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Table 2 Characteristics of included trials

From: Reporting of harms in oncological clinical study reports submitted to the European Medicines Agency compared to trial registries and publications—a methodological review

Clinical development phase

N (%)

 Phase II

12 (29)

 Phase II/III

4 (10)

 Phase III

26 (61)

Blinding

N (%)

 Open label

22 (52)

 Double blind

20 (48)

Primary outcome

N (%)

 Progression-free survival

27 (64)

 Overall survival

8 (19)

 Progression-free survival and overall survival

3 (7)

 Other

4 (7)

Superiority design

40 (95%)

 

Median (IQR)

Number of participants randomised

364 (142–666)

Number of centres

99 (42–142)

  1. IQR interquartile range