Table 2.
Top 20 all grade treatment-related adverse events for tislelizumab monotherapy (left columns) and combination therapies (right columns) across 9 prospective clinical studies with complete results on tislelizumab.
| All grade TRAEs | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Trials |
NCT02407990 (ST, n=451) |
CTR20160872 (ST, N=300) |
CTR20170071 (UC, N=113) |
NCT03209973 (r/r cHL, N=70) |
Sum | Trials |
NCT02660034 (ST, N=49) |
RATIONALE 304 (NSCLC, Group A, n=222) |
RATIONALE 307 (NSCLC, arm A, n = 120) |
RATIONALE 307 (NSCLC, arm B, n = 118) |
NCT03432598 (NSCLC, N=54) |
NCT03469557 (ESCC/GEJ, N=30) |
Sum |
| Treatment | Tislelizumab monotherapy | Tislelizumab monotherapy | Tislelizumab monotherapy | Tislelizumab monotherapy | Treatment | Tislelizumab plus pamiparib | Tislelizumab plus chemotherapy | Tislelizumab plus chemotherapy | Tislelizumab plus chemotherapy | Tislelizumab plus chemotherapy | Tislelizumab plus chemotherapy | ||
| Fatigue | 28.4% | 7.7% | 6.0% | 7.1% | 163 | Anemia | 24.0% | 86.1% | 88.3% | 93.2% | 79.6% | 60.0% | 480 |
| Decreased appetite | 20.4% | 13.0% | 19.0% | 0.0% | 152 | Decreased neutrophil count | 0.0% | 82.0% | 63.3% | 61.0% | 72.2% | 40.0% | 381 |
| Anemia | 9.1% | 23.0% | 27.0% | 10.0% | 148 | Decreased white blood cell count | 0.0% | 82.4% | 53.3% | 57.6% | 74.1% | 43.3% | 368 |
| Nausea | 24.8% | 7.0% | 8.0% | 5.7% | 146 | Decreased platelet count | 10.0% | 69.9% | 34.2% | 44.1% | 42.6% | 40.0% | 288 |
| Increased AST | 5.0% | 23.0% | 17.0% | 10.0% | 118 | Nausea | 67.0% | 43.7% | 30.0% | 43.2% | 33.3% | 53.3% | 251 |
| Rash | 13.5% | 10.7% | 13.0% | 12.9% | 117 | Increased ALT | 24.0% | 48.6% | 41.7% | 34.7% | 37.0% | 30.0% | 240 |
| Diarrhea | 18.2% | 6.3% | 6.0% | 10.0% | 115 | Increased AST | 20.0% | 43.3% | 35.8% | 33.9% | 37.0% | 33.3% | 219 |
| Increased ALT | 5.6% | 19.0% | 16.0% | 12.9% | 109 | Decreased appetite | 0.0% | 33.8% | 43.3% | 44.1% | 35.2% | 56.7% | 215 |
| Vomiting | 14.7% | 6.0% | 8.0% | 5.7% | 97 | Fatigue | 57.0% | 38.3% | 24.2% | 17.8% | 35.2% | 50.0% | 197 |
| Constipation | 17.6% | 0.0% | 15.0% | 0.0% | 96 | Alopecia | 0.0% | 0.0% | 64.2% | 69.5% | 24.1% | 0.0% | 172 |
| Cough | 13.7% | 6.3% | 0.0% | 17.1% | 93 | Vomiting | 35.0% | 27.1% | 23.3% | 22.9% | 25.9% | 43.3% | 159 |
| Decreased weight | 8.9% | 10.7% | 0.0% | 8.6% | 78 | Constipation | 18.0% | 23.9% | 30.0% | 28.0% | 0.0% | 0.0% | 131 |
| Abdominal pain | 15.3% | 0.0% | 5.0% | 0.0% | 75 | Rash | 0.0% | 21.2% | 20.8% | 22.0% | 13.3% | 0.0% | 105 |
| Pyrexia | 0.0% | 5.0% | 19.0% | 54.3% | 74 | Pyrexia | 20.0% | 0.0% | 20.0% | 20.3% | 0.0% | 30.0% | 67 |
| Back pain | 14.8% | 0.0% | 0.0% | 5.7% | 71 | Pain in extremity | 10.0% | 0.0% | 33.3% | 14.4% | 0.0% | 0.0% | 62 |
| Increased gamma-glutamyl transferase | 0.0% | 14.3% | 6.0% | 0.0% | 50 | Hypoalbuminemia | 0.0% | 0.0% | 22.5% | 17.8% | 0.0% | 33.3% | 58 |
| Hypothyroidism | 0.0% | 5.0% | 10.0% | 32.9% | 49 | Musculoskeletal pain | 0.0% | 24.8% | 0.0% | 0.0% | 0.0% | 0.0% | 55 |
| Dyspnea | 9.9% | 0.0% | 0.0% | 0.0% | 45 | Arthralgia | 12.0% | 0.0% | 20.8% | 17.8% | 0.0% | 0.0% | 52 |
| Decreased neutrophil count | 0.0% | 9.0% | 5.0% | 14.3% | 43 | Hypoproteinemia | 0.0% | 23.0% | 0.0% | 0.0% | 0.0% | 0.0% | 51 |
| Decreased platelet count | 0.0% | 10.0% | 0.0% | 11.4% | 38 | Increased blood bilirubin level | 0.0% | 0.0% | 22.5% | 12.7% | 0.0% | 30.0% | 51 |
Abbreviations: TRAEs, treatment-related adverse effects; AST, aspartate aminotransferase; ALT, alanine transaminase; ST, solid tumors; UC, urothelial carcinoma; r/r cHL, relapsed or refractory classical Hodgkin lymphoma; NSCLC, non-small cell lung cancer; ESCC, esophageal squamous cell carcinoma; GEJ, gastric/gastroesophageal junction cancer.