Table 2.
Adverse events reported during the blinded treatment phase
|
Cediranib group (n=31) |
Placebo group (n=16) |
|||
|---|---|---|---|---|
| Grade 1–2 | Grade 3 | Grade 1–2 | Grade 3 | |
| Diarrhoea | 26 (84%) | 2 (6%) | 6 (38%) | 0 |
| Hypertension | 20 (65%) | 6 (19%) | 9 (56%) | 0 |
| Fatigue | 16 (52%) | 1 (3%) | 6 (38%) | 0 |
| Nausea | 12 (39%) | 0 | 3 (19%) | 0 |
| Dyspnoea | 11 (35%) | 0 | 2 (13%) | 1 (6%) |
| Decreased appetite | 9 (29%) | 0 | 6 (38%) | 0 |
| Arthralgia | 9 (29%) | 0 | 2 (13%) | 0 |
| Weight decreased | 9 (29%) | 0 | 2 (13%) | 0 |
| Headache | 9 (29%) | 0 | 4 (25%) | 0 |
| Hypothyroidism | 9 (29%) | 0 | 1 (6%) | 0 |
| Cough | 8 (26%) | 1 (3%) | 6 (38%) | 0 |
| Abdominal pain | 9 (29%) | 0 | 4 (25%) | 0 |
| Pain in extremity | 7 (23%) | 1 (3%) | 6 (38%) | 0 |
| Constipation | 8 (26%) | 0 | 3 (19%) | 0 |
| Mucosal inflammation | 6 (19%) | 1 (3%) | 1 (6%) | 0 |
| Palmar-plantar erythrodysaesthesia | 7 (23%) | 0 | 0 | 0 |
| Stomatitis | 5 (16%) | 0 | 1 (6%) | 0 |
| Back pain | 5 (16%) | 0 | 1 (6%) | 0 |
| Blood bilirubin increased | 4 (13%) | 0 | 1 (6%) | 0 |
| Dry skin | 4 (13%) | 0 | 0 | 0 |
| Insomnia | 4 (13%) | 0 | 2 (13%) | 0 |
| Lymphocyte count decreased | 3 (10%) | 1 (3%) | 1 (6%) | 0 |
| Upper respiratory tract infection | 4 (13%) | 0 | 1 (6%) | 0 |
| Asthenia | 3 (10%) | 1 (3%) | 0 | 0 |
| Neutrophil count decreased | 4 (13%) | 0 | 1 (6%) | 0 |
| Vomiting | 4 (13%) | 0 | 1 (6%) | 0 |
| Rash | 4 (13%) | 0 | 1 (6%) | 0 |
| Nasopharyngitis | 3 (10%) | 0 | 4 (25%) | 0 |
| Chest pain | 4 (13%) | 1 (3%) | 4 (25%) | 0 |
| Proteinuria | 3 (10%) | 0 | 2 (13%) | 0 |
| Dysphonia | 3 (10%) | 0 | 2 (13%) | 0 |
| γ-glutamyltransferase increased | 3 (10%) | 0 | 0 | 1 (6%) |
| Oedema peripheral | 2 (6%) | 0 | 2 (13%) | 0 |
| Epistaxis | 2 (6%) | 0 | 2 (13%) | 0 |
| Dry mouth | 2 (6%) | 0 | 2 (13%) | 0 |
| Haemoptysis | 2 (6%) | 0 | 2 (13%) | 0 |
| Oropharyngeal pain | 2 (6%) | 0 | 2 (13%) | 0 |
| Blood amylase increased | 0 | 1 (3%) | 2 (13%) | 0 |
| Pain | 1 (3%) | 0 | 2 (13%) | 0 |
| Anaemia | 1 (3%) | 0 | 3 (19%) | 0 |
| Injection site haematoma | 0 | 0 | 2 (13%) | 0 |
| Pruritus | 0 | 0 | 2 (13%) | 0 |
| Monoparesis | 0 | 0 | 2 (13%) | 0 |
| Lower respiratory tract infection | 0 | 0 | 2 (13%) | 0 |
| Blood alkaline phosphatase increased | 1 (3%) | 1 (3%) | 0 | 0 |
| Alanine aminotransferase increased | 1 (3%) | 1 (3%) | 0 | 0 |
| Pyrexia | 2 (6%) | 1 (3%) | 1 (6%) | 0 |
| Hypophosphataemia | 2 (6%) | 1 (3%) | 0 | 0 |
| Amenorrhoea | 1 (3%) | 1 (3%) | 0 | 0 |
| Partial seizures | 0 | 1 (3%) | 0 | 0 |
Adverse events were graded according to Common Terminology Criteria for Adverse Events version 4. Adverse events occuring in at least 10% of patients (or one or more patients for grade 3 or worse events) are reported here. There were no grade 4 adverse events or deaths due to these causes.