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Table 1 Concordance of result information between ClinicalTrials.gov and corresponding publications for phase III trials published in high-impact journals between January 1, 2016, and June 30, 2017

From: Consistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA

Result informationb,c

Trials reporting results in both sources, no. (%)

Result information in both sources

Concordant, no. (%)

Discordant, no. (%)

Cannot be compared, no. (%)

Cohort characteristics

 Completion rate

94 (100)

69 (73)

22 (23)

3 (3)

 Age distribution

93 (99)

70 (75)

20 (22)

3 (3)

 Sex distribution

89 (95)

67 (75)

19 (21)

3 (3)

 Race/ethnicity distribution

35 (37)

23 (66)

12 (34)

0

Trial intervention

94 (100)

83 (88)

11 (12)

0

Primary efficacy endpointa

94 (100)

70 (74)

20 (21)

4 (4)

Serious adverse events

93 (99)

41 (44)

24 (26)

28 (30)

  1. aTotal number of primary efficacy endpoints reported on ClinicalTrials.gov = 128 compared to publications = 112
  2. bTotal percentage of trials with at least one discrepancy across all categories = 87%
  3. cTotal percentage of trials with at least one discrepancy across all categories excluding race = 74%