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 @ 5:17 PM
Ignite Modification Date: 2025-12-25 @ 2:54 PM
NCT ID: NCT05049850
Description: None
Frequency Threshold: 0
Time Frame: AEs were collected on the AE CRF for each patient, from the time of signing of the informed consent and throughout the trial including the follow-up period. 35 Days in screening phase plus 181 Days in trial, a total of 216 Days.
Study: NCT05049850
Study Brief: A Study to Investigate DSA Rebound in Patients Treated With Imlifidase Prior to Transplantation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Imlifidase Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.) 0 None 2 3 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 26.0 View
Post procedural discharge NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 26.0 View
Wound evisceration NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 26.0 View
Donor specific antibody present NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 26.0 View
International normalised ratio increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 26.0 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 26.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 26.0 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 26.0 View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 26.0 View
Small intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 26.0 View
Abdominal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 26.0 View
Delayed graft function NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 26.0 View
Infusion related reaction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 26.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 26.0 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 26.0 View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 26.0 View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 26.0 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 26.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 26.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 26.0 View
Renal infarct NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 26.0 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 26.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 26.0 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 26.0 View