Summary of treatment-related adverse events occuring in more than 10% of patients
. | Weeks on/off treatment by dosage and worst grade CTC, no. patients (no. events) . | . | . | . | . | . | |||||
---|---|---|---|---|---|---|---|---|---|---|---|
Adverse event . | 4/2 wk, 50 mg, CTC 1-2 . | 4/2 wk, 50 mg, CTC 3-4 . | 4/2 wk, 75 mg, CTC 1-2 . | 4/2 wk, 75 mg, CTC 3-4 . | 4/1 wk, 50 mg, CTC 1-2 . | 4/1 wk, 50 mg, CTC 1-2 . | |||||
CTC, worst grade | 1-2 | 3-4 | 1-2 | 3-4 | 1-2 | 3-4 | |||||
Any events | 3 (3) | 0 | 1 (3) | 1 (4) | 5 (16) | 0 | |||||
Nausea | 1 (1) | 0 | 1 (1) | 0 | 3 (5) | 0 | |||||
Fatigue | 1 (1) | 0 | 0 | 1 (2) | 2 (2) | 0 | |||||
Jaundice | 1 (1) | 0 | 0 | 0 | 2 (2) | 0 | |||||
Lipase increase | 0 | 0 | 0 | 1 (2) | 1 (1) | 0 | |||||
Diarrhea | 0 | 0 | 1 (1) | 0 | 1 (1) | 0 | |||||
Vomiting | 0 | 0 | 1 (1) | 0 | 1 (1) | 0 | |||||
Constipation | 0 | 0 | 0 | 0 | 2 (2) | 0 | |||||
Headache | 0 | 0 | 0 | 0 | 2 (2) | 0 |
. | Weeks on/off treatment by dosage and worst grade CTC, no. patients (no. events) . | . | . | . | . | . | |||||
---|---|---|---|---|---|---|---|---|---|---|---|
Adverse event . | 4/2 wk, 50 mg, CTC 1-2 . | 4/2 wk, 50 mg, CTC 3-4 . | 4/2 wk, 75 mg, CTC 1-2 . | 4/2 wk, 75 mg, CTC 3-4 . | 4/1 wk, 50 mg, CTC 1-2 . | 4/1 wk, 50 mg, CTC 1-2 . | |||||
CTC, worst grade | 1-2 | 3-4 | 1-2 | 3-4 | 1-2 | 3-4 | |||||
Any events | 3 (3) | 0 | 1 (3) | 1 (4) | 5 (16) | 0 | |||||
Nausea | 1 (1) | 0 | 1 (1) | 0 | 3 (5) | 0 | |||||
Fatigue | 1 (1) | 0 | 0 | 1 (2) | 2 (2) | 0 | |||||
Jaundice | 1 (1) | 0 | 0 | 0 | 2 (2) | 0 | |||||
Lipase increase | 0 | 0 | 0 | 1 (2) | 1 (1) | 0 | |||||
Diarrhea | 0 | 0 | 1 (1) | 0 | 1 (1) | 0 | |||||
Vomiting | 0 | 0 | 1 (1) | 0 | 1 (1) | 0 | |||||
Constipation | 0 | 0 | 0 | 0 | 2 (2) | 0 | |||||
Headache | 0 | 0 | 0 | 0 | 2 (2) | 0 |