Table 6.

Serious adverse events: clinical details

Number	Site	Arm	Event type	Outcome	Relationship*	Additional details
GAS230	Mbale	Plan C	Convulsions	Resolved	Unlikely	Lethargic at admission and suffered repeated seizures/status (controlled by IV diazepam) after admission leading to worsening conscious level. Previous history of seizures prior to admission (in this illness). Severe malaria anaemia: received 1 unit of whole blood.
GAS263	Mbale	Slow	Suspected Pulmonary oedema	Fatal	Unlikely	Severe pneumonia and gastroenteritis. Left-sided pleural effusion on x-ray. Lethargic at admission. Had worsening difficulty in breathing needing supplemental oxygen. Died about 36 h into admission.
GAS002	Kilifi	Plan C	Cardiovascular collapse/heart failure	Fatal	Probable	Comatose, hypoglycaemic and in shock at admission. Fluid boluses x 2: post-resuscitation echo showed “worsening biventricular function, tricuspid regurgitation and right atrial enlargement” treated with frusemide intravenously. Died 13 h into admission: cause of death: heart failure.
GAS003	Kilifi	Plan C	Cardiovascular collapse	Fatal	Unlikely	Severe pneumonia and gastroenteritis and had prolonged capillary refilling and a weak pulse at admission. Required supplemental oxygen at admission but did get a bolus. Died 1-h post-admission following cardiovascular collapse. Blood culture: Haemophilus influenzae.
GAS004	Kilifi	Slow	Convulsions	Resolved	Unlikely	Comatose and hypoglycaemic at admission. Suffered seizures on day 3 of admission. Admission history suggested seizures (in this illness) prior to admission. Seizures were controlled with I.V phenobarbitone
GAS007	Kilifi	Slow	Cardiovascular collapse	Fatal	Unlikely	Comatose at admission, very sick needing supplemental oxygen (saturations 52%) by mask and had hepatomegaly 4 cm BCM. Suffered seizures following admission which were controlled with I.V phenytoin. Died about 10 h into admission following cardiac arrest that was preceded by respiratory arrest.

*By attending clinician