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: 2025-12-24 @ 3:29 PM
Ignite Modification Date: 2025-12-25 @ 1:44 PM
NCT ID: NCT00621192
Description: Any AE that occurred between the time informed consent was obtained and the initial dose of study, that was considered related to a protocol specified procedure, were reported. The Investigator was responsible for assessing relationship of AE to study medication using the following definitions:Not related, possibly, probably or definitely related.
Frequency Threshold: 5
Time Frame: Adverse Events (AEs) were recorded from the time of informed consent until 72 hours following the last dose of study drug for non-Serious Adverse Events (SAEs) and until 30 days after the last dose of study drug for SAEs.
Study: NCT00621192
Study Brief: Pharmacokinetic (PK) and Safety Study of Meropenem in Young Infants With Intra-abdominal Infections
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
1. GA <32 Wks; PNA<2 Wks Group 1: GA at birth below 32 weeks - PNA \< 2 weeks; None None 9 39 9 39 View
2. GA <32 Wks; PNA 91days ≥ 2Wks Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and \< 91 days None None 18 103 8 103 View
3. GA ≥ 32 Wks; PNA <2 Wks Group 3: GA at birth 32 weeks or older - PNA \< 2 weeks; None None 2 31 2 31 View
4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and \< 91 days. None None 5 27 3 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Congenital diaphragmatic Hernia SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 13.0 View
Patent Ductus Arteriosus SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 13.0 View
Retinopathy of Prematurity SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Colonic Stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Illeal Perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Intestinal Ischaemia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Intestinal Stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Necrotising Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Rectal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Abdominal Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Bacterial Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Fungal Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Meningitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Respiratory Synctial Virus Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Wound Dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Chest X-Ray Abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Subarachnoid Haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Apnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Pneumonia Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Pulmonary Haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Respiratory Arrest SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Respiratory Distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View