Table 3.
Undesirable events, compliance, and blinding.
| FeSO4 n = 74 |
Placebo n = 71 |
Absolute difference | Significance level Fisher's exact test |
|
|---|---|---|---|---|
| Undesirable events, n (%) | ||||
| Hard stools | 13 (17.6%) | 3 (4.2%) | 13.4% | P = 0.015 |
| Liquid stools | 9 (12.2%) | 3 (4.2%) | 8.0% | P = 0.130 |
| Abdominal pain | 7 (9.5%) | 4 (5.6%) | 3.9% | P = 0.534 |
| Nausea | 2 (2.7%) | 0 (0%) | 2.7% | P = 0.497 |
| Any gastrointestinal | 25 (33.8%) | 8 (11.3%) | 22.5% | P = 0.001 |
| Other events | 6 (8.1%) | 3 (4.2%) | 3.9% | P = 0.495 |
| Any event | 29 (39.2%) | 11 (15.5%) | 23.7% | P = 0.002 |
| Days with correct dosing (compliance)a | ||||
| Mean (SD) | 26.3 (3.9) | 26.5 (2.8) | -0.2 | P = 0.624 |
| Median (range) | 27 (7 to 35) | 27 (13 to 35) | 0 | |
| Believed to have receivedb n (%) | ||||
| FeSO4 | 44 (60.3%) | 9 (12.9%) | 37.4% | P < 0.001 |
| Placebo | 13 (18.8%) | 42 (60.0%) | 41.2% | |
| Does not know | 16 (21.9%) | 19 (27.1%) | 5.2% |
aThe container with remaining pills was not returned by two donors from the control group. bOne patient from the intervention group did not answer.