Table III.
Adverse events occurring as any grade in ≥20% or as grade ≥3 in ≥5% of all patients
| Grade | Schedule A* (n = 29) | Schedule B† (n = 35) | Schedule C72‡ (n = 29) | Schedule C90§ (n = 20) | All patients (N = 113) | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| Any | ≥3 | Any | ≥3 | Any | ≥3 | Any | ≥3 | Any | ≥3 | |
| Haematological events, % | ||||||||||
| Febrile neutropenia | 48 | 35 | 66 | 60 | 62 | 55 | 50 | 45 | 58 | 50 |
| Thrombocytopenia | 45 | 45 | 69 | 69 | 69 | 62 | 60 | 60 | 61 | 59 |
| Anaemia | 41 | 38 | 54 | 46 | 66 | 55 | 60 | 60 | 55 | 49 |
| Neutropenia | 41 | 38 | 26 | 26 | 28 | 28 | 25 | 25 | 30 | 29 |
| Leucopenia | 7 | 7 | 14 | 14 | 0 | 0 | 5 | 5 | 7 | 7 |
| Non-haematological events, % | ||||||||||
| Cardiac disorders | ||||||||||
| Tachycardia | 38 | 0 | 40 | 0 | 17 | 0 | 25 | 5 | 31 | 1 |
| Gastrointestinal disorders | ||||||||||
| Diarrhoea | 83 | 7 | 77 | 6 | 69 | 0 | 65 | 10 | 74 | 5 |
| Stomatitis/oral mucositis | 72 | 28 | 57 | 11 | 55 | 28 | 55 | 25 | 60 | 22 |
| Nausea | 76 | 3 | 60 | 0 | 86 | 3 | 55 | 5 | 70 | 3 |
| Vomiting | 55 | 0 | 29 | 0 | 52 | 7 | 25 | 0 | 41 | 2 |
| Constipation | 41 | 0 | 37 | 0 | 17 | 0 | 20 | 0 | 30 | 0 |
| Oral pain | 7 | 3 | 14 | 3 | 17 | 10 | 30 | 15 | 16 | 7 |
| General disorders/administration site conditions | ||||||||||
| Peripheral oedema | 59 | 10 | 49 | 3 | 52 | 3 | 40 | 0 | 50 | 4 |
| Fatigue | 52 | 17 | 57 | 20 | 41 | 14 | 35 | 15 | 48 | 17 |
| Asthenia | 31 | 10 | 40 | 9 | 21 | 7 | 10 | 0 | 27 | 7 |
| Chills | 28 | 0 | 34 | 0 | 28 | 3 | 30 | 0 | 30 | 1 |
| Pyrexia | 17 | 0 | 26 | 3 | 24 | 0 | 35 | 0 | 25 | 1 |
| Infections and infestations | ||||||||||
| Aggregate sepsis¶ | 52 | 55** | 43 | 34** | 21 | 24 | 45 | 45** | 40 | 39** |
| Aggregate infections¶ | 45 | 21 | 37 | 6** | 45 | 10 | 35 | 20 | 41 | 13** |
| Aggregate pneumonia¶ | 41 | 31** | 40 | 34** | 38 | 28 | 35 | 25** | 39 | 30** |
| Metabolism and nutrition disorders | ||||||||||
| Anorexia | 72 | 28 | 51 | 9 | 59 | 10 | 55 | 0 | 59 | 12 |
| Hypokalaemia | 72 | 41 | 54 | 20 | 59 | 21 | 65 | 15 | 62 | 25 |
| Hypomagnesaemia | 52 | 3 | 40 | 0 | 48 | 0 | 30 | 0 | 43 | 1 |
| Hypophosphataemia | 45 | 24 | 23 | 3 | 21 | 7 | 25 | 15 | 28 | 12 |
| Dehydration | 28 | 14 | 20 | 0 | 10 | 3 | 25 | 15 | 20 | 7 |
| Hypocalcaemia | 28 | 14 | 14 | 6 | 31 | 10 | 20 | 10 | 23 | 10 |
| Hyperglycaemia | 10 | 7 | 20 | 6 | 21 | 10 | 15 | 5 | 17 | 7 |
| Nervous system disorders | ||||||||||
| Headache | 35 | 0 | 26 | 3 | 31 | 3 | 10 | 0 | 27 | 2 |
| Dizziness | 21 | 0 | 20 | 0 | 24 | 0 | 20 | 0 | 21 | 0 |
| Psychiatric disorders | ||||||||||
| Insomnia | 41 | 0 | 37 | 0 | 38 | 0 | 15 | 0 | 35 | 0 |
| Confusional state | 28 | 14 | 26 | 0 | 28 | 3 | 10 | 5 | 24 | 5 |
| Anxiety | 24 | 0 | 40 | 0 | 41 | 3 | 20 | 0 | 33 | 1 |
| Respiratory, thoracic, and mediastinal disorders | ||||||||||
| Cough | 45 | 0 | 31 | 0 | 38 | 0 | 25 | 0 | 35 | 0 |
| Dyspnea | 38 | 24 | 40 | 9 | 38 | 3 | 25 | 15 | 36 | 12 |
| Rales | 35 | 0 | 23 | 0 | 7 | 0 | 15 | 0 | 20 | 0 |
| Epistaxis | 24 | 0 | 37 | 0 | 28 | 7 | 25 | 0 | 29 | 2 |
| Pleural effusion | 24 | 0 | 23 | 9 | 38 | 0 | 10 | 0 | 25 | 3 |
| Hypoxia | 10 | 7 | 17 | 14 | 21 | 3 | 10 | 0 | 15 | 7 |
| Skin and subcutaneous tissue disorders | ||||||||||
| Alopecia | 41 | 0 | 23 | 0 | 45 | 0 | 25 | 0 | 34 | 0 |
| Petechiae | 28 | 0 | 31 | 0 | 14 | 0 | 0 | 0 | 20 | 0 |
| Rash | 24 | 0 | 23 | 0 | 35 | 3 | 15 | 0 | 25 | 1 |
| Vascular disorders | ||||||||||
| Hypotension | 38 | 17 | 31 | 3 | 35 | 0 | 30 | 15 | 34 | 8 |
| Hypertension | 21 | 10 | 11 | 9 | 10 | 3 | 0 | 0 | 12 | 6 |
*
72 mg/m2 on days 1, 8, and 15.
†
72 mg/m2 on days 1 and 8.
‡
72 mg/m2 on days 1 and 4.
§
90 mg/m2 on days 1 and 4.
¶
Aggregate sepsis includes sepsis, bacteraemia, viraemia and fungaemia, and represents 32 preferred terms; aggregate infections represent 30 preferred terms; aggregate pneumonia represents 10 preferred terms.
**
Includes 1 or more grade 5 events. Grade 5 aggregate sepsis was observed with schedules A (n = 4), B (n = 3), and C90 (n = 2); grade 5 aggregate pneumonia was observed with Schedules A (n = 1), B (n = 1), and C90 (n = 2); grade 5 aggregate infection was observed with Schedule B (n = 1).