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 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 12:36 AM
NCT ID:
NCT04465760
Description:
None
Frequency Threshold:
5
Time Frame:
30 days post administration of the study drug.
Study:
NCT04465760
Study Brief:
Xisomab 3G3 for the Prevention of Catheter-Associated Thrombosis in Patients With Cancer Receiving Chemotherapy
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Supportive Care (Xisomab 3G3) | Patients receive xisomab 3G3 IV or via catheter within 48 hours of catheter placement. Patients then receive standard of care chemotherapy 2 days later. After approximately 2 weeks, patients undergo standard of care ultrasound for possible CAT. Xisomab 3G3: Given IV or via catheter | 0 | None | 0 | 9 | 9 | 9 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Vaginal yeast infection | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.0) | View |
| GI upset | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Access site pain | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Access site erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Peripheral neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Cold sensitivity | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Access site bruise | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Arm pain | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Gum bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| Rectal bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Paresthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Contact dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Deep Vein Thrombosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Jaw pain | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Eye floaters | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (4.0) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Postoperative pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| Non cardiac- chest pain | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Loss of appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Lower extremity edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Shoulder pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Joint pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Body Ache | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Muscle spasm | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Skin irritation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |