month 2.5 to Month 14

Notes
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	C3C (6-12W) Group	RTS,S/AS01 (6-12W) Group
Number of subjects analysed	2008	3995
Units: n/T
number (not applicable)
RfoCPFMI-PCD 6-12W M2.5-14	0.484	0.367

Vaccine efficacy (VE) RTS,S/AS01 vs control

Statistical analysis description

Comparison groups

C3C (6-12W) Group v RTS,S/AS01 (6-12W) Group

Number of subjects included in analysis

6003

Analysis specification

Pre-specified

Analysis type

superiority ^[5]

P-value

< 0.0001 ^[6]

Method

Regression, Cox

Parameter type

VE (see above)

Point estimate

31.315

Confidence interval

level

97.5%

sides

2-sided

lower limit

23.556

upper limit

38.286

Notes
[5] - Point estimate of efficacy was adjusted for study site as stratification factor for the analysis. Criterion for success = lower limit (LL) of 97.5% confidence interval (CI) of VE > 0.
[6] - The p-value presented was calculated using the likelihood ratio test.

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of PCD and of secondary case definitions (SCD) 1, SCD 2 and SCD 3

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End point title

Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of PCD and of secondary case definitions (SCD) 1, SCD 2 and SCD 3 ^[7]

End point description

PCD = malaria episode with PFAP>5000 parasites/µL accompanied by fever and occurring in a child unwell brought for treatment to a healthcare facility or a case of malaria meeting the PCD of severe malaria disease (see below endpoints on severe malaria for details). SCD1 = malaria episode with PFAP>0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. SCD2 = malaria episode with PFAP>500 parasites/μL and fever at time of presentation in a subject unwell brought for treatment to a healthcare facility. SCD3 = malaria episode with PFAP>20.000 parasites/μL and fever at time of presentation in a subject unwell and brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as number of events reported (n) over time (T) elapsed until all events occurred in each group. Results are uncorrected for double enrolment of 1 subject receiving RTS,S/AS01.

End point type

Secondary

End point timeframe

From Month 2.5 to Month 14

Notes
[7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	C3C (5-17M) Group	C3C (6-12W) Group	RTS,S/AS01 (5-17M)	RTS,S/AS01 (6-12W) Group
Number of subjects analysed	1466	2008	2830	3995
Units: n/T
number (not applicable)
RaCPFMI PCD	1.468	0.908	0.735	0.639
RaCPFMI SCD1	2.312	1.403	1.224	0.989
RaCPFMI SCD2	1.628	1.031	0.847	0.736
RaCPFMI SCD3	1.244	0.731	0.625	0.515

No statistical analyses for this end point

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of PCD, overall and by centre

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End point title

Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of PCD, overall and by centre ^[8]

End point description

End point type

Secondary

End point timeframe

From Month 2.5 to Month 20

Notes
[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: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	C3C (5-17M) Group	C3C (6-12W) Group	RTS,S/AS01 (5-17M)	RTS,S/AS01 (6-12W) Group
Number of subjects analysed	2328	2007	4557	3996
Units: n/T
number (not applicable)
RaCPFMI PCD – Agogo (N=192;221;371;418)	1.16	0.79	0.56	0.64
RaCPFMI PCD – Bagamoyo (N=235;244;462;502)	0.28	0.14	0.1	0.08
RaCPFMI PCD – Kilifi (N=171;102;336;186)	0.04	0.02	0.01	0.04
RaCPFMI PCD – Kintampo (N=296;99;602;199)	1.85	1.49	1.01	1.53
RaCPFMI PCD – Kombewa (N=311;196;609;387)	1.87	1.32	1.21	0.94
RaCPFMI PCD – Korogwe (N=293;183;568;382)	0.11	0.05	0.04	0.03
RaCPFMI PCD – Lambarene (N=196;62;380;147)	0.2	0.12	0.11	0.11
RaCPFMI PCD – Lilongwe (N=183;258;359;500)	0.32	0.5	0.2	0.3
RaCPFMI PCD – Manhica (N=0;188;0;381)	0	0.12	0	0.1
RaCPFMI PCD – Nanoro (N=198;225;389;441)	2.4	2.39	1.42	1.93
RaCPFMI PCD – Siaya (N=253;229;481;453)	3.31	2.75	2.01	2.03
RaCPFMI of PCD – Across (N=2328;2007;4557;3996)	1.17	0.92	0.69	0.71

No statistical analyses for this end point

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of SCD1, SCD2 and SCD3, overall

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End point title

Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of SCD1, SCD2 and SCD3, overall ^[9]

End point description

SCD1 = malaria episode with PFAP>0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. SCD2 = malaria episode with PFAP>500 parasites/μL and fever at time of presentation in a subject unwell brought for treatment to a healthcare facility. SCD3 = malaria episode with PFAP>20.000 parasites/μL and fever at time of presentation in a subject unwell and brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as number of events reported (n) over time (T) elapsed until all events occurred in each group. Results are across centres, and are uncorrected for double enrolment of 1 subject receiving RTS,S/AS01.

End point type

Secondary

End point timeframe

From Month 2.5 to Month 20

Notes
[9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	C3C (5-17M) Group	C3C (6-12W) Group	RTS,S/AS01 (5-17M)	RTS,S/AS01 (6-12W) Group
Number of subjects analysed	2328	2007	4557	3996
Units: n/T
number (not applicable)
RaCPFMI SCD1	1.78	1.42	1.09	1.09
RaCPFMI SCD2	1.3	1.04	0.78	0.81
RaCPFMI SCD3	1.01	0.76	0.59	0.58

No statistical analyses for this end point

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of primary case definition (PCD) by centres & across centres

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End point title

Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of primary case definition (PCD) by centres & across centres

End point description

End point type

Secondary

End point timeframe

From Month 2.5 to Study End (with a median follow-up time post Dose 1 of 48 months post for 5-17 M groups and 38 months for 6-12W groups).

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	2276	2306	2336	1985	2005	2007
Units: n/T
number (not applicable)
RaCPFMI PCD – Kilifi (N=163;172;172;90;95;102)	0.02	0.03	0.08	0.06	0.04	0.04
RaCPFMI PCD – Korogwe (N=286;282;293;191;191;183)	0.04	0.05	0.1	0.05	0.07	0.09
RaCPFMI PCD – Lamberene (N=187;196;196;72;75;62)	0.15	0.15	0.23	0.1	0.18	0.17
RaCPFMI PCD – Bagamoyo (N=228;242;236;252;249;245)	0.16	0.21	0.27	0.08	0.11	0.15
RaCPFMI PCD – Lilongwe (N=176;183;185;247;250;257	0.09	0.2	0.23	0.25	0.29	0.42
RaCPFMI PCD – Agogo (N=188;183;191;209;209;221)	0.59	0.73	1.01	0.59	0.77	0.84
RaCPFMI PCD – Kombewa (N=315;301;312;195;193;196)	1.26	1.37	1.64	1.37	1.37	1.62
RaCPFMI PCD – Kintampo (N=299;310;30198;101;100)	1.11	1.31	1.71	1.65	1.71	1.69
RaCPFMI PCD – Manhica (N=0;0;0;193;187;188)	0	0	0	0.18	0.14	0.2
RaCPFMI PCD – Nanoro (N=194;195;198;217;224;224)	1.95	2.18	2.69	2.59	2.79	3.14
RaCPFMI PCD – Siaya (N=240;242;252;221;231;229)	2.09	2.55	3.15	2.43	2.67	3.12
RaCPFMI PCD Across(N=2276;23062336;1985;2005;2007)	0.79	0.9	1.14	0.86	0.95	1.08

No statistical analyses for this end point

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of Secondary Case Definition 1 (SCD1) and Primary Case Definition (PCD1) – across centres;

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End point title

Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of Secondary Case Definition 1 (SCD1) and Primary Case Definition (PCD1) – across centres;

End point description

CPFMI of SCD1 = malaria episode with PFAP>0 & fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as number of events reported (n) over time (T) elapsed until all events occurred in each group. Results are presented across centres,

End point type

Secondary

End point timeframe

From Month 2.5 to Study End (with a median follow-up time post Dose 1 of 48 months post for 5-17 M groups and 38 months for 6-12W groups).

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	2276	2306	2336	1985	2005	2007
Units: n/T
number (not applicable)
RaCPFMI SCD1	1.26	1.41	1.81	1.29	1.43	1.61

No statistical analyses for this end point

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of Primary Case Definition (PCD) and Secondary Case Definition 1 (SCD1)

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End point title

Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of Primary Case Definition (PCD) and Secondary Case Definition 1 (SCD1)

End point description

CPFMI of PCD = episode of malaria for which PFAP>5000 parasites/µL accompanied by presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. CPFMI of SCD1 = malaria episode with PFAP>0 & fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as number of events reported (n) over time (T) elapsed until all events occurred in each group. Results are across centres,

End point type

Secondary

End point timeframe

From Booster at Month 20 to Study End (with a median follow-up time post Dose 1 of 48 months post for 5-17 M groups and 38 months for 6-12W groups).

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	2017	2057	2050	1743	1788	1762
Units: n/T
number (not applicable)
RaCPFMI PCD	0.87	1.03	1.1	1.01	1.21	1.23
RaCPFMI SCD1	1.39	1.65	1.82	1.48	1.79	1.8

No statistical analyses for this end point

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of PCD and SCD1 across centres

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End point title

Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of PCD and SCD1 across centres

End point description

End point type

Secondary

End point timeframe

From Month 33 to Study End (with a median follow-up time post Dose 1 of 48 months post for 5-17 M groups and 38 months for 6-12W groups).

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	1784	1838	1864	1516	1548	1546
Units: n/T
number (not applicable)
RaCPFMI PCD (N=1784;1838;1864;1516;1548;1546)	1.01	1.1	1.1	1.18	1.31	1.29
RaCPFMI SCD1 (N=1784;1838;1864;1516;1547;1546)	1.61	1.79	1.88	1.73	1.92	1.91

No statistical analyses for this end point

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of PCD –by centre & across centres

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End point title

Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of PCD –by centre & across centres

End point description

End point type

Secondary

End point timeframe

From Month 2.5 to Month 32

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	2276	2306	2336	1985	2005	2007
Units: n/T
number (not applicable)
RaCPFMI PCD – Kilifi (N=163;172;172;90;95;102)	0.03	0.04	0.09	0.06	0.04	0.05
RaCPFMI PCD – Korogwe (N=286;282;293;191;191;183)	0.04	0.03	0.08	0.02	0.06	0.06
RaCPFMI PCD – Lamberene (N=187;196;196;72;75;62)	0.14	0.14	0.21	0.1	0.18	0.18
RaCPFMI PCD – Bagamoyo (N=228;242;236;252;249;246)	0.13	0.19	0.31	0.08	0.11	0.15
RaCPFMI PCD – Lilongwe (N=176;183;185;247;250;257	0.11	0.22	0.29	0.27	0.32	0.47
RaCPFMI PCD – Agogo (N=188;183;191;209;209;221)	0.59	0.75	1.15	0.56	0.72	0.86
RaCPFMI PCD – Kombewa (N=315;301;312;195;193;196)	1.12	1.29	1.67	1.28	1.25	1.55
RaCPFMI PCD – Kintampo (N=299;310;301;98;101;100)	1.08	1.17	1.87	1.52	1.6	1.6
RaCPFMI PCD – Manhica (N=0;0;0;193;187;188)	0	0	0	0.15	0.12	0.15
RaCPFMI PCD – Nanoro (N=194;195;198;217;224;224)	1.42	1.67	2.45	2.27	2.53	2.92
RaCPFMI PCD – Siaya (N=954;242;252;221;231;229)	1.91	2.46	3.25	2.41	2.54	3.09
RaCPFMI PCDAcross(N=2276;2306;2336;1985;2005;2007)	0.68	0.81	1.15	0.8	0.88	1.03

No statistical analyses for this end point

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of Secondary Case Definition 1 (SCD1)

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End point title

Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of Secondary Case Definition 1 (SCD1)

End point description

CPFMI of SCD1 = malaria episode with PFAP>0 & fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, number of CPFMI events reported (n) over period elapsed until all CPFMI events reported occurred for each group (T in year = sum of FU period in years censored at last occurrence of event in each group). Analysis was performed on subjects aged 5-17 months at enrolment.

End point type

Secondary

End point timeframe

From Month 2.5 to Month 32

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	2276	2306	2336	1985	2005	2007
Units: n/T
number (not applicable)
RaCPFMI SCD1	1.1	1.24	1.78	1.19	1.33	1.54

No statistical analyses for this end point

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of Primary Case Definition (PCD) and Secondary Case Definition 1 (SCD1)

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End point title

Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of Primary Case Definition (PCD) and Secondary Case Definition 1 (SCD1)

End point description

CPFMI of PCD = episode of malaria for which PFAP>5000 parasites/µL accompanied by presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. CPFMI of SCD1 = malaria episode with PFAP>0 & fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, number of CPFMI events reported (n) over period elapsed until all CPFMI events reported occurred for each group (T in year = sum of FU period in years censored at last occurrence of event in each group). Analysis was performed on subjects aged 5-17 months at enrolment.

End point type

Secondary

End point timeframe

From Booster at Month 20 to Month 32.

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	2017	2057	2050	1743	1788	1762
Units: n/T
number (not applicable)
RaCPFMI PCD	0.72	0.96	1.1	0.91	1.15	1.2
RaCPFMI SCD1	1.14	1.48	1.74	1.35	1.72	1.74

No statistical analyses for this end point

Secondary: Percentage (%) of subjects with severe PFMI (SPFMI) of PCD, SCD1, SCD2 and SCD3 across centres

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End point title

Percentage (%) of subjects with severe PFMI (SPFMI) of PCD, SCD1, SCD2 and SCD3 across centres

End point description

SPFMI of PCD = PFMI>5000 parasites/μL, at least one severity marker & no co-morbidity diagnosis. SPFMI of SCD1 = PFMI>5000 parasites/μL and with one or more severity marker. SPFMI of SCD2 = PFMI>0 with one or more severity marker and without co-morbidity diagnosis. SPFMI of SCD3 = PFMI>5000 parasites/μL, with one or more severity marker, & without co-morbidity or HIV. Severity markers = prostration; respiratory distress; Blantyre score =< 2; ≥ 2 seizures in 24 h prior to admission, emergency room & hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE -10.0 mmol/L,l < 5.0 mmol/L; anaemia<5.0 g/dL. Comorbidities = radiographically proven pneumonia; meningitis; positive blood culture on a blood culture taken within 72 h of admission; gastroenteritis with dehydration. A Analysis was performed in a pooled manner across age categories. Results presented are uncorrected for double enrolment of one subject in 5-17 months age category receiving RTS,S/AS01.

End point type

Secondary

End point timeframe

From Month 2.5 up to time when 250 subjects diagnosed with severe malaria of PCD, SCD1, SCD2 and SCD3

End point values	RTS,S/AS01 Group	C3C Group
Number of subjects analysed	8597	4364
Units: percentage
number (not applicable)
SPFMI PCD	0.019	0.03
SPFMI SCD1	0.023	0.036
SPFMI SCD2	0.023	0.034
SPFMI SCD3	0.019	0.03

No statistical analyses for this end point

Secondary: Percentage (%) of subjects with severe PFMI (SPFMI) of PCD and SCD1

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End point title

Percentage (%) of subjects with severe PFMI (SPFMI) of PCD and SCD1 ^[10]

End point description

SPFMI of PCD = PFMI>5000 parasites/μL, at least one severity marker & no co-morbidity diagnosis. SPFMI of SCD1 = PFMI>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score =< 2; ≥ 2 seizures in 24 h prior to admission, emergency room & hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE -10.0 mmol/L,l  5.0 mmol/L; anaemia<5.0 g/dL. Comorbidities = radiographically proven pneumonia; meningitis; positive blood culture on a blood culture taken within 72 h of admission; gastroenteritis with dehydration. SPFMI of SCD1 = PFMI>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score =< 2; ≥ 2 seizures in 24 h prior to admission, emergency room & hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE -10.0 mmol/L,l  5.0 mmol/L; anaemia<5.0 g/dL. Results presented are uncorrected for double enrolment of one subject in 5-17 months age category recei

End point type

Secondary

End point timeframe

From Month 2.5 to Month 14

Notes
[10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	C3C (5-17M) Group	C3C (6-12W) Group	RTS,S/AS01 (5-17M)	RTS,S/AS01 (6-12W) Group
Number of subjects analysed	1466	2008	2830	3995
Units: percentage
number (not applicable)
SPFMI PCD	3.8	2.3	2	1.5
SPFMI SCD1	4.9	2.5	2.6	1.6

No statistical analyses for this end point

Secondary: Percentage (%) of subjects with severe PFMI (SPFMI) of PCD and SCD1

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End point title

Percentage (%) of subjects with severe PFMI (SPFMI) of PCD and SCD1 ^[11]

End point description

SPFMI of PCD = PFMI>5000 parasites/μL, at least one severity marker & no co-morbidity diagnosis. SPFMI of SCD1 = PFMI>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score =< 2; ≥ 2 seizures in 24 h prior to admission, emergency room & hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE <=-10.0 mmol/L,l  5.0 mmol/L; anaemia<5.0 g/dL. Comorbidities = radiographically proven pneumonia; meningitis; positive blood culture on a blood culture taken within 72 h of admission; gastroenteritis with dehydration. SPFMI of SCD1 = PFMI>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score =< 2; ≥ 2 seizures in 24 h prior to admission, emergency room & hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE <=-10.0 mmol/L,l >= 5.0 mmol/L; anaemia<5.0 g/dL. Results presented are uncorrected for double enrolment of one subject in 5-17 months age category

End point type

Secondary

End point timeframe

From Month 2.5 to Month 20 at Booster

Notes
[11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	C3C (5-17M) Group	C3C (6-12W) Group	RTS,S/AS01 (5-17M)	RTS,S/AS01 (6-12W) Group
Number of subjects analysed	2328	2007	4557	3996
Units: percentage
number (not applicable)
SPFMI PCD	0.04	0.03	0.03	0.03
SPFMI SCD1	0.05	0.03	0.03	0.03

No statistical analyses for this end point

Secondary: Percentage (%) of subjects with severe PFMI (SPFMI) of PCD and SCD1

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End point title

Percentage (%) of subjects with severe PFMI (SPFMI) of PCD and SCD1

End point description

SPFMI of PCD = PFMI>5000 parasites/μL, at least one severity marker & no co-morbidity diagnosis. SPFMI of SCD1 = PFMI>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score =< 2; ≥ 2 seizures in 24 h prior to admission, emergency room & hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE <=-10.0 mmol/L,l >= 5.0 mmol/L; anaemia<5.0 g/dL. Comorbidities = radiographically proven pneumonia; meningitis; positive blood culture on a blood culture taken within 72 h of admission; gastroenteritis with dehydration. SPFMI of SCD1 = PFMI>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score =< 2; ≥ 2 seizures in 24 h prior to admission, emergency room & hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE <=-10.0 mmol/L,l >= 5.0 mmol/L; anaemia<5.0 g/dL.

