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Table 1 Discrepancies in the reporting of AEs from AR trials between ClinicalTrials.gov and corresponding publications

From: Reporting of the safety from allergic rhinitis trials registered on ClinicalTrials.gov and in publications: An observational study

 

SAEs n (%)

OAEs n (%)

Deaths n (%)

 

Reporting rate

ClinicalTrials.gov

45 (100.0)

45 (100.0)

14 (100.0)a

Publications

34 (75.6)

44 (97.8)

6 (42.9)

P value b

< 0.001

0.317

0.001

 

AEs reported as zero

ClinicalTrials.gov

24 (53.3)

12 (26.7)

12 (85.7)

Publications

18 (40.0)

5 (11.1)

5 (35.7)

P value c

0.001

< 0.001

0.014

 

Number of reported AEs per trial (range)

ClinicalTrials.gov

0–28

0–10,648

0–1

Publications

0–15

0–2,769

0–1

P value b

0.003

< 0.001

0.127

 

Number of patients with AEs per trial (range)

ClinicalTrials.gov

0–23

0–1,031

0–1

Publications

0–11

0–1,215

0–1

P value b

0.006

< 0.001

0.127

 

Reported AEs per trial (median, 95% CI)

ClinicalTrials.gov

0 (95% CI 0.87–4.51)

21 (95% CI -60.86–1000.59)

0 (95% CI -0.07–0.35)

Publications

0 (95% CI 0.30–2.01)

77.5 (95% CI 57.78–338.31)

0 (95% CI -0.05–0.14)

 

Number of patients with AEs per trial (median, 95% CI)

ClinicalTrials.gov

0 (95% CI 0.78–3.88)

18 (95% CI 26.39–150.59)

0 (95% CI -0.07–0.35)

Publications

0 (95% CI 0.28–1.72)

59 (95% CI 54.75–188.73)

0 (95% CI -0.05–0.14)

  1. Abbreviations: SAE – Serious Adverse Event, OAE – Other Adverse Event, CI – Confidence interval
  2. aSum of 6 pre-Rule trials and 9 post-Rule trials that had reported deaths
  3. bInconsistencies in reporting assessed by the Mann-Whitney Test with a significance set at P < .05
  4. cInconsistencies in reporting assessed by the Chi-square test with a significance set at P < .05