Table 3.
Description of Deaths Among Participants in the Sierra Leone Trial to Introduce a Vaccine Against Ebola, by MedDRA System Organ Class and Preferred Term
| Variable | Immediate Vaccinated, No.a (n = 4172) |
Unvaccinated, No. (n = 4398) |
Crossover Vaccinated, No.b (n = 3787) |
|---|---|---|---|
| Blood and lymphatic system disorders | |||
| Sickle cell anemia with crisis | 0 | 1 | 0 |
| Cardiac disorders | |||
| Myocardial infarction | 0 | 0 | 1 |
| Gastrointestinal disorders | |||
| Acute abdomen | 1 | 0 | 0 |
| Pancreatitis | 1 | 0 | 0 |
| Peptic ulcer perforation | 0 | 1 | 0 |
| General disorders not otherwise classified | |||
| Drowning | 0 | 0 | 1 |
| Electrocution | 1 | 0 | 0 |
| Hepatobiliary disorders | |||
| Hepatic cirrhosis | 0 | 0 | 1 |
| Infectious and infestations | |||
| HIV wasting syndrome | 1 | 0 | 0 |
| Malaria | 1 | 0 | 1 |
| Pulmonary tuberculosis | 0 | 1 | 0 |
| Pyonephrosis | 0 | 0 | 1 |
| Injury, poisoning, and procedural complications | |||
| Skeletal injury | 0 | 0 | 1 |
| Spinal cord injury | 0 | 0 | 1 |
| Neoplasms benign, malignant and unspecified (including cysts and polyps) | |||
| Hepatocellular carcinoma | 0 | 1 | 0 |
| Nasopharyngeal cancer | 0 | 1 | 0 |
| Nervous system disorders | |||
| Cerebrovascular accident | 0 | 0 | 1 |
| Hemorrhagic stroke | 0 | 0 | 1 |
| Renal and urinary disorders | |||
| Renal failure | 0 | 1 | 0 |
| Unknown | |||
| Unknown | 3 | 0 | 1 |
| Total | 8 | 6 | 10 |
Abbreviation: HIV, human immunodeficiency virus.
aThe median number of days from vaccination to death was 98 (range, 63–179 days).
bThe median number of days from vaccination to death was 114 (range, 18–203 days).