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 @ 3:53 PM
Ignite Modification Date:
2025-12-25 @ 1:58 PM
NCT ID:
NCT00423592
Description:
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
Frequency Threshold:
5
Time Frame:
Baseline to Week 189
Study:
NCT00423592
Study Brief:
Phase 2 Study of Ambrisentan for Liver Function Test Rescue in Pulmonary Arterial Hypertension
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Ambrisentan | All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg). | None | None | 17 | 36 | 36 | 36 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 8.0 | View |
| microcytic anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (8.0) | View |
| acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| atrial tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| right ventricular failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| gastrointestinal arteriovenous malformation | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (8.0) | View |
| diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| infusion site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| catheter site cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| central line infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| lobar pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| pneumococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| staphylococcal bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| blood potassium increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.0) | View |
| dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.0) | View |
| hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.0) | View |
| hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.0) | View |
| breast cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | View |
| dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| dizziness postural | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.0) | View |
| azotaemia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (8.0) | View |
| chronic obstructive airways disease exacerbated | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| pulmonary hypertension | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (8.0) | View |
| lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (8.0) | View |
| atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| tricuspid valve incompetence | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (8.0) | View |
| conjunctival haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (8.0) | View |
| vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (8.0) | View |
| abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| infusion site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| drug hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (8.0) | View |
| bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| bronchitis acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| eye infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| infusion site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| localised infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| post procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| excercise capacity decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.0) | View |
| international normalised ratio increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.0) | View |
| weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.0) | View |
| dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.0) | View |
| fluid retention | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.0) | View |
| hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.0) | View |
| hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.0) | View |
| arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| pain in jaw | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| shoulder pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| dizziness postural | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.0) | View |
| depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.0) | View |
| insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.0) | View |
| cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| crackles lung | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| dyspnoea exacerbated | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| pharyngolaryngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| pleuritic pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| pulmonary hypertension | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| rales | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| pruritis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| rash macular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |