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 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
NCT ID:
NCT00550732
Description:
The Safety Population included all enrolled participants who received at least one dose of study medication.
Frequency Threshold:
5
Time Frame:
Up to 12 months
Study:
NCT00550732
Study Brief:
A Study to Examine the Efficacy and Safety of Posaconazole When Introduced Early in the Treatment of Refractory Fungal Infections (P05090 AM2)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Posaconazole | Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month. | None | None | 16 | 40 | 35 | 40 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | Version 12.1 | View |
| Cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | Version 12.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Version 12.1 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | Version 12.1 | View |
| Generalised oedema | SYSTEMATIC_ASSESSMENT | General disorders | Version 12.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | Version 12.1 | View |
| Bronchopneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | Version 12.1 | View |
| Device related sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | Version 12.1 | View |
| Ludwig angina | SYSTEMATIC_ASSESSMENT | Infections and infestations | Version 12.1 | View |
| Lung infection pseudomonal | SYSTEMATIC_ASSESSMENT | Infections and infestations | Version 12.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | Version 12.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | Version 12.1 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | Version 12.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | Version 12.1 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | Version 12.1 | View |
| Streptococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | Version 12.1 | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Version 12.1 | View |
| Liver function test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | Version 12.1 | View |
| Oxygen saturation decreased | SYSTEMATIC_ASSESSMENT | Investigations | Version 12.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | Version 12.1 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | Version 12.1 | View |
| Colon cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Version 12.1 | View |
| Neurotoxicity | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Version 12.1 | View |
| Renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | Version 12.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Version 12.1 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Version 12.1 | View |
| Pulmonary cavitation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Version 12.1 | View |
| Pulmonary haemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Version 12.1 | View |
| Respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Version 12.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Petechiae | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | Version 12.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | Version 12.1 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | Version 12.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Version 12.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Version 12.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Version 12.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Version 12.1 | View |
| Oral pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Version 12.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Version 12.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | Version 12.1 | View |
| Disease progression | SYSTEMATIC_ASSESSMENT | General disorders | Version 12.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | Version 12.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | Version 12.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | Version 12.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | Version 12.1 | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | Version 12.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | Version 12.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | Version 12.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | Version 12.1 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | Version 12.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Version 12.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Version 12.1 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Version 12.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | Version 12.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Version 12.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Version 12.1 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Version 12.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Version 12.1 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Version 12.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | Version 12.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | Version 12.1 | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | Version 12.1 | View |