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:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
NCT ID:
NCT01074216
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT01074216
Study Brief:
Vitamin D Levels in Stage IV Colorectal Cancer Patients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| All Patients | Stage IV colorectal cancer patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter. | None | None | 13 | 54 | 37 | 54 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| Allergic reaction | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-4.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTC-4.0 | View |
| Catheter related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTC-4.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTC-4.0 | View |
| Death NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-4.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-4.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-4.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTC-4.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| Generalized muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTC-4.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-4.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTC-4.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTC-4.0 | View |
| Infections and infestations | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTC-4.0 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTC-4.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-4.0 | View |
| Obstruction gastric | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-4.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTC-4.0 | View |
| Prostate infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTC-4.0 | View |
| Renal and urinary disorders | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTC-4.0 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-4.0 | View |
| Surgical and medical procedures - Other | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| Upper gastrointestinal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-4.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTC-4.0 | View |
| Urinary tract obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTC-4.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-4.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-4.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-4.0 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-4.0 | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-4.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-4.0 | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-4.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-4.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-4.0 | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-4.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTC-4.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-4.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-4.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-4.0 | View |
| Prothrombin ratio and international normalized ratio increased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-4.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-4.0 | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-4.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-4.0 | View |
| Surgical and medical procedures - Other | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-4.0 | View |