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 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
NCT ID:
NCT03789318
Group ID:
EG000
Title:
CA-008 5 mg (0.05 mg/mL) Cohort 1
Description:
Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
CA-008 5 mg: 5 mg CA-008 reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
2
Serious Number At Risk:
9
Other Number Affected:
9
Other Number At Risk:
9
Study:
NCT03789318
Results Section:
NCT03789318
Adverse Events Module:
NCT03789318