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 @ 2:22 AM
Ignite Modification Date:
2025-12-26 @ 12:54 AM
NCT ID:
NCT02453334
Description:
None
Frequency Threshold:
5
Time Frame:
1 year, 7 months
Study:
NCT02453334
Study Brief:
Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer®
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Injectafer | 2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer | 0 | None | 28 | 121 | 96 | 121 | View |
| Normal Saline | Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline | 0 | None | 22 | 118 | 95 | 118 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastrointestinal Disorders | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Disease progression | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| Malignant neoplasm progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | View |
| Respiratory, Thoracic and Mediastinal Disorders | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Blood And Lymphatic System Disorders | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (18.0) | View |
| Infections And Infestations | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Renal And Urinary Disorders | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (18.0) | View |
| Cardiac Disorders | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.0) | View |
| Hepatobiliary Disorders | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (18.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.0) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.0) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.0) | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (18.0) | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (18.0) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (18.0) | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.0) | View |
| Infections and Infestations | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | View |
| Respiratory, Thoracic and Mediastinal Disorders | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.0) | View |
| Vascular Disorders | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.0) | View |
| Malignant neoplasm progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | View |
| Neoplasm progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | View |
| Hepatobiliary Disorders | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (18.0) | View |