Table 2. Pimasertib-related treatment-emergent adverse events by worst grade (occurring in ≥2 patients overall (all grades) by preferred term): safety population.
|
Pimasertib 45 mg per day (n=10) |
Pimasertib 60 mg per day (n=6) |
Overall (n=16) |
|||||||
|---|---|---|---|---|---|---|---|---|---|
|
Grade |
Grade |
Grade |
|||||||
| System organ class preferred term | 1/2 | 3 | 4 | 1/2 | 3 | 4 | 1/2 | 3 | 4 |
| Patients with ≥1 TEAE (by worst grade) | 5 | 5 | 0 | 2 | 2 | 2 | 7 | 7 | 2 |
|
Gastrointestinal disorders (n) | |||||||||
| Diarrhoea | 4 | 2 | 0 | 4 | 0 | 0 | 8 | 2 | 0 |
| Vomiting | 2 | 0 | 0 | 3 | 0 | 0 | 5 | 0 | 0 |
| Nausea | 2 | 0 | 0 | 2 | 0 | 0 | 4 | 0 | 0 |
| Stomatitis | 1 | 0 | 0 | 2 | 0 | 0 | 3 | 0 | 0 |
|
Skin and subcutaneous tissue disorders (n) | |||||||||
| Rash | 4 | 0 | 0 | 4 | 0 | 0 | 8 | 0 | 0 |
| Dermatitis acneiform | 1 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 |
|
General disorders and administration site conditions (n) | |||||||||
| Asthenia | 4 | 0 | 0 | 2 | 0 | 0 | 6 | 0 | 0 |
| Mucositis | 1 | 1 | 0 | 0 | 2 | 0 | 1 | 3 | 0 |
|
Eye disorders (n) | |||||||||
| Serous retinal detachment | 5 | 0 | 0 | 1 | 0 | 0 | 6 | 0 | 0 |
|
Blood and lymphatic system disorders (n) | |||||||||
| Neutropenia | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 1 | 2 |
|
Metabolism and nutrition disorders (n) | |||||||||
| Hypomagnesaemia | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
Abbreviation: TEAE=treatment-emergent adverse event.
Patients could have more than one event within a system organ class and a preferred term.