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. |