End point type

Secondary

End point timeframe

From Month 2.5 to study end, from booster (Month 20) to study end, from Month 33 to study end and from Month 2.5 to Month 32 and Month 20 (booster) to Month 32

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	2276	2306	2336	1985	2005	2007
Units: percentage
number (not applicable)
PCD, M2.5 to SE (N=2276;2306;2336;1985;2005;2007)	0.04	0.06	0.06	0.04	0.04	0.05
PCD, M20 to SE (N=2017;2057;2051;1743;1788;1762)	0.03	0.04	0.02	0.02	0.03	0.03
PCD, M33 to SE (N=1784;1838;1864;1516;1548;1546)	0.01	0.02	0.01	0.01	0.01	0.01
PCD, M2.5 to M32 (N=2276;2306;2336;1985;2005;2007)	0.03	0.05	0.05	0.04	0.04	0.04
PCD M20 to M32 (N=2017;2057;2051;1743;1788;1762)	0.02	0.02	0.02	0.01	0.02	0.02
SCD1, M2.5 to SE (N=2276;2306;2336;1985;2005;2007)	0.05	0.07	0.07	0.04	0.05	0.06
SCD1, M20 to SE (N=2017;2057;2051;1743;1788;1762)	0.03	0.04	0.03	0.02	0.03	0.03
SCD1, M33 to SE(N=1784;1838;1864;1516;1548;1546)	0.01	0.02	0.01	0.01	0.01	0.01
SCD1 M2.5 to M32 (N=2276;2306;2336;1985;2005;2007)	0.04	0.06	0.06	0.04	0.04	0.05
SCD1 M20 to M32 (N=2017;2057;2051;1743;1788;1762)	0.02	0.03	0.02	0.01	0.02	0.02

No statistical analyses for this end point

Secondary: Percentage (%) of subjects with incident severe anaemia (ISA) and malaria hospitalization (MH) for case definitions (CD) considered

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End point title

Percentage (%) of subjects with incident severe anaemia (ISA) and malaria hospitalization (MH) for case definitions (CD) considered ^[12]

End point description

CD considered were CD1 for ISA and CD1 and CD2 for MH. ISA of CD1 was defined as a documented hemoglobin < 5.0 g/dL identified at clinical presentation to morbidity surveillance system in association with a P. falciparum parasitemia > 5000 parasites/μL. MH of CD1 was defined as a medical hospitalization with confirmed P. falciparum > 5000 parasites/μL. MH of CD2 was defined as a hospitalization which, in the judgment of the principal investigator, P. falciparum infection was the sole or a major contributing factor to the presentation. Results presented are uncorrected for double enrolment of one subject in 5-17 months age category receiving RTS,S/AS01.

End point type

Secondary

End point timeframe

From Month 2.5 to Month 20

Notes
[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: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	C3C (5-17M) Group	C3C (6-12W) Group	RTS,S/AS01 (5-17M)	RTS,S/AS01 (6-12W) Group
Number of subjects analysed	2328	2007	4557	3996
Units: percentage
number (not applicable)
ISA CD1	0.01	0.01	0.01	0.01
MH CD1	0.09	0.05	0.05	0.04
MH CD2	0.1	0.06	0.06	0.05

No statistical analyses for this end point

Secondary: Percentage (%) of subjects with incident severe anaemia (ISA), malaria hospitalization (MH) and fatal malaria (FM) for case definitions (CD) considered

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End point title

Percentage (%) of subjects with incident severe anaemia (ISA), malaria hospitalization (MH) and fatal malaria (FM) for case definitions (CD) considered

End point description

ISA CD considered were CD1, CD2 and CD3. ISA of CD1 was defined as a documented hemoglobin < 5.0 g/dL identified at clinical presentation to morbidity surveillance system in association with a P. falciparum parasitemia > 5000 parasites/μL. ISA of CD2 was defined as a documented hemoglobin < 5.0 g/dL identified at clinical presentation to morbidity surveillance system in association with a P. falciparum parasitemia > 0 parasites/μL ISA of CD3 was defined as a documented hemoglobin < 5.0 g/dL identified at clinical presentation to morbidity surveillance system. MH CD considered were CD1 and CD2. MH of CD1 was defined as a medical hospitalization with confirmed P. falciparum > 5000 parasites/μL. MH of CD2 was defined as a hospitalization which, in the judgment of the principal investigator, P. falciparum infection was the sole or a major contributing factor to the presentation. FM CD considered were primary CD (PCD) and sedondary CDs 1 and 4 (SCD1 and SCD4). FM of PCD was defined as

End point type

Secondary

End point timeframe

From Month 2.5 to Study End

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	2276	2306	2336	1985	2005	2007
Units: percentage
number (not applicable)
ISA CD1	0.01	0.01	0.02	0.01	0.01	0.02
ISA CD2	0.01	0.02	0.02	0.01	0.02	0.02
ISA CD3	0.02	0.02	0.02	0.02	0.03	0.03
MH CD1	0.07	0.1	0.12	0.06	0.07	0.08
MH CD2	0.09	0.11	0.13	0.08	0.09	0.1
FM PCD	0	0	0	0	0	0
FM SCD1	0	0	0	0	0	0
FM SCD4	0	0	0	0	0.01	0

No statistical analyses for this end point

Secondary: Percentage (%) of subjects with incident severe anaemia (ISA), malahria hospitalization *MH) and fatal malaria (FM) for case definitions (CD) considered

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End point title

Percentage (%) of subjects with incident severe anaemia (ISA), malahria hospitalization *MH) and fatal malaria (FM) for case definitions (CD) considered

End point description

End point type

Secondary

End point timeframe

From Month 2.5 to Month 32

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	2276	2306	2336	1985	2005	2007
Units: percentage
number (not applicable)
ISA CD1	0.01	0.01	0.01	0.01	0.01	0.01
ISA CD2	0.01	0.01	0.02	0.01	0.01	0.01
ISA CD3	0.01	0.02	0.02	0.02	0.02	0.02
MH CD1	0.06	0.09	0.11	0.05	0.06	0.07
MH CD2	0.08	0.1	0.12	0.07	0.08	0.09
FM PCD	0	0	0	0	0	0
FM SCD1	0	0	0	0	0	0
FM SCD4	0	0	0	0	0	0

No statistical analyses for this end point

Secondary: Percentage (%) of subjects with prevalent parasitemia, prevalent gametocytemia and prevalent severe and moderate anemia

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End point title

Percentage (%) of subjects with prevalent parasitemia, prevalent gametocytemia and prevalent severe and moderate anemia ^[13]

End point description

End point type

Secondary

End point timeframe

At Month 20 (Booster)

Notes
[13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	C3C (5-17M) Group	C3C (6-12W) Group	RTS,S/AS01 (5-17M)	RTS,S/AS01 (6-12W) Group
Number of subjects analysed	2100	1766	4140	3571
Units: percentage
number (not applicable)
PP (N=2100;1766;4140;3571)	0.11	0.08	0.07	0.07
PSA (N=2097;1765;4139;3571)	0	0	0	0
PMA (N=2097;1765;4139;3571)	0.03	0.04	0.03	0.04
PG (N=2025;0;4021;0)	0.04	0	0.03	0

No statistical analyses for this end point

Secondary: Percentage (%) of subjects with prevalent parasitemia and prevalent severe and moderate anemia

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End point title

Percentage (%) of subjects with prevalent parasitemia and prevalent severe and moderate anemia

End point description

Prevalent parasitemia (PP) was defined as a documented P. falciparum asexual parasite density > 0 identified at timing of assessment. Prevalent severe anemia (PSA) was defined as a documented hemoglobin < 5.0 g/dL identified at timing of assessment. Prevalent moderate anemia (PMA) was defined as a documented hemoglobin < 8.0 g/dL identified at timing of assessment. Analysis was performed on subjects aged 5-17 months at enrolment. Study End (Early) corresponds to children whose Month 32 visit took place after 30 June 2012 and who had one cross-sectional visit at study end. These children’s last study visit was relatively earlier, with a median follow-up time of 14 months post Month 32. Study End (Late) corresponds to children whose Month 32 visit took place before (and including) 30 June 2012, and who had 2 cross-sectional visits after Month 32. These children’s last study visit was relatively later, with a median follow-up time of 17 months post Month 32).

End point type

Secondary

End point timeframe

At Month (M) 32, at (M) 44, at Study End (SE) (Early) and at SE (Late)

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	1935	1967	1979	1637	1656	1648
Units: percentage
number (not applicable)
PP M32 (N=1935;1963;1976;1635;1656;1647)	0.09	0.1	0.14	0.09	0.11	0.1
PSA M32 (N=1934;1967;1979;1637;1655;1648)	0	0	0	0	0	0
PMA M32 (N=1934;1967;1979;1637;1655;1648)	0.02	0.02	0.02	0.02	0.04	0.03
PP M44 (N=1039;1072;1093;0;0;0)	0.16	0.17	0.2	0	0	0
PSA M44 (N=1041;1072;1094;0;0;0)	0	0	0	0	0	0
PMA M44 (N=1041;1072;1094;0;0;0)	0.01	0.02	0.01	0	0	0
PP SE (Early) (N=681;661;672;1481;1472;1487)	0.09	0.1	0.14	0.11	0.14	0.13
PSA SE (Early) (N=681;661;672;1481;1472;1486)	0	0	0	0	0	0
PMA SE (Early) (N=681;661;672;1481;1472;1486)	0.01	0.02	0.03	0.03	0.03	0.03
PP SE (Late) (N=1054;1059;1104;0;0;0)	0.18	0.18	0.21	0	0	0
PSA SE (Late) (N=1053;1057;1104;0;0;0)	0	0	0	0	0	0
PMA SE (Late) (N=1053;1057;1104;0;0;0)	0.03	0.03	0.02	0	0	0

No statistical analyses for this end point

Secondary: Time to all episodes of severe PFMI (SPFMI) of primary case definition (PCD) and secondary case definition (SCD1; SCD2; SCD3) across centres

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End point title

Time to all episodes of severe PFMI (SPFMI) of primary case definition (PCD) and secondary case definition (SCD1; SCD2; SCD3) across centres

End point description

SPFMI of PCD = PFMI>5000 parasites/μL, at least one severity marker & no co-morbidity diagnosis. SPFMI of SCD1 = PFMI>5000 parasites/μL and with one or more severity marker. SPFMI of SCD2 = PFMI>0 with one or more severity marker and without co-morbidity diagnosis. SPFMI of SCD3 = PFMI>5000 parasites/μL, with one or more severity marker, & without co-morbidity or HIV. Severity markers = prostration; respiratory distress; Blantyre score =< 2; ≥ 2 seizures in 24 h prior to admission, emergency room & hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE -10.0 mmol/L,l  5.0 mmol/L; anaemia<5.0 g/dL. Co-morbidities = radiographically proven pneumonia; meningitis; positive blood culture on a blood culture taken within 72 h of admission; gastroenteritis with dehydration. Time to all episodes of SPFMI is expressed as a rate of all SPFMI (RaSPFMI), that is, number of events reported (n) over period elapsed until all events reported occurred for each group (T in year = sum of FU perio

End point type

Secondary

End point timeframe

From Month 2.5 up to time when 250 subjects diagnosed with severe malaria of PCD; SCD1; SCD2; SCD3

End point values	RTS,S/AS01 Group	C3C Group
Number of subjects analysed	8597	4364
Units: n/T
number (not applicable)
RaSPFMI PCD	0.019	0.03
RaSPFMI SCD1	0.023	0.036
RaSPFMI SCD2	0.023	0.034
RaSPFMI SCD3	0.019	0.03

No statistical analyses for this end point

Secondary: Percentage (%) of subjects with pneumonia, all-cause hospitalization and sepsis, as per case definitions assessed

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End point title

Percentage (%) of subjects with pneumonia, all-cause hospitalization and sepsis, as per case definitions assessed ^[14]

End point description

Pneumonia case definitions assessed are primary case definition (PCD) and secondary case definitions (SCD) 1, 2 and 3. Pneumonia of PCD was defined as cough or difficulty breathing (on history) AND tachypnea ( 50 breaths per minute < 1 year,  40 breaths per minute  1year) AND lower chest wall indrawing. Pneumonia of SCD1 was defined as pneumonia of PCD accompanied by chest X-ray (CXR) consolidation or pleural effusion on x-ray taken within 72 h of admission. Pneumonia of SCD2 was defined as pneumonia of PCD accompanied by consolidation or pleural effusion or other infiltrates on a chest x-ray taken within 72 h of admission. Pneumonia of SCD3 was defined as pneumonia of PCD accompanied by an oxygen saturation less than 90%. Results presented are uncorrected for double enrolment of one subject in 5-17 months age category receiving RTS,S/AS01. All-cause hospitalization case definition assessed was the primary case definition (PCD). All-cause hospitalization of PCD was defined as a

End point type

Secondary

End point timeframe

From Month 2.5 to Month 20

Notes
[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: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	C3C (5-17M) Group	C3C (6-12W) Group	RTS,S/AS01 (5-17M)	RTS,S/AS01 (6-12W) Group
Number of subjects analysed	2328	2007	4557	3996
Units: percentage
number (not applicable)
Pneumonia PCD	0.03	0.04	0.03	0.04
Pneumonia SCD1	0	0.01	0.01	0.01
Pneumonia SCD2	0.02	0.03	0.02	0.03
Pneumonia SCD3	0.01	0.01	0	0.01
All-Cause Hospitalization PCD	0.19	0.19	0.15	0.18
Sepsis CD1	0.02	0.01	0.02	0.02
Sepsis CD2	0.01	0.01	0.01	0.01

No statistical analyses for this end point

Secondary: Percentage (%) of subjects with fatal malaria (FM) and all-cause mortality (ACM) as per case definitions assessed

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End point title

Percentage (%) of subjects with fatal malaria (FM) and all-cause mortality (ACM) as per case definitions assessed ^[15]

End point description

Fatal malaria case definitions assessed were the primary case definition (PCD) and the secondary case definition (SCD) 1. Fatal malaria of PCD was defined as a case of severe malaria meeting the primary case definition of severe malaria disease (see above endpoint for definition) with a fatal outcome. Fatal malaria of SCD1 was defined as a case of severe malaria meeting the secondary case definition 1 severe malaria disease (see above endpoint for definition) with a fatal outcome. All-cause mortality case definitions assessed were the case definitions (CD) 1 and 2. All-cause mortality of CD1 was defined as a fatality (of any cause) (including mortality in the community and in hospital). All-cause mortality of CD2 was defined as a fatality (medical cause) (including mortality in the community and in hospital), at the exclusion of trauma which may be diagnosed by verbal autopsy. Results presented are uncorrected for double enrolment of one subject in 5-17 months age category receivi

End point type

Secondary

End point timeframe

From Month 2.5 to Month 20

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: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	C3C (5-17M) Group	C3C (6-12W) Group	RTS,S/AS01 (5-17M)	RTS,S/AS01 (6-12W) Group
Number of subjects analysed	2328	2007	4557	3996
Units: percentage
number (not applicable)
Fatal Malaria PCD	0	0	0	0
Fatal Malaria SCD1	0	0	0	0
All-cause mortality CD1	0.01	0.01	0.01	0.01
All-cause mortality CD2	0.01	0.01	0.01	0.01

No statistical analyses for this end point

Secondary: Percentage (%) of subjects with pneumonia, all-cause hospitalization/mortality and sepsis, as per case definitions assessed

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End point title

Percentage (%) of subjects with pneumonia, all-cause hospitalization/mortality and sepsis, as per case definitions assessed

End point description

Pneumonia of PCD was defined as cough or difficulty breathing (on history) AND tachypnea (>= 50 breaths per minute < 1 year, >= 40 breaths per minute >= 1year) AND lower chest wall indrawing,SCD1 was defined as pneumonia of PCD accompanied by chest X-ray (CXR) consolidation or pleural effusion on x-ray taken within 72 h of admission,SCD2 was defined as pneumonia of PCD accompanied by consolidation or pleural effusion or other infiltrates on a chest x-ray taken within 72 h of admission,SCD3 was defined as pneumonia of PCD accompanied by an oxygen saturation less than 90%.All-cause hospitalization of PCD was defined as a medical hospitalization of any cause (excluding planned admissions for medical investigation/care or elective surgery and trauma).All-cause mortality of CD1 was defined as a fatality (of any cause),of CD2 defined as a fatality (medical cause).Sepsis of CD1 was defined as a child with positive blood culture;CD2 defined as a child with positive salmonella blood culture.

End point type

Secondary

End point timeframe

From Month 2.5 to Study End

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	2276	2306	2336	1985	2005	2007
Units: percentage
number (not applicable)
All-Cause Hospitalization PCD	0.21	0.22	0.24	0.23	0.23	0.24
Sepsis CD 1	0.02	0.02	0.03	0.02	0.02	0.02
Sepsis CD 2	0.01	0.01	0.02	0.01	0.02	0.01
Pneumonia PCD	0.04	0.03	0.03	0.05	0.05	0.05
Pneumonia SCD1	0.01	0.01	0.01	0.01	0.01	0.01
Pneumonia SCD2	0.03	0.02	0.02	0.03	0.03	0.03
Pneumonia SCD3	0	0	0.01	0.01	0.01	0.01
All-Cause Mortality CD1	0.01	0.01	0.01	0.02	0.02	0.01
All-Cause Mortality CD2	0.01	0.01	0.01	0.02	0.02	0.01

No statistical analyses for this end point

Secondary: Percentage (%) of subjects with blood transfusion, as per case definition assessed

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End point title

Percentage (%) of subjects with blood transfusion, as per case definition assessed

End point description

Blood transfusion case definition assessed was the case definition 1 (CD1). Blood transfusion of CD1 was defined as a child with inpatient admission with documented blood transfusion.

End point type

Secondary

End point timeframe

From Month 2.5 to Study End

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	2276	2306	2336	1985	2005	2007
Units: percentage
number (not applicable)
Blood transfusion CD1	0.03	0.03	0.04	0.03	0.03	0.04

No statistical analyses for this end point

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of primary case definition (PCD) by gender & overall

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End point title

Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of primary case definition (PCD) by gender & overall

End point description

CPFMI of PCD = episode of malaria for which PFAP>5000 parasites/µL accompanied by presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, number of CPFMI events reported (n) over period elapsed until all CPFMI events reported occurred for each group (T in year = sum of FU period in years censored at last occurrence of event in each group). Analysis was performed on subjects aged 5-17 months at enrolment and of 6-12 weeks. Results presented are by gender and overall.

End point type

Secondary

End point timeframe

From Month 2.5 to Month 32

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	2276	2306	2336	1985	2005	2007
Units: n/T
number (not applicable)
RaCPFMI PCD Females(N=1123;1137;1167;967;976;1014)	0.72	0.8	1.11	0.76	0.79	1.06
RaCPFMI PCD Males(N=1153;1169;1169;1018;1029;993)	0.65	0.81	1.19	0.83	0.96	1.01
RaCPFMI PCDOverall(N=2276;2306;2336;1985;2005;2007	0.68	0.81	1.15	0.8	0.88	1.03

No statistical analyses for this end point

Secondary: Height, weight and mid upper arm circumference for age z-score (HAZ, WAZ and MUACZ)

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End point title

Height, weight and mid upper arm circumference for age z-score (HAZ, WAZ and MUACZ) ^[16]

End point description

Anthropometry consisted of length/height for age z-score [HAZ] (children <2 years length measure and children ≥2 years standing height measure), weight for age z-score [WAZ] (low weight for age z-score ≤-2, very low weight for age ≤-3) and mid-upper arm circumference for age z-score [MUACZ] measurements.

