Adverse events by treatment allocation
| Adverse event . | High dose (n = 31)* . | Standard dose (n = 31)* . | Odds ratio† . | 95% CI . | P‡ . |
|---|---|---|---|---|---|
| Pain syndrome | 16 (51.6) | 16 (51.6) | 1.00 | (0.37-2.71) | 1.00 |
| Fever | 7 (22.6) | 4 (12.9) | 1.97 | (0.51-7.56) | 0.51 |
| Blood bilirubin increased | 3 (9.7) | 4 (12.9) | 0.72 | (0.15-3.58) | 1.00 |
| Anemia | 2 (6.5) | 4 (12.9) | 0.47 | (0.08-2.57) | 0.68 |
| Injury | 3 (9.7) | 2 (6.5) | 1.55 | (0.24-10.01) | 1.00 |
| Cholecystitis | 2 (6.5) | 2 (6.5) | 1.00 | (0.13-7.59) | 1.00 |
| Surgical procedure | 2 (6.5) | 1 (3.2) | 2.07 | (0.18-24.08) | 1.00 |
| Urinary tract infection | 3 (9.7) | 1 (3.2) | 3.21 | (0.32-32.74) | 0.62 |
| Viral syndrome | 2 (6.5) | 1 (3.2) | 2.07 | (0.18-24.08) | 1.00 |
| Constipation | 4 (12.9) | 0 (0.0) | 10.31 | (0.53-20.18) | 0.12 |
| Adverse event . | High dose (n = 31)* . | Standard dose (n = 31)* . | Odds ratio† . | 95% CI . | P‡ . |
|---|---|---|---|---|---|
| Pain syndrome | 16 (51.6) | 16 (51.6) | 1.00 | (0.37-2.71) | 1.00 |
| Fever | 7 (22.6) | 4 (12.9) | 1.97 | (0.51-7.56) | 0.51 |
| Blood bilirubin increased | 3 (9.7) | 4 (12.9) | 0.72 | (0.15-3.58) | 1.00 |
| Anemia | 2 (6.5) | 4 (12.9) | 0.47 | (0.08-2.57) | 0.68 |
| Injury | 3 (9.7) | 2 (6.5) | 1.55 | (0.24-10.01) | 1.00 |
| Cholecystitis | 2 (6.5) | 2 (6.5) | 1.00 | (0.13-7.59) | 1.00 |
| Surgical procedure | 2 (6.5) | 1 (3.2) | 2.07 | (0.18-24.08) | 1.00 |
| Urinary tract infection | 3 (9.7) | 1 (3.2) | 3.21 | (0.32-32.74) | 0.62 |
| Viral syndrome | 2 (6.5) | 1 (3.2) | 2.07 | (0.18-24.08) | 1.00 |
| Constipation | 4 (12.9) | 0 (0.0) | 10.31 | (0.53-20.18) | 0.12 |
The table summarizes the number of participants with adverse events that were at least grade 2 in severity and occurred in ≥3 participants during the 2-year treatment period.
CI, confidence interval.
All data are n (%).
Mantel-Haenszel odds ratio when all cells have ≥1 count; logit odds ratio when a 0 cell is present.
Fisher’s exact test.