Table 3.
Treatment-emergent expected adverse events (EAEs) and unexpected adverse events (UAEs)
| EAEs | No. of affected patients | Maximum grade CTCAE / (Clavien–Dindo) |
|---|---|---|
| Nausea | 12 | 3 (I) |
| Vomiting | 9 | 2 (I) |
| Diarrhea | 8 | 2 (I) |
| Stomatitis | 1 | 1 (I) |
| Loss of hair | 1 | 1 (I) |
| UAEs | No. of affected patients | Maximum grade CTCAE / (Clavien–Dindo) |
|---|---|---|
| Anemia | 4 | 3 (I) |
| Atrial fibrillation | 2 | 3 (II) |
| Tachycardia | 1 | 3 (I) |
| Surgical site infection | 2 | 3 (IIIa) |
| Pneumonia | 2 | 3 (II) |
| Pulmonary embolism | 1 | 2 (II) |
| Myocardial infarction | 1 | 2 (IIIa) |
| Pleural effusion | 5 | 1 (II) |
| Exanthema | 2 | 1 (I) |
| Fatigue | 1 | 1 (I) |
| Dysgeusia | 1 | 1 (I) |
| Inappetence | 1 | 1 (I) |
| Exsiccosis | 1 | 1 (I) |
| Obstipation | 1 | 1 (I) |
| Back pain | 1 | 1 (I) |
| Flank pain | 1 | 1 (I) |
| Fever | 1 | 1 (I) |
| Leukopenia | 1 | 1 (I) |
| Urinary tract infection | 1 | 1 (II) |
| Pancreatitis | 1 | 1 (I) |
AEs documented in the modified intention-to-treat group (n = 16) are classified as EAEs (n = 31) or UAEs (n = 31) and are organized according to maximum severity (CTCAE v.4.0) and number of patients affected, including corresponding grades according to the Clavien–Dindo classification (not foreseen in the trial protocol)
EAEs expected adverse events, UAEs unexpected adverse events, CTCAE Common Terminology Criteria for Adverse Events, AEs adverse events