Table 4.
Adverse effects with dose modification over time during the treatment period
| 1st year All grades n = 64 n/% |
Grade 3–4 n = 64 n/% |
2st years All grades n = 54 n/% |
Grade 3–4 n = 54 |
After 2sd years All grades n = 41 n/% |
Grade 3–4 n = 41 n/% |
Whole period (all grades and non-graded) n = 64 n/% |
Grade 3–4 n/N/% |
Dose modification whole period n = 64 n/N/% |
|
|---|---|---|---|---|---|---|---|---|---|
| Infections | |||||||||
| Stomatitis/mouth ulceration | 28/44 | 1/2 | 18/33 | 17/42 | 40/63 | 2/35/6 | 10/40/25 | ||
| Upper respiratory tract infection | 19/30 | 1/2 | 11/20 | 3/7 | 24/38 | 1/24/4 | |||
| Rash | 9/14 | 2/4 | 5/12 | 17/27 | 3/17/18 | ||||
| Pyrexia | 10/16 | 4/6 | 9/17 | 3/6 | 1/2 | 1/2 | 13/20 | 4/12/33 | 4/13/31 |
| Skin infection included erythema nodusum | 7/11 | 1/2 | 1/2 | 5/12 | 1/2 | 11/17 | 3/12/25 | 4/11/37 | |
| Nausea/vomiting | 7/11 | 1/2 | 3/7 | 9/14 | 1/9/11 | 2/9/22 | |||
| Diarrhoea | 6/10 | 1/2 | 2/4 | 1/2 | 9/14 | 1/9/11 | |||
| Dermatitis acne | 4/6 | 6/11 | 3/7 | 8/13 | 2/8/25 | ||||
| Pneumonia | 5/8 | 5/8 | 3/6 | 2/4 | 5/12 | 4/10 | 8/13 | 8/8/100 | 5/8/63 |
| Gastroenteritis | 1/2 | 3/10 | 1/2 | 7/11 | 3/7/43 | ||||
| Urinary tract and/or pyelonephritis infections | 3/5 | 4/7 | 2/5 | 6/9 | 1/6/17 | 2/6/33 | |||
| Otitis | 4/6 | 1/2 | 2/5 | 5/8 | |||||
| Genital infection* | 1/2 | 3/5 | |||||||
| Immune deficiency | 1/2 | 1/2 | 2/4 | 2/4 | 1/2 | 1/2 | 2/3 | 2/64/3 | |
| Abscess | 1/2 | 1/2 | |||||||
| Infected polyp | 1/2 | 1/2 | |||||||
| Mononucleosis | 1/2 | 1/2 | 1/1/100 | ||||||
| Hepatitis B virus | 1/2 | 1/2 | |||||||
| Appendicitis | 1/2 | 1/2 | |||||||
| Acute encephalitis | 1/2 | 1/2 | 1/64/2 | 1/1/100 | |||||
| Chronic osteomyelitis | 1/2 | 1/2 | 1/2 | 1/2 | 1/64/2 | ||||
| Other adverse effects | |||||||||
| Tiredness | 9/14 | 1/2 | 4/7 | 1/2 | 5/12 | 14/22 | 2/64/14 | 1/14/7 | |
| Pruritus | 1/2 | 7/11 | |||||||
| Amenorrhea or irregular menses n/N/% | 4/21/19 | 1/21/5 | 6/21/29 | ||||||
| Cysts ** | 2/4 | 3/6 | 2/4 | 6/9 | 2/64/14 | ||||
| Constipation | 3/5 | 1/2 | 5/8 | ||||||
| Headache | 2/3 | ||||||||
| Diabetes mellitus | 1/2 | 1/2 | 1/1/100 | ||||||
| Cerebral oedema | 1/2 | 1/2 | 1/2 | 1/64/2 | 1/1/100 | ||||
| Laboratory abnormalities | |||||||||
| Any lab abnormality*** | 35/55 | 29/4 | 16/39 | 46/72 | |||||
| Increased cholesterol | 25/39 | 22/41 | 18/44 | 26/41 | 2/26/8 | ||||
| Hypertriglyceridemia | 13/20 | 8/15 | 8/20 | 19/30 | |||||
| Neutropenia | 7/11 | 6/11 | 2/4 | 4/10 | 3/7 | 7/11 | 4/64/6 | 1/7/14 | |
| Leucopoenia | 13/25 | 1/2 | 7/13 | 1/2 | 6/15 | 1/2 | 16/25 | 2/64/4 | 3/16/19 |
| Anaemia | 12/19 | 6/11 | 5/12 | 17/27 | |||||
| Hyperglycaemia | 1/2 | 1/2 | 2/4 | 3/7 | 4/6 | 1/64/2 | 1/4/25 | ||
| Hypophosphatemia | 5/8 | 1/2 | 2/5 | 6/9 | 1/6/17 | ||||
| Thrombocytopenia | 4/7 | 1/2 | 2/4 | 4/6 | 1/64/2 | 1/4/25 | |||
| ASAT | 1/2 | 1/2 | |||||||
| ALAT | 2/3 | 1/2 | 2/3 | 1/64/2 | 1/2/50 | ||||
| GGT | 2/3 | 2/4 | 1/2 | 3/5 |
*Genital infection (vaginal infection n = 2, testes infection n = 1)
**Cysts: (ovarian, clitoris, pilonidal)
***According to the National Cancer Institute Common Terminology Criteria version 5