Table 2.
Treatment emergent adverse events occurring in more than 10% of patients or of special interest per treatment arm
| Depatux-M with Temozolomide N = 88 | Depatux-M N = 84 | Lomustine or Temozolomide N = 77 (56*/21) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade | 1–2 | 3 | 4 | 5 | 1–2 | 3 | 4 | 5 | 1–2 | 3 | 4 | 5 |
| Gastrointestinal | 47 | 25 | 3 | 25 | 2 | 1 | ||||||
| Nausea | 21 | 8 | 1 | 12 | ||||||||
| Diarrhea | 8 | 6 | 4 | |||||||||
| Eye disorders | 44 | 28 | 1 | 40 | 19 | 1 | 3 | |||||
| Infections | 25 | 4 | 1 | 18 | 4 | 8 | 3 | 1 | ||||
| Investigations | ||||||||||||
| ALAT increase | 49 | 1 | 33 | 1 | 19*/6 | 2*/0 | ||||||
| Bilirubin | 8 | 3 | 6 | 5 | ||||||||
| Glucose | 3 | 3 | 2 | |||||||||
| Fatigue | 26 | 7 | 24 | 4 | 15 | 1 | ||||||
| Hematology | ||||||||||||
| Hemoglobin | 27 | 1 | 2 | 24 | 1 | 31*/8 | 8*/0 | 3*/0 | ||||
| WBC | 25 | 2 | 1 | 11 | 10 | 23*/6 | 8*/1 | 2*/0 | ||||
| Neutrophils | 14 | 2 | 3 | 5 | 1 | 14*/2 | 15*/5 | 3*/1 | ||||
| Lymphocytes | 35 | 26 | 29 | 11 | 25*/9 | 11*/3 | 3*/0 | |||||
| Platelets | 54 | 7 | 36*/9 | 15*/8 | 9*/1 | |||||||
| Any | 49 | 28 | 14*/9 | |||||||||
| Febrile neutropenia | 1 | |||||||||||
| Musculoskeletal | 25 | 2 | 13 | 3 | 12 | 4 | ||||||
| Nervous system | 36 | 17 | 4 | 37 | 19 | 1 | 1 | 28 | 13 | 2 | ||
| Respiratory | 15 | 5 | 1 | 3 | 6 | 9 | 3 | |||||
| Pulmonary embolism | 0 | 2 | 1 | 1 | 0 | 3 | ||||||
| Venous thrombosis | 1 | 1 | 1 | 2 | ||||||||
| Rash | 7 | 2 | 3 | |||||||||
| Nervous system | 35 | 18 | 4 | 37 | 20 | 1 | 1 | 32 | 12 | 2 |
ALAT = alanine aminotransferase; WBC = white blood cell.
In the control arm, for ALAT and hematology adverse events, rates were higher in the lomustine treated patients compared with temozolomide treated patients. *Lomustine treated patients.
One patient in the Depatux-M monotherapy arm died from an intracranial hemorrhage that was considered related.