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Table 5 Variables collected in step 3 for eligible randomized controlled trials retrieved on comparison level

From: The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs

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