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Table 4 Secondary endpoint discrepancies stratified by endpoints absent from the protocol and absent from the registry

From: Discrepancies in endpoints between clinical trial protocols and clinical trial registration in randomized trials in oncology

  Number of trials n = 71 (%) Secondary Endpoints absent from registry n = 36 (%) P value Secondary Endpoints absent from protocol n = 19 (%) P value
Trial Initiation Period
 1994–2005 30 (42) 15 (42) 0.9191 8 (42) 0.9878
 2006–2010 41 (58) 21 (58)   11 (58)  
Trial Result
 Negative 37 (52) 22 (61) 0.1237 10 (53) 0.9578
 Positive 34 (49) 14 (39)   9 (47)  
Funding Source
 Non-pharma 33 (46) 13 (36) 0.0757 8 (42) 0.6551
 Pharma 38 (54) 23 (64)   11 (58)  
Duration of Trial
 < 3 years 30 (42) 18 (50) 0.1802 9 (47) 0.5979
 ≥ 3 years 41 (58) 18 (50)   10 (53)  
Number of protocol non-primary endpointsa
 ≤ 6 36 (51) 15 (42) 0.1224 9 (47) 0.7340
 > 6 35 (49) 21 (58)   10 (53)  
Protocol Lengtha
 ≤ 34 pages 36 (51) 18 (50) 0.8292 8 (42) 0.0326
 > 34 pages 35 (49) 18 (50)   11 (58)  
Study Phaseb
 II 10 (14) 6 (17) 0.5993 3 (16) 0.3972
 III 57 (50) 29 (81)   14 (74)  
Study Intervention
 Systemic 53 (75) 30 (83) 0.0880 15 (79) 0.7624
 Non-systemic 18 (25) 6 (17)   4 (21)  
Protocol Type
 Full 60 (85) 31 (86) 0.7048 18 (95) 0.2670
 Appended 11 (15) 5 (14)   1 (5)  
  1. aDichotomized at the median
  2. b4 unspecified trials not included