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. 2007 Jun 7;8:16. doi: 10.1186/1745-6215-8-16

Table 1.

Suggested data collection form completed with data extracted from the report of the example trial in bladder cancer [6]

Trial Reference: BA06 (Chemotherapy) (No chemotherapy)
Randomisation ratio (e.g. 1:1) 1 1
Patients randomised 491 485
Patients analysed 491 485
Observed events 229 256
Logrank expected events Not reported Not reported
Hazard ratio, confidence interval (& level e.g. 95%) 0.85, CI 0.71 to1.02 (95%)
Logrank variance Not reported
Logrank observed minus-expected events Not reported
Hazard ratio and confidence interval (& level e.g. 95%) or standard error or variance from adjusted or unadjusted Cox Not reported
Test statistic, 2-sided p-value to 2 significant figures (& test used e.g. logrank, Mantel-Haenzsel or Cox) Not reported, 0.075 (logrank)
Advantage to research or control? Research
Actuarial or Kaplan Meier curves reported? Yes, Kaplan Meier
Numbers at risk reported Yes
Follow-up details Min = 14 months, Max = 82 months (Estimated from recruitment of 69 months, 11/9 – 7/95 and median follow-up of 48 months)