End point type

Secondary

End point timeframe

At Month 20 (Booster)

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: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	C3C (5-17M) Group	C3C (6-12W) Group	RTS,S/AS01 (5-17M)	RTS,S/AS01 (6-12W) Group
Number of subjects analysed	2974	2179	5949	4358
Units: z-score
arithmetic mean (standard deviation)
HAZ	-1.6 ( 1 )	-1.7 ( 1.2 )	-1.6 ( 1 )	-1.7 ( 1.1 )
WAZ	-1 ( 1 )	-0.9 ( 1 )	-1 ( 1 )	-0.9 ( 1 )
MUACZ	-0.3 ( 0.9 )	-0.1 ( 1 )	-0.3 ( 0.9 )	-0.1 ( 1 )

No statistical analyses for this end point

Secondary: Height, weight and mid upper arm circumference for age z-score (HAZ, WAZ and MUACZ)

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End point title

Height, weight and mid upper arm circumference for age z-score (HAZ, WAZ and MUACZ)

End point description

End point type

Secondary

End point timeframe

At Month (M) 32, at (M) 44, at Study End (SE) (Early) and at SE (Late)

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	2363	2382	2392	1726	1731	1725
Units: z-score
arithmetic mean (standard deviation)
HAZ (M 32) [2363;2382;2392;1726;1731;1725]	-1.3 ( 1 )	-1.4 ( 1 )	-1.4 ( 1 )	-1.5 ( 1.1 )	-1.4 ( 1.1 )	-1.5 ( 1.1 )
WAZ (M32) [2363;2382;2392;1726;1731;1725]	-0.9 ( 0.9 )	-1 ( 0.9 )	-1 ( 0.9 )	-0.9 ( 1 )	-0.9 ( 1 )	-0.9 ( 1 )
MUACZ (M32) [2363;2382;2392;1726;1731;1725]	-0.4 ( 0.9 )	-0.4 ( 0.9 )	-0.4 ( 0.8 )	-0.4 ( 0.9 )	-0.3 ( 1 )	-0.4 ( 1 )
HAZ (M 44) [1275;1289;1307;0;0;0]	-1.1 ( 1 )	-1.2 ( 0.9 )	-1.2 ( 1 )	0 ( 0 )	0 ( 0 )	0 ( 0 )
WAZ (M44) [1275;1289;1307;0;0;0]	-0.9 ( 0.9 )	-1 ( 0.9 )	-0.9 ( 0.8 )	0 ( 0 )	0 ( 0 )	0 ( 0 )
MUACZ (M44) [1275;1289;1307;0;0;0]	-0.7 ( 0.8 )	-0.7 ( 0.9 )	-0.6 ( 0.8 )	0 ( 0 )	0 ( 0 )	0 ( 0 )
HAZ (SE early) [774;755;768;1555;1533;1549]	-1.3 ( 1 )	-1.3 ( 1 )	-1.3 ( 1 )	-1.4 ( 1 )	-1.4 ( 1 )	-1.4 ( 1 )
WAZ (SE early) [774;755;768;1555;1533;1549]	-1 ( 0.8 )	-1 ( 0.8 )	-1 ( 0.8 )	-0.9 ( 0.9 )	-0.9 ( 0.9 )	-0.9 ( 0.9 )
MUACZ (SE early) [774;755;768;1555;1533;1549]	-0.8 ( 0.9 )	-0.8 ( 0.9 )	-0.8 ( 0.8 )	-0.5 ( 0.9 )	-0.4 ( 0.9 )	-0.5 ( 0.9 )
HAZ (SE late) [1290;1283;1317;0;0;0]	-1 ( 0.9 )	-1.1 ( 0.9 )	-1.1 ( 1 )	0 ( 0 )	0 ( 0 )	0 ( 0 )
WAZ (SE late) [1290;1283;1317;0;0;0]	-0.9 ( 0.9 )	-1 ( 0.9 )	-1 ( 0.8 )	0 ( 0 )	0 ( 0 )	0 ( 0 )
MUACZ (SE late) [1290;1283;1317;0;0;0]	-0.7 ( 0.8 )	-0.8 ( 0.9 )	-0.7 ( 0.8 )	0 ( 0 )	0 ( 0 )	0 ( 0 )

No statistical analyses for this end point

Secondary: Anti Plasmodium falciparum circumsporozoite (anti-CS) antibody concentrations in the 1st 200 subjects in each center

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End point title

Anti Plasmodium falciparum circumsporozoite (anti-CS) antibody concentrations in the 1st 200 subjects in each center ^[17]

End point description

End point type

Secondary

End point timeframe

At baseline & M3

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: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	C3C (5-17M) Group	C3C (6-12W) Group	RTS,S/AS01 (5-17M)	RTS,S/AS01 (6-12W) Group
Number of subjects analysed	529	627	1036	1234
Units: EL.U/mL
geometric mean (confidence interval 95%)
Anti-CS (Screening) [N=526;627;1036;1234]	0.3 (0.3 to 0.3)	0.4 (0.4 to 0.5)	0.3 (0.3 to 0.3)	0.4 (0.4 to 0.4)
Anti-CS (PIII[M3]) [N=529;627;1034;1221]	0.3 (0.3 to 0.3)	0.3 (0.3 to 0.3)	621 (591.5 to 651.9)	210.5 (198.2 to 223.6)

No statistical analyses for this end point

Secondary: Anti-CS antibody concentrations in the 1st 200 HIV-infected subjects in each center

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End point title

Anti-CS antibody concentrations in the 1st 200 HIV-infected subjects in each center ^[18]

End point description

Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value greater than or equal to (≥) 0.5 EL.U/mL. Results were assessed in the 1st 200 HIV-infected subjects enrolled in each study center. HIV infection was confirmed if present at screening or identified by morbidity surveillance, not infection confirmed by antibody testing after 18 months of age or by PCR by the time of the analysis of results up to the Month 14 time point for the respective 5-17 months and 6-12 weeks age categories.

End point type

Secondary

End point timeframe

At baseline & M3

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: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	C3C (5-17M) Group	C3C (6-12W) Group	RTS,S/AS01 (5-17M)	RTS,S/AS01 (6-12W) Group
Number of subjects analysed	17	5	29	25
Units: EL.U/mL
geometric mean (confidence interval 95%)
Anti-CS (Screening) [N=16;5;28;25]	0.4 (0.3 to 0.5)	0.3 (0.3 to 0.3)	0.3 (0.2 to 0.5)	0.3 (0.2 to 0.4)
Anti-CS (PIII[M3]) [N=17;5;29;24]	0.5 (0.2 to 1.7)	0.3 (0.3 to 0.3)	264.7 (137.5 to 509.6)	125.3 (58.1 to 270.3)

No statistical analyses for this end point

Secondary: Anti-CS antibody concentrations across sites

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End point title

Anti-CS antibody concentrations across sites

End point description

End point type

Secondary

End point timeframe

At M20, M21 & M32

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	63	61	60	66	69	64
Units: EL.U/mL
geometric mean (confidence interval 95%)
Anti-CS Agogo (PIII[M20]) [55;57;54;55;55;66]	34.1 (24 to 48.3)	52.1 (41.3 to 65.7)	0.3 (0.3 to 0.4)	5.1 (3.4 to 7.6)	5.6 (3.8 to 8.4)	0.3 (0.2 to 0.3)
Anti-CS Agogo (PIV[M21]) [51;53;53;55;55;65]	265 (220.9 to 317.9)	48.3 (37.6 to 61.9)	0.3 (0.2 to 0.3)	137.6 (95 to 199.3)	5.3 (3.5 to 8)	0.3 (0.2 to 0.3)
Anti-CS Agogo (PIV[M32]) [53;54;54;52;53;64]	46.3 (34.8 to 61.6)	28.8 (21.8 to 37.9)	0.3 (0.2 to 0.3)	14.8 (9.5 to 23.1)	2.9 (1.9 to 4.5)	0.3 (0.3 to 0.4)
Anti-CS Bagamoyo (PIII[M20]) [16;18;25;47;54;42]	26.6 (14.2 to 49.9)	23.1 (11.1 to 47.8)	0.3 (0.3 to 0.3)	6.9 (4.8 to 10)	7.6 (5.1 to 11.4)	0.3 (0.2 to 0.3)
Anti-CS Bagamoyo (PIV[M21]) [16;18;24;46;53;42]	306.6 (206.5 to 455.4)	31.8 (19.4 to 52.2)	0.6 (0.2 to 1.4)	169.9 (129.8 to 222.5)	7.2 (4.5 to 11.6)	0.3 (0.2 to 0.4)
Anti-CS Bagamoyo (PIV[M32]) [16;17;24;43;49;40	44.6 (27.2 to 73.3)	16.9 (10.2 to 27.9)	0.3 (0.3 to 0.3)	14.4 (9.6 to 21.7)	3.7 (2.4 to 5.7)	0.3 (0.3 to 0.3)
Anti-CS Kilifi (PIII[M20]) [N=43;50;42;43;56;53]	34.3 (26.3 to 44.7)	33.1 (26.3 to 41.6)	0.3 (0.3 to 0.3)	6.6 (4.6 to 9.6)	6.1 (4 to 9.4)	0.3 (0.2 to 0.3)
Anti-CS Kilifi (PIV[M21]) [N=40;49;41;41;54;51]	308.4 (251.8 to 377.7)	24.3 (18.1 to 32.8)	0.3 (0.3 to 0.3)	229.3 (175.4 to 299.9)	5.3 (3.4 to 8.2)	0.3 (0.3 to 0.3)
Anti-CS Kilifi (PIV[M32]) [N=42;47;39;42;51;50]	59.4 (45.7 to 77.2)	14.9 (11 to 20.2)	0.3 (0.3 to 0.4)	19.8 (14.1 to 27.8)	2.8 (1.8 to 4.4)	0.3 (0.3 to 0.3)
Anti-CS Kintampo (PIII[M20]) [N=57;51;52;52;55;46]	50.8 (37.2 to 69.5)	36.6 (26.4 to 50.7)	0.4 (0.3 to 0.5)	3.8 (2.5 to 5.8)	3.7 (2.5 to 5.6)	0.3 (0.3 to 0.4)
Anti-CS Kintampo (PIV[M21]) [N=54;47;47;47;50;43]	266.8 (188.9 to 377)	41.2 (31.2 to 54.6)	0.3 (0.2 to 0.3)	128.8 (95.7 to 173.4)	3.2 (2 to 5)	0.3 (0.3 to 0.4)
Anti-CS Kintampo (PIV[M32]) [N=50;46;49;47;47;42]	70.9 (55.2 to 90.9)	20.2 (14.3 to 28.5)	0.4 (0.3 to 0.5)	13.3 (8.1 to 21.9)	2.2 (1.4 to 3.4)	0.3 (0.3 to 0.3)
Anti-CS Kombewa (PIII[M20]) [N=54;50;60;54;54;54]	39.8 (29.9 to 53)	46.6 (33.2 to 65.3)	0.3 (0.3 to 0.4)	5.5 (3.6 to 8.4)	8.7 (5.8 to 13)	0.4 (0.3 to 0.5)
Anti-CS Kombewa (PIV[M21]) [N=52;50;59;50;51;52]	308.5 (252.4 to 377)	37.1 (26.7 to 51.5)	0.4 (0.3 to 0.4)	146.3 (96.6 to 221.6)	9.2 (6 to 14.2)	0.4 (0.3 to 0.5)
Anti-CS Kombewa (PIV[M32]) [N=48;46;56;46;48;51]	53.8 (40.3 to 71.7)	19.8 (14.1 to 27.7)	0.3 (0.3 to 0.4)	8.3 (4.8 to 14.3)	4.3 (2.8 to 6.6)	0.4 (0.3 to 0.4)
Anti-CS Korogwe (PIII[M20]) [N=55;61;52;52;48;57]	29.4 (21.4 to 40.4)	28.2 (22.5 to 35.3)	0.3 (0.3 to 0.3)	7.9 (5.3 to 11.8)	8.1 (5.2 to 12.7)	0.3 (0.2 to 0.3)
Anti-CS Korogwe (PIV[M21]) [N=50;61;48;50;46;54]	305.6 (266.4 to 350.5)	27.1 (20.7 to 35.5)	0.3 (0.2 to 0.3)	178.3 (141.2 to 225.1)	7.6 (4.8 to 11.9)	0.3 (0.2 to 0.4)
Anti-CS Korogwe (PIV[M32]) [N=52;56;44;49;42;48]	47.4 (37.5 to 59.9)	16.8 (13.1 to 21.7)	0.3 (0.2 to 0.3)	19.6 (13 to 29.6)	4.9 (3 to 7.9)	0.3 (0.2 to 0.3)
Anti-CS Lambarene (PIII[M20]) [N=32;30;29;44;46;39	8.2 (5.8 to 11.6)	11.1 (7 to 17.6)	0.3 (0.2 to 0.3)	7.7 (5.1 to 11.6)	8.3 (5.8 to 12.1)	0.3 (0.3 to 0.3)
Anti-CS Lambarene (PIV[M21]) [N=32;30;29;43;45;35]	203.6 (155.1 to 267.3)	10.6 (6.6 to 16.8)	0.3 (0.2 to 0.3)	251.3 (184.8 to 341.7)	7.4 (5 to 10.8)	0.3 (0.2 to 0.3)
Anti-CS Lambarene (PIV[M32]) [N=29;29;27;38;43;33]	23 (15.6 to 33.9)	5.9 (3.6 to 9.9)	0.3 (0.2 to 0.4)	21 (13.9 to 31.7)	4.1 (2.9 to 5.8)	0.3 (0.2 to 0.3)
Anti-CS Lilongwe (PIII[M20]) [N=21;17;25;48;46;53]	45.9 (28.6 to 73.8)	22.2 (11.2 to 44)	0.4 (0.2 to 0.7)	5.1 (3.2 to 8.3)	7.4 (4.7 to 11.5)	0.3 (0.3 to 0.4)
Anti-CS Lilongwe (PIV[M21]) [N=23;15;24;44;45;51]	285 (228.5 to 355.4)	17 (8.1 to 35.7)	0.3 (0.2 to 0.4)	126.1 (92.7 to 171.5)	8 (5.2 to 12.1)	0.3 (0.2 to 0.4)
Anti-CS Lilongwe (PIV[M32]) [N=19;16;22;45;46;50]	45.6 (28.8 to 72.3)	12.7 (6.4 to 25.3)	0.3 (0.2 to 0.4)	15.4 (9.3 to 25.4)	4.5 (3.1 to 6.6)	0.3 (0.2 to 0.3)
Anti-CS Nanoro (PIII[M20]) [N=63;60;56;50;69;53]	57.2 (43.4 to 75.4)	61.8 (46.3 to 82.4)	0.3 (0.3 to 0.3)	2.7 (1.7 to 4.4)	3.2 (2.1 to 4.7)	0.3 (0.3 to 0.4)
Anti-CS Nanoro (PIV[M21]) [N=63;60;56;50;68;53]	520.5 (443.4 to 611.1)	71.1 (54.8 to 92.3)	0.3 (0.2 to 0.3)	163.2 (121.4 to 219.4)	3.1 (2 to 4.6)	0.3 (0.3 to 0.4)
Anti-CS Nanoro (PIV[M32]) [N=60;57;51;45;66;51]	69.2 (55.2 to 86.9)	35 (25.7 to 47.9)	0.3 (0.3 to 0.3)	11.9 (7.4 to 19.2)	2.8 (2 to 4)	0.5 (0.4 to 0.6)
Anti-CS Siaya (PIII[M20]) [N=46;44;31;40;40;48]	28.4 (18.4 to 44)	32.8 (21.6 to 50.1)	0.3 (0.3 to 0.4)	7 (4.2 to 11.5)	8.9 (5.5 to 14.2)	0.4 (0.3 to 0.5)
Anti-CS Siaya (PIV[M21]) [N=45;42;28;41;39;45]	398.1 (324.6 to 488.2)	36.4 (22.6 to 58.6)	0.3 (0.2 to 0.4)	171.5 (109.8 to 267.9)	8.4 (5.2 to 13.6)	0.4 (0.3 to 0.5)
Anti-CS Siaya (PIV[M32]) [N=45;40;27;36;36;42]	55.8 (41.4 to 75.3)	21.7 (13.4 to 35.1)	0.4 (0.3 to 0.5)	23.6 (14.2 to 39.1)	5.5 (3.3 to 9.2)	0.5 (0.4 to 0.7)
Anti-CS Manhica (PIII[M20]) [N=0;0;0;45;46;43]	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	12.3 (8.4 to 18.1)	14.7 (10 to 21.5)	0.3 (0.3 to 0.3)
Anti-CS Manhica (PIV[M21]) [N=0;0;0;36;38;28]	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	260.2 (176.4 to 383.8)	12.3 (7.7 to 19.5)	0.3 (0.2 to 0.3)
Anti-CS Manhica (PIV[M32]) [N=0;0;0;35;34;30]	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	25.4 (14.8 to 43.5)	6.8 (4 to 11.5)	0.3 (0.3 to 0.3)

No statistical analyses for this end point

Secondary: Anti-CS antibody concentrations by site in Agogo, Lilongwe and Siaya

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End point title

Anti-CS antibody concentrations by site in Agogo, Lilongwe and Siaya

End point description

End point type

Secondary

End point timeframe

At M44 & SE

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	104	101	98	101	103	131
Units: EL.U/mL
geometric mean (confidence interval 95%)
Anti-CS Agogo (PIII[M44]) [N=47;50;45;0;0;0	27.7 (20.1 to 38.1)	17.9 (13.5 to 23.6)	0.3 (0.2 to 0.3)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)
Anti-CS Agogo (SE) [N=47;48;49;32;35;51]	23.2 (16.7 to 32.3)	17.2 (12.7 to 23.3)	0.3 (0.2 to 0.3)	6.1 (3.2 to 11.4)	2.1 (1.3 to 3.4)	0.3 (0.2 to 0.4)
Anti-CS Lilongwe (PIII[M44]) [N=15;16;19;0;0;0]	30.5 (21.4 to 43.5)	8.5 (4.5 to 15.9)	0.3 (0.2 to 0.3)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)
Anti-CS Lilongwe (SE) [N=16;17;23;35;38;42]	26.9 (18.3 to 39.5)	7.2 (4.1 to 12.5)	0.3 (0.3 to 0.3)	10.9 (6.3 to 18.7)	2.8 (1.8 to 4.2)	0.3 (0.2 to 0.3)
Anti-CS Siaya (PIII[M44]) [N=41;35;22;0;0;0]	41.4 (29.7 to 57.9)	21.2 (14 to 32)	0.5 (0.4 to 0.8)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)
Anti-CS Siaya (SE) [N=41;34;26;34;30;38]	27.4 (19.4 to 38.9)	15.8 (10.2 to 24.4)	0.4 (0.3 to 0.6)	10.4 (6.1 to 17.7)	3.3 (1.9 to 5.6)	0.4 (0.3 to 0.6)
Anti-CS Across (PIV[M44]) [N=103;101;86;0;0;0]	33 (26.9 to 40.3)	16.8 (13.5 to 21)	0.3 (0.3 to 0.4)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)
Anti-CS Across (SE) [N=104;99;98;101;103;131]	25.4 (20.6 to 31.2)	14.4 (11.4 to 18.1)	0.3 (0.3 to 0.4)	8.9 (6.5 to 12.3)	2.6 (2 to 3.4)	0.3 (0.3 to 0.4)

No statistical analyses for this end point

Secondary: Anti-CS antibody concentrations in the first 200 subjects in each center, by tertiles

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End point title

Anti-CS antibody concentrations in the first 200 subjects in each center, by tertiles ^[19]

End point description

End point type

Secondary

End point timeframe

At Study Month 3

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: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	R3C (5-17M) Group	R3C (6-12W) Group
Number of subjects analysed	545	639
Units: EL.U/mL
geometric mean (confidence interval 95%)
Anti-CS At Month 3 – Tertile 1 (N=181;212)	264.15 (238.2 to 292.9)	78.45 (69.4 to 88.6)
Anti-CS At Month 3 – Tertile 2 (N=182;214)	613.79 (598.3 to 629.7)	230.68 (224.7 to 236.8)
Anti-CS At Month 3 – Tertile 3 (N=182;213)	1351.41 (1276.3 to 1431)	592.65 (557.8 to 629.6)
Anti-CS At Month 3 – Across Tertiles (N=545;639)	603.77 (563.6 to 646.8)	220.9 (204.1 to 239)

No statistical analyses for this end point

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of primary case definition (PCD) by tertile

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End point title

Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of primary case definition (PCD) by tertile ^[20]

End point description

CPFMI of PCD = episode of malaria for which PFAP>5000 parasites/µL accompanied by presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, number of CPFMI events reported (n) over period elapsed until all CPFMI events reported occurred for each group (T in year = sum of FU period in years censored at last occurrence of event in each group). RaCPFMI was calculated by tertile of anti-CS response post primary vaccination pooled across sites, on subjects in R3C (5-17M; 6-12W) (or R3C below) and C3C (5-17M; 6-12W) (or C3C below) groups taking into account the first 200 participants per site.

