Table 3. Adverse events of treatment with nintedanib.
| Variable | All cases | Severe cases | Non-severe cases | P value |
|---|---|---|---|---|
| Number | 22 | 8 | 14 | |
| Incidence of more than 1 adverse event | 20 (91%) | 7 (88%) | 13 (93%) | |
| Highest severity of adverse event evaluated by CTCAE ver. 4.0-grade | 0.84 | |||
| No adverse event | 2 (9%) | 1 (13%) | 1 (7%) | |
| 1 | 11 (50%) | 3 (37%) | 8 (57%) | |
| 2 | 6 (27%) | 3 (37%) | 3 (21%) | |
| 3 | 3 (13%) | 1 (13%) | 2 (14%) | |
| 4 | 0 | 0 | 0 | |
| Discontinuation of treatment | 12 (55%) | 3 (37%) | 9 (64%) | 0.38 |
| Permanent discontinuation | 2 (9%) | 1 (13%) | 1 (7%) | |
| Temporary discontinuation | 10 (45%) | 2 (25%) | 8 (57%) | |
| Adverse event | ||||
| Diarrhea | 16 (73%) | 5 (63%) | 11 (79%) | 0.62 |
| Grade (1/2/3/4 or 5) | 12/4/0/0 | 4/1/0/0 | 8/3/0/0 | |
| Elevation of aminotransferase | 12 (55%) | 4 (50%) | 8 (57%) | 1.0 |
| Grade (1/2/3/4 or 5) | 10/1/1/0 | 3/1/0/0 | 7/0/1/0 | |
| Nausea | 2 (9%) | 1 (13%) | 1 (7%) | |
| Grade (1/2/3/4 or 5) | 0/1/1/0 | 0/1/0/0 | 0/0/1/0 | |
| Vomiting | 2 (9%) | 1 (13%) | 1 (7%) | |
| Grade (1/2/3/4 or 5) | 1/0/1/0 | 0/0/1/0 | 1/0/0/0 | |
| Thrombocytopenia | 1 (4%) | 0 | 1 (7%) | |
| Grade (1/2/3/4 or 5) | 0/0/1/0 | 0/0/0/0 | 0/0/1/0 |
CTCAE ver. 4.0, Common terminology criteria for adverse events version 4.0.