Table 2.
Summary of overall adverse event incidence in the Japanese patient subgroup
| n (%) | Tislelizumab (n = 25) |
Chemotherapy (n = 23) |
|---|---|---|
| Overall TEAE incidence | ||
| Any TEAE | 24 (96.0) | 22 (95.7) |
| ≥ Grade 3 TEAE | 11 (44.0) | 16 (69.6) |
| Serious TEAE | 9 (36.0) | 10 (43.5) |
| TEAE leading to treatment discontinuation | 2 (8.0) | 4 (17.4) |
| TEAE leading to dose modificationa | 8 (32.0) | 16 (69.6) |
| TEAE leading to deathb | 0 (0.0) | 0 (0.0) |
| Any TRAE | 17 (68.0) | 22 (95.7) |
| ≥ Grade 3 TRAE | 6 (24.0) | 11 (47.8) |
| Serious TRAE | 4 (16.0) | 2 (8.7) |
| TRAE leading to treatment discontinuation | 2 (8.0) | 2 (8.7) |
| TRAE leading to dose modificationa | 4 (16.0) | 16 (69.6) |
| TRAE leading to deathb | 0 (0.0) | 0 (0.0) |
| Incidence of most common TRAEs occurring in ≥ 10% of patients in either treatment arm by preferred termc | ||
| Fatigue | 3 (12.0) | 5 (21.7) |
| Hypothyroidism | 3 (12.0) | 0 (0.0) |
| Malaise | 3 (12.0) | 4 (17.4) |
| Pneumonitis | 3 (12.0) | 2 (8.7) |
| Pruritus | 3 (12.0) | 1 (4.3) |
| Arthralgia | 2 (8.0) | 6 (26.1) |
| Stomatitis | 1 (4.0) | 6 (26.1) |
| White blood cell count decreased | 1 (4.0) | 12 (52.2) |
| Alopecia | 0 (0.0) | 11 (47.8) |
| Decreased appetite | 0 (0.0) | 5 (21.7) |
| Myalgia | 0 (0.0) | 3 (13.0) |
| Neutrophil count decreased | 0 (0.0) | 13 (56.5) |
| Peripheral sensory neuropathy | 0 (0.0) | 7 (30.4) |
All data are presented as number of patients with at least one event (percentage of patients). Data are presented for the Japanese subgroup of the safety population, which comprised all randomized patients who received at least one dose of a study drug, analyzed according to the actual study drug received. TRAEs include TEAEs that were considered by the investigator to be related to study drug or TEAEs with a missing causality. Adverse event grades were based on National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03. Adverse events were coded using Medical Dictionary for Regulatory Activities version 23.0
TEAE treatment-emergent adverse event, TRAE treatment-related treatment-emergent adverse event
aDose modification included dose held, dose interruption and dose reduction for the chemotherapy arm, and dose held and dose interruption for the tislelizumab arm
bDeaths caused by disease progression were excluded
cOrdered by decreasing incidence in the tislelizumab arm