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 @ 7:16 PM
Ignite Modification Date:
2025-12-25 @ 4:54 PM
NCT ID:
NCT00075803
Description:
None
Frequency Threshold:
0
Time Frame:
1 year
Study:
NCT00075803
Study Brief:
Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN 0101)
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardiovascular arrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Intracranial hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Cardiac arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Pulmoary embolus | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| troponin level grade 4 | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (12.0) | View |
| hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| Guillian-Barre syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| PTLD | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| acute renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.0) | View |
| confusion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (12.0) | View |
| Cholecystitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (12.0) | View |
| AV Block - third Degree | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Acute Mental Status Change | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.0) | View |
| Urinary Frequency/urgency | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.0) | View |
| Elevated Magnesium | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.0) | View |
| Deep Vein Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| Renal Cell Carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| Cerebrovascular Ischemia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Thrombotic Thrombocytopenic Purpura | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.0) | View |
| Sagittal Sinus Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Death at home, unexpected | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| Pain, Site Right Kidney | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Appendectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (12.0) | View |
| Photopsia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Psychosis | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.0) | View |
| Seizures | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| EKG Abnormality | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Arrythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| Left Ventricular Systolic Dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Renal Failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.0) | View |
| Hemorrhagic Cystitis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.0) | View |
| Hepatic Dysfunction | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (12.0) | View |
| Mucositis/Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Hemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| HUS/TTP/thrombotic microangiopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.0) | View |
| Vascular Leak Syndrome | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Allergic Reaction / Hypersensitivity | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| Rigors/Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Vomitting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Photopsia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Psychosis | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.0) | View |
| Seizures | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| EKG Abnormality | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Left Ventricular Systolic Dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Hemorrhagic Cystitis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.0) | View |
| Hepatic Dysfunction | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (12.0) | View |
| Liver Abnormality | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (12.0) | View |
| Mucositis/Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Allergic Reaction / Hypersensitivity | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| Rigors, chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |