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 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
NCT ID:
NCT00514020
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00514020
Study Brief:
Fluorouracil, Oxaliplatin, and Leucovorin in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Oxaliplatin + Leucovorin + 5-Fluorouracil | Patients receive oxaliplatin IV over 2 hours, leucovorin calcium intravenously (IV) over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression. | None | None | 14 | 24 | 24 | 24 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| fever (in the absence of neutropenia, where neutropenia is defined as ANC < 1.0 x 10e9/L) | None | General disorders | None | View |
| nausea | None | Gastrointestinal disorders | None | View |
| obstruction, GU-ureter | None | Renal and urinary disorders | None | View |
| pain-abdomen NOS | None | Gastrointestinal disorders | None | View |
| urinary retention | None | Renal and urinary disorders | None | View |
| vomiting | None | Gastrointestinal disorders | None | View |
| INR (international normalized ratio of prothrombin) | None | Blood and lymphatic system disorders | None | View |
| ALT, SGPT (serum glutamic pyruvic transaminase) | None | Metabolism and nutrition disorders | None | View |
| death not associated with CTCAE-disease progression NOS | None | General disorders | None | View |
| infection with normal ANC or Grade 1 or 2 neutrophils-skin (cellulitis) | None | Skin and subcutaneous tissue disorders | None | View |
| supraventricular and nodal arrhythmia-atrial fibrillation | None | Cardiac disorders | None | View |
| AST, SGOT (serum glutamic oxaloacetic transaminase) | None | Metabolism and nutrition disorders | None | View |
| constipation | None | Gastrointestinal disorders | None | View |
| distension/bloating, abdominal | None | Gastrointestinal disorders | None | View |
| dysphagia | None | Gastrointestinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| diarrhea | None | Gastrointestinal disorders | None | View |
| dizziness | None | Nervous system disorders | None | View |
| glucose, serum-high-hyperglycemia | None | Metabolism and nutrition disorders | None | View |
| heartburn/dyspepsia | None | Gastrointestinal disorders | None | View |
| insomnia | None | Psychiatric disorders | None | View |
| nausea | None | Gastrointestinal disorders | None | View |
| Neutrophils/granulocytes (ANC/AGC) | None | Blood and lymphatic system disorders | None | View |
| pain-abdomen NOS | None | Gastrointestinal disorders | None | View |
| Pain-extremity-limb | None | Musculoskeletal and connective tissue disorders | None | View |
| platelets | None | Blood and lymphatic system disorders | None | View |
| potassium, serum-low (hypokalemia) | None | Metabolism and nutrition disorders | None | View |
| vision/blurred vision | None | Eye disorders | None | View |
| weight loss | None | Investigations | None | View |
| albumin, serum-low | None | Metabolism and nutrition disorders | None | View |
| anorexia | None | Metabolism and nutrition disorders | None | View |
| ascites (non-malignant) | None | Gastrointestinal disorders | None | View |
| AST, SGOT (serum glutamine oxaloacetic transminase) | None | Investigations | None | View |
| bilirubin (hyperbilirubinemia) | None | Hepatobiliary disorders | None | View |
| calcium, serum-low-hypocalcemia | None | Metabolism and nutrition disorders | None | View |
| constipation | None | Gastrointestinal disorders | None | View |
| creatine | None | Investigations | None | View |
| dermatology/skin-other | None | Skin and subcutaneous tissue disorders | None | View |
| distension/bloating, abdominal | None | Gastrointestinal disorders | None | View |
| dysphagia | None | Gastrointestinal disorders | None | View |
| edema-limb | None | Musculoskeletal and connective tissue disorders | None | View |
| fatigue | None | General disorders | None | View |
| hemoglobin | None | Investigations | None | View |
| leukocytes (total WBC) | None | Blood and lymphatic system disorders | None | View |
| lymphopenia | None | Blood and lymphatic system disorders | None | View |
| metabolic/laboratory-other | None | Investigations | None | View |
| mood alteration-anxiety | None | Psychiatric disorders | None | View |
| mood alteration-depression | None | Psychiatric disorders | None | View |
| mucositis/stomatitis (clinical exam)-oral cavity | None | Gastrointestinal disorders | None | View |
| Mucositis/stomatitis (functional/symptomatic)-oral cavity | None | Gastrointestinal disorders | None | View |
| neuropathy - sensory | None | Nervous system disorders | None | View |
| pain-other | None | General disorders | None | View |
| rash-hand-foot skin reaction | None | Skin and subcutaneous tissue disorders | None | View |
| sodium, serum-low (hyponatremia) | None | Metabolism and nutrition disorders | None | View |
| Taste alteration (dysgeusia) | None | Gastrointestinal disorders | None | View |
| vomiting | None | Gastrointestinal disorders | None | View |
| fever in the absence of neutropenia, where neutropenia is defined as ANC < 1.0 x 12e9/L | None | Infections and infestations | None | View |
| infection with normal ANC or Grade 1 or 2 neutrophils-abdomen NOS | None | Infections and infestations | None | View |
| alkaline phosphatase | None | Investigations | None | View |
| ALT/SGPT (serum glutamine pyruvic transminase) | None | Investigations | None | View |