Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
NCT ID:
NCT04456920
Group ID:
EG000
Title:
Experimental Group 1
Description:
PRO (Patient Reported Outcomes) gathered via a phone consultation
phone consultation: At D1, D2 and D3, patients in the experimental group 1 will receive a call from a neuro-psychologist during which pain, anxiety and esthetical biopsy impact will be assessed using numeric or visual analog scales during a semi-direct interview. During this call, any adverse events related to the breast biopsy and concomitant treatment taken will be collected. If detected, pain or significative distress would be specifically managed.
phone consultation: At D4 post biopsy, patients will receive a phone call from a neuro-psychologist to assess pain, anxiety and esthetical impact, using numeric scales, and to collect adverse events. If detected, pain or significative distress would be specifically managed.
And at D10 (+/- 2 days), all patients will physically come to the Cancer center in the consultation of biopsy results announcement. At the beginning of this consultation, pain, anxiety and esthetical impact will be assessed using numeric scales. . The adverse events related to the breast biopsy and concomitant treatment taken will be collected. Insomnia will be evaluated by the Insomnia Severity Index. If detected, pain or significative distress would be managed as usually in the center.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
63
Other Number Affected:
44
Other Number At Risk:
63
Study:
NCT04456920
Results Section:
NCT04456920
Adverse Events Module:
NCT04456920