Likely cause of event: (Please tick all that apply) drug/treatment Standard treatment Progressive disease Concurrent medication Concurrent disorder Other Please specify: Relationship to Directly related Possibly related Not related Outcome: Fatal Life threatening Hospitalisation required/prolonged Permanent or significant disability/incapacity Other Please specify: Was this serious adverse event anticipated in the original study protocol? Yes No Was it described in the Participant Information Sheet? Yes No Do you believe this report raises any safety concerns for the participants enrolled in Yes No the study? Will be changes to the study as a result of this event e.g. Participant Information Yes No Sheet and Consent Form / Protocol etc.? If yes, must be submitted as an amendment ASAP Will you continue to recruit/study participants to this study? Yes No Has the relevant site RGO i.e. site where the participant was recruited, been notified Yes No of this SAE. Additional information: Name of Principal Investigator: Signature: Date:
Likely cause of event: (Please tick all that apply) drug/treatment Standard treatment Progressive disease Concurrent medication Concurrent disorder Other Please specify: Relationship to Directly related Possibly related Not related Outcome: Fatal Life threatening Hospitalisation required/prolonged Permanent or significant disability/incapacity Other Please specify: Was this serious adverse event anticipated in the original study protocol? Yes No Was it described in the Participant Information Sheet? Yes No Do you believe this report raises any safety concerns for the participants enrolled in the study? Yes No Will be changes to the study as a result of this event e.g. Participant Information Sheet and Consent Form / Protocol etc.? If yes, must be submitted as an amendment ASAP Yes No Will you continue to recruit/study participants to this study? Yes No Has the relevant site RGO i.e. site where the participant was recruited, been notified of this SAE. Yes No Additional information: Name of Principal Investigator: Signature: Date:
Initial-Serious-Adverse-Event-Form-V3-08062016.docx