Table 3 Adverse events in the multivitamin and placebo armsa
Multivitamin | Placebo | P-value | ||||
|---|---|---|---|---|---|---|
Endpoint | Month | n | # of events (%) | n | # of events (%) | |
Severe anemia (HB <7 g/dL) | 6 | 191 | 1 (0.5 %) | 190 | 0 | 0.995b |
12 | 183 | 0 | 188 | 0 | ||
18 | 181 | 0 | 187 | 1 (0.5 %) | ||
Nausea | 1–3 | 194 | 62 (32.0 %) | 195 | 79 (40.5 %) | 0.088c |
4–6 | 191 | 38 (19.9 %) | 190 | 44 (23.2 %) | ||
10–12 | 183 | 25 (13.7 %) | 188 | 33 (17.6 %) | ||
16–18 | 181 | 28 (15.5 %) | 187 | 36 (19.3 %) | ||
Vomiting | 1–3 | 194 | 34 (17.5 %) | 195 | 52 (26.7 %) | 0.058c |
4–6 | 191 | 18 (9.4 %) | 190 | 23 (12.1 %) | ||
10–12 | 183 | 15 (8.2 %) | 188 | 22 (11.7 %) | ||
16–18 | 181 | 17 (9.4 %) | 187 | 19 (10.2 %) | ||
High ALT (>200 IU/I) | 6 | 191 | 0 | 190 | 0 | 0.496b |
12 | 183 | 1 (0.5 %) | 188 | 1 (0.5 %) | ||
18 | 181 | 0 | 187 | 1 (0.5 %) | ||