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Table 3 Adverse events (AEs) with possible relationship to ertumaxomab treatment (Adverse Drug Reaction) graded according to CTC AE (version 4.0)

From: A phase I trial of the trifunctional anti Her2 × anti CD3 antibody ertumaxomab in patients with advanced solid tumors

 

Dose level 1

Dose level 5

Dose level 9

Dose level 13

Ʃ

AEs

(n = 3)

(n = 4)

(n = 3)

(n = 4)

(n = 14)

n

n

n

n

n [%]

AEs

G1/G2

G3

G1/G2

G3

G1/G2

G3

G1/G2

G3

Ʃ

Fatigue

2

1

1

3

2

1

3

1

14 (100,0)

Cephalgia

2

-

3

-

3

-

4

-

12 (85,7)

Chills

3

-

2

-

3

-

3

-

11 (78,6)

Nausea

1

-

2

-

2

-

3

-

8 (61,5)

Emesis

1

-

2

-

2

-

2

-

7 (50,0)

Fever

1

-

2

1

2

-

1

1

7 (50,0)

Hypertension

3

-

2

-

1

-

1

-

7 (50,0)

Tumorpain

-

-

1

2

2

-

1

1

7 (50,0)

Paina

1

-

4

-

1

-

-

-

6 (42,9)

Diarrhea

1

-

2

-

1

-

1

-

5 (42,9)

Pain in the limbs

-

-

2

-

-

-

3

-

5 (42,9)

↑CRP

1

-

1

-

1

-

1

-

4 (28,6)

Tachycardia

1

-

1

-

2

-

-

-

4 (28,6)

↑GGT

-

-

2

-

1

-

-

-

3 (21,4)

↑ALT/AST

-

-

1

-

1

-

-

-

2 (14,3)

↓Lymphocytes

-

-

2

-

-

-

-

-

2 (14,3)

Agitation

-

-

1

-

-

-

1

-

2 (14,3)

Dermatitis

-

-

2

-

-

-

-

-

2 (14,3)

Hypotension

1

-

-

-

1

-

-

-

2 (14,3)

Dizziness

-

-

-

-

1

-

1

-

2 (14,3)

Sensorium

-

-

2

-

-

-

-

-

2 (14,3

Allergic reactionb

-

-

1

-

-

-

-

-

1 (7,1)

  1. Per patient every AE was counted once with its highest CTC grade. Only AE occurring in > 1 pt are listed (exception: allergic reaction)
  2. Abbreviations: G grade according to CTC criteria, CRP C-reactive protein, ALT/AST aspartate aminotransferase/alanine aminotransferase, GGT gamma-glutamyl transpeptidase
  3. aPain: not further specified
  4. bSymptoms: Sensorium, edema, tachypnea, cold hands, CRP elevation
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BMC Cancer

ISSN: 1471-2407

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