Table 3.
Adverse events.
| Event | Iron (N = 203) | Placebo (N = 202) | p value |
|---|---|---|---|
| All adverse events | |||
| Number of participants reporting events—N (%) | 41 (20.2) | 28 (13.9) | 0.090* |
| Total number of adverse events—N | 52 | 29 | 0.019** |
| Number of ≥ grade 3 adverse events—N | 1 | 1 | |
| Number of serious adverse events—N | 0 | 0 | |
| Drug associated adverse eventsa | |||
| Number of participants reporting events—N (%) | 10(4.9) | 9(4.5) | 0.820* |
| Total number of adverse events—N | 15 | 9 | 0.320** |
| Allergic reaction or bronchospasm | 2 | 0 | |
| Fatigue or insomnia | 4 | 4 | |
| Gastrointestinal symptoms | 2 | 1 | |
| Respiratory symptoms | 2 | 0 | |
| Neuropathy or taste alteration | 3 | 3 | |
| Palpitation | 1 | 0 | |
| Rash | 1 | 1 | |
Adverse events were rated by the principal investigator according to National Cancer Institute, Common Terminology Criteria for Adverse Events, version 3.0.
aCertainly or likely related to the study drug as rated by the principal investigator.
*p value calculated using the chi-squared test.
**p value calculated using repeated measures ANOVA.