Table 3 Treatment-emergent (all-causality) AEs of interest experienced by ⩾20% of the study population in either treatment group (all cycles)a

From: Phase Ib study of CP-868,596, a PDGFR inhibitor, combined with docetaxel with or without axitinib, a VEGFR inhibitor

 

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)

  1. Abbreviations: AE=adverse event; ALT=alanine amino transferase; PPE=palmar–plantar erythrodysaesthia syndrome.
  2. aThe safety population comprised all patients who received at least one dose of study medication.
  3. bOne grade 4.
  4. cSeven grade 4.
  5. dPooled data: rash, rash erythematous, rash generalised, rash maculopapular, rash pruritic, and heat rash.
Back to article page