Table 3.

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

	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)

Per patient every AE was counted once with its highest CTC grade. Only AE occurring in > 1 pt are listed (exception: allergic reaction)

Abbreviations: G grade according to CTC criteria, CRP C-reactive protein, ALT/AST aspartate aminotransferase/alanine aminotransferase, GGT gamma-glutamyl transpeptidase

^aPain: not further specified

^bSymptoms: Sensorium, edema, tachypnea, cold hands, CRP elevation