Summary of Changes
Patient documents have been updated.
Changes include:
- Dinutuximab beta has been added as a new trial question, in 2 additional randomisation arms.
- Number of patients to be recruited has been increased from 160 to 224.
- 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]