Table 4 Most frequent AEs (reported in >2 out of 10 patients) and most frequent AEs assessed as related to cilengitide (>2 out of 10 patients in total)

From: Phase I/II trial of cilengitide with cetuximab, cisplatin and 5-fluorouracil in recurrent and/or metastatic squamous cell cancer of the head and neck: findings of the phase I part

 

Most frequent AEsa,b

Most frequent AEs related c to cilengitide ( n =10 patients) a

 

n =10 patients

Cohort 1 ( n =3)

Cohort 2 ( n =3)

Cohort 3 ( n =4)

Cilengitide

All doses

500 mg

1000 mg

2000 mg

Constipation

8

   

Rash

7

   

Nausea

7

0

3

1

Anorexia

7

1

2

1

Fatigue

6

   

Asthenia

5

0

2

2

Pyrexia

5

   

Diarrhoea

5

   

Vomiting

5

0

2

1

Skin fissures

4

   

Stomatitis

4

   

Anaemia

4

   

Neutropenia

4

   

Mucosal inflammation

3

0

1

2

Dry skin

3

0

2

1

Hypokalaemia

3

   

Dizziness

3

   

Paraesthesia

3

   
  1. Abbreviation: AEs=adverse events.
  2. aRegardless of toxicity grade.
  3. bAny AEs, regardless of relatedness to cilengitide.
  4. cInvestigators assessed AEs either as ‘related’ or as ‘not related’.
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