Table 2 All-grade AEs with a frequency of >10% in the AML dose-escalation study (safety analysis set)

From: Phase I studies of AZD1208, a proviral integration Moloney virus kinase inhibitor in solid and haematological cancers

MedDRA preferred term

AZD1208 120 mg n = 4

AZD1208 240 mg n = 6

AZD1208 480 mg n = 6

AZD1208 700 mg n = 7

AZD1208 900 mg n = 9

Total N = 32

Patients with any AE

3 (75.0)

6 (100.0)

6 (100.0)

7 (100.0)

9 (100.0)

31 (96.9)

Gastrointestinal

  Nausea

3 (75.0)

4 (66.7)

1 (16.7)

5 (71.4)

2 (22.2)

15 (46.9)

  Diarrhoea

1 (25.0)

1 (16.7)

3 (50.0)

5 (71.4)

4 (44.4)

14 (43.8)

  Vomiting

2 (50.0)

3 (50.0)

2 (33.3)

2 (28.6)

1 (11.1)

10 (31.3)

  Abdominal pain

1 (25.0)

0

1 (16.7)

3 (42.9)

1 (11.1)

6 (18.8)

  Stomatitis

1 (25.0)

1 (16.7)

3 (50.0)

0

0

5 (15.6)

  Decreased appetite

0

1 (16.7)

0

2 (28.6)

1 (11.1)

4 (12.5)

General disorders

  Fatigue

1 (25.0)

1 (16.7)

4 (66.7)

2 (28.6)

2 (22.2)

10 (31.3)

  Oedema peripheral

1 (25.0)

1 (16.7)

3 (50.0)

2 (28.6)

2 (22.2)

9 (28.1)

  Asthenia

1 (25.0)

0

1 (16.7)

1 (14.3)

2 (22.2)

5 (15.6)

  Chills

0

1 (16.7)

0

1 (14.3)

2 (22.2)

4 (12.5)

  Pyrexia

0

0

1 (16.7)

0

3 (33.3)

4 (12.5)

Vascular disorders

  Hypotension

1 (25.0)

2 (33.3)

2 (33.3)

3 (42.9)

2 (22.2)

10 (31.3)

Blood and lymphatic system disorders

  Febrile neutropenia

3 (75.0)

2 (33.3)

0

1 (14.3)

3 (33.3)

9 (28.1)

Respiratory disorders

  Cough

0

1 (16.7)

1 (16.7)

4 (57.1)

2 (22.2)

8 (25.0)

  Dyspnoea

0

1 (16.7)

2 (33.3)

2 (28.6)

2 (22.2)

7 (21.9)

Metabolic and nutritional disorders

  Hypocalcaemia

1 (25.0)

1 (16.7)

1 (16.7)

3 (42.9)

1 (11.1)

7 (21.9)

  Hypokalaemia

0

0

3 (50.0)

2 (28.6)

2 (22.2)

7 (21.9)

  Hypomagnesaemia

1 (25.0)

1 (16.7)

2 (33.3)

2 (28.6)

1 (11.1)

7 (21.9)

  Hypophosphataemia

1 (25.0)

0

2 (33.3)

1 (14.3)

2 (22.2)

6 (18.8)

  Hyperglycaemia

0

0

2 (33.3)

1 (14.3)

2 (22.2)

5 (15.6)

  Dehydration

0

0

0

0

4 (44.4)

4 (12.5)

Infections and infestations

  Pneumonia

1 (25.0)

3 (50.0)

2 (33.3)

0

0

6 (18.8)

 Nervous system disorders

  Headache

0

0

3 (50.0)

1 (14.3)

0

4 (12.5)

Skin and subcutaneous disorders

  Rash

0

0

1 (16.7)

1 (14.3)

2 (22.2)

4 (12.5)

  Maculopapular rash

0

1 (16.7)

0

2 (28.6)

1 (11.1)

4 (12.5)

Renal and urinary disorders

  Renal failure acute

0

1 (16.7)

2 (33.3)

1 (14.3)

0

4 (12.5)

Eye disorders

  Vision blurred

1 (25.0)

0

3 (50.0)

0

0

4 (12.5)

  1. Data are n (%) patients with AEs, sorted in decreasing frequency of preferred term (sorted by total column even when not reported). The number of evaluable patients in each dose cohort was: 120 mg, n = 3; 240 mg, n = 3; 480 mg, n = 3; 700 mg, n = 4; 900 mg, n = 3. Data include AEs with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of study medication. MedDRA version 17.0. was used.
  2. AE adverse event, AML acute myeloid leukaemia, MedDRA Medical Dictionary for Regulatory Activities
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