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 @ 6:58 PM
Ignite Modification Date:
2025-12-25 @ 4:31 PM
NCT ID:
NCT01414257
Description:
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold:
1.0
Time Frame:
None
Study:
NCT01414257
Study Brief:
Methotrexate (Rheumatrex) High Dose Special Investigation (Regulatory Post Marketing Commitment Plan)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Methotrexate | None | None | None | 69 | 2838 | 340 | 2838 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Liver disorder | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.1 | View |
| Skin ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Renal failure acute | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.1 | View |
| Cerebrovascular arteriovenous malformation | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 16.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Administration site reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Helicobacter test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| White blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Airway burns | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Lumbar vertebral fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Heat illness | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Tendon rupture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Hip arthroplasty | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.1 | View |
| Interstitial lung disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Pleurisy | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Pulmonary mass | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Gastric polyps | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Duodenal ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Gastric ulcer haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Large intestine polyp | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Enterocolitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Pneumonia mycoplasmal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Liver abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Bronchopneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Acute tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Tuberculous pleurisy | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Ear infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Pneumonia pneumococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Lung infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Lymphoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | View |
| Gastric cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | View |
| Lung neoplasm malignant | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | View |
| Colon cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | View |
| Lung adenocarcinoma recurrent | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | View |
| Breast cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | View |
| Bladder cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | View |
| Lymphadenopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.1 | View |
| Haemorrhagic anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.1 | View |
| Disseminated intravascular coagulation | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.1 | View |
| Pancytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.1 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.1 | View |
| Subarachnoid haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Cerebral haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 16.1 | View |
| Aortic valve incompetence | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Pneumocystis jirovecii pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Hepatic function abnormal | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.1 | View |
| Liver disorder | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.1 | View |
| White blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |