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Table 1 Severe malaria definitions for reporting of SAEs

From: Randomized, controlled trial of the long term safety, immunogenicity and efficacy of RTS,S/AS02D malaria vaccine in infants living in a malaria-endemic region

Severe malaria anaemia

Asexual P. falciparum parasitemia > 0 definitive reading

 

Haematocrit < 15%1

 

No other more probable cause of illness

Cerebral malaria

Asexual P. falciparum parasitemia > 0 definitive reading

 

Coma score ≤ 22

 

No other identifiable cause of loss of consciousness

Severe malaria (other)

Asexual P. falciparum parasitemia > 0 definitive reading

 

No other more probable cause of illness

 

Does not meet criteria for severe malaria anaemia or cerebral malaria

 

One of the following:

 

Multiple seizures3

 

Prostration4

 

Hypoglycaemia5

 

Acidosis

 

Circulatory collapse