Table 3 Safety outcomes by allocation
Placebo (n = 129)a | Vitamin D (n = 127)b | ||||
---|---|---|---|---|---|
No. of events | Proportion of participants with one or more events (%) | No. of events | Proportion of participants with one or more events (%) | ||
Fatal serious adverse eventc | 2 | 2/128 (1.6) | 0 | 0/123 (0.0) | |
Non-fatal serious adverse eventc | 9 | 9/128 (7.0) | 3 | 3/123 (2.4) | |
Non-serious adverse event leading to discontinuation of study supplement | 0 | 0/128 (0.0) | 0 | 0/123 (0.0) | |
Relapse of SAM (complicated or uncomplicated) | 4 | 4/128 (3.1) | 3 | 3/123 (2.4) | |
Other monitored safety conditions | Hypercalcaemiad | 6 | 5/128 (3.9) | 2 | 2/123 (1.6) |
Hypervitaminosis De | 1 | 1/83 (1.2) | 22 | 22/85 (25.9) | |
Hypercalciuriaf | 56 | 50/128 (39.1) | 51 | 44/123 (35.8) |