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Table 3 Percentage of study participants with final diagnoses for the main interim analysis endpoints

From: Baseline incidence of meningitis, malaria, mortality and other health outcomes in infants and young sub-Saharan African children prior to the introduction of the RTS,S/AS01E malaria vaccine

6 to 12 weeks

Kombewa, Kenya

Kintampo, Ghana

Navrongo, Ghana

Overall

N = 1979

N = 4297

N = 972

N = 7248

e

n

%

e

n

%

e

n

%

e

n

%

AESI

0

0

0.0

0

0

0.0

0

0

0.0

0

0

0.0

Meningitis

0

0

0.0

0

0

0.0

0

0

0.0

0

0

0.0

Malaria

479

375

19.0

898

685

15.9

48

43

4.4

1425

1103

15.2

Other AEa leading to hospitalization

62

38

1.9

439

233

5.4

111

46

4.7

612

317

4.4

All-cause hospitalization

39

39

2.0

268

240

5.6

54

47

4.8

361

326

4.5

5 to 17 months

Kombewa, Kenya

Kintampo, Ghana

Navrongo, Ghana

Overall

N = 2240

N = 3655

N = 1186

N = 7081

e

n

%

e

n

%

e

n

%

e

n

%

AESI

1

1

0.04

1

1

0.0

0

0

0.0

2

2

0.0

Meningitis

3

3

0.1

1

1

0.0

0

0

0.0

4

4

0.1

Malaria

639

505

22.5

1363

938

22.7

127

118

10.0

2129

1561

22.0

Other AEa leading to hospitalization

119

69

3.1

495

254

6.7

188

78

6.6

802

392

5.5

All-cause hospitalization

85

79

3.5

310

262

7.2

92

78

6.6

487

419

5.9

  1. According-to-protocol cohort
  2. AESI: adverse event of special interest; AE: adverse event; N: total number of study participants by study group or by study site; e, number of events reported; n, number of study participants in each category; %, percentage of study participants who reported at least one event
  3. The AESI in this study refer to a list of 15 diseases: Acute disseminated encephalomyelitis, Encephalitis, Guillain-Barré syndrome, Generalized convulsive seizure, Hypotonic hypo-responsive episode, Intussusception, Hepatic insufficiency, Renal insufficiency, Juvenile chronic arthritis, Stevens Johnson syndrome and toxic epidermal necrolysis, Henoch Schonlein purpura, Kawasaki disease, Diabetes mellitus type 1, Thrombocytopenia, Anaphylaxis
  4. aAdverse events other than AESI, malaria or meningitis