Adverse events
. | Iron group . | Placebo group . | P . |
---|---|---|---|
All adverse events | |||
Number of patients reporting events, n (%) | 23 (53%) | 31 (66%) | ns |
Total number of adverse events, n | 52 | 53 | ns |
Number of serious adverse events, n | 1 | 1 | |
Appendicitis | 1 | 0 | |
Traffic accident | 0 | 1 | |
Drug-associated adverse events | |||
Number of patients reporting events, n | 9 (21%) | 3 (7%) | .05 |
Total number of adverse events, n | 17 | 4 | ns |
Nausea | 6 | 1 | |
Chills | 4 | 0 | |
Headache | 3 | 1 | |
Dizziness | 1 | 1 | |
Chest pain | 1 | 0 | |
Dysaesthesia | 1 | 0 | |
Dysgeusia | 1 | 0 | |
Diarrhea | 0 | 1 |
. | Iron group . | Placebo group . | P . |
---|---|---|---|
All adverse events | |||
Number of patients reporting events, n (%) | 23 (53%) | 31 (66%) | ns |
Total number of adverse events, n | 52 | 53 | ns |
Number of serious adverse events, n | 1 | 1 | |
Appendicitis | 1 | 0 | |
Traffic accident | 0 | 1 | |
Drug-associated adverse events | |||
Number of patients reporting events, n | 9 (21%) | 3 (7%) | .05 |
Total number of adverse events, n | 17 | 4 | ns |
Nausea | 6 | 1 | |
Chills | 4 | 0 | |
Headache | 3 | 1 | |
Dizziness | 1 | 1 | |
Chest pain | 1 | 0 | |
Dysaesthesia | 1 | 0 | |
Dysgeusia | 1 | 0 | |
Diarrhea | 0 | 1 |
P values were calculated with the χ2 test or the Mann Whitney U test (number of events per patient).
ns indicates not significant and no trend (P > .10).