Table 3. Treatment-emergent (all-causality) AEs of interest experienced by ⩾20% of the study population in either treatment group (all cycles)a.
|
CP-856,596+docetaxel (n=39)
|
CP-856,596+docetaxel+axitinib (n=9)
|
|||||
|---|---|---|---|---|---|---|
| AE | Grade 1/2, n (%) | Grade 3/4, n (%) | Total | Grade 1/2, n (%) | Grade 3/4, n (%) | Total |
| Nausea | 27 (69.2) | 5 (12.8) | 32 (82.1) | 4 (44.4) | 0 | 4 (44.4) |
| Diarrhoea | 22 (56.4) | 3 (7.7) | 25 (64.1) | 5 (55.6) | 0 | 5 (55.6) |
| Vomiting | 22 (56.4) | 1 (2.6) | 23 (59.0) | 4 (44.4) | 0 | 4 (44.4) |
| Constipation | 20 (51.3) | 0 | 20 (51.3) | 4 (44.4) | 0 | 4 (44.4) |
| Fatigue | 11 (28.2) | 6 (15.4) | 17 (43.6) | 4 (44.4) | 1 (11.1) | 5 (55.6) |
| Anaemia | 10 (25.6) | 6b (15.4) | 16 (41.0) | 1 (11.1) | 0 | 1 (11.1) |
| Dyspnoea | 10 (25.6) | 4 (10.3) | 14 (35.9) | 4 (44.4) | 0 | 4 (44.4) |
| Lethargy | 10 (25.6) | 3 (7.7) | 13 (33.3) | 5 (55.6) | 1 (11.1) | 6 (66.7) |
| Neutropenia | 3 (7.7) | 10c (25.6) | 13 (33.3) | 0 | 0 | 0 |
| Pyrexia | 11 (28.2) | 2 (5.1) | 13 (33.3) | 4 (44.4) | 0 | 4 (44.4) |
| Anorexia | 11 (28.2) | 1 (2.6) | 12 (30.8) | 2 (22.2) | 0 | 2 (22.2) |
| Rashd | 12 (30.8) | 0 | 12 (30.8) | 3 (33.3) | 0 | 3 (33.3) |
| Peripheral oedema | 11 (28.2) | 0 | 11 (28.2) | 0 | 0 | 0 |
| Mucosal inflammation | 8 (20.5) | 1 (2.6) | 9 (23.1) | 2 (22.2) | 2 (22.2) | 4 (44.4) |
| Dysguesia | 9 (23.1) | 0 | 9 (23.1) | 2 (22.2) | 0 | 2 (22.2) |
| Pain | 6 (15.3) | 3 (7.7) | 9 (23.1) | I (11.1) | 0 | 1 (11.1) |
| Headache | 8 (20.5) | 0 | 8 (20.5) | I (11.1) | 0 | 1 (11.1) |
| Cough | 6 (15.4) | 0 | 6 (15.4) | 2 (22.2) | 0 | 2 (22.2) |
| Tachycardia | 8 (20.5) | 0 | 8 (20.5) | 1 (11.1) | 0 | 1 (11.1) |
| Febrile neutropenia | 1 (2.6) | 4 (10.3) | 5 (12.8) | 0 | 2b (22.2) | 2 (22.2) |
| Dehydration | 5 (12.8) | 0 | 5 (12.8) | 1 (11.1) | 1 (11.1) | 2 (22.2) |
| ALT increased | 4 (10.3) | 0 | 4 (10.3) | 2 (22.2) | 0 | 2 (22.2) |
| Hypertension | 3 (7.7) | 0 | 3 (7.7) | 6 (66.7) | 0 | 6 (66.7) |
| Epistaxis | 3 (7.7) | 0 | 3 (7.7) | 2 (22.2) | 0 | 2 (22.2) |
| Peripheral neuropathy | 1 (2.6) | 0 | 1 (2.6) | 1 (11.1) | 1 (11.1) | 2 (22.2) |
| Dysphonia | 1 (2.6) | 0 | 1 (2.6) | 4 (44.4) | 0 | 4 (44.4) |
| Lacrimation increased | 0 | 0 | 0 | 3 (33.3) | 0 | 3 (33.3) |
| Abdominal discomfort | 1 (2.6) | 0 | 1 (2.6) | 2 (22.0) | 0 | 2 (22.0) |
| Chest pain | 3 (7.7) | 0 | 3 (7.7) | 2 (22.2) | 0 | 2 (22.2) |
| Hypotension | 3 (7.7) | 0 | 3 (7.7) | 1 (11.1) | 1 (11.1) | 2 (22.2) |
| Insomnia | 4 (10.3) | 0 | 4 (10.3) | 2 (22.2) | 0 | 2 (22.2) |
| PPE | 1 (2.6) | 0 | 1 (2.6) | 2 (22.2) | 0 | 2 (22.2) |
| Paraesthesia | 3 (7.7) | 0 | 3 (7.7) | 2 (22.2) | 0 | 2 (22.2) |
| Toothache | 0 | 0 | 0 | 2 (22.2) | 0 | 2 (22.2) |
Abbreviations: AE=adverse event; ALT=alanine amino transferase; PPE=palmar–plantar erythrodysaesthia syndrome.
a
The safety population comprised all patients who received at least one dose of study medication.
b
One grade 4.
c
Seven grade 4.
d
Pooled data: rash, rash erythematous, rash generalised, rash maculopapular, rash pruritic, and heat rash.