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Table 2 Adverse Events and outcomes by intention to treat other than where otherwise indicated.

From: The BRAIN TRIAL: a randomised, placebo controlled trial of a Bradykinin B2 receptor antagonist (Anatibant) in patients with traumatic brain injury

 

High dose XY2405

Medium dose XY2405

Low dose XY2405

All doses XY2405 combined

Placebo

Number of patients

57

56

58

171

57

Number (%) of patients with at least one serious adverse event

15/57 (26.3%)

15/52# (28.8%)

13/54# (24.1%)

43/163# (26.4%)

RR = 1.37 (0.76, 2.46)

1 sided P = 0.19

11/57 (19.3%)

Number (%) of patients with at least one serious adverse event (Per Protocol analysis)

15/56 (26.8%)

15/48 (31.3%)

12/46 (26.1%)

42/150 (28.0%)

RR = 1.48 (0.80, 2.74)

1 sided P = 0.13

10/53 (18.9%)

Number (%) of patients with at least one serious adverse event which is suspected to be related to study drug

0

0

0

0

0

Number of serious adverse events#

     

0

42 (73.3%)

37 (71.2%)

41 (75.9%)

120 (73.6%)

46 (80.7%)

1

12 (21.1%)

8 (15.4%)

11 (20.4%)

31 (19.0%)

7 (12.3%)

2

2 (3.5%)

5 (9.6%)

1 (1.9%)

8 (4.9%)

3 (5.3%)

3+

1 (1.8%)

2 (3.8%)

1 (1.9%)

4 (2.5%)

1 (1.8%)

Total number SAEs

19

25

16

60

16

Glasgow Coma Score at day 15

12.54

12.63

12.29

12.48

13.00

 

δ = -0.36

P > 0.05

(-1.56, 0.92)

δ = -0.48

P > 0.05

(-1.55, 0.78)

δ = -0.80

P > 0.05

(-2.00, 0.53)

δ = -0.55,

P > 0.05

(-1.42, 0.59)

Ref

 

10.70*

10.60*

10.74*

10.68*

δ = -0.78 P > 0.05

(-2.08, 0.61)

11.42*

Ref

HIREOS at day 15

3.98

3.89**

3.92

3.93

3.54

 

δ = 0.43 P > 0.05

(-0.17, 1.05)

δ = 0.42 P > 0.05

(-0.19, 0.98)

δ = 0.39 P > 0.05

(-0.21, 0.98)

δ = 0.41 P > 0.05

(-0.06, 0.89)

Ref

Disability Rating Scale at day 15

11.26

10.61**

11.63

11.18

9.73

 

δ = 1.17 P > 0.05

(-2.70, 4.60)

δ = 1.46 P > 0.05

(-1.60, 4.80)

δ = 2.22 P > 0.05

(-1.25, 5.66)

δ = 1.62 P > 0.05

(-1.16, 4.23)

Ref

 

14.88*

14.63*

14.69*

14.74*

δ = 1.97 P > 0.05

(-1.27, 5.00)

12.93*

Ref

All cause mortality up to day 15: (%)

11/57 (19.3%)

11/52#(21.2%)

9/54# (16.7%)

31/163# (19.0%)

RR = 1.20 (0.61, 2.36)

1 sided P = 0.37

9/57 (15.8%)

Number (%) of patients with erythema at injection site classified as moderate, intense or very intense.

12/57 (21.1%)

3/52# (5.8%)

4/54# (7.4%)

19/163# (11.7%)

1 sided P = 0.003

0/57 (0.0%)

  1. δ's represent differences between mean levels in each group and the placebo group, adjusted for baseline GCS scores using ANCOVA. 95% CI's are non-parametric bias-corrected and accelerated bootstrap confidence intervals (calculated using 2,000 replications).
  2. The statistical significance of differences between groups in 15-day mortality rates and numbers of patients with erythema at injection site classified as moderate, intense or very intense are obtained using Fisher's exact test.
  3. # denominator does not include individuals who were excluded from analyses
  4. * with deaths coded as GCS = 3 and DRS coded as 30
  5. ** includes data on one individual who withdrew consent except for HIREOS & DRS
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ISSN: 1745-6215