Table 1.
Adverse events to tilsotolimod + ipilimumab (N = 62)
Characteristic | Patients, n (%) |
---|---|
Patients with at least one TEAE | 61 (98.4) |
Patients with at least one grade 3/4 TEAE | 30 (48.4) |
Patients with at least one SAE | 20 (32.3) |
Patients with at least one immune-related TEAE | 16 (25.8) |
Patients discontinuing tilsotolimod due to TEAEs | 3 (4.8) |
Patients discontinuing ipilimumab due to TEAEs | 6 (9.7) |
Patients discontinuing tilsotolimod due to immune-related TEAEs | 4 (6.5) |
Patients discontinuing ipilimumab due to immune-related TEAEs | 3 (4.8) |
Most common TEAEsa | |
Fatigue | 32 (51.6) |
Nausea | 25 (40.3) |
Anemia | 24 (38.7) |
Diarrhea | 23 (37.1) |
Pyrexia | 22 (35.5) |
ALT increased | 20 (32.3) |
Vomiting | 19 (30.6) |
Headache | 18 (29.0) |
Rash | 17 (27.4) |
AST increased | 16 (25.8) |
Chills | 16 (25.8) |
Most common grade 3/4 TEAEsb | |
Diarrhea | 4 (6.5) |
ALT increased | 4 (6.5) |
AST increased | 4 (6.5) |
Colitisc | 4 (6.5) |
Fatigue | 3 (4.8) |
Most common immune-related TEAEsd | |
Hypophysitis | 5 (8.1) |
Rash | 5 (8.1) |
Colitisc | 4 (6.5) |
ALT increased | 4 (6.5) |
AST increased | 4 (6.5) |
Diarrhea | 4 (6.5) |
Hepatitise | 3 (4.8) |
Most common grade 3/4 immune-related TEAEsd | |
Colitisc | 3 (4.8) |
ALT increased | 3 (4.8) |
AST increased | 3 (4.8) |
Hepatitise | 2 (3.2) |
Hypophysitis | 2 (3.2) |
Diarrhea | 2 (3.2) |
Abbreviation: SAE, severe adverse effect.
TEAEs that occurred in ≥25% of patients are shown and are listed in order of decreasing frequency.
Grade 3 or 4 TEAEs that occurred in ≥3 patients are shown and are listed in order of decreasing frequency.
Includes preferred terms of colitis, autoimmune colitis, and enterocolitis.
Includes events that occurred in ≥3. Immune-related AEs were identified during a sponsor review following database lock that was confirmed with the investigators.
Includes patients with immune-related hepatitis or autoimmune hepatitis.