Table 4.
Treatment-emergent adverse events in US phase 2 trial patients
| Relationship to PRL3-zumab | Unrelateda |
Possibly relateda |
Relateda |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | ≥4 | 1 | 2 | 3 | ≥4 | 1 | 2 | 3 | ≥4 | |
| Any TEAEb | 127 | 105 | 55 | 3 | 25 | 13 | 0 | 0 | 14 | 6 | 0 | 0 |
| Any serious TEAE | 0 | 2 | 36 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Action taken because of TEAE | ||||||||||||
| Dose interruption | 0 | 0 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Dose reduction | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment discontinuation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| TEAE in each system | ||||||||||||
| Nervous system disorders | 9 | 2 | 2 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
| Respiratory, thoracic, and mediastinal disorders | 7 | 11 | 2 | 1 | 1 | 0 | 0 | 0 | 3 | 1 | 0 | 0 |
| Cardiac disorders | 3 | 2 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Psychiatric disorders | 4 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Gastrointestinal disorders | 19 | 22 | 14 | 0 | 10 | 1 | 0 | 0 | 4 | 0 | 0 | 0 |
| Hepatobiliary disorders | 0 | 2 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Musculoskeletal/connective tissue disorders | 13 | 10 | 3 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
| Renal and urinary disorders | 2 | 3 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Eye disorders | 5 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Reproductive system and breast disorders | 2 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| General/administration site disorders | 15 | 9 | 3 | 0 | 7 | 4 | 0 | 0 | 0 | 1 | 0 | 0 |
| Skin and subcutaneous tissue disorders | 4 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
| Blood and lymphatic system disorders | 5 | 5 | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Vascular disorders | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Neoplasms benign, malignant, and unspecified | 3 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Metabolism and nutrition disorders | 17 | 20 | 2 | 0 | 1 | 3 | 0 | 0 | 2 | 0 | 0 | 0 |
| Infections and infestations | 2 | 5 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Investigations | 13 | 5 | 6 | 0 | 3 | 2 | 0 | 0 | 0 | 1 | 0 | 0 |
| Injury, poisoning, and procedural complications | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Ear and labyrinth disorders | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Endocrine disorders | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
“Unrelated, possibly related, related” indicate relationship to study drug.
TEAE, treatment-emergent adverse event.