Table 3.
Overall summary of treatment-emergent adverse events (safety population)
| MB02 (N = 311) | EU-bevacizumab (N = 310) | p value | |
|---|---|---|---|
| Total number of TEAEs | 2174 | 2166 | |
| Number of patients with | |||
| Any TEAE regardless of causality | 288 (92.6) | 288 (92.9) | 0.89 |
| Grade 3 or 4 TEAE | 131 (42.1) [271] | 125 (40.3) [269] | 0.65 |
| In combination therapy period (≤Week 18) | 286 (92.0) [1646] | 278 (89.7) [1574] | |
| In monotherapy period (≥Week 18) | 142 (45.7) [528] | 161 (51.9) [592] | |
| Any treatment-related TEAEa | 264 (84.9) | 270 (87.1) | |
| IP-related TEAEs | 125 (40.2) [412] | 125 (40.3) [397] | 0.97 |
| Grade 3 or 4 treatment-related TEAE | 98 (31.5) [187] | 91 (29.4) [190] | 0.56 |
| In combination therapy period (≤Week 18) | 259 (83.3) [1305] | 265 (85.5) [1284] | |
| In monotherapy period (≥Week 18) | 94 (30.2) [284] | 91 (29.4) [261] | |
| Any TEAE leading to discontinuation | 72 (23.2) [116] | 63 (20.3) [79] | 0.39 |
| Treatment-related TEAEs leading to discontinuationa | 42 (13.5) [54] | 33 (10.6) [42] | 0.27 |
| Any serious TEAE | 58 (18.6) [88] | 54 (17.4) [86] | 0.69 |
| Any treatment-related serious TEAEa | 33 (10.6) [51] | 33 (10.6) [52] | 0.99 |
| Any fatal TEAE | 23 (7.4) [23] | 24 (7.7) [24] | 0.87 |
| Any treatment-related fatal TEAEa | 7 (2.3) [7] | 5 (1.6) [5] | 0.56 |
Percentages ( ) were based on N. The number of events is presented in brackets [ ]. p-Values were calculated using Chi-Squared Test
IP investigational medicinal product, N number of subjects on intended set, PT preferred term, TEAE treatment-emergent adverse event
aAn adverse event was related if assessment of causality was possible, probable or very likely/certain