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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:47 PM
NCT ID:
NCT00026494
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00026494
Study Brief:
Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 15mg/m2 - Vinorelbine | Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases | None | None | 4 | 7 | 7 | 7 | View |
| 20mg/m2 - Vinorelbine | Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases | None | None | 4 | 4 | 4 | 4 | View |
| 25mg/m2 - Vinorelbine | Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases | None | None | 8 | 22 | 19 | 22 | View |
| 30mg/m2 - Vinorelbine | Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases | None | None | 9 | 16 | 16 | 16 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-2.0 | View |
| Leukocytes | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-2.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Speech Impair | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-2.0 | View |
| CNS hemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-2.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTC-2.0 | View |
| Hemoglobin (Hgb) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-2.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Neutrophils | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Supravent arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTC-2.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-2.0 | View |
| Mood alteration-depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTC-2.0 | View |
| Muscle weakness | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Neurology, other | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-2.0 | View |
| Neuropathy-motor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-2.0 | View |
| Constitut symptoms, other | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Infection without neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTC-2.0 | View |
| Syndromes, other | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain/cramping | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Arthralgia (joint pain) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTC-2.0 | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-2.0 | View |
| Bicarbonate | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Bilirubin | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Blood,Bone marrow,other | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| CNS hemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-2.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-2.0 | View |
| Creatinine | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Dermatology, skin other | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTC-2.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-2.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Hearing, other | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Hemoglobin (Hgb) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hypermagnesmia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Incontinence | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Infection without neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTC-2.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Leukocytes | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Mood alteration-depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTC-2.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Neurology, other | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-2.0 | View |
| Neuropathy-motor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-2.0 | View |
| Neuropathy-sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-2.0 | View |
| Neutrophils | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Ocular-Vision other | SYSTEMATIC_ASSESSMENT | Eye disorders | CTC-2.0 | View |
| Pain, other | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Pelvic pain | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Prothrombin time (PT) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Partial thromboplastin time (PTT) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Rash, desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTC-2.0 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-2.0 | View |
| SGOT (AST) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| SGPT (ALT) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Vision-blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTC-2.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-2.0 | View |