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.
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Summary
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EudraCT number |
2012-005716-26 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
31 Jan 2014
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Results information
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Results version number |
v1 |
This version publication date |
10 Mar 2016
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First version publication date |
01 Aug 2015
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Other versions |
v2 , v3 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
110021
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00866619 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
GlaxoSmithKline Biologicals
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Sponsor organisation address |
GlaxoSmithKline Biologicals, Rue de l’Institut 89, Rixensart, B-1330, Belgium, Rixensart, Belgium, B-1330
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Public contact |
Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
15 Jul 2014
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Jan 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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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).
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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.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
27 Mar 2009
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety, Efficacy | ||
Long term follow-up duration |
12 Months | ||
Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Ghana: 2621
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Country: Number of subjects enrolled |
Tanzania, United Republic of: 3210
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Country: Number of subjects enrolled |
Mozambique: 1637
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Country: Number of subjects enrolled |
Malawi: 1626
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Country: Number of subjects enrolled |
Gabon: 930
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Country: Number of subjects enrolled |
Kenya: 4154
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Country: Number of subjects enrolled |
Burkina Faso: 1281
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Worldwide total number of subjects |
15459
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
15459
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
Screening included the following: check for inclusion/exclusion criteria, vaccination contraindications/precautions & subjects’ medical history, & signing informed consent forms. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Pre-assignment period milestones
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Number of subjects started |
15459 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number of subjects completed |
15459 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Entire Study Period (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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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
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Investigational medicinal product code |
RTS,S+AS01E
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Other name |
RTS,S, GSK 257049, RTS,S/AS01
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Pharmaceutical forms |
Powder and suspension for suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
3 primary doses according to a Month 0, 1 and 2 followed by a booster dose at Month 20.
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Arm title
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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
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Investigational medicinal product code |
RTS,S+AS01E
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Other name |
RTS,S, GSK 257049, RTS,S/AS01
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Pharmaceutical forms |
Powder and suspension for suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
3 primary doses according to a Month 0, 1 and 2
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Investigational medicinal product name |
MENJUGATE KIT
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Investigational medicinal product code |
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Other name |
Menjugate, MenC
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Pharmaceutical forms |
Powder and solvent for suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
One dose at Month 20
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Arm title
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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
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Investigational medicinal product code |
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Other name |
Rabies
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Pharmaceutical forms |
Powder and suspension for suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
3-dose primary vaccination course according to a Month 0, 1 and 2
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Investigational medicinal product name |
MENJUGATE KIT
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Investigational medicinal product code |
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Other name |
Menjugate, MenC
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Pharmaceutical forms |
Powder and solvent for suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
One dose at Month 20
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Arm title
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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
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Investigational medicinal product code |
RTS,S+AS01E
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Other name |
RTS,S, GSK 257049, RTS,S/AS01
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Pharmaceutical forms |
Powder and suspension for suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
3 primary doses according to a Month 0, 1 and 2 followed by a booster dose at Month 20.
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Investigational medicinal product name |
Tritanrix-HepB
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Investigational medicinal product code |
DTPw-HBV
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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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
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Investigational medicinal product name |
Hiberix
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Investigational medicinal product code |
Hib
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Other name |
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Pharmaceutical forms |
Powder and solution for solution for injection
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Routes of administration |
Intramuscular use
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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
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Investigational medicinal product name |
Polio Sabin (Oral)
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Investigational medicinal product code |
OPV
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Other name |
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Pharmaceutical forms |
Oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
3 primary doses according to a Month 0, 1 and 2 followed by a booster dose at Month 20.
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Arm title
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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
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Investigational medicinal product code |
RTS,S+AS01E
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Other name |
RTS,S, GSK 257049, RTS,S/AS01
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Pharmaceutical forms |
Powder and suspension for suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
3 primary doses according to a Month 0, 1 and 2
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Investigational medicinal product name |
MENJUGATE KIT
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Investigational medicinal product code |
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Other name |
Menjugate, MenC
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Pharmaceutical forms |
Powder and solvent for suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
One dose at Month 20
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Investigational medicinal product name |
Tritanrix-HepB
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Investigational medicinal product code |
DTPw-HBV
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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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
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Investigational medicinal product name |
Hiberix
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Investigational medicinal product code |
Hib
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Other name |
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Pharmaceutical forms |
Powder and solution for solution for injection
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Routes of administration |
Intramuscular use
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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
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Investigational medicinal product name |
Polio Sabin (Oral)
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Investigational medicinal product code |
OPV
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Other name |
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Pharmaceutical forms |
Oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
3 primary doses according to a Month 0, 1 and 2 followed by a booster dose at Month 20.
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Arm title
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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
|
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Investigational medicinal product code |
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Other name |
Menjugate, MenC
|
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Pharmaceutical forms |
Powder and solvent for suspension for injection
|
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Routes of administration |
Intramuscular use
|
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Dosage and administration details |
3 primary doses according to a Month 0, 1 and 2 followed by a booster dose at Month 20.
|
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Investigational medicinal product name |
Tritanrix-HepB
|
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Investigational medicinal product code |
DTPw-HBV
|
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Other name |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Suspension for injection
|
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Routes of administration |
Intramuscular use
|
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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
|
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Investigational medicinal product name |
Hiberix
|
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Investigational medicinal product code |
Hib
|
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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
|
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Investigational medicinal product name |
Polio Sabin (Oral)
|
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Investigational medicinal product code |
OPV
|
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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.
|
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|
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Baseline characteristics reporting groups
|
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Reporting group title |
R3R (5-17M) Group
|
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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 the same RTS,S/AS01 vaccine administered at Month 20. The RTS,S/AS01 vaccine was administered intramuscularly in the left deltoid. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 |
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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
R3R (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 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 |
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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
R3R (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 the same RTS,S/AS01 vaccine administered at Month 20. The RTS,S/AS01 vaccine was administered intramuscularly in the left deltoid. | ||
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 |
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. | ||
Reporting group title |
R3R (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 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. | ||
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 |
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. | ||
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.
|
||
|
||||||||||||||||
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: Analysis for this endpoint was done only on subjects in 6-12weeks age category, and, for subjects receiving RTS,S, in a pooled manner, that is, pooling subjects from R3R (6-12W) and R3C (6-12W). |
||||||||||||||||
|
||||||||||||||||
Statistical analysis title |
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. |
||||||||||||||||
|
||||||||||||||||
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 6-12 weeks [4] | |||||||||||||||
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 6-12 weeks (6-12W) age category
|
|||||||||||||||
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: Analysis for this endpoint was done only on subjects in 5-17 months age category, and, for subjects receiving RTS,S, in a pooled manner, that is, pooling subjects from R3R (5-17M) and R3C (5-17M). |
||||||||||||||||
|
||||||||||||||||
Statistical analysis title |
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 (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. |
||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Adverse events information
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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.
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||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.0
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Reporting groups
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Reporting group title |
R3R (5-17M) Group
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||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 the same RTS,S/AS01 vaccine administered at Month 20. The RTS,S/AS01 vaccine was administered intramuscularly in the left deltoid. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 |
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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
R3R (6-12W) Group
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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 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
R3C (6-12W) Group
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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
|
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Reporting group 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
RTS,S/AS01 (5-17M) Group
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Reporting group 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
RTS,S/AS01 (6-12W) Group
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Reporting group 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. |
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. [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: Number of subject exposed for this AE is as per number of subjects actually exposed to this AE taking into account its type (SAE vs AE), the period of assessment considered and based on subjects with available results. In case subjects exposed per group are marked as totalling 1, it means the group considered was not applicable for the specified AE/period considered. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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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. |
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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. |
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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. |
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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. |
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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.
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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. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
