Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 2:44 AM
Ignite Modification Date: 2025-12-26 @ 1:23 AM
NCT ID: NCT02475733
Description: Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Frequency Threshold: 5
Time Frame: Baseline until the LFU visit (up to a maximum study duration of 50 days)
Study: NCT02475733
Study Brief: Evaluation of Safety,Pharmacokinetics and Efficacy of CAZ-AVI With Metronidazole in Children Aged 3 Months to 18 Years Old With Complicated Intra-abdominal Infections (cIAIs).
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole 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. 0 None 5 61 14 61 View
Meropenem Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion. 0 None 1 22 6 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Large intestine perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Postoperative ileus NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Renal colic NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
Urethral meatus stenosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Infusion site phlebitis NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View