Table 7.
Adverse events summary
| Number of Patients with at least one: | Tosedostat 120 mg N=38 |
Tosedostat 240 mg→120 mg N=35 |
Overall N=73 |
|---|---|---|---|
|
| |||
| AE | 38 (100) | 35 (100) | 73 (100) |
| SAE | 32 (84) | 30 (86) | 62 (85) |
| AE with outcome of death | 13 (34) | 17 (49) | 30 (41) |
| Treatment-relateda AE | 23 (61) | 25 (71) | 48 (66) |
| AE leading to study terminationb | 9 (24) | 11 (31) | 20 (27) |
| AE leading to a dose reduction | 0 | 3 (9) | 3 (4) |
| AE leading to temporary dose interruption | 19 (50) | 17 (49) | 36 (49) |
| CTCAE grade 3, 4 or 5 AE | 34 (90) | 33 (94) | 67 (92) |
CTCAE=Common Terminology Criteria for Adverse Events v3.0
Grade 3=severe AE; Grade 4=life-threatening or disabling AE; Grade 5=Death related to AE
a
Treatment-related=possibly, probably or definitely related to study drug.
b
Includes both AEs leading to study termination and AEs leading to permanent discontinuation of study drug.