Table 2:
Summary of Safety for NIAGARA
| AE category | Number (%) of patients | |||||
|---|---|---|---|---|---|---|
| Neoadjuvant period | Adjuvant period | Overall period | ||||
| GC-D (N=530) |
GC (N=526) |
GC-D (N=383) |
GC (N=383) |
GC-D (N=530) |
GC (N=526) |
|
| Any AE | 520 (98.1) | 515 (97.9) | 331 (86.4) | 273 (71.3) | 527 (99.4) | 525 (99.8) |
| Any AE of CTCAE Grade 3 or 4 | 249 (47.0) | 271 (51.5) | 119 (31.1) | 91 (23.8) | 368 (69.4) | 355 (67.5) |
| grade 5 AEs | 6 (1.1) | 10 (1.9) | 7 (1.8) | 6 (1.6) | 27 (5.1) | 29 (5.5) |
| Any SAE (including events with outcome of death) | 125 (23.6) | 118 (22.4) | 101 (26.4) | 85 (22.2) | 326 (61.5) | 287 (54.6) |
| Any AE leading to discontinuation of study treatment | 79 (14.9) | 80 (15.2) | 30 (7.8) | 0 | 112 (21.1) | 80 (15.2) |
| Any AE leading to discontinuation of durvalumab | 50 (9.4) | NA | 30 (7.8) | NA | 86 (16.2) | NA |
| Any AE leading to discontinuation of G or C | 72 (13.6) | 80 (15.2) | NA | NA | 72 (13.6) | 80 (15.2) |
| Any AE leading to dose interruption or reduction of study treatment | 269 (50.8) | 247 (47.0) | 75 (19.6) | 0 | 305 (57.5) | 247 (47.0) |
| Any AE leading to dose interruption of durvalumab | 132 (24.9) | NA | 75 (19.6) | NA | 192 (36.2) | NA |
| Any AE leading to dose interruption or reduction of G or C (at least one component) | 260 (49.1) | 247 (47.0) | NA | NA | 260 (49.1) | 247 (47.0) |
Source: table 44, NIAGARA clinical study report (U.S. FDA. Clinical Review–BLA 761069, supplements 050; not public).
AE: adverse Events, SAE: Serious Adverse Event