End point type

Secondary

End point timeframe

From Month 2.5 to Month 32

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: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	R3C (5-17M) Group	C3C (5-17M) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	182	565	214	677
Units: n/T
number (not applicable)
R3C Tertile 1 & C3C Tertile 1 (N=181;565;212;677	0.68	1.21	1.29	0.93
R3C Tertile 2 & C3C Tertile 2 (N=182;565;214;677)	0.78	1.21	0.7	0.93
R3C Tertile 3 & C3C Tertile 3 (N=182;565;213;677)	1.03	1.21	0.58	0.93

No statistical analyses for this end point

Secondary: Anti-CS antibody concentrations in the first 200 subjects in each center, by tertiles

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End point title

Anti-CS antibody concentrations in the first 200 subjects in each center, by tertiles ^[21]

End point description

End point type

Secondary

End point timeframe

At Study Month 21

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: Due to the complex study design and multiple time points, the study results were presented across multiple end points, covering the baseline groups.

End point values	R3R (5-17M) Group	R3R (6-12W) Group
Number of subjects analysed	465	546
Units: EL.U/mL
geometric mean (confidence interval 95%)
Anti-CS At Month 21 – Tertile 1 (N=154;181)	138.15 (123.5 to 154.5)	47.99 (41.2 to 55.9)
Anti-CS At Month 21 – Tertile 2 (N=156;183)	311.35 (303.4 to 319.6)	194.85 (189.9 to 200)
Anti-CS At Month 21 – Tertile 3 (N=155;182)	675.24 (632.8 to 720.5)	479.44 (446.8 to 514.5)
Anti-CS At Month 21 – Across Tertiles (N=465;546)	307.93 (286.2 to 331.3)	165.31 (150 to 182.2)

No statistical analyses for this end point

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of primary case definition (PCD) by tertile

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End point title

Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of primary case definition (PCD) by tertile ^[22]

End point description

CPFMI of PCD = episode of malaria for which PFAP>5000 parasites/µL accompanied by presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, number of CPFMI events reported (n) over period elapsed until all CPFMI events reported occurred for each group (T in year = sum of FU period in years censored at last occurrence of event in each group). RaCPFMI was calculated by tertile of anti-CS response post booster vaccination pooled across sites, on subjects in R3R (5-17M; 6-12W) (or R3R below) and C3C (5-17M; 6-12W) (or C3C below) groups taking into account the first 200 participants per site.

End point type

Secondary

End point timeframe

From Booster at Month 20 to Month 32

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: Due to the complex study design and multiple time points, the study results were presented across multiple end points, covering the baseline groups.

End point values	R3R (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	156	479	420	594
Units: n/T
number (not applicable)
R3R Tertile 1 & C3C Tertile 1 (N=154;479;420;594)	0.68	1.21	0.99	0.94
R3R Tertile 2 & C3C Tertile 2 (N=156;479;362;594)	0.68	1.21	0.84	0.94
R3R Tertile 3 & C3C Tertile 3 (N=155;479;276;594)	0.77	1.21	0.64	0.94

No statistical analyses for this end point

Secondary: Anti-Hepatitis B (anti-HBs) antibody concentrations in the 1st 200 subjects in each center

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End point title

Anti-Hepatitis B (anti-HBs) antibody concentrations in the 1st 200 subjects in each center ^[23]

End point description

End point type

Secondary

End point timeframe

At baseline & M3

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: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	C3C (5-17M) Group	C3C (6-12W) Group	RTS,S/AS01 (5-17M)	RTS,S/AS01 (6-12W) Group
Number of subjects analysed	526	627	1029	1213
Units: mIU/mL
geometric mean (confidence interval 95%)
Anti-HBs (Screening) [N=515;561;1017;1120]	168.6 (142.8 to 199.2)	8.5 (7.7 to 9.4)	166.3 (148 to 186.8)	8.6 (8 to 9.3)
Anti-HBs (PIII[M3]) [N=526;627;1029;1213]	127.5 (108.8 to 149.4)	728.8 (643.6 to 825.2)	81567.7 (75442.7 to 88189.9)	13674.3 (12811.5 to 14595.3)

No statistical analyses for this end point

Secondary: Anti-HBs antibody concentrations in the 1st 200 HIV-infected subjects in each center

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End point title

Anti-HBs antibody concentrations in the 1st 200 HIV-infected subjects in each center ^[24]

End point description

Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The seropositivity and seroprotection cut-offs were than or equal to (≥) 10 and 100 mIU/mL, respectively. Results were assessed in the 1st 200 HIV-infected subjects enrolled in each study center. HIV infection was confirmed if present at screening or identified by morbidity surveillance, not infection confirmed by antibody testing after 18 months of age or by PCR by the time of the analysis of results up to the Month 14 time point for the respective 5-17 months and 6-12 weeks age categories.

End point type

Secondary

End point timeframe

At baseline & M3

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: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	C3C (5-17M) Group	C3C (6-12W) Group	RTS,S/AS01 (5-17M)	RTS,S/AS01 (6-12W) Group
Number of subjects analysed	17	5	29	25
Units: mIU/mL
geometric mean (confidence interval 95%)
Anti-HBs (Screening) [N=15;5;28;25]	63.6 (19.4 to 208.4)	5 (5 to 5)	98.6 (43.8 to 222)	7.5 (4.8 to 11.6)
Anti-HBs (PIII[M3]) [N=17;5;29;24]	37.1 (9.1 to 151.9)	197.2 (7.7 to 5081.7)	37476.5 (17766 to 79054.9)	1996.2 (561.6 to 7095.8)

No statistical analyses for this end point

Secondary: Anti-HBs antibody titers in the first 200 subjects in each center

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End point title

Anti-HBs antibody titers in the first 200 subjects in each center ^[25]

End point description

End point type

Secondary

End point timeframe

At M20 & M21

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: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	R3R (5-17M) Group	R3R (6-12W) Group
Number of subjects analysed	95	134
Units: mIU/mL
geometric mean (confidence interval 95%)
Anti-HBs (PIII[M20]) (N=95;134)	5068.5 (3711.3 to 6922)	1532.5 (1240.6 to 1893.2)
Anti-HBs (PIV[M21]) (N=94;48)	95206.4 (72395.4 to 125204.9)	116458.1 (86865.7 to 156131.6)

No statistical analyses for this end point

Secondary: Anti-Poliomyelitis 1, 2 & 3 antibody titers

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End point title

Anti-Poliomyelitis 1, 2 & 3 antibody titers ^[26]

End point description

Anti-Polio 1, 2 and 3 antibody titers were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seroprotection cut -off for the assay was ≥1:8.

End point type

Secondary

End point timeframe

At baseline & M3

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: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	C3C (6-12W) Group	RTS,S/AS01 (6-12W) Group
Number of subjects analysed	474	931
Units: Titer
geometric mean (confidence interval 95%)
Anti-Polio 1 (Screening) [N=469;928]	43.3 (36.2 to 51.9)	47.4 (41.7 to 53.8)
Anti-Polio 1(PIII[M3]) [N=464;913]	417.6 (351.4 to 496.2)	334.9 (295.2 to 379.8)
Anti-Polio 2 (Screening) [N=468;928]	40.3 (34.2 to 47.5)	38.6 (34.6 to 43.2)
Anti-Polio 2 (PIII[M3]) [N=466;913]	450.8 (393.9 to 516)	372.1 (334.5 to 414)
Anti-Polio 3 (Screening) [N=474;931]	9.1 (8 to 10.3)	9.4 (8.6 to 10.3)
Anti-Polio 3 (PIII[M3]) [N=466;913]	95.9 (82 to 112.2)	80 (71 to 90.1)

No statistical analyses for this end point

Secondary: Subjects with solicited local symptoms post PRI in 1st 200 subjects in each center

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End point title

Subjects with solicited local symptoms post PRI in 1st 200 subjects in each center ^[27]

End point description

Solicited local symptoms assessed include pain, redness and swelling. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity.

End point type

Secondary

End point timeframe

Post Primary vaccination (PRI)

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: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	C3C (5-17M) Group	C3C (6-12W) Group	RTS,S/AS01 (5-17M)	RTS,S/AS01 (6-12W) Group
Number of subjects analysed	721	738	1479	1462
Units: Subjects
Any Pain Dose 1 [N=721;738;1479;1462]	61	215	247	435
Any Redness Dose 1 [N=721;738;1479;1462]	26	89	66	176
Any Swelling Dose 1 [N=721;738;1479;1462]	77	125	140	227
Any Pain Dose 2 [N=708;721;1435;1412]	41	178	179	383
Any Redness Dose 2 [N=708;721;1435;1412]	18	90	26	124
Any Swelling Dose 2 [N=708;721;1435;1412]	50	128	140	228
Any Pain Dose 3 [N=699;710;1407;1378]	22	153	108	345
Any Redness Dose 3 [N=699;710;1407;1378]	13	63	42	113
Any Swelling Dose 3 [N=699;710;1407;1378]	35	111	134	185

No statistical analyses for this end point

Secondary: Subjects with solicited general symptoms post PRI in 1st 200 subjects in each center

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End point title

Subjects with solicited general symptoms post PRI in 1st 200 subjects in each center ^[28]

End point description

Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.

End point type

Secondary

End point timeframe

Post Primary vaccination (PRI)

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: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	C3C (5-17M) Group	C3C (6-12W) Group	RTS,S/AS01 (5-17M)	RTS,S/AS01 (6-12W) Group
Number of subjects analysed	721	738	1479	1462
Units: Subjects
Any Drowsiness Dose 1 [N=721;738;1479;1462]	27	65	91	164
Any Irritability Dose 1 [N=721;738;1479;1462]	41	157	165	370
Any Loss of appetite Dose 1 [N=721;738;1479;1462]	71	52	202	124
Any Temperature Dose 1 [N=721;738;1479;1462]	108	192	385	459
Any Drowsiness Dose 2 [N=708;721;1435;1412]	37	55	99	135
Any Irritability Dose 2 [N=708;721;1435;1412]	45	123	192	289
Any Loss of appetite Dose 2 [N=708;721;1435;1412]	47	43	151	105
Any Temperature Dose 2 [N=708;721;1435;1412]	100	154	503	411
Any Drowsiness Dose 3 [N=699;710;1407;1378]	29	44	97	124
Any Irritability Dose 3 [N=699;710;1407;1378]	27	104	138	287
Any Loss of appetite Dose 3 [N=699;710;1407;1378]	40	45	138	106
Any Temperature Dose 3 [N=699;710;1407;1378]	77	111	457	429

No statistical analyses for this end point

Secondary: Subjects with solicited local symptoms post Boost in 1st 200 subjects in each center

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End point title

Subjects with solicited local symptoms post Boost in 1st 200 subjects in each center

End point description

Solicited local symptoms assessed include pain, redness and swelling. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity.

End point type

Secondary

End point timeframe

Post Booster vaccination (BST)

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	641	639	633	608	625	621
Units: Subjects
Any Pain	109	45	41	59	20	25
Any Redness	15	13	8	9	12	9
Any Swelling	42	35	30	45	28	43

No statistical analyses for this end point

Secondary: Subjects with solicited general symptoms post Boost in 1st 200 subjects in each center

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End point title

Subjects with solicited general symptoms post Boost in 1st 200 subjects in each center

End point description

End point type

Secondary

End point timeframe

Post Booster vaccination (BST)

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	641	639	633	608	625	621
Units: Subjects
Any Drowsiness	55	22	21	33	19	15
Any Irritability	63	25	18	46	23	23
Any Loss of appetite	66	27	21	45	27	18
Any Temperature	233	70	45	152	52	58

No statistical analyses for this end point

Secondary: Subjects with seizures by diagnostic certainty level

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End point title

Subjects with seizures by diagnostic certainty level

End point description

End point type

Secondary

End point timeframe

Post BST by diagnostic certainty level

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	2447	2472	2473	1825	1837	1827
Units: Subjects
Diagnostic certainty Level 1	1	1	0	1	0	0
Diagnostic certainty Level 2	5	2	1	3	0	1
Diagnostic certainty Level 3	0	0	0	0	0	0
Diagnostic certainty Level 4	1	0	0	0	0	0
Diagnostic certainty Level 5	1	1	0	0	0	0

No statistical analyses for this end point

Secondary: Subjects with mucocutaneous changes reported (all levels) in 1st 200 subjects in each centre

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End point title

Subjects with mucocutaneous changes reported (all levels) in 1st 200 subjects in each centre ^[29]

End point description

End point type

Secondary

End point timeframe

Post Booster vaccination (BST)

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: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	605	617	614
Units: Subjects
Cutaneous and/or mucosal change	64	47	59

No statistical analyses for this end point

Secondary: Subjects with meningitis and encephalitis SAEs

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End point title

Subjects with meningitis and encephalitis SAEs

End point description

End point type

Secondary

End point timeframe

At Month0-Study End (SE)

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	2976	2972	2974	2180	2178	2179
Units: Subjects
Any Meningitis and Encephalitis	15	12	5	7	8	7

No statistical analyses for this end point

Secondary: Subjects with meningitis and encephalitis SAEs

Top of page

End point title

Subjects with meningitis and encephalitis SAEs

End point description

End point type

Secondary

End point timeframe

Booster (BST) to Study End (SE)

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	2681	2719	2702	1966	1996	1976
Units: Subjects
Any Meningitis and Encephalitis	4	4	0	0	2	3

No statistical analyses for this end point

Secondary: Subjects with potential immune-mediated disorders (pIMDs)

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End point title

Subjects with potential immune-mediated disorders (pIMDs)

End point description

End point type

Secondary

End point timeframe

From Month0-Study End (SE)

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	2976	2972	2974	2180	2178	2179
Units: Subjects
Any pIMD(s)	5	1	4	3	1	2

No statistical analyses for this end point

Secondary: Subjects with unsolicited adverse events (AEs)

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End point title

Subjects with unsolicited adverse events (AEs) ^[30]

End point description

End point type

Secondary

End point timeframe

Post PRI in 1st 200 subjects in each center

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: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	C3C (5-17M) Group	C3C (6-12W) Group	RTS,S/AS01 (5-17M)	RTS,S/AS01 (6-12W) Group
Number of subjects analysed	721	738	1479	1462
Units: Subjects
Any AE(s)	626	600	1273	1161

No statistical analyses for this end point

Secondary: Subjects with unsolicited AEs related or leading to vaccine withdrawal

Top of page

End point title

Subjects with unsolicited AEs related or leading to vaccine withdrawal ^[31]

End point description

End point type

Secondary

End point timeframe

Post PRI in 1st 200 subjects in each center

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: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	C3C (5-17M) Group	C3C (6-12W) Group	RTS,S/AS01 (5-17M)	RTS,S/AS01 (6-12W) Group
Number of subjects analysed	2003	2179	3997	4358
Units: Subjects
Any AE(s)	72	231	399	578

No statistical analyses for this end point

Secondary: Subjects with unsolicited AEs

Top of page

End point title

Subjects with unsolicited AEs

End point description

End point type

Secondary

End point timeframe

Post Booster (BST) in 1st 200 in each center

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	641	639	633	608	625	621
Units: Subjects
Any AE(s)	232	205	215	231	239	240

No statistical analyses for this end point

Secondary: Subjects with unsolicited AEs related to or leading to vaccination withdrawal in the low-weight (LW) and very low weight (VLW) category

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End point title

Subjects with unsolicited AEs related to or leading to vaccination withdrawal in the low-weight (LW) and very low weight (VLW) category ^[32]

End point description

End point type

Secondary

End point timeframe

Post Pri among 1st 200 subjects in each center in HIV infected subjects

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: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	C3C (5-17M) Group	C3C (6-12W) Group	RTS,S/AS01 (5-17M)	RTS,S/AS01 (6-12W) Group
Number of subjects analysed	364	126	695	221
Units: Subjects
Any AE(s), in LW (N=364;126;695;221)	21	17	68	38
Any AE(s), in VLW (N=97;67;207;147	6	10	27	24

No statistical analyses for this end point

Secondary: Subjects with unsolicited AEs related to or leading to vaccination withdrawal

Top of page

End point title

Subjects with unsolicited AEs related to or leading to vaccination withdrawal

End point description

End point type

Secondary

End point timeframe

Post Pri and Post BST among 1st 200 subjects in each center in HIV infected subjects

End point values	RTS,S/AS01 Group	R3R Group	R3C Group	C3C Group
Number of subjects analysed	84	33	35	41
Units: Subjects
Any AE(s) post PRI (N=84;0;0;41)	13	0	0	3
Any AE(s) post BST (N=0;33;35;28)	0	2	0	0

No statistical analyses for this end point

Secondary: Subjects with unsolicited AEs related to or leading to vaccination withdrawal in the low-weight (LW) and very low weight (VLW) category

Top of page

End point title

Subjects with unsolicited AEs related to or leading to vaccination withdrawal in the low-weight (LW) and very low weight (VLW) category

End point description

End point type

Secondary

End point timeframe

Post Booster (BST) among 1st 200 in each center in HIV infected among 1st 200 in each center

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	273	297	293	230	208	195
Units: Subjects
Any AE(s) in LW (N=273;297;293;230;208;195)	4	1	0	2	0	1
Any AE(s) in VLW (N=48;49;59;45;45;68)	5	0	0	2	0	0

No statistical analyses for this end point

Secondary: Subjects with serious adverse events (SAEs)

Top of page

End point title

Subjects with serious adverse events (SAEs) ^[33]

End point description

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

End point type

Secondary

End point timeframe

From Month0-Month 14

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: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	C3C (5-17M) Group	C3C (6-12W) Group	RTS,S/AS01 (5-17M)	RTS,S/AS01 (6-12W) Group
Number of subjects analysed	2974	2179	5949	4358
Units: Subjects
Any SAE(s)	634	419	1040	782

No statistical analyses for this end point

Secondary: Subjects with serious adverse events (SAEs)

Top of page

End point title

Subjects with serious adverse events (SAEs) ^[34]

End point description

End point type

Secondary

End point timeframe

30 days post primary vaccination (PRI)

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: Due to the complex study design and number of time points covered, the results were presented over multiple end points.

End point values	C3C (5-17M) Group	C3C (6-12W) Group	RTS,S/AS01 (5-17M)	RTS,S/AS01 (6-12W) Group
Number of subjects analysed	2974	2179	5949	4358
Units: Subjects
Any SAE(s)	181	96	312	192

No statistical analyses for this end point

Secondary: Subjects with SAEs

Top of page

End point title

Subjects with SAEs ^[35]

End point description

End point type

Secondary

End point timeframe

From Month 0 to Month 20

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: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	C3C (5-17M) Group	C3C (6-12W) Group	RTS,S/AS01 (5-17M)	RTS,S/AS01 (6-12W) Group
Number of subjects analysed	2974	2179	5949	4358
Units: Subjects
Any SAE(s), M0-M20	676	503	1108	959

No statistical analyses for this end point

Secondary: Subjects with SAEs

Top of page

End point title

Subjects with SAEs

End point description

End point type

Secondary

End point timeframe

From Booster at Month 20 to Study end

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	2681	2719	2702	1966	1996	1976
Units: Subjects
Any SAE(s)	276	316	287	180	193	201

No statistical analyses for this end point

Secondary: Subjects with SAEs

Top of page

End point title

Subjects with SAEs

End point description

End point type

Secondary

End point timeframe

From Month 0 to Study End

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	2976	2972	2974	2180	2178	2179
Units: Subjects
Any SAE(s), M0-Study End	720	752	846	580	602	619

No statistical analyses for this end point

Secondary: Subjects with SAEs

Top of page

End point title

Subjects with SAEs

End point description

End point type

Secondary

End point timeframe

30 days post Booster

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	2447	2472	2473	1825	1837	1827
Units: Subjects
Any SAE(s), 30 Days post Booster	34	22	27	19	19	20

No statistical analyses for this end point

Secondary: Subjects with SAEs

Top of page

End point title

Subjects with SAEs

End point description

End point type

Secondary

End point timeframe

From Month0-Month 20 (Booster),from Month20-Study End (SE), and from Month0-Study End

End point values	R3R Group	R3C Group	C3C Group
Number of subjects analysed	51	54	48
Units: Subjects
Any SAE(s), M0-M20 (N=51;54;48	43	39	36
Any SAE(s), M20-SE (N=38;42;32)	19	19	16
Any SAE(s), M0-SE (N=51;54;48)	47	46	42

No statistical analyses for this end point

Secondary: Subjects with SAEs in LW at baseline

Top of page

End point title

Subjects with SAEs in LW at baseline ^[36]

End point description

End point type

Secondary

End point timeframe

Month0-Month20

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: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	C3C (5-17M) Group	C3C (6-12W) Group	RTS,S/AS01 (5-17M)	RTS,S/AS01 (6-12W) Group
Number of subjects analysed	364	126	695	221
Units: Subjects
Any SAE(s)	89	38	174	63

No statistical analyses for this end point

Secondary: Subjects with SAEs with LW

Top of page

End point title

Subjects with SAEs with LW

End point description

End point type

Secondary

End point timeframe

From Booster-Study End in Low Weight at Booster

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	277	304	297	232	211	195
Units: Subjects
Any SAE(s)	32	40	38	34	21	24

No statistical analyses for this end point

Secondary: Subjects with SAEs in VLW at baseline

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End point title

Subjects with SAEs in VLW at baseline ^[37]

End point description

The SAEs were reported in subjects of very low weight (VLW) at baseline

End point type

Secondary

End point timeframe

From Month 0-Month20

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: As per the study design, some results were presented for pooled study groups, included in the analysis subsets but accounting for 2 or more of the baseline groups.

End point values	C3C (5-17M) Group	C3C (6-12W) Group	RTS,S/AS01 (5-17M)	RTS,S/AS01 (6-12W) Group
Number of subjects analysed	97	67	207	147
Units: Subjects
Any SAE(s)	28	17	55	48

No statistical analyses for this end point

Secondary: Subjects with SAEs

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End point title

Subjects with SAEs

End point description

End point type

Secondary

End point timeframe

Booster-Study End in VLW at Booster

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	48	50	60	48	47	68
Units: Subjects
Any SAE(s)	5	8	11	6	9	15

No statistical analyses for this end point

Other pre-specified: Number (%) of subjects with fatal outcomes, by gender

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End point title

Number (%) of subjects with fatal outcomes, by gender

End point description

Mortality was presented as overall mortality (OM up to M20 and up to study end), mortality due to severe malaria as per secondary case definition(SM SCD), cerebral malaria as per secondary case definition (CM SCD), meningitis (Men), fatal all-cause traumas (FAT) and fatal malaria (FM). SCD= Plasmodium falciparum malaria > 5000 parasites/mcLand 1 or more markers of severe malaria (prostration, respiratory distress, Blantyre score =<2, seizures 2 or more, hypoglycemia < 2.2 mmol/L, acidosis BE =<-10.0 mmol/L,lactate >= 5.0 mmol/L, anemia < 5.0 g/dL.

End point type

Other pre-specified

End point timeframe

From Month 0 to Study End (study end in 5-17 months age category, with a median follow-up time of 48 months post Dose 1 and in 6-12 weeks age category, with a median follow-up time of 38 months post Dose 1)

End point values	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	C3C (6-12W) Group
Number of subjects analysed	2976	2972	2974	2180	2139	2179
Units: Subjects
OM (M0-M20) Females	27	20	14	20	24	13
OM (M0-SE) Females	35	32	17	27	29	16
OM (M0-M20) Males	19	8	19	20	29	21
OM (M0-SE) Males	26	19	29	24	26	26
SM SCD, All, Females	75	107	100	57	49	75
SM SCD, All, Males	87	115	134	78	80	79
SM SCD, Fatal, Females	4	4	2	2	0	0
SM SCD, Fatal, Males	3	4	2	2	2	2
CM SCD, All, Females	16	14	7	1	5	7
CM SCD, All, Males	10	14	9	9	7	3
CM SCD, Fatal, Females	3	4	2	1	0	0
CM SCD, Fatal, Males	2	1	0	1	1	0
FAT, Females	3	4	1	1	1	2
FAT, Males	4	1	3	1	2	0
FM, Females	9	8	4	5	4	3
FM, Males	4	9	8	3	8	3
Men, All, Females	5	5	1	2	2	3
Men, All, Males	6	5	2	3	5	3
Men, Fatal, Females	2	3	0	0	0	1
Men, Fatal, Males	2	0	1	1	1	2

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Solicited and unsolicited AEs: respectively 7-day (D) (D0-6) & 30-D (D0-29) follow-up (FU) periods post vaccination (PRI or BST); SAEs: Month [M] 0 to study end (median FU = 48M in 5-17M subjects & 38M for 6-12W subjects).

Adverse event reporting additional description

In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’. Occurrence of reported AEs (all/related) was not available & is encoded as equal to number of subjects affected.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

17.0

Reporting group title

R3R (5-17M) Group

Reporting group description

Reporting group title

R3C (5-17M) Group

Reporting group description

Subjects in this group, aged 5 to 17 months at first vaccination, received a 3-dose primary vaccination course of the RTS,S/AS01 vaccine (also referred to as RTS,S or GSK 257049, vaccine) according to a Month 0, 1 and 2 followed by a booster dose of Menjugate (or MenC vaccine) administered at Month 20. The RTS,S/AS01 and MenC vaccines were administered intramuscularly in the left deltoid.

Reporting group title

C3C (5-17M) Group

Reporting group description

Reporting group title

R3R (6-12W) Group

Reporting group description

Reporting group title

R3C (6-12W) Group

Reporting group description

Subjects in this group, aged 6 to 12 weeks at first vaccination, received a 3-dose primary vaccination course of the RTS,S/AS01 vaccine (also referred to as RTS,S or GSK 257049, vaccine) co-administered with Polio Sabin (or OPV vaccine) and Tritanrix HepB/Hib (or DTPwHepB/Hib vaccine) (reconstituted from Tritanrix HepB and Hiberix vaccines) according to a Month 0, 1 and 2 followed by a booster dose of dose of Menjugate (or MenC vaccine) co-administered with OPV vaccine at Month 20. All vaccines were administered intramuscularly, except the OPV vaccine given orally; the primary RTS,S/AS01 vaccine doses were injected in the anterolateral left thigh; the MenC vaccine was injected in the left thigh for children < 1 year of age and into the left deltoid in children > 1 year of age; the DTPwHepB/Hib vaccine was injected in the anterolateral right thigh.

