Table 4.
Safety Endpoints: serious adverse events (SAEs).
| Safety | Usual diet + RUTF (N = 424) | Usual diet (N = 422) |
|---|---|---|
| Number of patients with one or more SAEs, n (%) | 69 (16.3%) | 50 (11.8%) |
| Number of patients with a fatal SAE, n (%) | 15 (3.5%) | 10 (2.4%) |
| Total number of SAEs | 164 | 108 |
| Relatedness to RUTF, n (%) | ||
| Unlikely | 14 (10.8%) | – |
| Unrelated | 98 (75.4%) | – |
| Not reporteda | 18 (13.8%) | – |
| Allergic reaction to RUTF, n/N (%) | 0/414 (0.0%) | – |
| SAE type, number of events | ||
| Anaemia | 11 | 6 |
| Cardiovascular disorders | 4 | 8 |
| Gastroenteritis/diarrhoea/vomiting | 9 | 10 |
| Hematologic disorders | 5 | 0 |
| Malaria | 27 | 25 |
| Malnutrition | 1 | 2 |
| Meningitis | 1 | 0 |
| Respiratory disorders | 55 | 31 |
| Septicaemia/sepsis | 10 | 7 |
| Sickle cell crisis | 16 | 5 |
| Other | 25 | 14 |
a
Relatedness to RUTF not reported for SAEs among children who were co-enrolled in the COAST trial.