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Table 7 Reporting of Early Termination Parameters in Trials Terminated Early (n = 32)

From: A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials

Parameter Pediatric Journals (n = 18) General Journals (n = 14)
Motive(s) for termination*   
   Adequately reported 18 (100) 12 (86)
   Terminated for efficacy 3 (17) 3 (21)
   Terminated for harm 2 (11) 4 (29)
   Terminated for futility 3 (17) 4 (29)
   Other reasons reported (stand-alone or additional) 13 (72) 2 (14)
Rationale for termination (i.e. stopping guidelines/rules)   
   Reported 15 (73) 13 (93)
   Unclear or Not Reported 3 (17) 1 (7)
DMC role in early termination   
   Reported 3 (17) 12 (86)
   Unclear or Not Reported 15 (83) 2 (14)
Timing of early termination #   
   Reported 8 (44) 8 (57)
   Unclear or Not Reported 10 (56) 6 (43)
Adjustment of results for interim analysis (p value, CI or estimate)   
   Reported 2 (11) 8 (57)
   Unclear or Not Reported 16 (89) 6 (43)
Section of paper where reference to early termination was reported   
   Title/Abstract 4 (22) 5 (36)
   Methods 14 (78) 14 (100)
   Results 13 (72) 6 (43)
   Discussion 10 (56) 3 (21)
  1. N (%)
  2. †refers to trials with one or more arms terminated before planned
  3. *Does not equal 100%, as some reports/articles contained data in more than one category
  4. #reporting was considered adequate when it was clear that trial termination was determined by one of the interim analyses, and on which parameter the timing of this interim analysis was based