Table 3 Treatment-emergent adverse events by preferred term (Safety analysis set)
Variable | Invimestrocel group (N = 20) | Standard treatment group (N = 10) |
|---|---|---|
≥ 1 TEAE | 20 (100) | 10 (100) |
≥ 1 serious TEAE | 10 (50) | 4 (40) |
≥ 1 TEAE leading to death | 3 (15) | 1 (10) |
≥ 1 TEAE possibly related to invimestrocel | 5 (25) | 0 |
≥ 1 serious TEAE possibly related to invimestrocel | 1 (5) | 0 |
TEAEs occurring in ≥ 2 patients in the invimestrocel groups | ||
Insomnia | 9 (45) | 5 (50) |
Diarrhea | 7 (35) | 1 (10) |
Constipation | 6 (30) | 3 (30) |
Pyrexia | 6 (30) | 0 |
Anemia | 5 (25) | 0 |
Decubitus ulcer | 4 (20) | 2 (20) |
Hepatic function abnormal | 4 (20) | 1 (10) |
Pneumonia | 3 (15) | 1 (10) |
Atrial fibrillation | 3 (15) | 1 (10) |
Acute kidney injury | 3 (15) | 1 (10) |
Acute respiratory distress syndrome | 2 (10) | 1 (10) |
Hypernatremia | 2 (10) | 2 (20) |
Atelectasis | 2 (10) | 0 |
Cough | 2 (10) | 1 (10) |
Pneumothorax | 2 (10) | 0 |
Skin exfoliation | 2 (10) | 0 |
Drug eruption | 1 (5) | 1 (10) |
Arthralgia | 2 (10) | 0 |
Chills | 2 (10) | 0 |
ALT increased | 2 (10) | 0 |
AST increased | 2 (10) | 0 |