Reporting group title

RTS,S/AS01 (5-17M) Group

Reporting group description

Reporting group title

C3C (6-12W) Group

Reporting group description

Reporting group title

RTS,S/AS01 (6-12W) Group

Reporting group description

Serious adverse events	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	RTS,S/AS01 (5-17M) Group	C3C (6-12W) Group	RTS,S/AS01 (6-12W) Group
Total subjects affected by serious adverse events
subjects affected / exposed	720 / 2976 (24.19%)	752 / 2972 (25.30%)	846 / 2974 (28.45%)	580 / 2180 (26.61%)	602 / 2178 (27.64%)	0 / 1479 (0.00%)	619 / 2179 (28.41%)	0 / 1462 (0.00%)
number of deaths (all causes)	61	51	46	51	55	0	42	0
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute promyelocytic leukaemia
subjects affected / exposed ^[1]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
Brain neoplasm
subjects affected / exposed ^[2]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Inflammatory pseudotumour
subjects affected / exposed ^[3]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Langerhans’ cell histiocytosis
subjects affected / exposed ^[4]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Haematoma
subjects affected / exposed ^[5]	2 / 2976 (0.07%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypovolaemic shock
subjects affected / exposed ^[6]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Shock
subjects affected / exposed ^[7]	0 / 2976 (0.00%)	3 / 2972 (0.10%)	5 / 2974 (0.17%)	1 / 2180 (0.05%)	2 / 2178 (0.09%)	0 / 1 (0.00%)	4 / 2179 (0.18%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 5	0 / 1	0 / 2	0 / 0	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Death
subjects affected / exposed ^[8]	3 / 2976 (0.10%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	2 / 2180 (0.09%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	3 / 2179 (0.14%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 0	0 / 2	0 / 1	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 3	0 / 1	0 / 0	0 / 2	0 / 1	0 / 0	0 / 3	0 / 0
Drowning
subjects affected / exposed ^[9]	3 / 2976 (0.10%)	2 / 2972 (0.07%)	3 / 2974 (0.10%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 2	0 / 3	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 3	0 / 2	0 / 3	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0
Generalised oedema
subjects affected / exposed ^[10]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hernia
subjects affected / exposed ^[11]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypothermia
subjects affected / exposed ^[12]	1 / 2976 (0.03%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 1	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injection site reaction
subjects affected / exposed ^[13]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyrexia
subjects affected / exposed ^[14]	18 / 2976 (0.60%)	10 / 2972 (0.34%)	16 / 2974 (0.54%)	15 / 2180 (0.69%)	11 / 2178 (0.51%)	0 / 1 (0.00%)	18 / 2179 (0.83%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	1 / 18	2 / 10	0 / 16	2 / 15	0 / 11	0 / 0	2 / 18	0 / 0
deaths causally related to treatment / all	0 / 3	0 / 0	0 / 3	0 / 1	0 / 0	0 / 0	0 / 2	0 / 0
Immune system disorders
Allergy to arthropod sting
subjects affected / exposed ^[15]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	2 / 2179 (0.09%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Anaphylactic reaction
subjects affected / exposed ^[16]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypersensitivity
subjects affected / exposed ^[17]	0 / 2976 (0.00%)	3 / 2972 (0.10%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Social circumstances
Child abuse
subjects affected / exposed ^[18]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sexual abuse
subjects affected / exposed ^[19]	2 / 2976 (0.07%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Acquired phimosis
subjects affected / exposed ^[20]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Apnoeic attack
subjects affected / exposed ^[21]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Asphyxia
subjects affected / exposed ^[22]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Aspiration
subjects affected / exposed ^[23]	1 / 2976 (0.03%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Asthma
subjects affected / exposed ^[24]	9 / 2976 (0.30%)	6 / 2972 (0.20%)	8 / 2974 (0.27%)	6 / 2180 (0.28%)	3 / 2178 (0.14%)	0 / 1 (0.00%)	7 / 2179 (0.32%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 9	0 / 6	0 / 8	0 / 6	0 / 3	0 / 0	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bronchial hyperreactivity
subjects affected / exposed ^[25]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bronchospasm
subjects affected / exposed ^[26]	2 / 2976 (0.07%)	0 / 2972 (0.00%)	3 / 2974 (0.10%)	3 / 2180 (0.14%)	5 / 2178 (0.23%)	0 / 1 (0.00%)	5 / 2179 (0.23%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 3	0 / 3	0 / 5	0 / 0	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cough
subjects affected / exposed ^[27]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Epistaxis
subjects affected / exposed ^[28]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	2 / 2974 (0.07%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Interstitial lung disease
subjects affected / exposed ^[29]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Obstructive airways disorder
subjects affected / exposed ^[30]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed ^[31]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia aspiration
subjects affected / exposed ^[32]	7 / 2976 (0.24%)	1 / 2972 (0.03%)	6 / 2974 (0.20%)	2 / 2180 (0.09%)	2 / 2178 (0.09%)	0 / 1 (0.00%)	4 / 2179 (0.18%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 7	0 / 1	0 / 6	0 / 2	0 / 2	0 / 0	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 1	0 / 1	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
Pneumonitis
subjects affected / exposed ^[33]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary oedema
subjects affected / exposed ^[34]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory acidosis
subjects affected / exposed ^[35]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory arrest
subjects affected / exposed ^[36]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory disorder
subjects affected / exposed ^[37]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Neurodevelopmental disorder
subjects affected / exposed ^[38]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Accidental exposure to product
subjects affected / exposed ^[39]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Accidental poisoning
subjects affected / exposed ^[40]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Animal bite
subjects affected / exposed ^[41]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Arthropod sting
subjects affected / exposed ^[42]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bronchitis chemical
subjects affected / exposed ^[43]	3 / 2976 (0.10%)	1 / 2972 (0.03%)	2 / 2974 (0.07%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Burns first degree
subjects affected / exposed ^[44]	2 / 2976 (0.07%)	2 / 2972 (0.07%)	1 / 2974 (0.03%)	2 / 2180 (0.09%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 1	0 / 2	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Burns second degree
subjects affected / exposed ^[45]	1 / 2976 (0.03%)	5 / 2972 (0.17%)	2 / 2974 (0.07%)	3 / 2180 (0.14%)	2 / 2178 (0.09%)	0 / 1 (0.00%)	3 / 2179 (0.14%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 5	0 / 2	0 / 3	0 / 2	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Chemical injury
subjects affected / exposed ^[46]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Chemical poisoning
subjects affected / exposed ^[47]	1 / 2976 (0.03%)	1 / 2972 (0.03%)	7 / 2974 (0.24%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 7	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Clavicle fracture
subjects affected / exposed ^[48]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Crush injury
subjects affected / exposed ^[49]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Disinfectant poisoning
subjects affected / exposed ^[50]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Exposure to toxic agent
subjects affected / exposed ^[51]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Eye contusion
subjects affected / exposed ^[52]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Eye injury
subjects affected / exposed ^[53]	1 / 2976 (0.03%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Femur fracture
subjects affected / exposed ^[54]	3 / 2976 (0.10%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	2 / 2180 (0.09%)	2 / 2178 (0.09%)	0 / 1 (0.00%)	2 / 2179 (0.09%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 1	0 / 2	0 / 2	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Foreign body
subjects affected / exposed ^[55]	4 / 2976 (0.13%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Foreign body aspiration
subjects affected / exposed ^[56]	1 / 2976 (0.03%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Fractured skull depressed
subjects affected / exposed ^[57]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Greenstick fracture
subjects affected / exposed ^[58]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Head injury
subjects affected / exposed ^[59]	1 / 2976 (0.03%)	1 / 2972 (0.03%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	4 / 2178 (0.18%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1	0 / 0	0 / 4	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
Herbal toxicity
subjects affected / exposed ^[60]	2 / 2976 (0.07%)	3 / 2972 (0.10%)	2 / 2974 (0.07%)	0 / 2180 (0.00%)	2 / 2178 (0.09%)	0 / 1 (0.00%)	3 / 2179 (0.14%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 3	0 / 2	0 / 0	0 / 2	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 3	0 / 1	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
Human bite
subjects affected / exposed ^[61]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed ^[62]	1 / 2976 (0.03%)	1 / 2972 (0.03%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Joint injury
subjects affected / exposed ^[63]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Laceration
subjects affected / exposed ^[64]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	2 / 2974 (0.07%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Limb injury
subjects affected / exposed ^[65]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Limb traumatic amputation
subjects affected / exposed ^[66]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Penis injury
subjects affected / exposed ^[67]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Petroleum distillate poisoning
subjects affected / exposed ^[68]	2 / 2976 (0.07%)	2 / 2972 (0.07%)	4 / 2974 (0.13%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 4	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonitis chemical
subjects affected / exposed ^[69]	4 / 2976 (0.13%)	1 / 2972 (0.03%)	4 / 2974 (0.13%)	2 / 2180 (0.09%)	2 / 2178 (0.09%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 1	0 / 4	0 / 2	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Poisoning
subjects affected / exposed ^[70]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary contusion
subjects affected / exposed ^[71]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed ^[72]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	2 / 2974 (0.07%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sciatic nerve injury
subjects affected / exposed ^[73]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin injury
subjects affected / exposed ^[74]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Snake bite
subjects affected / exposed ^[75]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Soft tissue injury
subjects affected / exposed ^[76]	2 / 2976 (0.07%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	3 / 2179 (0.14%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Thermal burn
subjects affected / exposed ^[77]	15 / 2976 (0.50%)	10 / 2972 (0.34%)	15 / 2974 (0.50%)	14 / 2180 (0.64%)	9 / 2178 (0.41%)	0 / 1 (0.00%)	11 / 2179 (0.50%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 15	0 / 10	0 / 15	0 / 14	0 / 9	0 / 0	0 / 11	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0
Tibia fracture
subjects affected / exposed ^[78]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vaccination failure
subjects affected / exposed ^[79]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	2 / 2179 (0.09%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Wound
subjects affected / exposed ^[80]	1 / 2976 (0.03%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Wrist fracture
subjects affected / exposed ^[81]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Congenital, familial and genetic disorders
Atrial septal defect
subjects affected / exposed ^[82]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cerebral palsy
subjects affected / exposed ^[83]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Choledochal cyst
subjects affected / exposed ^[84]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Congenital megacolon
subjects affected / exposed ^[85]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Cryptorchism
subjects affected / exposed ^[86]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Fallot’s tetralogy
subjects affected / exposed ^[87]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
Glucose-6-phosphate dehydrogenase deficiency
subjects affected / exposed ^[88]	0 / 2976 (0.00%)	2 / 2972 (0.07%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hydrocele
subjects affected / exposed ^[89]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Phimosis
subjects affected / exposed ^[90]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sickle cell anaemia
subjects affected / exposed ^[91]	1 / 2976 (0.03%)	4 / 2972 (0.13%)	1 / 2974 (0.03%)	1 / 2180 (0.05%)	3 / 2178 (0.14%)	0 / 1 (0.00%)	5 / 2179 (0.23%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 4	0 / 1	0 / 1	0 / 3	0 / 0	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Sickle cell anaemia with crisis
subjects affected / exposed ^[92]	4 / 2976 (0.13%)	4 / 2972 (0.13%)	6 / 2974 (0.20%)	1 / 2180 (0.05%)	4 / 2178 (0.18%)	0 / 1 (0.00%)	5 / 2179 (0.23%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 4	0 / 6	0 / 1	0 / 4	0 / 0	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
Trisomy 21
subjects affected / exposed ^[93]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urethral valves
subjects affected / exposed ^[94]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ventricular septal defect
subjects affected / exposed ^[95]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	2 / 2974 (0.07%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Cardiac arrest
subjects affected / exposed ^[96]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed ^[97]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiomyopathy
subjects affected / exposed ^[98]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pericardial effusion
subjects affected / exposed ^[99]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Arachnoid cyst
subjects affected / exposed ^[100]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cerebellar ataxia
subjects affected / exposed ^[101]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cerebral atrophy
subjects affected / exposed ^[102]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Convulsion
subjects affected / exposed ^[103]	57 / 2976 (1.92%)	45 / 2972 (1.51%)	58 / 2974 (1.95%)	45 / 2180 (2.06%)	32 / 2178 (1.47%)	0 / 1 (0.00%)	32 / 2179 (1.47%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 57	0 / 45	0 / 58	0 / 45	0 / 32	0 / 0	0 / 32	0 / 0
deaths causally related to treatment / all	0 / 8	0 / 8	0 / 10	0 / 4	0 / 4	0 / 0	0 / 4	0 / 0
Depressed level of consciousness
subjects affected / exposed ^[104]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Encephalomalacia
subjects affected / exposed ^[105]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Encephalopathy
subjects affected / exposed ^[106]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Epilepsy
subjects affected / exposed ^[107]	3 / 2976 (0.10%)	10 / 2972 (0.34%)	2 / 2974 (0.07%)	1 / 2180 (0.05%)	2 / 2178 (0.09%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 10	0 / 2	0 / 1	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Febrile convulsion
subjects affected / exposed ^[108]	159 / 2976 (5.34%)	184 / 2972 (6.19%)	164 / 2974 (5.51%)	100 / 2180 (4.59%)	90 / 2178 (4.13%)	0 / 1 (0.00%)	101 / 2179 (4.64%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	6 / 159	1 / 184	1 / 164	3 / 100	1 / 90	0 / 0	0 / 101	0 / 0
deaths causally related to treatment / all	0 / 4	0 / 1	0 / 3	0 / 2	0 / 3	0 / 0	0 / 3	0 / 0
Haemorrhage intracranial
subjects affected / exposed ^[109]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hemiparesis
subjects affected / exposed ^[110]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hemiplegia
subjects affected / exposed ^[111]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hydrocephalus
subjects affected / exposed ^[112]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Loss of consciousness
subjects affected / exposed ^[113]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Meningism
subjects affected / exposed ^[114]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	2 / 2974 (0.07%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Mental retardation
subjects affected / exposed ^[115]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolic encephalopathy
subjects affected / exposed ^[116]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Monoparesis
subjects affected / exposed ^[117]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Myoclonus
subjects affected / exposed ^[118]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Paraparesis
subjects affected / exposed ^[119]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Speech disorder developmental
subjects affected / exposed ^[120]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Uraemic encephalopathy
subjects affected / exposed ^[121]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed ^[122]	126 / 2976 (4.23%)	150 / 2972 (5.05%)	197 / 2974 (6.62%)	90 / 2180 (4.13%)	106 / 2178 (4.87%)	0 / 1 (0.00%)	116 / 2179 (5.32%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 126	0 / 150	0 / 197	0 / 90	0 / 106	0 / 0	0 / 116	0 / 0
deaths causally related to treatment / all	0 / 10	0 / 7	0 / 12	0 / 3	0 / 14	0 / 0	0 / 4	0 / 0
Dislocation of vertebra
subjects affected / exposed ^[123]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Disseminated intravascular coagulation
subjects affected / exposed ^[124]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Haemolysis
subjects affected / exposed ^[125]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Haemolytic anaemia
subjects affected / exposed ^[126]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
Hypochromic anaemia
subjects affected / exposed ^[127]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intravascular haemolysis
subjects affected / exposed ^[128]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	2 / 2974 (0.07%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Leukaemoid reaction
subjects affected / exposed ^[129]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lymphadenitis
subjects affected / exposed ^[130]	4 / 2976 (0.13%)	3 / 2972 (0.10%)	1 / 2974 (0.03%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	2 / 2179 (0.09%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 3	0 / 1	0 / 1	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Neutropenia
subjects affected / exposed ^[131]	1 / 2976 (0.03%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pancytopenia
subjects affected / exposed ^[132]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed ^[133]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
Deafness
subjects affected / exposed ^[134]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hearing impaired
subjects affected / exposed ^[135]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Eye disorders
Periorbital oedema
subjects affected / exposed ^[136]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Aphthous stomatitis
subjects affected / exposed ^[137]	1 / 2976 (0.03%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Colitis
subjects affected / exposed ^[138]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Constipation
subjects affected / exposed ^[139]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Enteritis
subjects affected / exposed ^[140]	10 / 2976 (0.34%)	18 / 2972 (0.61%)	15 / 2974 (0.50%)	7 / 2180 (0.32%)	10 / 2178 (0.46%)	0 / 1 (0.00%)	18 / 2179 (0.83%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 10	0 / 18	0 / 15	0 / 7	0 / 10	0 / 0	0 / 18	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 3	0 / 0
Food poisoning
subjects affected / exposed ^[141]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	2 / 2974 (0.07%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastritis
subjects affected / exposed ^[142]	0 / 2976 (0.00%)	2 / 2972 (0.07%)	2 / 2974 (0.07%)	2 / 2180 (0.09%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	4 / 2179 (0.18%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 2	0 / 2	0 / 1	0 / 0	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed ^[143]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal motility disorder
subjects affected / exposed ^[144]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrooesophageal reflux disease
subjects affected / exposed ^[145]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Haematemesis
subjects affected / exposed ^[146]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
Ileus paralytic
subjects affected / exposed ^[147]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed ^[148]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	3 / 2179 (0.14%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed ^[149]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	2 / 2180 (0.09%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
Intestinal perforation
subjects affected / exposed ^[150]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intussusception
subjects affected / exposed ^[151]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
Mouth ulceration
subjects affected / exposed ^[152]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rectal polyp
subjects affected / exposed ^[153]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rectal prolapse
subjects affected / exposed ^[154]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Stomatitis
subjects affected / exposed ^[155]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	1 / 2974 (0.03%)	2 / 2180 (0.09%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Stress ulcer
subjects affected / exposed ^[156]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Umbilical hernia
subjects affected / exposed ^[157]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Umbilical hernia, obstructive
subjects affected / exposed ^[158]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Upper gastrointestinal haemorrhage
subjects affected / exposed ^[159]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vomiting
subjects affected / exposed ^[160]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Cholecystitis
subjects affected / exposed ^[161]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Drug hypersensitivity
subjects affected / exposed ^[162]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatitis
subjects affected / exposed ^[163]	0 / 2976 (0.00%)	2 / 2972 (0.07%)	1 / 2974 (0.03%)	1 / 2180 (0.05%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatitis acute
subjects affected / exposed ^[164]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatitis toxic
subjects affected / exposed ^[165]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Immune reconstitution inflammatory syndrome
subjects affected / exposed ^[166]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Dermatitis
subjects affected / exposed ^[167]	1 / 2976 (0.03%)	1 / 2972 (0.03%)	2 / 2974 (0.07%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dermatitis allergic
subjects affected / exposed ^[168]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dermatitis exfoliative
subjects affected / exposed ^[169]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Drug eruption
subjects affected / exposed ^[170]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Erythema multiforme
subjects affected / exposed ^[171]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rash
subjects affected / exposed ^[172]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rash maculo-papular
subjects affected / exposed ^[173]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rash papular
subjects affected / exposed ^[174]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin lesion
subjects affected / exposed ^[175]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Stevens-Johnson syndrome
subjects affected / exposed ^[176]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urticaria
subjects affected / exposed ^[177]	1 / 2976 (0.03%)	1 / 2972 (0.03%)	1 / 2974 (0.03%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vitiligo
subjects affected / exposed ^[178]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Glomerulonephritis
subjects affected / exposed ^[179]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Glomerulonephritis acute
subjects affected / exposed ^[180]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
Hydronephrosis
subjects affected / exposed ^[181]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nephritis
subjects affected / exposed ^[182]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nephrotic syndrome
subjects affected / exposed ^[183]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal failure acute
subjects affected / exposed ^[184]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal tubular necrosis
subjects affected / exposed ^[185]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
Urinary retention
subjects affected / exposed ^[186]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthritis
subjects affected / exposed ^[187]	2 / 2976 (0.07%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Compartment syndrome
subjects affected / exposed ^[188]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dactylitis
subjects affected / exposed ^[189]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	2 / 2180 (0.09%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Joint effusion
subjects affected / exposed ^[190]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Myositis
subjects affected / exposed ^[191]	2 / 2976 (0.07%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed ^[192]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rickets
subjects affected / exposed ^[193]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Torticollis
subjects affected / exposed ^[194]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Abscess
subjects affected / exposed ^[195]	7 / 2976 (0.24%)	7 / 2972 (0.24%)	5 / 2974 (0.17%)	4 / 2180 (0.18%)	8 / 2178 (0.37%)	0 / 1 (0.00%)	5 / 2179 (0.23%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 7	0 / 7	0 / 5	0 / 4	0 / 8	0 / 0	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abscess jaw
subjects affected / exposed ^[196]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abscess limb
subjects affected / exposed ^[197]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	3 / 2974 (0.10%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 3	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abscess neck
subjects affected / exposed ^[198]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Acarodermatitis
subjects affected / exposed ^[199]	0 / 2976 (0.00%)	2 / 2972 (0.07%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
AIDS dementia complex
subjects affected / exposed ^[200]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Amoebiasis
subjects affected / exposed ^[201]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Arthritis bacterial
subjects affected / exposed ^[202]	2 / 2976 (0.07%)	7 / 2972 (0.24%)	1 / 2974 (0.03%)	3 / 2180 (0.14%)	3 / 2178 (0.14%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 7	0 / 1	0 / 3	0 / 3	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ascariasis
subjects affected / exposed ^[203]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Atypical pneumonia
subjects affected / exposed ^[204]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
Bacteraemia
subjects affected / exposed ^[205]	0 / 2976 (0.00%)	2 / 2972 (0.07%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bacterial infection
subjects affected / exposed ^[206]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	2 / 2179 (0.09%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bone tuberculosis
subjects affected / exposed ^[207]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Brain abscess
subjects affected / exposed ^[208]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Breast abscess
subjects affected / exposed ^[209]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bronchiolitis
subjects affected / exposed ^[210]	25 / 2976 (0.84%)	13 / 2972 (0.44%)	18 / 2974 (0.61%)	19 / 2180 (0.87%)	13 / 2178 (0.60%)	0 / 1 (0.00%)	24 / 2179 (1.10%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 25	0 / 13	0 / 18	0 / 19	0 / 13	0 / 0	0 / 24	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bronchitis
subjects affected / exposed ^[211]	13 / 2976 (0.44%)	15 / 2972 (0.50%)	21 / 2974 (0.71%)	6 / 2180 (0.28%)	11 / 2178 (0.51%)	0 / 1 (0.00%)	3 / 2179 (0.14%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 13	0 / 15	0 / 21	0 / 6	0 / 11	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
Bronchopneumonia
subjects affected / exposed ^[212]	33 / 2976 (1.11%)	35 / 2972 (1.18%)	40 / 2974 (1.34%)	35 / 2180 (1.61%)	19 / 2178 (0.87%)	0 / 1 (0.00%)	34 / 2179 (1.56%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 33	0 / 35	0 / 40	0 / 35	0 / 19	0 / 0	0 / 34	0 / 0
deaths causally related to treatment / all	0 / 3	0 / 1	0 / 1	0 / 4	0 / 2	0 / 0	0 / 2	0 / 0
Bullous impetigo
subjects affected / exposed ^[213]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Burkholderia cepacia complex sepsis
subjects affected / exposed ^[214]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Burn infection
subjects affected / exposed ^[215]	1 / 2976 (0.03%)	2 / 2972 (0.07%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Candida infection
subjects affected / exposed ^[216]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cellulitis
subjects affected / exposed ^[217]	8 / 2976 (0.27%)	7 / 2972 (0.24%)	6 / 2974 (0.20%)	6 / 2180 (0.28%)	4 / 2178 (0.18%)	0 / 1 (0.00%)	6 / 2179 (0.28%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 8	0 / 7	0 / 6	0 / 6	0 / 4	0 / 0	0 / 6	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cellulitis of male external genital organ
subjects affected / exposed ^[218]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cellulitis orbital
subjects affected / exposed ^[219]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cellulitis pharyngeal
subjects affected / exposed ^[220]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Central nervous system viral infection
subjects affected / exposed ^[221]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cerebral malaria
subjects affected / exposed ^[222]	4 / 2976 (0.13%)	4 / 2972 (0.13%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	2 / 2179 (0.09%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 4	0 / 0	0 / 1	0 / 1	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 3	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
Cholera
subjects affected / exposed ^[223]	1 / 2976 (0.03%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Conjunctivitis
subjects affected / exposed ^[224]	2 / 2976 (0.07%)	4 / 2972 (0.13%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 4	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Conjunctivitis bacterial
subjects affected / exposed ^[225]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	1 / 2974 (0.03%)	1 / 2180 (0.05%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Croup infectious
subjects affected / exposed ^[226]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dermatitis infected
subjects affected / exposed ^[227]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Disseminated tuberculosis
subjects affected / exposed ^[228]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dysentery
subjects affected / exposed ^[229]	11 / 2976 (0.37%)	13 / 2972 (0.44%)	9 / 2974 (0.30%)	4 / 2180 (0.18%)	6 / 2178 (0.28%)	0 / 1 (0.00%)	7 / 2179 (0.32%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 11	0 / 13	0 / 9	0 / 4	0 / 6	0 / 0	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Eczema infected
subjects affected / exposed ^[230]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Empyema
subjects affected / exposed ^[231]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Encephalitis
subjects affected / exposed ^[232]	4 / 2976 (0.13%)	1 / 2972 (0.03%)	2 / 2974 (0.07%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 1	0 / 2	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0
Encephalitis viral
subjects affected / exposed ^[233]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Encephalomyelitis
subjects affected / exposed ^[234]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Enterococcal sepsis
subjects affected / exposed ^[235]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Erysipelas
subjects affected / exposed ^[236]	1 / 2976 (0.03%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Escherichia sepsis
subjects affected / exposed ^[237]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	2 / 2179 (0.09%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Escherichia urinary tract infection
subjects affected / exposed ^[238]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	2 / 2974 (0.07%)	1 / 2180 (0.05%)	2 / 2178 (0.09%)	0 / 1 (0.00%)	2 / 2179 (0.09%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2	0 / 1	0 / 2	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Exanthema subitum
subjects affected / exposed ^[239]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Febrile infection
subjects affected / exposed ^[240]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Furuncle
subjects affected / exposed ^[241]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed ^[242]	153 / 2976 (5.14%)	148 / 2972 (4.98%)	177 / 2974 (5.95%)	162 / 2180 (7.43%)	171 / 2178 (7.85%)	0 / 1 (0.00%)	171 / 2179 (7.85%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 153	0 / 148	0 / 177	0 / 162	0 / 171	0 / 0	0 / 171	0 / 0
deaths causally related to treatment / all	0 / 14	0 / 7	0 / 8	0 / 14	0 / 11	0 / 0	0 / 10	0 / 0
Gastroenteritis Escherichia coli
subjects affected / exposed ^[243]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis salmonella
subjects affected / exposed ^[244]	2 / 2976 (0.07%)	3 / 2972 (0.10%)	0 / 2974 (0.00%)	5 / 2180 (0.23%)	2 / 2178 (0.09%)	0 / 1 (0.00%)	4 / 2179 (0.18%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 3	0 / 0	0 / 5	0 / 2	0 / 0	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis shigella
subjects affected / exposed ^[245]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis viral
subjects affected / exposed ^[246]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal candidiasis
subjects affected / exposed ^[247]	0 / 2976 (0.00%)	2 / 2972 (0.07%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Giardiasis
subjects affected / exposed ^[248]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gingivitis
subjects affected / exposed ^[249]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Groin abscess
subjects affected / exposed ^[250]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Haemophilus sepsis
subjects affected / exposed ^[251]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Helminthic infection
subjects affected / exposed ^[252]	2 / 2976 (0.07%)	8 / 2972 (0.27%)	6 / 2974 (0.20%)	1 / 2180 (0.05%)	2 / 2178 (0.09%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 8	0 / 6	0 / 1	0 / 2	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatitis A
subjects affected / exposed ^[253]	2 / 2976 (0.07%)	2 / 2972 (0.07%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatitis B
subjects affected / exposed ^[254]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatitis infectious
subjects affected / exposed ^[255]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
HIV associated nephropathy
subjects affected / exposed ^[256]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
HIV infection
subjects affected / exposed ^[257]	22 / 2976 (0.74%)	19 / 2972 (0.64%)	18 / 2974 (0.61%)	20 / 2180 (0.92%)	16 / 2178 (0.73%)	0 / 1 (0.00%)	12 / 2179 (0.55%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 22	0 / 19	0 / 18	0 / 20	0 / 16	0 / 0	0 / 12	0 / 0
deaths causally related to treatment / all	0 / 6	0 / 4	0 / 8	0 / 5	0 / 5	0 / 0	0 / 2	0 / 0
HIV infection WHO clinical stage II
subjects affected / exposed ^[258]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
HIV infection WHO clinical stage III
subjects affected / exposed ^[259]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
HIV infection WHO clinical stage IV
subjects affected / exposed ^[260]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
Impetigo
