Table 3.
Adverse events of special interest for ramucirumab
| All (N = 83) (%) |
No ascites (N = 43) (%) |
Small to moderate ascites (N = 26) (%) |
Massive ascites (N = 14) (%) |
P value* | |||||
|---|---|---|---|---|---|---|---|---|---|
| All (%) | ≥ Gr3(%) | All (%) | ≥ Gr3(%) | All (%) | ≥ Gr3(%) | All (%) | ≥ Gr3(%) | ||
| Hypertension | 24 (29) | 2 (2) | 11 (26) | 0 | 10 (38) | 1 (4) | 3 (21) | 1 (7) | 0.27 |
| Bleeding or haemorrhage | 19 (23) | 2 (2) | 9 (21) | 2 (5) | 6 (23) | 0 | 4 (29) | 0 | 0.39 |
| Proteinuria | 9 (11) | 0 | 4 (9) | 0 | 5 (19) | 0 | 0 | 0 | 0.16** |
| Liver injury or failure | 6 (7) | 0 | 2 (5) | 0 | 2 (8) | 0 | 2 (14) | 0 | 0.48** |
| Gastrointestinal haemorrhage | 5 (6) | 2 (2) | 3 (7) | 2 (5)a | 1 (4) | 0 | 1 (7) | 0 | 0.39 |
| Gastrointestinal perforation | 1 (1) | 1 (1) | 0 | 0 | 1 (4) | 1 (4) | 0 | 0 | 0.33 |
| Infusion-related reaction | 0 | 0 | 0 | 0 | 1 (4) | 0 | 0 | 0 | 0.33** |
*Comparison in grade 3 or more
**Comparison in all grades
aOne patient died due to peritoneal metastasis which infiltrated to small intestine