Reporting and Analysis Plan - Evaluation of Secondary Malignancies in Patients Treated with Dabrafenib in Randomized, Controlled Trials (201710)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Meta-analysis
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Systematic review and meta-analysis

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DABRAFENIB
• Medical condition to be studied:
  Metastatic malignant melanoma

Population studied

• Short description of the study population:
  Metastatic malignant melanoma patients treated with Dabrafenib.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Metastatic malignant melanoma patients
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  The objective of this analysis is to describe more fully the secondary malignancy data from subjects treated with dabrafenib.
• Data analysis plan:
  All analyses will use the Safety population (SAFETY) for each study, which comprises all randomized subjects who received at least one dose of study medication and will be based on the actual treatment received if this differed from that to which the subject was randomized. All analyses will be presented by actual treatment arm (e.g. dabrafenib monotherapy,dabrafenib plus trametinib, DTIC). Comparisons will be made within each study, since the comparator arms differ in each of the randomized studies. All programming will be performed using SAS* version 9.1.3 or greater and S-Plus version 7.0 or higher in a UNIX† environment. All data analyses and tables, listings, and figures will use the formats in the Integrated Data Standards Library (IDSL), unless there is no standard for a particular analysis. Any non-standard data displays will follow the general format of the IDSL and Therapeutic Standards Team (TST) data displays to the extent possible.