Table 8. Frequency of gastrointestinal (GI) perforation in phase II and III studies evaluating onartuzumab.
| GI perforation | ||||||
|---|---|---|---|---|---|---|
| Ona | Control | All grades, n (%) | Grade ≥3, n (%) | |||
| Study | n | n | Ona | Control | Ona | Control |
| GO27819 | 65 | 64 | 4 (6.2) | No events | 4 (6.2) | No events |
| GO27820 | 54 | 52 | 1 (1.9) | No events | No events | No events |
| GO27821 Bev cohort (1) | 69 | 69 | 2 (2.9) | No events | 1 (1.4) | No events |
| GO27821 Pem cohort (2) | 58 | 57 | 1 (1.8) | No events | 1 (1.8) | No events |
| GO27827 | 99 | 93 | 2 (2.0) | 2 (2.2) | 2 (2.0) | 2 (2.2) |
| OAM4861g Ona + Bev + Pac cohort* | 62 | 62* | 2 (3.2) | No events | 2 (3.2) | No events |
| OAM4861g Ona + Pbo + Pac cohort* | 58 | 62* | No events | No events | No events | No events |
| OAM4971g | 248 | 244 | 1 (0.4) | 1 (0.4) | 1 (0.4) | 1 (0.4) |
| YO28252 | 60 | 60 | 3 (5.0) | 2 (3.3) | 2 (3.3) | 1 (1.7) |
Bev = bevacizumab, Ona = onartuzumab, Pac = paclitaxel, Pbo = placebo, Pem = pemetrexed.
*Study OAM4861g had 3 arms: Ona + Bev + Pac (n = 62); Ona + Pbo + Pac (n = 58); Pbo + Bev + Pac (n = 62), referred to here as the control arm.