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Table 3 Variables collected in step 2 for trials that were randomized or explicitly labeled as pivotal

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

Trial characteristics (for any trial identified in step 2)

 Trial name reference

(Character string)

Reference trial name.

 Trial name 1

(Character string)

Alternative trial name 1.

 Trial name 2

(Character string)

Alternative trial name 2.

 Pivotal

“Yes”; “No”

Trial eligibility criteria: the trial is described as “pivotal” (or similar).

 Randomized

“Yes”; “No”; “Single-arm”

Trial eligibility criteria: patients are randomly assigned to treatment arms.

 On-label

“Yes”; “No”; “Partially”; “Not reported”

Trial eligibility criteria: the drug of interest is tested in the approved indication.

 Comparator

“Yes”; “No”; “Partially”; “Not reported”

Trial eligibility criteria: the control intervention does not contain the active component of the drug under review.

 Relevance

“Yes”; “No”

Trial eligibility criteria: two reviewers consider that this trial was definitely used for approval, but none of the abovementioned eligibility criteria are met.

 Eligible rationale

“explicitly pivotal”; “likely pivotal”; “other pivotal”; “not eligible”

The rationale for trial eligibility based on eligibility algorithm.