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 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
NCT ID:
NCT01375569
Description:
None
Frequency Threshold:
0
Time Frame:
25 months, 15 days
Study:
NCT01375569
Study Brief:
TRC105 for Liver Cancer That Has Not Responded to Sorafenib
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| TRC105 in Liver Cancer | TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks. | 0 | None | 5 | 11 | 11 | 11 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Hepatic failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (4.0) | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Chest wall pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Edema limbs | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Eye disorders - Other, specify (eye itchiness and redness) | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (4.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Gallbladder infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Gingival pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Hemorrhoidal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypermagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Infections and infestations - Other, specify (oral thrush) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Oral hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Rectal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Sore throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Telangiectasia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Thromboembolic event | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Tumor pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | View |
| Vaginal hemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Activated partial thromboplastin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (4.0) | View |
| CPK increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Chest pain - cardiac | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Respiratory, thoracic and mediastinal disorders - Other, specify (hemoptysis) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Serum amylase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |