Table 2.
Summary of Adverse Events
| No CNS Metastases N=15 |
CNS Metastases N=10 |
All patients N=25 |
||||
|---|---|---|---|---|---|---|
| n (%)a | TEAE | TRAEb | TEAE | TRAEb | TEAE | TRAEb |
| Any grade AE | 15 (100) | 15 (100) | 10 (100) | 10 (100) | 25 (100) | 25 (100) |
| ≥Grade 3 AE | 10 (67) | 5 (33) | 6 (60) | 2 (20) | 16 (64) | 7 (28) |
| SAE | 5 (33) | 0 (0) | 4 (40) | 1 (10) | 9 (36) | 1 (4) |
| AE leading to study discontinuation | 1 (7) | 0 (0) | 1 (10) | 1 (10) | 2 (8) | 1 (4) |
| AE leading to death on treatment c | 1 (7) | 0 (0) | 0 (0) | 0 (0) | 1 (4) | 0 (0) |
| AE leading to death within 30 days of discontinuing study treatment c | 0 (0) | 0 (0) | 1 (10) | 1 (10) | 1 (4) | 1 (4) |
| TRAEs in ≥10% all patients by preferred term d | ||||||
| Any | ≥Grade 3 | Any | ≥Grade 3 | Any | ≥Grade 3 | |
| Hypertension | 4 (47) | 2 (13) | 5 (50) | 0 (0) | 12 (48) | 2 (8) |
| Diarrhoea | 6 (40) | 0 (0) | 3 (30) | 0 (0) | 9 (36) | 0 (0) |
| Stomatitis | 3 (20) | 0 (0) | 3 (30) | 0 (0) | 6 (24) | 0 (0) |
| Platelet count decreased | 4 (27) | 2 (13) | 2 (20) | 2 (20) | 6 (24) | 4 (16) |
| Rash | 4 (27) | 0 (0) | 1 (10) | 0 (0) | 5 (20) | 0 (0) |
| Proteinuria | 3 (20) | 0 (0) | 2 (20) | 0 (0) | 5 (20) | 0 (0) |
| Pruritis | 3 (20) | 0 (0) | 1 (10) | 0 (0) | 4 (16) | 0 (0) |
| Gingival bleeding | 3 (20) | 0 (0) | 1 (10) | 0 (0) | 4 (16) | 0 (0) |
| Petechiae | 3 (20) | 0 (0) | 0 (0) | 0 (0) | 3 (12) | 0 (0) |
| Thrombocytopenia | 3 (20) | 0 (0) | 0 (0) | 0 (0) | 3 (12) | 0 (0) |
| Asthenia | 1 (7) | 0 (0) | 2 (20) | 0 (0) | 3 (12) | 0 (0) |
| Fatigue | 3 (20) | 0 (0) | 0 (0) | 0 (0) | 3 (12) | 0 (0) |
| Edema peripheral | 2 (13) | 0 (0) | 1 (10) | 0 (0) | 3 (12) | 0 (0) |
| Paronychia | 2 (13) | 0 (0) | 1 (10) | 0 (0) | 3 (12) | 0 (0) |
| Infusion-related reaction | 3 (20) | 0 (0) | 0 (0) | 0 (0) | 3 (12) | 0 (0) |
| Neutrophil count decreased | 1 (7) | 0 (0) | 2 (20) | 1 (10) | 3 (12) | 1 (4) |
| Epitaxis | 3 (20) | 0 (0) | 0 (0) | 0 (0) | 3 (12) | 0 (0) |
a
Patients may be counted in more than one category.
b
AEs considered related to study treatment as judged by the investigator.
c
Deaths are also included as SAEs and discontinuations due to AEs.
d
Shown by Medical Dictionary for Regulatory Activities preferred terms. Full listing of TRAEs are in Supplementary Table S2.
AE, adverse event; CNS, central nervous system; N, number of patients in population; n, number of patients in specified category; SAE, serious AE; TEAE, treatment-emergent AE; TRAE, treatment-related AE