Table 2. Serious Adverse Events During Spermidine or Placebo Supplementation.
| Characteristic | Participants by group | IRR (95% CI) | P value | ||
|---|---|---|---|---|---|
| Total (n = 100) | Spermidine (n = 51) | Placebo (n = 49) | |||
| Observation time, median (IQR), d | 368 (365-376) | 367 (364-372) | 369 (365-380) | NA | NA |
| Total SAE | |||||
| Participants, No. | 19 | 7 | 12 | NA | .30 |
| IR per 100 PY (95% CI) | 19.8 (12.2-30.0) | 14.9 (6.4-28.8) | 24.4 (13.1-40.9) | 0.61 (0.23-1.52) | |
| Fatal or life-threatening events | |||||
| Participants, No. | 1 | 1 | 0 | NA | >.99 |
| IR per 100 PY (95% CI) | 1.0 (0.1-4.6) | 2.1 (0.1-9.4) | NA | 0 | |
| Acute hospital (inpatient hospital treatment or its extension) | |||||
| Participants, No. | 16 | 5 | 11 | NA | .17 |
| IR per 100 PY (95% CI) | 16.6 (9.8-26.2) | 10.7 (3.8-22.9) | 22.4 (11.6-38.3) | 0.48 (0.15-1.31) | |
| Malignant/neoplastic processes | |||||
| Participants, No. | 2 | 1 | 1 | NA | .97 |
| IR per 100 PY (95% CI) | 2.1 (0.3-6.4) | 2.1 (0.1-9.4) | 2.0 (0.1-8.9) | 1.05 (0.04-26.49) | |
Abbreviations: IR, incidence rate; IRR, incidence rate ratio; NA, not applicable; PY, person-years; SAE, serious adverse event.