subjects affected / exposed ^[261]	1 / 2976 (0.03%)	2 / 2972 (0.07%)	3 / 2974 (0.10%)	2 / 2180 (0.09%)	2 / 2178 (0.09%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 3	0 / 2	0 / 2	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infected skin ulcer
subjects affected / exposed ^[262]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infection
subjects affected / exposed ^[263]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injection site abscess
subjects affected / exposed ^[264]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injection site cellulitis
subjects affected / exposed ^[265]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Klebsiella sepsis
subjects affected / exposed ^[266]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Laryngitis
subjects affected / exposed ^[267]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Listeria sepsis
subjects affected / exposed ^[268]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Liver abscess
subjects affected / exposed ^[269]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lobar pneumonia
subjects affected / exposed ^[270]	6 / 2976 (0.20%)	5 / 2972 (0.17%)	7 / 2974 (0.24%)	8 / 2180 (0.37%)	9 / 2178 (0.41%)	0 / 1 (0.00%)	7 / 2179 (0.32%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 6	0 / 5	0 / 7	0 / 8	0 / 9	0 / 0	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
Lower respiratory tract infection
subjects affected / exposed ^[271]	2 / 2976 (0.07%)	3 / 2972 (0.10%)	6 / 2974 (0.20%)	0 / 2180 (0.00%)	4 / 2178 (0.18%)	0 / 1 (0.00%)	2 / 2179 (0.09%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 3	0 / 6	0 / 0	0 / 4	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ludwig angina
subjects affected / exposed ^[272]	2 / 2976 (0.07%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lymph node abscess
subjects affected / exposed ^[273]	0 / 2976 (0.00%)	2 / 2972 (0.07%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lymph node tuberculosis
subjects affected / exposed ^[274]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lymphadenitis bacterial
subjects affected / exposed ^[275]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Malaria
subjects affected / exposed ^[276]	294 / 2976 (9.88%)	342 / 2972 (11.51%)	421 / 2974 (14.16%)	180 / 2180 (8.26%)	208 / 2178 (9.55%)	0 / 1 (0.00%)	233 / 2179 (10.69%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 294	0 / 342	0 / 421	0 / 180	0 / 208	0 / 0	0 / 233	0 / 0
deaths causally related to treatment / all	0 / 10	0 / 13	0 / 11	0 / 6	0 / 9	0 / 0	0 / 4	0 / 0
Mastoiditis
subjects affected / exposed ^[277]	2 / 2976 (0.07%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Measles
subjects affected / exposed ^[278]	7 / 2976 (0.24%)	2 / 2972 (0.07%)	5 / 2974 (0.17%)	14 / 2180 (0.64%)	10 / 2178 (0.46%)	0 / 1 (0.00%)	8 / 2179 (0.37%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 7	0 / 2	0 / 5	0 / 14	0 / 10	0 / 0	0 / 8	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Meningitis
subjects affected / exposed ^[279]	5 / 2976 (0.17%)	5 / 2972 (0.17%)	1 / 2974 (0.03%)	2 / 2180 (0.09%)	3 / 2178 (0.14%)	0 / 1 (0.00%)	3 / 2179 (0.14%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 5	0 / 1	0 / 2	0 / 3	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 2	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
Meningitis haemophilus
subjects affected / exposed ^[280]	1 / 2976 (0.03%)	2 / 2972 (0.07%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Meningitis meningococcal
subjects affected / exposed ^[281]	3 / 2976 (0.10%)	2 / 2972 (0.07%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Meningitis pneumococcal
subjects affected / exposed ^[282]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	2 / 2178 (0.09%)	0 / 1 (0.00%)	2 / 2179 (0.09%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 2	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 1	0 / 0	0 / 2	0 / 0
Meningitis salmonella
subjects affected / exposed ^[283]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	2 / 2180 (0.09%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Meningitis tuberculous
subjects affected / exposed ^[284]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Meningitis viral
subjects affected / exposed ^[285]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Moraxella infection
subjects affected / exposed ^[286]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Mumps
subjects affected / exposed ^[287]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Mycobacterium ulcerans infection
subjects affected / exposed ^[288]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nasopharyngitis
subjects affected / exposed ^[289]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Oral candidiasis
subjects affected / exposed ^[290]	5 / 2976 (0.17%)	5 / 2972 (0.17%)	4 / 2974 (0.13%)	1 / 2180 (0.05%)	2 / 2178 (0.09%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 5	0 / 4	0 / 1	0 / 2	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Oropharyngeal candidiasis
subjects affected / exposed ^[291]	1 / 2976 (0.03%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed ^[292]	3 / 2976 (0.10%)	2 / 2972 (0.07%)	3 / 2974 (0.10%)	1 / 2180 (0.05%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	2 / 2179 (0.09%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 2	0 / 3	0 / 1	0 / 1	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Otitis externa
subjects affected / exposed ^[293]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Otitis media
subjects affected / exposed ^[294]	19 / 2976 (0.64%)	10 / 2972 (0.34%)	22 / 2974 (0.74%)	11 / 2180 (0.50%)	11 / 2178 (0.51%)	0 / 1 (0.00%)	7 / 2179 (0.32%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 19	0 / 10	0 / 22	0 / 11	0 / 11	0 / 0	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Otitis media acute
subjects affected / exposed ^[295]	2 / 2976 (0.07%)	2 / 2972 (0.07%)	2 / 2974 (0.07%)	2 / 2180 (0.09%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 2	0 / 2	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Otitis media chronic
subjects affected / exposed ^[296]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Parotitis
subjects affected / exposed ^[297]	0 / 2976 (0.00%)	2 / 2972 (0.07%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Perineal abscess
subjects affected / exposed ^[298]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Periorbital cellulitis
subjects affected / exposed ^[299]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Peritonitis
subjects affected / exposed ^[300]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pharyngitis
subjects affected / exposed ^[301]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Plasmodium ovale infection
subjects affected / exposed ^[302]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumococcal bacteraemia
subjects affected / exposed ^[303]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumococcal sepsis
subjects affected / exposed ^[304]	5 / 2976 (0.17%)	4 / 2972 (0.13%)	3 / 2974 (0.10%)	5 / 2180 (0.23%)	4 / 2178 (0.18%)	0 / 1 (0.00%)	3 / 2179 (0.14%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 4	0 / 3	0 / 5	0 / 4	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 1	0 / 1	0 / 0	0 / 3	0 / 0
Pneumocystis jirovecii pneumonia
subjects affected / exposed ^[305]	2 / 2976 (0.07%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	4 / 2180 (0.18%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1	0 / 4	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 2	0 / 1	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed ^[306]	202 / 2976 (6.79%)	215 / 2972 (7.23%)	223 / 2974 (7.50%)	217 / 2180 (9.95%)	206 / 2178 (9.46%)	0 / 1 (0.00%)	202 / 2179 (9.27%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 202	0 / 215	0 / 223	0 / 217	0 / 206	0 / 0	0 / 202	0 / 0
deaths causally related to treatment / all	0 / 15	0 / 7	0 / 8	0 / 12	0 / 15	0 / 0	0 / 9	0 / 0
Pneumonia pneumococcal
subjects affected / exposed ^[307]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia streptococcal
subjects affected / exposed ^[308]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia viral
subjects affected / exposed ^[309]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Postoperative wound infection
subjects affected / exposed ^[310]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pseudomonal sepsis
subjects affected / exposed ^[311]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary tuberculosis
subjects affected / exposed ^[312]	7 / 2976 (0.24%)	1 / 2972 (0.03%)	4 / 2974 (0.13%)	6 / 2180 (0.28%)	6 / 2178 (0.28%)	0 / 1 (0.00%)	2 / 2179 (0.09%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 7	0 / 1	0 / 4	0 / 6	0 / 6	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed ^[313]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyoderma
subjects affected / exposed ^[314]	1 / 2976 (0.03%)	1 / 2972 (0.03%)	3 / 2974 (0.10%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 3	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyomyositis
subjects affected / exposed ^[315]	1 / 2976 (0.03%)	1 / 2972 (0.03%)	3 / 2974 (0.10%)	1 / 2180 (0.05%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 3	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rabies
subjects affected / exposed ^[316]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory tract infection
subjects affected / exposed ^[317]	2 / 2976 (0.07%)	2 / 2972 (0.07%)	2 / 2974 (0.07%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 2	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rubella
subjects affected / exposed ^[318]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Salmonella bacteraemia
subjects affected / exposed ^[319]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Salmonella sepsis
subjects affected / exposed ^[320]	36 / 2976 (1.21%)	34 / 2972 (1.14%)	42 / 2974 (1.41%)	25 / 2180 (1.15%)	34 / 2178 (1.56%)	0 / 1 (0.00%)	37 / 2179 (1.70%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 36	0 / 34	0 / 42	0 / 25	0 / 34	0 / 0	0 / 37	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 1	0 / 2	0 / 1	0 / 2	0 / 0	0 / 2	0 / 0
Salmonellosis
subjects affected / exposed ^[321]	1 / 2976 (0.03%)	3 / 2972 (0.10%)	2 / 2974 (0.07%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Schistosomiasis
subjects affected / exposed ^[322]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sepsis
subjects affected / exposed ^[323]	33 / 2976 (1.11%)	27 / 2972 (0.91%)	43 / 2974 (1.45%)	23 / 2180 (1.06%)	15 / 2178 (0.69%)	0 / 1 (0.00%)	13 / 2179 (0.60%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 33	0 / 27	0 / 43	0 / 23	0 / 15	0 / 0	0 / 13	0 / 0
deaths causally related to treatment / all	0 / 7	0 / 4	0 / 5	0 / 6	0 / 5	0 / 0	0 / 5	0 / 0
Septic shock
subjects affected / exposed ^[324]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Shigella infection
subjects affected / exposed ^[325]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin bacterial infection
subjects affected / exposed ^[326]	2 / 2976 (0.07%)	0 / 2972 (0.00%)	2 / 2974 (0.07%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin infection
subjects affected / exposed ^[327]	3 / 2976 (0.10%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Staphylococcal sepsis
subjects affected / exposed ^[328]	3 / 2976 (0.10%)	6 / 2972 (0.20%)	1 / 2974 (0.03%)	5 / 2180 (0.23%)	5 / 2178 (0.23%)	0 / 1 (0.00%)	2 / 2179 (0.09%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 6	0 / 1	0 / 5	0 / 5	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Staphylococcal skin infection
subjects affected / exposed ^[329]	1 / 2976 (0.03%)	2 / 2972 (0.07%)	2 / 2974 (0.07%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 2	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Streptococcal infection
subjects affected / exposed ^[330]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Streptococcal sepsis
subjects affected / exposed ^[331]	1 / 2976 (0.03%)	1 / 2972 (0.03%)	2 / 2974 (0.07%)	1 / 2180 (0.05%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	2 / 2179 (0.09%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 2	0 / 1	0 / 1	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
Subcutaneous abscess
subjects affected / exposed ^[332]	5 / 2976 (0.17%)	4 / 2972 (0.13%)	2 / 2974 (0.07%)	6 / 2180 (0.28%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	3 / 2179 (0.14%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 4	0 / 2	0 / 6	0 / 1	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Superinfection
subjects affected / exposed ^[333]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Taeniasis
subjects affected / exposed ^[334]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tinea capitis
subjects affected / exposed ^[335]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tonsillitis
subjects affected / exposed ^[336]	1 / 2976 (0.03%)	1 / 2972 (0.03%)	3 / 2974 (0.10%)	1 / 2180 (0.05%)	2 / 2178 (0.09%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 3	0 / 1	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Toxic shock syndrome
subjects affected / exposed ^[337]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tracheobronchitis
subjects affected / exposed ^[338]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Trichiniasis
subjects affected / exposed ^[339]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tuberculosis
subjects affected / exposed ^[340]	4 / 2976 (0.13%)	5 / 2972 (0.17%)	6 / 2974 (0.20%)	2 / 2180 (0.09%)	4 / 2178 (0.18%)	0 / 1 (0.00%)	3 / 2179 (0.14%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 5	0 / 6	0 / 2	0 / 4	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 2	0 / 0
Typhoid fever
subjects affected / exposed ^[341]	1 / 2976 (0.03%)	1 / 2972 (0.03%)	3 / 2974 (0.10%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 3	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed ^[342]	29 / 2976 (0.97%)	39 / 2972 (1.31%)	43 / 2974 (1.45%)	19 / 2180 (0.87%)	31 / 2178 (1.42%)	0 / 1 (0.00%)	24 / 2179 (1.10%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 29	0 / 39	0 / 43	0 / 19	0 / 31	0 / 0	0 / 24	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed ^[343]	22 / 2976 (0.74%)	23 / 2972 (0.77%)	28 / 2974 (0.94%)	11 / 2180 (0.50%)	15 / 2178 (0.69%)	0 / 1 (0.00%)	22 / 2179 (1.01%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 22	0 / 23	0 / 28	0 / 11	0 / 15	0 / 0	0 / 22	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
Urinary tract infection bacterial
subjects affected / exposed ^[344]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection pseudomonal
subjects affected / exposed ^[345]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urosepsis
subjects affected / exposed ^[346]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vaginal infection
subjects affected / exposed ^[347]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Varicella
subjects affected / exposed ^[348]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	2 / 2180 (0.09%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 2	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
Viral infection
subjects affected / exposed ^[349]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Wound infection
subjects affected / exposed ^[350]	1 / 2976 (0.03%)	1 / 2972 (0.03%)	2 / 2974 (0.07%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Wound sepsis
subjects affected / exposed ^[351]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed ^[352]	1 / 2976 (0.03%)	1 / 2972 (0.03%)	1 / 2974 (0.03%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Failure to thrive
subjects affected / exposed ^[353]	1 / 2976 (0.03%)	0 / 2972 (0.00%)	2 / 2974 (0.07%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hyperkalaemia
subjects affected / exposed ^[354]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	1 / 2178 (0.05%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed ^[355]	10 / 2976 (0.34%)	10 / 2972 (0.34%)	18 / 2974 (0.61%)	2 / 2180 (0.09%)	3 / 2178 (0.14%)	0 / 1 (0.00%)	3 / 2179 (0.14%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 10	0 / 10	0 / 18	0 / 2	0 / 3	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 3	0 / 1	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
Hypokalaemia
subjects affected / exposed ^[356]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	1 / 2179 (0.05%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypoproteinaemia
subjects affected / exposed ^[357]	0 / 2976 (0.00%)	2 / 2972 (0.07%)	1 / 2974 (0.03%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Kwashiorkor
subjects affected / exposed ^[358]	11 / 2976 (0.37%)	4 / 2972 (0.13%)	17 / 2974 (0.57%)	8 / 2180 (0.37%)	8 / 2178 (0.37%)	0 / 1 (0.00%)	4 / 2179 (0.18%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 11	0 / 4	0 / 17	0 / 8	0 / 8	0 / 0	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0	0 / 1	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
Malnutrition
subjects affected / exposed ^[359]	27 / 2976 (0.91%)	27 / 2972 (0.91%)	21 / 2974 (0.71%)	20 / 2180 (0.92%)	30 / 2178 (1.38%)	0 / 1 (0.00%)	19 / 2179 (0.87%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 27	0 / 27	0 / 21	0 / 20	0 / 30	0 / 0	0 / 19	0 / 0
deaths causally related to treatment / all	0 / 4	0 / 3	0 / 3	0 / 3	0 / 3	0 / 0	0 / 5	0 / 0
Marasmus
subjects affected / exposed ^[360]	6 / 2976 (0.20%)	8 / 2972 (0.27%)	4 / 2974 (0.13%)	6 / 2180 (0.28%)	5 / 2178 (0.23%)	0 / 1 (0.00%)	7 / 2179 (0.32%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 6	0 / 8	0 / 4	0 / 6	0 / 5	0 / 0	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 3	0 / 4	0 / 2	0 / 2	0 / 2	0 / 0	0 / 2	0 / 0
Metabolic acidosis
subjects affected / exposed ^[361]	0 / 2976 (0.00%)	0 / 2972 (0.00%)	0 / 2974 (0.00%)	1 / 2180 (0.05%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Underweight
subjects affected / exposed ^[362]	0 / 2976 (0.00%)	1 / 2972 (0.03%)	0 / 2974 (0.00%)	0 / 2180 (0.00%)	0 / 2178 (0.00%)	0 / 1 (0.00%)	0 / 2179 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[25] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[26] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[27] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[28] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[29] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[30] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[31] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[32] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[33] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[34] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[35] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[36] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[37] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[38] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[39] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[40] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[41] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[42] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[43] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[44] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[45] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[46] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[47] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[48] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[49] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[50] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[51] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[52] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[53] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[54] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[55] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[56] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[57] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[58] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[59] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[60] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[61] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[62] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[63] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[64] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[65] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[66] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[67] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[68] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[69] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[70] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[71] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[72] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[73] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[74] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[75] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[76] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[77] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[78] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[79] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[80] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[81] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[82] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[83] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[84] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[85] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[86] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[87] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[88] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[89] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[90] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[91] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[92] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[93] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[94] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[95] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[96] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[97] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[98] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[99] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[100] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[101] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[102] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[103] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[104] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[105] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[106] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[107] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[108] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[109] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[110] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[111] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[112] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[113] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[114] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[115] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[116] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[117] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[118] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[119] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[120] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[121] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[122] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[123] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[124] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[125] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[126] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[127] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[128] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[129] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[130] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[131] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[132] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[133] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[134] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[135] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[136] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[137] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[138] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[139] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[140] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[141] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[142] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[143] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[144] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[145] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[146] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[147] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[148] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[149] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[150] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[151] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[152] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[153] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[154] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[155] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[156] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[157] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[158] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[159] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[160] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[161] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[162] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[163] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[164] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[165] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[166] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[167] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[168] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[169] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[170] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[171] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[172] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[173] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[174] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[175] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[176] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[177] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[178] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[179] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[180] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[181] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[182] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[183] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[184] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[185] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[186] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[187] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[188] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[189] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[190] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[191] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[192] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[193] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[194] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[195] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[196] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[197] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[198] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[199] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[200] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[201] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[202] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[203] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[204] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[205] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[206] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[207] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[208] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[209] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[210] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[211] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[212] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[213] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[214] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[215] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[216] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[217] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[218] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[219] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[220] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[221] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[222] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[223] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[224] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[225] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[226] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[227] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[228] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[229] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[230] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[231] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[232] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[233] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[234] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[235] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[236] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[237] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[238] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[239] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[240] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[241] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[242] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[243] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[244] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[245] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[246] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[247] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[248] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[249] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[250] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[251] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[252] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[253] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[254] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[255] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[256] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[257] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[258] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[259] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[260] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[261] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[262] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[263] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[264] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[265] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[266] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[267] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[268] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[269] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[270] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[271] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[272] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[273] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[274] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[275] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[276] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[277] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[278] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[279] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[280] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[281] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[282] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[283] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[284] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[285] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[286] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[287] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[288] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[289] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[290] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[291] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[292] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[293] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[294] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[295] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[296] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[297] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[298] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[299] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[300] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[301] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[302] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[303] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[304] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[305] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[306] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[307] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[308] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[309] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[310] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[311] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[312] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[313] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[314] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[315] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[316] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[317] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[318] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[319] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[320] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[321] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[322] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[323] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.affected.
[324] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[325] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[326] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[327] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[328] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[329] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[330] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[331] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[332] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[333] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[334] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[335] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[336] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[337] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[338] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[339] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[340] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[341] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[342] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[343] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[344] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[345] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[346] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[347] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[348] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[349] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[350] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[351] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[352] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[353] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[354] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[355] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[356] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[357] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[358] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[359] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[360] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[361] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[362] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: In this section, RTS,S/AS01 (5-17M) & RTS,S/AS01 (6-12W) groups are only applicable for solicited & unsolicited AEs post PRI vaccination, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.

