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 @ 3:55 PM
Ignite Modification Date:
2025-12-25 @ 2:00 PM
NCT ID:
NCT02395692
Description:
None
Frequency Threshold:
0
Time Frame:
Day 1 and 30 days after the last dose of the study drug
Study:
NCT02395692
Study Brief:
Methoxyamine and Temozolomide in Treating Patients With Recurrent Glioblastoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Treatment (Methoxyamine, Temozolomide) | Patients receive methoxyamine PO QD and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Methoxyamine: Given PO Temozolomide: Given PO | 9 | None | 0 | 19 | 18 | 19 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Alanine Aminotransferase 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 |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Dysphasia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 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 |
| Anal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Cholesterol high | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Cognitive disturbance | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Cushingoid | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (4.0) | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Generalized muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| INCREASED BOWEL MOVEMENTS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| COLON POLYP | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Muscle weakness left-sided | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Musculoskeletal and connective tissue disorder - Other | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Myositis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Nervous system disorders - Other, EXTREMELY HOT SENSATION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Nervous system disorders - Other, Vasogenic Edema | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Skin and subcutaneous tissue disorders - Other, SORE IN GROIN AREA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Weight Gain | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Investigations - Other, TRIGLYCERIDES HIGH | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Urine discoloration | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |