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Table 1 Characteristics of the random sample of 300 phase III or IV trials with at least one serious adverse event (SAE) posted at ClinicalTrials.gov for which publications were sought

From: Comparison of serious adverse events posted at ClinicalTrials.gov and published in corresponding journal articles

Characteristic

Sample of trials with at least one SAE posted at ClinicalTrials.gov

Sample of trials with corresponding published article

(n = 300)

(n = 202)

Study phase

 III

234 (78)

168 (83)

 IV

66 (22)

34 (17)

Study design

 Parallel groups

287 (95)

197 (97)

 Cross-over

9 (3)

5 (3)

 Factorial

2 (1)

0 (0)

 Other

2 (1)

0 (0)

No. of intervention groups

 Two

233 (78)

169 (88)

 Three

60 (20)

33 (12)

 Other

7 (2)

0 (0)

Primary funding source

 Industry

264 (88)

178 (88)

 US National Institutes of Health

8 (3)

7 (3)

 US federal funding

1 (0)

1 (1)

 Other

27 (9)

16 (8)

Medical condition

 Endocrinology

41 (14)

32 (16)

 Infectious diseases

38 (13)

22 (11)

 Cardiology

31 (10)

18 (9)

 Neurology

29 (10)

23 (11)

 Oncology

29 (10)

23 (11)

 Rheumatology

22 (7)

13 (7)

 Pulmonary

20 (6)

15 (7)

 Other

90 (30)

56 (28)

Study location

 At least one site in the United States

205 (68)

140 (69)

 No site in the United States

95 (32)

62 (31)

Type of journal

 Specialty

 

165 (82)

 General

 

37 (18)

ClinicalTrials.gov NCT reported in article

 Yes

 

162 (80)

 No

 

40 (20)

  1. Data are no. (%)