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 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:41 PM
NCT ID:
NCT00108069
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00108069
Study Brief:
Tamoxifen and Bortezomib to Treat Recurrent Brain Tumors
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| GBM (Glioblastoma Multiforme) | Bortezomib : intravenous (IV) injection 1.3 mg/m\^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle Tamoxifen citrate : oral dose 120 mg twice a day, every day | None | None | 11 | 30 | 26 | 30 | View |
| AG (Anaplastic Glioma) | Bortezomib : intravenous (IV) injection 1.3 mg/m\^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle Tamoxifen citrate : oral dose 120 mg twice a day, every day | None | None | 3 | 12 | 10 | 12 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Death not associated with CTCAE term: Death NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTCv3.0 | View |
| Death not associated with CTCAE term: Disease progression NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTCv3.0 | View |
| Fatigue (asthenia, lethargy, malaise) | SYSTEMATIC_ASSESSMENT | General disorders | CTCv3.0 | View |
| Infection - Other (Specify, infection w/unknown ANC) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv3.0 | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv3.0 | View |
| Neuropathy: motor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv3.0 | View |
| Pain: head/headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv3.0 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv3.0 | View |
| Somnolence/depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv3.0 | View |
| Speech impairment (e.g., dysphagia or aphasia) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv3.0 | View |
| Vascular - Other (Specify-deep vein thrombosis) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCv3.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv3.0 | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv3.0 | View |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC<1.0 x 10e9/L) | SYSTEMATIC_ASSESSMENT | General disorders | CTCv3.0 | View |
| Muscle weakness, genralized or specific area (not due to neuropathy): Right-sided | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv3.0 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv3.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Death not associated with CTCAE term: Disease progression NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTCv3.0 | View |
| ALT, SGPT (serum glutamic pyruvic transaminase) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Albumin, serum-low (hypoalbuminemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv3.0 | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv3.0 | View |
| Blood/Bone Marrow - Other (Specify, elevated white blood count;) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv3.0 | View |
| Calcium, serum-low (hypocalcemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Cognitive disturbance | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv3.0 | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv3.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv3.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv3.0 | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv3.0 | View |
| Edema: limb | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv3.0 | View |
| Extremity - lower (gait-walking) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv3.0 | View |
| Fatigue (asthenia, lethargy, malaise) | SYSTEMATIC_ASSESSMENT | General disorders | CTCv3.0 | View |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC<1.0 x 10e9/L) | SYSTEMATIC_ASSESSMENT | General disorders | CTCv3.0 | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv3.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv3.0 | View |
| Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv3.0 | View |
| Lymphatics - Other (Specify) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv3.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv3.0 | View |
| Magnesium, serum-high (hypermagnesemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv3.0 | View |
| Mood alteration: depression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv3.0 | View |
| Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv3.0 | View |
| Muscle weakness, generalized or specific area (not due to neuropathy): Facial | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv3.0 | View |
| Muscle weakness, generalized or specific area (not due to neuropathy): Left-sided | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv3.0 | View |
| Muscle weakness, generalized or specific area (not due to neuropathy): Right-sided | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv3.0 | View |
| Muscle weakness, generalized or specific area (not due to neuropathy): Whole-body/generalized | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv3.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv3.0 | View |
| Neuropathy: motor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv3.0 | View |
| Neuropathy: sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv3.0 | View |
| Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv3.0 | View |
| Nystagmus | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCv3.0 | View |
| Ocular/Visual - Other (Specify, horizontal diplopia) | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCv3.0 | View |
| Pain - Other (Specify, L side - hip and rib) | SYSTEMATIC_ASSESSMENT | General disorders | CTCv3.0 | View |
| Pain: Back | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv3.0 | View |
| Pain: head/headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv3.0 | View |
| Phosphate, serum-low (hypophosphatemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv3.0 | View |
| Potassium, serum-high (hyperkalemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv3.0 | View |
| Sodium, serum-low (hyponatremia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Somnolence/depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv3.0 | View |
| Speech impairment (e.g., dysphagia or aphasia) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv3.0 | View |
| Vision-flashing lights/floaters | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCv3.0 | View |
| Weight gain | SYSTEMATIC_ASSESSMENT | General disorders | CTCv3.0 | View |
| Bicarbonate, serum-low | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Bilirubin (hyperbilirubinemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Calcium, serum-high (hypercalcemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Constitutional symptoms - Other (Specify, fatigue) | SYSTEMATIC_ASSESSMENT | General disorders | CTCv3.0 | View |
| Creatinine | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Hemorrhage: GI: Rectum | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv3.0 | View |
| Glucose, serum-high (hyperglycemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv3.0 | View |
| Osteoporosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv3.0 | View |
| Urinary frequency/urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCv3.0 | View |
| AST, SGOT (serum glutamic oxaloacetic transaminase) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Sodium, serum-high (hypernatremia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv3.0 | View |
| Vision-blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCv3.0 | View |