Reporting and Analysis Plan - ECHO Analyses From Randomized Controlled Trials of Dabrafenib to Evaluate the Potential for Cardiac Valve Abnormalities (201709)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• 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:
  Subjects treated with dabrafenib, either as monotherapy or in combination with other anti-cancer therapies on randomized controlled clinical trials
• 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 fully describe the results of the independently reviewed ECHO data of subjects treated with dabrafenib.
• Data analysis plan:
  All analyses of the independently reviewed ECHO data will use the Safety population (SAFETY), 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 treatment arm (e.g. dabrafenib monotherapy, dabrafenib plus trametinib, DTIC). 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 IntegratedData 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.