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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