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:
EG004
Title:
Placebo for Cohorts 2 and 3
Description:
Cohorts 2 \& 3:
Placebo comparator in each cohort is identical in appearance to the investigational product, containing the same excipients as the active comparator.
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).
Placebo: Each cohort will use placebo 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:
0
Serious Number At Risk:
12
Other Number Affected:
11
Other Number At Risk:
12
Study:
NCT03789318
Results Section:
NCT03789318
Adverse Events Module:
NCT03789318