Table 4

Summary of adverse events (safety analysis set*)

Antibody Negative

(N = 1317)

Antibody Positive

(N = 65)

Predose Positive

(N = 46)

Developing Antibody Positive

(N = 21)


Patients with any adverse event, n (%)

1312 (100)

65 (100)

46 (100)

21 (100)

Worst grade of 3

716 (54)

26 (40)

18 (39)

8 (38)

Worst grade of 4

264 (20)

18 (28)

15 (33)

4 (19)

Worst grade of 5

82 (6)

6 (9)

2 (4)

4 (19)

Any serious adverse event

544 (41)

32 (49)

23 (50)

10 (48)

Patients with any adverse event leading to permanent discontinuation of any study drug, n (%)

299 (23)

16 (25)

8 (17)

8 (38)

Not serious

217 (16)

12 (18)

6 (13)

6 (29)

Serious

108 (8)

6 (9)

3 (7)

3 (14)

Patients with any treatment-related adverse event§, n (%)

1298 (99)

65 (100)

46 (100)

21 (100)

Worst grade of 3

739 (56)

30 (46)

20 (43)

11 (52)

Worst grade of 4

204 (15)

15 (23)

13 (28)

2 (10)

Worst grade of 5

13 (1)

1 (2)

0

1 (5)

Any serious adverse event

314 (24)

20 (31)

14 (30)

6 (29)

Patients with any adverse event leading to permanent discontinuation of any study drug, n (%)

251 (19)

11 (17)

5 (11)

6 (29)

Not serious

200 (15)

9 (14)

4 (9)

5 (24)

Serious

64 (5)

2 (3)

1 (2)

1 (5)


*The safety analysis set included all patients who were enrolled, randomized, and received at least one dose of study treatment in studies 20050203, 20050181, 20050184, and 20060277. Patients not testing positive by ELISA, Biacore, and bioassay or with all antibody results missing were included.

Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 12.0.

Severity was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, with the exception of some dermatology/skin adverse events, which were graded using CTCAE version 3.0 with modifications. Fatal adverse events were classified as grade 5.

§The investigator considered there to be a reasonable possibility that the event may have been caused by study drug.

Weeraratne et al. BMC Clinical Pharmacology 2011 11:17   doi:10.1186/1472-6904-11-17

Open Data