Table 2.
Summary of the adverse events and adverse drug reactions.
| Phase 1 (N = 6) | Phase 2a (N = 34) | |
|---|---|---|
| Patients with any AE | 4 (66.7) (22.3–95.7%) | 29 (85.3) (68.9–95.1%) |
| Number of events | 7 | 126 |
| Patient characteristics | ||
| Patients with serious AE | 1 (16.7) (0.4–64.1%) | 16 (47.1) (29.8–64.9%) |
| Patients with ADR | 2 (33.3) (4.3–77.7%) | 7 (20.6) (8.7–37.9%) |
| Patients with serious ADR | 0 (0.0) | 1 (2.9) (0.1–15.3%) |
| Patients with unexpected ADR | 0 (0.0) | 0 (0.0) |
| Grade | ||
| Grade 1/mild AE | 4 (66.7) | 23 (67.6) |
| Grade 2/moderate AE | 0 (0.0) | 18 (52.9) |
| Grade 3/severe AE | 1 (16.7) | 13 (38.2) |
| Grade 4/life-threatening or disabling AE | 0 (0.0) | 0 (0.0) |
| Grade 5/death related to AE | 0 (0.0) | 2 (5.9) |
| Outcome | ||
| Recovered | 3 (50.0) | 24 (70.6) |
| Recovered with sequelae | 0 (0.0) | 2 (5.9) |
| Recovering | 0 (0.0) | 7 (20.6) |
| Not yet recovered | 2 (33.3) | 14 (41.2) |
| Lost to follow-up | 0 (0.0) | 0 (0.0) |
| Death | 1 (16.7) | 3 (8.8) |
| Action taken with NP | ||
| Dose not changed | 4 (66.7) | 25 (73.5) |
| Dose delayed | 1 (16.7) | 5 (5.9) |
| IP withdrawn | 1 (16.7) | 12 (35.3) |
AE, adverse event; ADR, adverse drug reaction; NP, injection of SMT-NKs and pembrolizumab. Data are presented as n (%) with or without a 95% confidence interval.