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 @ 2:44 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
NCT ID:
NCT02475733
Group ID:
EG000
Title:
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole
Description:
Participants with Creatinine clearance(CrCL) \>=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(\<)18 years: 2000 mg CAZ/500 mg AVI (body weight \>=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight \<40 kg), 2) Age 6 months to \<6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to \<6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
5
Serious Number At Risk:
61
Other Number Affected:
14
Other Number At Risk:
61
Study:
NCT02475733
Results Section:
NCT02475733
Adverse Events Module:
NCT02475733