TABLE 2.
Overall adverse events
| Overall AE a summary | Number of subject (n = 21) | % |
|---|---|---|
| Total number of adverse event (AE) | 197 | |
| Number of subject reporting at least one AE | 21 | 100.0 |
| AE by severity | ||
| Grade 1 | 3 | 14.3 |
| Grade 2 | 5 | 23.8 |
| Grade 3 | 10 | 47.6 |
| Grade 4 | 1 | 4.8 |
| Grade 5 (peritoneal PD; CNS PD) | 2 | 9.5 |
| Number of subject reporting at least one SAE | 12 | 57.1 |
| AE related to ADI‐PEG 20 | 11 | 52.4 |
| AE related to cisplatin | 17 | 81.0 |
| AE related to pemetrexed | 17 | 81.0 |
Abbreviations: CNS, central nervous system; PD, progressive disease.
a
AE is defined as any untoward medical occurrence in a subject administered with ADIPemCis and that does not necessarily have a causal relationship with the treatment.