Table 4.
Adverse Events | 35 mg iron group (n = 57*) | 60 mg iron group (n = 47*) |
No. subjects (%) who reported any adverse event(s) | 27 (47%) | 21 (45%) |
Nausea and/or vomiting(NVP) | 12 (21%) | 9 (19%) |
[Proportion who reported NVP before starting assigned multivitamin] | [11/12] | [9/9] |
Constipation | 13/57 (23%) | 10/47 (21%) |
[Proportion who reported constipation before starting assigned multivitamin] | [7/13] | [5/10] |
Heartburn/Acid reflux | 4/57 (7%) | 1/47 (2%) |
[Proportion who reported heartburn/reflux before starting assigned multivitamin] | [2/4] | [1/1] |
Diarrhea | 1/57 (2%) | 3/47 (6%) |
[Proportion who reported diarrhea before starting assigned multivitamin] | [1/1] | [1/3] |
Abdominal pain/cramps | 5/57 (9%) | 5/47 (11%) |
[Proportion who reported abdominal pain or cramps before starting assigned multivitamin] | [1/5] | [2/5] |
Swallowing difficulties with tablet size | 2/57 (4%) | None |
[Proportion who reported swallowing difficulties before starting assigned multivitamin] | [0/2] |
*Only subjects who completed the study, with no significant difference detected when partial data from subjects who did not complete the study were included.