Variable | (Data type), data value or code | Description and further elaboration |
---|---|---|
Overall survival OR progression-free survival | ||
Is the endpoint reported | “Yes”; “No” | . |
Response criteria | (Character string) | Progression-free survival only: response criteria used to measure response to treatment |
Number of patients in arm 1 | (Integer) | Number of patients in arm 1 included in the endpoint analysis |
Number of patients in arm 2 | (Integer) | Number of patients in arm 2 included in the endpoint analysis |
Number of events in arm 1 | (Integer) | Number of patients with events in arm 1 included in the endpoint analysis |
Number of events in arm 2 | (Integer) | Number of patients with events in arm 2 included in the endpoint analysis |
Hazard ratio: coverage probability | (Float) | Confidence level (1-alpha) in the endpoint analysis |
Hazard ratio: point estimate | (Float) | Hazard ratio point estimate (selection rule: primary analysis according to the US Food and Drug Administration, but longest follow-up) |
Hazard ratio: lower confidence bound | (Float) | The lower bound of the confidence interval of the hazard ratio estimate |
Hazard ratio: upper confidence bound | (Float) | The upper bound of the confidence interval of the hazard ratio estimate |
Randomization ratio | “1:1”; “Not 1:1” | Randomization ratio, extracted for incomplete endpoint effects to derive appropriate statistics [25, 26] |
Regression P value | (Float) | Regression P value of the endpoint effect, extracted for incomplete endpoint effects to derive appropriate statistics [25, 26] |
Test type | “1-sided”; “2-sided”; “Not reported” | One- or two-sided P value, extracted for incomplete endpoint effects to derive appropriate statistics [25, 26] |
Hazard rate in arm 1 | (Float) | Hazard rate in arm 1, extracted for incomplete endpoint effects to derive appropriate statistics [25, 26] |
Hazard rate in arm 2 | (Float) | Hazard rate in arm 2, extracted for incomplete endpoint effects to derive appropriate statistics [25, 26] |
Logrank observed minus expected events in arm 1 | (Integer) | Logrank Observed minus Expected (O-E) events in arm 1 (endpoint analysis), extracted for incomplete endpoint effects to derive appropriate statistics [25, 26] |
Logrank observed minus expected events in arm 2 | (Integer) | Logrank Observed minus Expected (O-E) events in arm 2 (endpoint analysis), extracted for incomplete endpoint effects to derive appropriate statistics [25, 26] |
Logrank variance | (Float) | Logrank variance (endpoint analysis), extracted for incomplete endpoint effects to derive appropriate statistics [25, 26] |
Median survival time in arm 1: point estimate | (Float) | Median survival time (point estimate) in arm 1 |
Median survival time in arm 1: lower confidence bound | (Float) | The lower bound of the confidence interval of the median survival time in arm 1 |
Median survival time in arm 1: upper confidence bound | (Float) | The upper bound of the confidence interval of the median survival time in arm 1 |
Median survival time in arm 2 | (Float) | Median survival time (point estimate) in arm 2 |
Median survival time in arm 2: lower confidence bound | (Float) | Lower bound of the confidence interval of the median survival time in arm 2 |
Median survival time in arm 2: upper confidence bound | (Float) | Upper bound of the confidence interval of the median survival time in arm 2 |
Time unit | “Days”; “Weeks”; “Months”; “Years”; “Not reported” | Time unit used to measure median survival improvement |
Tumor response | ||
Is the endpoint reported | “Yes”; “No” | . |
Primary endpoint | “Yes”; “No” | Is the tumor response endpoint described as the primary endpoint of the trial |
Type of hypothesis tested | “Superiority”; “Not 1° endpoint”; “Non-inferiority” | Is the trial designed to demonstrate the superiority of the test drug over control in tumor response |
Response criteria | (Character) | Set of response criteria used to measure tumor response |
Number of patients in arm 1 | (Integer) | Number of patients in arm 1 included in the tumor response endpoint analysis |
Number of patients in arm 2 | (Integer) | Number of patients in arm 2 included in the tumor response endpoint analysis |
Number of events in arm 1 | (Integer) | Number of patients with events in arm 1 included in the tumor response endpoint analysis |
Number of events in arm 2 | (Integer) | Number of patients with events in arm 2 included in the tumor response endpoint analysis |