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Table 5 Comparison of 15 harms criteria (CONSORT-harms extension used as a benchmark)

From: Reporting of harms outcomes: a comparison of journal publications with unpublished clinical study reports of orlistat trials

   Trial ID
Criteria Description of item NM16189 M37013 M37002 M37047 BM15421
Methods criteria 1 List addressed adverse events (AEs) with definitions. CSR CSR CSR CSR CSR
2 Mode of collecting harms data. BOTH b BOTH b BOTH b CSR BOTH a
3 Timing and time frame of surveillance for adverse events. BOTH b Pub CSR NR BOTH a
4 Attribution methods. CSR NR CSR NR NR
5 Intensity of ascertainment. CSR BOTH b CSR CSR CSR
6 Harms related monitoring. CSR BOTH b CSR CSR CSR
7 Coding of AEs. CSR CSR BOTH a CSR CSR
8 Handling of recurrent events. NR CSR NR CSR NR
9 Timing issues. CSR CSR CSR NR CSR
10 Plans to perform any statistical analyses and inferences. CSR BOTH a BOTH a BOTH a BOTH a
Total items satisfied for methods criteria in clinical study report (CSR) (% of total 10 items assessed) 9 (90) 8 (80) 9 (90) 7 (70) 8 (80)
Total items satisfied for methods criteria in publication (% of total ten items assessed) 2 (20) 5 (50) 3 (30) 1 (10) 3 (30)
Results criteria 11 Withdrawals and discontinuations. BOTH a BOTH a BOTH a BOTH a CSR
12 Denominators for analyses on harms. BOTH b BOTH b BOTH a CSR BOTH b
13 Specifying AE type. BOTH a BOTH a BOTH a BOTH a BOTH a
14 Grading or scaling used. NR BOTH a BOTH a BOTH a BOTH a
15 Seriousness per arm. BOTH a BOTH a BOTH a BOTH a BOTH a
Total items satisfied for results criteria in the CSR (% of total five items assessed) 4 (80) 5 (100) 5 (100) 5 (100) 5 (100)
Total items satisfied for results criteria in the publication (% of total five items assessed) 4 (80) 5 (100) 5 (100) 4 (80) 4 (80)
Total items satisfied in CSR (% of total 15 items assessed) 13 (87) 13 (87) 14 (93) 12 (80) 13 (87)
Total items satisfied in publication (% of total 15 items assessed) 6 (40) 10 (67) 8 (53) 5 (33) 7 (47)
  1. Footnote:
  2. BOTH ‘reported in CSR and the corresponding journal publication’, CSR ‘only reported within the CSR’, Pub ‘only reported in journal publication’, NR ‘neither reported in the CSR or journals publication’. Completeness of data where agreement (BOTH) is made coded as: a ‘More complete in CSR’; b ‘Similar quality for both documents’; - ‘less complete in the CSR’