Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 3:35 PM
Ignite Modification Date: 2025-12-25 @ 1:47 PM
NCT ID: NCT00843492
Description: Serious adverse events (SAEs) and non-serious AEs were collected in members of the As-Treated Population, comprised of all participants having received at least one dose of study treatment.
Frequency Threshold: 1
Time Frame: None
Study: NCT00843492
Study Brief: A Study to Evaluate the Efficacy and Safety of Fondaparinux for the Prevention of Venous Blood Clots in Patients With a Plaster Cast or Other Type of Immobilization for a Below-knee Injury Not Needing Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Nadroparin 2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters \[ml\] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3) None None 9 670 95 670 View
Fondaparinux 2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3) None None 6 674 93 674 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendicitis None Infections and infestations None View
Haematoma infection None Infections and infestations None View
Subcutaneous abscess None Infections and infestations None View
Joint dislocation None Injury, poisoning and procedural complications None View
Ankle fracture None Injury, poisoning and procedural complications None View
Abdominal wall haematoma None Gastrointestinal disorders None View
Faecaloma None Gastrointestinal disorders None View
Fracture malunion None Musculoskeletal and connective tissue disorders None View
Haemarthrosis None Musculoskeletal and connective tissue disorders None View
Presyncope None Nervous system disorders None View
Transient ischaemic attack None Nervous system disorders None View
Angioedema None Skin and subcutaneous tissue disorders None View
Blister None Skin and subcutaneous tissue disorders None View
Cardiac failure None Cardiac disorders None View
Pyrexia None General disorders None View
Prostate cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Lymphadenopathy None Blood and lymphatic system disorders None View
Oedema peripheral None General disorders None View
Dizziness None Nervous system disorders None View
Hypertension None Vascular disorders None View
Pruritus None Skin and subcutaneous tissue disorders None View
Haematoma None Vascular disorders None View
Injection site haematoma None General disorders None View
Pain in extremity None Musculoskeletal and connective tissue disorders None View
Nausea None Gastrointestinal disorders None View
Headache None Nervous system disorders None View