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

Non-serious adverse events	R3R (5-17M) Group	R3C (5-17M) Group	C3C (5-17M) Group	R3R (6-12W) Group	R3C (6-12W) Group	RTS,S/AS01 (5-17M) Group	C3C (6-12W) Group	RTS,S/AS01 (6-12W) Group
Total subjects affected by non serious adverse events
subjects affected / exposed	233 / 2976 (7.83%)	205 / 2972 (6.90%)	626 / 2974 (21.05%)	231 / 2180 (10.60%)	239 / 2178 (10.97%)	1273 / 1479 (86.07%)	600 / 2179 (27.54%)	1161 / 1462 (79.41%)
General disorders and administration site conditions
Pain – PRI
alternative assessment type: Systematic
subjects affected / exposed ^[363]	0 / 1 (0.00%)	0 / 1 (0.00%)	105 / 721 (14.56%)	0 / 1 (0.00%)	0 / 1 (0.00%)	401 / 1479 (27.11%)	342 / 738 (46.34%)	705 / 1462 (48.22%)
occurrences all number	0	0	105	0	0	401	342	705
Redness – PRI
alternative assessment type: Systematic
subjects affected / exposed ^[364]	0 / 1 (0.00%)	0 / 1 (0.00%)	49 / 721 (6.80%)	0 / 1 (0.00%)	0 / 1 (0.00%)	122 / 1479 (8.25%)	163 / 738 (22.09%)	292 / 1462 (19.97%)
occurrences all number	0	0	49	0	0	122	163	292
Swelling – PRI
alternative assessment type: Systematic
subjects affected / exposed ^[365]	0 / 1 (0.00%)	0 / 1 (0.00%)	119 / 721 (16.50%)	0 / 1 (0.00%)	0 / 1 (0.00%)	303 / 1479 (20.49%)	248 / 738 (33.60%)	427 / 1462 (29.21%)
occurrences all number	0	0	119	0	0	303	248	427
Pain – BST
alternative assessment type: Systematic
subjects affected / exposed ^[366]	109 / 641 (17.00%)	45 / 639 (7.04%)	41 / 633 (6.48%)	59 / 608 (9.70%)	29 / 625 (4.64%)	0 / 1 (0.00%)	25 / 621 (4.03%)	0 / 1 (0.00%)
occurrences all number	109	45	41	59	29	0	25	0
Swelling – BST
alternative assessment type: Systematic
subjects affected / exposed ^[367]	42 / 641 (6.55%)	35 / 639 (5.48%)	30 / 633 (4.74%)	45 / 608 (7.40%)	28 / 625 (4.48%)	0 / 1 (0.00%)	43 / 621 (6.92%)	0 / 1 (0.00%)
occurrences all number	42	35	30	45	28	0	43	0
Drowsiness - PRI
alternative assessment type: Systematic
subjects affected / exposed ^[368]	0 / 1 (0.00%)	0 / 1 (0.00%)	78 / 721 (10.82%)	0 / 1 (0.00%)	0 / 1 (0.00%)	230 / 1479 (15.55%)	121 / 738 (16.40%)	285 / 1462 (19.49%)
occurrences all number	0	0	78	0	0	230	121	285
Irritability – PRI
alternative assessment type: Systematic
subjects affected / exposed ^[369]	0 / 1 (0.00%)	0 / 1 (0.00%)	96 / 721 (13.31%)	0 / 1 (0.00%)	0 / 1 (0.00%)	369 / 1479 (24.95%)	244 / 738 (33.06%)	574 / 1462 (39.26%)
occurrences all number	0	0	96	0	0	369	244	574
Loss of appetite - PRI
alternative assessment type: Systematic
subjects affected / exposed ^[370]	0 / 1 (0.00%)	0 / 1 (0.00%)	132 / 721 (18.31%)	0 / 1 (0.00%)	0 / 1 (0.00%)	398 / 1479 (26.91%)	104 / 738 (14.09%)	243 / 1462 (16.62%)
occurrences all number	0	0	132	0	0	398	104	243
Fever (axillary temperature ≥37.5°C) - PRI
alternative assessment type: Systematic
subjects affected / exposed ^[371]	0 / 1 (0.00%)	0 / 1 (0.00%)	235 / 721 (32.59%)	0 / 1 (0.00%)	0 / 1 (0.00%)	897 / 1479 (60.65%)	331 / 738 (44.85%)	839 / 1462 (57.39%)
occurrences all number	0	0	235	0	0	897	331	839
Drowsiness – BST
alternative assessment type: Systematic
subjects affected / exposed ^[372]	55 / 641 (8.58%)	22 / 639 (3.44%)	21 / 633 (3.32%)	33 / 608 (5.43%)	19 / 625 (3.04%)	0 / 1 (0.00%)	15 / 621 (2.42%)	0 / 1 (0.00%)
occurrences all number	55	22	21	33	19	0	15	0
Irritability – BST
alternative assessment type: Systematic
subjects affected / exposed ^[373]	63 / 641 (9.83%)	25 / 639 (3.91%)	18 / 633 (2.84%)	46 / 608 (7.57%)	23 / 625 (3.68%)	0 / 1 (0.00%)	23 / 621 (3.70%)	0 / 1 (0.00%)
occurrences all number	63	25	18	46	23	0	23	0
Loss of appetite – BST
alternative assessment type: Systematic
subjects affected / exposed ^[374]	66 / 641 (10.30%)	27 / 639 (4.23%)	21 / 633 (3.32%)	45 / 608 (7.40%)	27 / 625 (4.32%)	0 / 1 (0.00%)	18 / 621 (2.90%)	0 / 1 (0.00%)
occurrences all number	66	27	21	45	27	0	18	0
Fever (axillary temperature ≥37.5°C) - BST
alternative assessment type: Systematic
subjects affected / exposed ^[375]	233 / 641 (36.35%)	70 / 639 (10.95%)	45 / 633 (7.11%)	152 / 608 (25.00%)	52 / 625 (8.32%)	0 / 1 (0.00%)	58 / 621 (9.34%)	0 / 1 (0.00%)
occurrences all number	233	70	45	152	52	0	58	0
Pyrexia – PRI
subjects affected / exposed ^[376]	0 / 1 (0.00%)	0 / 1 (0.00%)	67 / 721 (9.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)	200 / 1479 (13.52%)	112 / 738 (15.18%)	251 / 1462 (17.17%)
occurrences all number	0	0	67	0	0	200	112	251
Pyrexia - BST
subjects affected / exposed ^[377]	44 / 641 (6.86%)	10 / 639 (1.56%)	7 / 633 (1.11%)	12 / 608 (1.97%)	11 / 625 (1.76%)	0 / 1 (0.00%)	39 / 621 (6.28%)	0 / 1 (0.00%)
occurrences all number	44	10	7	12	11	0	39	0
Gastrointestinal disorders
Diarrhoea - PRI
subjects affected / exposed ^[378]	0 / 1 (0.00%)	0 / 1 (0.00%)	88 / 721 (12.21%)	0 / 1 (0.00%)	0 / 1 (0.00%)	188 / 1479 (12.71%)	0 / 738 (0.00%)	0 / 1462 (0.00%)
occurrences all number	0	0	88	0	0	188	0	0
Respiratory, thoracic and mediastinal disorders
Cough - PRI
subjects affected / exposed ^[379]	0 / 1 (0.00%)	0 / 1 (0.00%)	41 / 721 (5.69%)	0 / 1 (0.00%)	0 / 1 (0.00%)	107 / 1479 (7.23%)	0 / 738 (0.00%)	0 / 1462 (0.00%)
occurrences all number	0	0	41	0	0	107	0	0
Infections and infestations
Conjunctivitis – PRI
subjects affected / exposed ^[380]	0 / 1 (0.00%)	0 / 1 (0.00%)	64 / 721 (8.88%)	0 / 1 (0.00%)	0 / 1 (0.00%)	111 / 1479 (7.51%)	63 / 738 (8.54%)	118 / 1462 (8.07%)
occurrences all number	0	0	64	0	0	111	63	118
Enteritis – PRI
subjects affected / exposed ^[381]	0 / 1 (0.00%)	0 / 1 (0.00%)	62 / 721 (8.60%)	0 / 1 (0.00%)	0 / 1 (0.00%)	124 / 1479 (8.38%)	72 / 738 (9.76%)	131 / 1462 (8.96%)
occurrences all number	0	0	62	0	0	124	72	131
Gastroenteritis- PRI
subjects affected / exposed ^[382]	0 / 1 (0.00%)	0 / 1 (0.00%)	170 / 721 (23.58%)	0 / 1 (0.00%)	0 / 1 (0.00%)	372 / 1479 (25.15%)	131 / 738 (17.75%)	220 / 1462 (15.05%)
occurrences all number	0	0	170	0	0	372	131	220
Malaria- PRI
subjects affected / exposed ^[383]	0 / 1 (0.00%)	0 / 1 (0.00%)	173 / 721 (23.99%)	0 / 1 (0.00%)	0 / 1 (0.00%)	265 / 1479 (17.92%)	70 / 738 (9.49%)	137 / 1462 (9.37%)
occurrences all number	0	0	173	0	0	265	70	137
Nasopharyngitis – PRI
subjects affected / exposed ^[384]	0 / 1 (0.00%)	0 / 1 (0.00%)	58 / 721 (8.04%)	0 / 1 (0.00%)	0 / 1 (0.00%)	115 / 1479 (7.78%)	55 / 738 (7.45%)	76 / 1462 (5.20%)
occurrences all number	0	0	58	0	0	115	55	76
Pneumonia – PRI
subjects affected / exposed ^[385]	0 / 1 (0.00%)	0 / 1 (0.00%)	71 / 721 (9.85%)	0 / 1 (0.00%)	0 / 1 (0.00%)	166 / 1479 (11.22%)	39 / 738 (5.28%)	86 / 1462 (5.88%)
occurrences all number	0	0	71	0	0	166	39	86
Rhinitis – PRI
subjects affected / exposed ^[386]	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 721 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1479 (0.00%)	75 / 738 (10.16%)	148 / 1462 (10.12%)
occurrences all number	0	0	0	0	0	0	75	148
Upper respiratory tract infection – PRI
subjects affected / exposed ^[387]	0 / 1 (0.00%)	0 / 1 (0.00%)	326 / 721 (45.21%)	0 / 1 (0.00%)	0 / 1 (0.00%)	638 / 1479 (43.14%)	312 / 738 (42.28%)	584 / 1462 (39.95%)
occurrences all number	0	0	326	0	0	638	312	584
Malaria - BST
subjects affected / exposed ^[388]	49 / 641 (7.64%)	53 / 639 (8.29%)	84 / 633 (13.27%)	34 / 608 (5.59%)	29 / 625 (4.64%)	0 / 1 (0.00%)	40 / 621 (6.44%)	0 / 1 (0.00%)
occurrences all number	49	53	84	34	29	0	40	0
Upper respiratory tract infection – BST
subjects affected / exposed ^[389]	61 / 641 (9.52%)	55 / 639 (8.61%)	55 / 633 (8.69%)	44 / 608 (7.24%)	56 / 625 (8.96%)	0 / 1 (0.00%)	55 / 621 (8.86%)	0 / 1 (0.00%)
occurrences all number	61	55	55	44	56	0	55	0
Gastroenteritis - BST
subjects affected / exposed ^[390]	17 / 641 (2.65%)	16 / 639 (2.50%)	13 / 633 (2.05%)	231 / 608 (37.99%)	239 / 625 (38.24%)	0 / 1 (0.00%)	240 / 621 (38.65%)	0 / 1 (0.00%)
occurrences all number	17	16	13	231	239	0	240	0

Notes
[363] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[364] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[365] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[366] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[367] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[368] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[369] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[370] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[371] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[372] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[373] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[374] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[375] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[376] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[377] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[378] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[379] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[380] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[381] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[382] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[383] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[384] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[385] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[386] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[387] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[388] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[389] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.
[390] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: In this section, R3R (5-17M), R3C (5-17M), R3R (6-12W) and R3C (6-12W) groups are only applicable for solicited SAEs, with all not applicable other Ns coded as ‘1’ and ns coded as ‘0’.

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Were there any global substantial amendments to the protocol? Yes

19 Aug 2008

The primary objective and endpoint were updated to make them case-driven. The number of episodes needed to have sufficient power and precision to evaluate the primary endpoint was added to the protocol. In the original protocol, malaria episodes occurring within 28 days of a previous episode were excluded from the analysis, to avoid including recrudescence of the first infection. However, since writing the protocol, all sites switched to highly effective first line therapy with artemisin combinations and recrudescence were rare. Therefore, the period of exclusion was reduced to 14 days to reflect the half-lives of these new therapeutic regimens and consequently the shorter period of time for which individuals were non-susceptible after anti-malarial therapy.

24 Oct 2008

RTS protein is derived from a sporozoite surface antigen of the Plasmodium falciparum strain NF54. Previous studies showed that protection was not limited to the NF54 parasite genotype. As part of Amendment 2, the collection of study samples for the determination of parasite genotyping to evaluate strain-specific efficacy and protection against infection due to multiple strains was added.

26 Nov 2009

Based on a theoretical concern that the use of new adjuvanted vaccines could promote a rupture of immunological self-tolerance, regulatory authorities required optimizing the data collection on immune-mediated diseases (IMD). As a result, GSK Biologicals decided to define IMD as adverse events of interest and to optimize auto-immunity data collection processes in studies of all GSK’s adjuvanted candidate vaccines. The protocol was adapted accordingly. The assessment of all unsolicited adverse events (AEs) in the first 200 subjects enrolled in each age category and at each study site was added in Amendment 3. The assessment of serious adverse events (SAEs) occurring within 30 days of each vaccination dose was added to the protocol in order to better assess any temporal relationship between SAE occurrence and variation across all studies performed at GSK Biologicals. The exclusion criterion on anemia was clarified by splitting the information over two lines. Anemia was defined as hemoglobin < 5.0 g/dL or or hemoglobin < 8 g/dL associated with clinical signs of heart failure or severe respiratory distress.

01 Dec 2010

This amendment 4 was done to increase the follow up period of the study. All subjects having their Visit 34 before and including on 30 September 2013 will be followed up. Due to the wide range of enrolment, there will be a variable number of months of follow-up after vaccination for individual children. Based on the actual enrolment, the mean follow-up time will be 49 months post Dose 1 (range: 41-55) for the 5 to 17 months age category and 41 months post Dose 1 (range: 32-48) for the 6 to 12 weeks age category. The protocol was amended to collect data on severe malaria; malaria hospitalization and parasite prevalence in the 11 participating centers using the same methodologies and case definitions as in the primary trial phase. Occurrence of SAEs will be monitored in all 11 centers. Surveillance for clinical malaria will take place in at least 3 centers with varying transmission levels. Immunogenicity endpoints will also be collected on a subset of individuals from both age categories in at least these 3 centers.

23 Jan 2012

Amendment 5 was developed to include an analysis time point at Month 20 (18 months post Dose 3). No changes have been made to the protocol endpoints or statistical methods but the protocol endpoints will be analyzed on data collected up to Month 20 as soon as these data are available. The rationale is to have the full scope of protocol defined efficacy and safety endpoints related to a primary schedule without booster in both age categories followed up for 20 months earlier than at study end (Visit 34) as initially planned. The detailed analysis of gender-specific vaccine efficacy will be reported in full at the end of the study (Visit 34). Also, the text related to the recording of concomitant medication was adapted to allow more flexibility in the collection of data on concomitant medication during the study.

08 Aug 2012

Amendment 6 was developed related to that, at a request from the European Medicines Agency’s (EMA), GSK Biologicals has updated its procedure for emergency unblinding during the conduct of a clinical study. According to the revised procedure, the responsibility and the decision to break the treatment code in emergency situations resides solely with the investigator and consequently, the investigator will have full authority to break the treatment code. Investigators will be granted an unrestricted, immediate and direct access to the individual treatment codes via an automated system.

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: Time to first or only clinical episode of Plasmodium falciparum (P. falciparum) malaria infection (CPFMI), or clinical malaria episode, of Primary Case Definition (CPFMI-PCD) - In subjects enrolled aged 5-17 months

Primary: Time to first or only clinical episode of Plasmodium falciparum (P. falciparum) malaria infection (CPFMI), or clinical malaria episode, of Primary Case Definition (CPFMI-PCD) - In subjects enrolled aged 5-17 months

Primary: Time to first or only clinical episode of Plasmodium falciparum (P. falciparum) malaria infection (CPFMI), or clinical malaria episode, of Primary Case Definition (CPFMI-PCD) – In subjects enrolled aged 6-12 weeks

Primary: Time to first or only clinical episode of Plasmodium falciparum (P. falciparum) malaria infection (CPFMI), or clinical malaria episode, of Primary Case Definition (CPFMI-PCD) – In subjects enrolled aged 6-12 weeks

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of PCD and of secondary case definitions (SCD) 1, SCD 2 and SCD 3

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of PCD and of secondary case definitions (SCD) 1, SCD 2 and SCD 3

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of PCD, overall and by centre

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of PCD, overall and by centre

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of SCD1, SCD2 and SCD3, overall

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of SCD1, SCD2 and SCD3, overall

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of primary case definition (PCD) by centres & across centres

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of primary case definition (PCD) by centres & across centres

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of Secondary Case Definition 1 (SCD1) and Primary Case Definition (PCD1) – across centres;

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of Secondary Case Definition 1 (SCD1) and Primary Case Definition (PCD1) – across centres;

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of Primary Case Definition (PCD) and Secondary Case Definition 1 (SCD1)

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of Primary Case Definition (PCD) and Secondary Case Definition 1 (SCD1)

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of PCD and SCD1 across centres

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of PCD and SCD1 across centres

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of PCD –by centre & across centres

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of PCD –by centre & across centres

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of Secondary Case Definition 1 (SCD1)

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of Secondary Case Definition 1 (SCD1)

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of Primary Case Definition (PCD) and Secondary Case Definition 1 (SCD1)

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of Primary Case Definition (PCD) and Secondary Case Definition 1 (SCD1)

Secondary: Percentage (%) of subjects with severe PFMI (SPFMI) of PCD, SCD1, SCD2 and SCD3 across centres

Secondary: Percentage (%) of subjects with severe PFMI (SPFMI) of PCD, SCD1, SCD2 and SCD3 across centres

Secondary: Percentage (%) of subjects with severe PFMI (SPFMI) of PCD and SCD1

Secondary: Percentage (%) of subjects with severe PFMI (SPFMI) of PCD and SCD1

Secondary: Percentage (%) of subjects with severe PFMI (SPFMI) of PCD and SCD1

Secondary: Percentage (%) of subjects with severe PFMI (SPFMI) of PCD and SCD1

Secondary: Percentage (%) of subjects with severe PFMI (SPFMI) of PCD and SCD1

Secondary: Percentage (%) of subjects with severe PFMI (SPFMI) of PCD and SCD1

Secondary: Percentage (%) of subjects with incident severe anaemia (ISA) and malaria hospitalization (MH) for case definitions (CD) considered

Secondary: Percentage (%) of subjects with incident severe anaemia (ISA) and malaria hospitalization (MH) for case definitions (CD) considered

Secondary: Percentage (%) of subjects with incident severe anaemia (ISA), malaria hospitalization (MH) and fatal malaria (FM) for case definitions (CD) considered

Secondary: Percentage (%) of subjects with incident severe anaemia (ISA), malaria hospitalization (MH) and fatal malaria (FM) for case definitions (CD) considered

Secondary: Percentage (%) of subjects with incident severe anaemia (ISA), malahria hospitalization *MH) and fatal malaria (FM) for case definitions (CD) considered

Secondary: Percentage (%) of subjects with incident severe anaemia (ISA), malahria hospitalization *MH) and fatal malaria (FM) for case definitions (CD) considered

Secondary: Percentage (%) of subjects with prevalent parasitemia, prevalent gametocytemia and prevalent severe and moderate anemia

Secondary: Percentage (%) of subjects with prevalent parasitemia, prevalent gametocytemia and prevalent severe and moderate anemia

Secondary: Percentage (%) of subjects with prevalent parasitemia and prevalent severe and moderate anemia

Secondary: Percentage (%) of subjects with prevalent parasitemia and prevalent severe and moderate anemia

Secondary: Time to all episodes of severe PFMI (SPFMI) of primary case definition (PCD) and secondary case definition (SCD1; SCD2; SCD3) across centres

Secondary: Time to all episodes of severe PFMI (SPFMI) of primary case definition (PCD) and secondary case definition (SCD1; SCD2; SCD3) across centres

Secondary: Percentage (%) of subjects with pneumonia, all-cause hospitalization and sepsis, as per case definitions assessed

Secondary: Percentage (%) of subjects with pneumonia, all-cause hospitalization and sepsis, as per case definitions assessed

Secondary: Percentage (%) of subjects with fatal malaria (FM) and all-cause mortality (ACM) as per case definitions assessed

Secondary: Percentage (%) of subjects with fatal malaria (FM) and all-cause mortality (ACM) as per case definitions assessed

Secondary: Percentage (%) of subjects with pneumonia, all-cause hospitalization/mortality and sepsis, as per case definitions assessed

Secondary: Percentage (%) of subjects with pneumonia, all-cause hospitalization/mortality and sepsis, as per case definitions assessed

Secondary: Percentage (%) of subjects with blood transfusion, as per case definition assessed

Secondary: Percentage (%) of subjects with blood transfusion, as per case definition assessed

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of primary case definition (PCD) by gender & overall

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of primary case definition (PCD) by gender & overall

Secondary: Height, weight and mid upper arm circumference for age z-score (HAZ, WAZ and MUACZ)

Secondary: Height, weight and mid upper arm circumference for age z-score (HAZ, WAZ and MUACZ)

Secondary: Height, weight and mid upper arm circumference for age z-score (HAZ, WAZ and MUACZ)

Secondary: Height, weight and mid upper arm circumference for age z-score (HAZ, WAZ and MUACZ)

Secondary: Anti Plasmodium falciparum circumsporozoite (anti-CS) antibody concentrations in the 1st 200 subjects in each center

Secondary: Anti Plasmodium falciparum circumsporozoite (anti-CS) antibody concentrations in the 1st 200 subjects in each center

Secondary: Anti-CS antibody concentrations in the 1st 200 HIV-infected subjects in each center

Secondary: Anti-CS antibody concentrations in the 1st 200 HIV-infected subjects in each center

Secondary: Anti-CS antibody concentrations across sites

Secondary: Anti-CS antibody concentrations across sites

Secondary: Anti-CS antibody concentrations by site in Agogo, Lilongwe and Siaya

Secondary: Anti-CS antibody concentrations by site in Agogo, Lilongwe and Siaya

Secondary: Anti-CS antibody concentrations in the first 200 subjects in each center, by tertiles

Secondary: Anti-CS antibody concentrations in the first 200 subjects in each center, by tertiles

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of primary case definition (PCD) by tertile

Secondary: Time to all episodes of clinical Plasmodium falciparum malaria infection (CPFMI) of primary case definition (PCD) by tertile

Secondary: Anti-CS antibody concentrations in the first 200 subjects in each center, by tertiles