Table 4 Variables collected in step 2 for eligible trials only
Variable | (Data type), data value or code | Description and further elaboration |
|---|---|---|
Trial characteristics (for any trial deemed eligible in step 2) | ||
Randomization | “Yes”; “No” | Random allocation of patients to trial arms |
N arms | (Integer) | The number of trial arms. |
Other trial characteristics | “Parallel”; “Cross-over”; “Uncontrolled/historic control” | Patients are randomized to a concurrent control (“Parallel”) or to a sequence of treatments (“Cross-over”). |
Comparison characteristics | ||
Arm 1 | ||
Type | “Experimental”; “Active”; “Placebo”; “No treatment”; “Dose-comparison” | In add-on trials, comparators were categorized as “active” whenever an intervention given on top of an active treatment (for example, standard of care with or without placebo). Comparators were categorized as “No treatment” if “supportive therapy” or “usual care” was given which included a wide variety of treatments rather than a specific intervention. |
Characteristics | (Character string) | All interventions in arm 1, including drug names, doses, and route of administration. Interventions used to avoid treatment-related complications were not recorded, such as pre-treatment with acetaminophen/diphenhydramine to reduce infusion reactions with intravenous infusion of therapeutic biologics, or anti-emetics to reduce nausea and vomiting associated with certain chemotherapies. |
Arm 2 | ||
Type | “Active”; “Placebo”; “No treatment”; “Dose-comparison”; “Uncontrolled/historic control” | See “Arm 1” above. |
Characteristics | (Character string) | See “Arm 1” above. |