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 @ 4:29 AM
Ignite Modification Date: 2025-12-26 @ 3:32 AM
NCT ID: NCT00319020
Description: None
Frequency Threshold: 5
Time Frame: From the first administration of study treatment and for an average of 31 months for frequent adverse events (up to 1 day after study treatment discontinuation), and for an average of 32 months (up to 28 days after study treatment discontinuation) for serious adverse events
Study: NCT00319020
Study Brief: Bosentan in Children With Pulmonary Arterial Hypertension Extension Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Patients With Previous Bosentan Patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan during FUTURE 1 / FUTURE 2 None None 9 15 12 15 View
Bosentan_naive Patients Patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan during FUTURE 1 / FUTURE 2 None None 9 21 16 21 View
Single Arm Bosentan_Total All patients included in Future 1 / FUTURE 2 whether they received bosentan or not bosentan before enrollment in FUTURE 1 None None 18 36 26 36 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ADENOIDECTOMY SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
ARTERIAL CATHETERISATION SYSTEMATIC_ASSESSMENT Investigations MedDRA View
AUTOIMMUNE HEPATITIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
BACTERAEMIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
BALLOON ATRIAL SEPTOSTOMY SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
BRONCHIAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
BRONCHITIS VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
CARDIAC FAILURE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
CATHETER SITE INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
CATHETERISATION CARDIAC SYSTEMATIC_ASSESSMENT Investigations MedDRA View
CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA View
CONVULSION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
DEVICE RELATED INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
DIAPHRAGMATIC HERNIA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
DYSTONIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
EAR INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA View
FLANK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
HAEMOGLOBIN DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
INJECTION SITE NODULE SYSTEMATIC_ASSESSMENT General disorders MedDRA View
IRON DEFICIENCY ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
LOBAR PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
LUNG INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
MEDICAL DEVICE COMPLICATION SYSTEMATIC_ASSESSMENT General disorders MedDRA View
PERICARDIAL EFFUSION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
PNEUMONIA VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
PULMONARY ARTERIAL HYPERTENSION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
PULMONARY ARTERIAL PRESSURE SYSTEMATIC_ASSESSMENT Investigations MedDRA View
PULMONARY HYPERTENSION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
PULMONARY VEIN STENOSIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
RESPIRATORY FAILURE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
RIGHT VENTRICULAR FAILURE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
SYSTEMIC-PULMONARY ARTERY SHUNT SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
VIRAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
VIRAL RHINITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
WHEEZING SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ADVERSE DRUG REACTION SYSTEMATIC_ASSESSMENT General disorders MedDRA View
AGGRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
CYANOSIS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
EAR PAIN SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
ENURESIS SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
EPISTAXIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA View
FLUSHING SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
H1N1 INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
NASAL CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
OTITIS MEDIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
PALPITATIONS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
PULMONARY ARTERIAL HYPERTENSION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
PULMONARY HYPERTENSION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
TONSILLITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
VIRAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ALLERGY TO PLANTS SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
CATHETER SITE PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ECZEMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
GASTROINTESTINAL VIRAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
MUSCULOSKELETAL PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
NIPPLE SWELLING SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
OROPHARYNGEAL PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
PERTUSSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
PHOTOPHOBIA SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
TOOTH DISCOLOURATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
VISION BLURRED SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
PHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View