Table 6 Serious adverse events: clinical 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.