Type of adverse event | Total N AEs/ subjects | Reason stop | Reason modi-fication | AEs CTC gr 3 | AEs CTC gr 2 | AEs CTC gr 1 | Median days to AE (range) |
---|---|---|---|---|---|---|---|
Leucopenia | 2/2 | 1 | – | 0 | 1 | 1 | 51 (13–88) |
GI disorders | 17/7 | 2 b | 4 | 2 | 9 | 6 | |
Diarrhea | 12/7 | 2b | 4 | 2 | 6 | 4 | 61 (0–305) |
Nausea | 3/3 | 1 | 2 | 4 (0–7) | |||
Ulcer | 2/2 | 2 | 65 (7–123) | ||||
General disorders | 35/11 | 3 b,c | 10 | 4 | 13 | 18 | |
Fatigue | 9/9 | 1 | 3 | 1 | 3 | 5 | 7 (0–54) |
Loss of appetite | 7/6 | 1 | 1 | 2 | 4 | 7 (3–139) | |
Weight problem | 2/2 | 2 | 65 (15–112) | ||||
Pain | 11/8 | 2a,b,c | 4 | 2 | 2 | 7 | 11 (0–139) |
Hypertension | 6/6 | 1 | 6 | 18 (7–193) | |||
Hepatobiliary disorders | 5/4 | 1 | 3 | 0 | 2 | 2 | 7 (6–85) |
Dermatologic disorders | 31/10 | 1 | 7 | 1 | 12 | 18 | 15 (4–145) |
Other | 33/11 | 3 c | 2 | 1 | 12 | 20 | |
Hoarseness | 2/2 | 2 | 17 (13–21) | ||||
Eyes and Vision | 5/4 | 1c | 1 | 1 | 2 | 2 | 9 (3–61) |
Headache | 2/2 | 2 | – | ||||
Infection/fever | 6/6 | 1c | 4 | 2 | 13 (3–167) | ||
Other related | 8/5 | 1c | 1 | 3 | 5 | – | |
Other not related | 10/7 | 1 | 9 | ||||
Serious adverse event | 0/0 | 0 | 0 | 0 | 0 | 0 | |
TOTAL events/patients: | 123/ 12 | 8/ 3 | 49/12 | 65/11 |