Extended Data Table 2.
Disposition of study treatment
| Efficacy population | Intention-to-treat population | |||
|---|---|---|---|---|
| Variable — no. (%) | Pembrolizumab group (N=133) | Placebo group (N=131) | Pembrolizumab group (N=217) | Placebo group (N=217) |
|
| ||||
| Started | 133 | 130 | 217 | 216 |
| Discontinued all study treatment | 79 (59.4) | 93 (71.5) | 90 (41.5) | 112 (51.9) |
| Adverse event | 7 (5.3) | 10(7.7) | 10(4.6) | 14(6.5) |
| Clinical progression | 4 (3.0) | 9 (6.9) | 6 (2.8) | 12 (5.6) |
| Non-study anticancer therapy | 2(1.5) | 3 (2.3) | 2 (0.9) | 3(1.4) |
| Physician decision | 1 (0.8) | 2(1.5) | 1 (0.5) | 2 (0.9) |
| Radiographic progression | 59 (44.4) | 64 (49.2) | 65 (30.0) | 76 (35.2) |
| Withdrawal by participant | 6 (4.5) | 5 (3.8) | 6 (2.8) | 5 (2.3) |
| Continuing any study treatment | 54 (40.6) | 37 (28.5) | 127 (58.5) | 104 (48.1) |
All percentages are calculated out of the number of participants who started study treatment. The treatment regimen included trastuzumab and chemotherapy in both groups.