Table 6.
Summary of temporally associated AEs (TAAEs) in phase III trial of RI-002.
| Total | 3-week cycle | 4-week cycle | |
|---|---|---|---|
| Total number of subjects | 59 | 19 | 40 |
| Total number of infusions | 793 | 294 | 499 |
| Number of infusions with ≥1 TAAEs | 113 | 36 | 77 |
| Total number of TAAEs | 158 | 47 | 111 |
| Mean number of TAAEs per infusion | 0.199 | 0.160 | 0.222 |
| Proportion of infusions with ≥1 TAAEs (one-sided 95% upper limit) |
0.142 (0.164) | 0.122 (0.156) | 0.154 (0.182) |
| Subjects with ≥1 TAAE, n (%) | |||
| Within 1 h | 28 (47.5) | 7 (36.8) | 21 (52.5) |
| Within 24 h | 40 (67.8) | 13 (68.4) | 27 (67.5) |
| Within 72 h | 43 (72.9) | 15 (78.9) | 28 (70.0) |
| Subjects with ≥1 study drug-related TAAE, n (%) | |||
| Within 1 h | 14 (23.7) | 5 (26.3) | 9 (22.5) |
| Within 24 h | 21 (35.6) | 7 (36.8) | 14 (35.0) |
| Within 72 h | 21 (35.6) | 7 (36.8) | 14 (35.0) |
| TAAEs reported by ≥5% total subjects, n (%) | |||
| Headache | 14 (23.7) | 3 (15.8) | 11 (27.5) |
| Sinusitis | 6 (10.2) | 2 (10.5) | 4 (10.0) |
| Nausea | 5 (8.5) | 1 (5.3) | 4 (10.0) |
| Acute sinusitis | 4 (6.8) | 1 (5.3) | 3 (7.5) |
| Fatigue | 4 (6.8) | 2 (10.5) | 2 (5.0) |
| Muscle spasms | 4 (6.8) | 1 (5.3) | 3 (7.5) |
| Adverse drug reaction | 3 (5.1) | 0 | 3 (7.5) |
| Bronchitis | 3 (5.1) | 0 | 3 (7.5) |
| Diarrhea | 3 (5.1) | 1 (5.3) | 2 (5.0) |
| Epistaxis | 3 (5.1) | 0 | 3 (7.5) |
| Myalgia | 3 (5.1) | 2 (10.5) | 1 (2.5) |
| Oropharyngeal pain | 3 (5.1) | 0 | 3 (7.5) |
| Pain in extremity | 3 (5.1) | 0 | 3 (7.5) |
| Pruritus | 3 (5.1) | 0 | 3 (7.5) |