Table 2 Most frequently observed treatment-emergent adverse eventsa.

From: Results of the phase IIa RADICAL trial of the FGFR inhibitor AZD4547 in endocrine resistant breast cancer

Treatment-emergent adverse event (AE)

Severity

Total

Grade 1–2

Grade 3

Events

Patients

Events

Patients

Events (N = 505)

Patients (N = 52)

Hyperphosphataemia

43

8.5%

26

50%

0

 

0

 

43

8.5%

26

50%

Dry mouth

29

5.7%

23

44%

0

 

0

 

29

5.7%

23

44%

Alopecia

23

4.6%

20

38%

0

 

0

 

23

4.6%

20

38%

Dysgeusia

15

3.0%

13

25%

0

 

0

 

15

3.0%

13

25%

Constipation

12

2.4%

12

23%

0

 

0

 

12

2.4%

12

23%

Nausea

14

2.8%

12

23%

0

 

0

 

14

2.8%

12

23%

Retinal pigment epithelium detachment (RPED)

16

3.2%

11

21%

0

 

0

 

16

3.2%

11

21%

Diarrhoea

16

3.2%

10

19%

0

 

0

 

16

3.2%

10

19%

Dyspepsia

14

2.8%

10

19%

0

 

0

 

14

2.8%

10

19%

Decreased appetite

14

2.8%

8

15%

0

 

0

 

14

2.8%

8

15%

Dry eye

9

1.8%

8

15%

0

 

0

 

9

1.8%

8

15%

Dry skin

9

1.8%

8

15%

0

 

0

 

9

1.8%

8

15%

Epistaxis

11

2.2%

8

15%

0

 

0

 

11

2.2%

8

15%

Stomatitis

10

2.0%

8

15%

0

 

0

 

10

2.0%

8

15%

Alanine aminotransferase increased

11

2.2%

7

13%

0

 

0

 

11

2.2%

7

13%

Aspartate aminotransferase increased

9

1.8%

6

12%

1

0.2%

1

2%

10

2.0%

7

13%

Blood calcium increased

9

1.8%

7

13%

0

 

0

 

9

1.8%

7

13%

Calcium phosphate product increased

11

2.2%

7

13%

0

 

0

 

11

2.2%

7

13%

Fatigue

12

2.4%

7

13%

1

0.2%

1

2%

13

2.6%

7

13%

Nail disorder

7

1.4%

7

13%

0

 

0

 

7

1.4%

7

13%

Onycholysis

6

1.2%

6

12%

0

 

0

 

6

1.2%

6

12%

Arthralgia

5

1.0%

5

10%

0

 

0

 

5

1.0%

5

10%

Blood albumin decreased

12

2.4%

5

10%

0

 

0

 

12

2.4%

5

10%

Blood alkaline phosphatase increased

5

1.0%

4

8%

1

0.2%

1

2%

6

1.2%

5

10%

Glossodynia

5

1.0%

5

10%

0

 

0

 

5

1.0%

5

10%

Lethargy

5

1.0%

5

10%

1

0.2%

1

2%

6

1.2%

5

10%

Mouth ulceration

13

2.6%

5

10%

0

 

0

 

13

2.6%

5

10%

Vomiting

6

1.2%

5

10%

0

 

0

 

6

1.2%

5

10%

Any treatment-emergent AEb

496

98.2%

50

96%

7

1.4%

6

12%

505

100%

50

96%

  1. aTreatment-emergent adverse events (AEs) occurring at any time point, in at least 10% of patients and are categorised as “definitely”, “possibly” or “probably” related to the study treatment. Out of the 822 AEs experienced by 52 study participants, 505 are classified as treatment-emergent AEs. There are study participants with repeated or multiple adverse events. Source data are provided as a Source Data file.
  2. bThere are 2 adverse events out of the total 505 treatment-emergent adverse events without severity grading. The severity of treatment-emergent AEs observed are only from grades 1–3. Of the 52 patients who reported experiencing AEs, 50 of them had treatment-emergent AE