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: 2025-12-26 @ 11:12 PM
Ignite Modification Date: 2025-12-26 @ 11:12 PM
NCT ID: NCT01825512
Description: None
Frequency Threshold: 4
Time Frame: through study completion, an average of 1 year for subject
Study: NCT01825512
Study Brief: Efficacy/Safety Study of Deferiprone Compared to Deferasirox in Paediatric Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Deferiprone 75-100 mg/kg/day seven days per week Deferiprone: Deferiprone 80 mg/mL oral solution 0 None 13 193 152 193 View
Deferasirox 20 to 40 mg/kg/day seven days per week Deferasirox: Deferasirox is used at the following dosage strengths: 125 mg, 250 mg and 500 mg 0 None 14 197 89 197 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
testicular injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications testicular injury View
splenectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures splenectomy View
agranulocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders agranulocytosis View
neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders neutropenia View
sickle cell anaemia with crisis subjects affected/exposed SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders sickle cell anaemia View
seizure SYSTEMATIC_ASSESSMENT Nervous system disorders seizure View
pyrexia SYSTEMATIC_ASSESSMENT General disorders pyrexia View
chest pain SYSTEMATIC_ASSESSMENT General disorders chest pain View
gait disturbance SYSTEMATIC_ASSESSMENT General disorders gait disturbance View
diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders diarrhoea View
hypertransaminasaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders hypertransaminasaemi View
acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders acute kidney injury View
pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders pain in extremity View
gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations gastroenteritis View
meningitis meningococcal SYSTEMATIC_ASSESSMENT Infections and infestations meningitis meningoco View
herpangina SYSTEMATIC_ASSESSMENT Infections and infestations herpangina View
pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations pneumonia View
subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations subcutaneous abscess View
urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations urinary tract infect View
herpes virus infection SYSTEMATIC_ASSESSMENT Infections and infestations herpes virus infecti View
impetigo SYSTEMATIC_ASSESSMENT Infections and infestations impetigo View
upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations upper respiratory tr View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders cough View
neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
abdominal pain SYSTEMATIC_ASSESSMENT General disorders None View
vomiting SYSTEMATIC_ASSESSMENT General disorders None View
arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View