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 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
NCT ID:
NCT01006369
Description:
None
Frequency Threshold:
5
Time Frame:
Adverse events were collected over a period of 128 days per patient.
Study:
NCT01006369
Study Brief:
Hydroxychloroquine, Capecitabine, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic Colorectal 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 |
|---|---|---|---|---|---|---|---|---|
| FOLFOX6 + Bevacizumab + Hydroxychloroquine | bevacizumab: Arm A: FOLFOX6 + Bevacizumab + Hydroxychloroquine: Bevacizumab will be administered intravenously 5 mg/kg in 100 cc Normal Saline every 14 days on day one Arm B: XELOX + Bevacizumab + Hydroxychloroquine: Bevacizumab will be administered intravenously 7.5 mg/kg in 100 cc Normal Saline every 21 days hydroxychloroquine: hydroxychloroquine 200 mg po BID daily | 11 | None | 4 | 13 | 13 | 13 | View |
| XELOX + Bevacizumab + Hydroxychloroquine | bevacizumab: Arm A: FOLFOX6 + Bevacizumab + Hydroxychloroquine: Bevacizumab will be administered intravenously 5 mg/kg in 100 cc Normal Saline every 14 days on day one Arm B: XELOX + Bevacizumab + Hydroxychloroquine: Bevacizumab will be administered intravenously 7.5 mg/kg in 100 cc Normal Saline every 21 days XELOX regimen: Capecitabine will be started at a dose of 1,000 mg/m2/day bid po (total daily dose = 2,000 mg/m2) for 14 days (28 doses) of the 21 day cycle. This cycle will be repeated every 21 days. Oxaliplatin will be started at a dose of 130 mg/m2, in 250 ml of D5W over 2 hours given day 1 of each cycle. This cycle will be repeated every 21 days. hydroxychloroquine: hydroxychloroquine 200 mg po BID daily | 14 | None | 12 | 25 | 25 | 25 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Allergic reaction/hypersensitivity | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Obstruction, GI - colon | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Gastrointestinal - other (specific) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Neuropathy: motor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Pain - chest wall | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Potassium, serum low | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Decreased hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hemolysis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Rash: hand-foot skin reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Mucositis/stomatitis - oral cavity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hemorrhage, pulmonary upper respiratory - nose | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Potassium, serum low (hypokalemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| ALT, SGPT | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| AST, SGOT | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Albumin, serum low | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Glucose, serum high | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Lipase | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Mood alteration - depression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Neurology - motor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Neuropathy - sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hiccups | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |