Substantial Amendment 11/12 (NSA04)

Summary of Changes

Patient documents have been updated.

Changes include:

  1. Dinutuximab beta has been added as a new trial question, in 2 additional randomisation arms.
  2. Number of patients to be recruited has been increased from 160 to 224.
  3. Patient Information Sheet and Parent Information Sheet have been amended following the addition of dinutuximab beta.
  • SA-12 Notification of a Substantial Amendment [.pdf]
  • SA-12 MHRA Approval [.pdf]
  • SA-12 MHRA Cover letter [.pdf]
  • SA-11 REC Approval  [.pdf]
  • SA-11 REC Cover letter  [.pdf]
  • SA11 NSA-04 HRA approval [.pdf]