Table 3. Crude Incidence of Acute Composite Radiation Therapy Oncology Group and Common Terminology Criteria for Adverse Events Grade 2 and Grade ≥3 Toxic Events, and Cumulative Incidence of Late Composite Radiation Therapy Oncology Group and Common Terminology Criteria for Adverse Events Grade 2 and Grade ≥3 Toxic Eventsa.
| Toxic Event | Crude Incidence, No. (%)b | Cumulative Incidence Estimate (95% CI) | ||
|---|---|---|---|---|
| 5 y | 7 y | 10 y | ||
| Grade 2 | ||||
| Acute GU | 153 (9.0) | NA | NA | NA |
| Acute GI | 56 (3.3) | NA | NA | NA |
| Late GU | 163 (9.6) | 11.2 (9.7-12.8) | 12.3 (10.8-14.0) | 13.4 (11.6-15.4) |
| Late GI | 67 (3.9) | 4.5 (3.6-5.6) | 4.5 (3.6-5.6) | 4.5 (3.6-5.6) |
| Grade ≥3 | ||||
| Acute GU | 13 (0.6) | NA | NA | NA |
| Acute GI | 2 (0.09) | NA | NA | NA |
| Late GU | 46 (2.1) | 1.8 (1.3-2.5) | 2.4 (1.8-3.2) | 3.2 (2.2-4.6) |
| Late GI | 7 (0.3) | 0.4 (0.2-0.8) | 0.4 (0.2-0.8) | 0.4 (0.2-0.8) |
Abbreviations: GI, gastrointestinal; GU, genitourinary; NA, not applicable.
a
Toxic event scoring derived per institutional or clinical trial protocol, as described in the Methods.
b
One trial, from Georgetown University, had only grade 3 or greater toxic event data. Thus, the denominator for grade 2 toxic event incidence calculations is 1700 vs 2142 for grade 3.