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 @ 2:54 PM
Ignite Modification Date:
2025-12-25 @ 1:19 PM
NCT ID:
NCT00823459
Description:
None
Frequency Threshold:
0
Time Frame:
Time of study start with first day of study dosing until patient is removed from protocol treatment up to 12 months of therapy
Study:
NCT00823459
Study Brief:
Everolimus in Treating Patients With Recurrent Low-Grade Glioma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Daily Intervention With RAD001 | RAD001 will be administered orally as once daily dose of 10 mg (two 5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Patients will be instructed to take RAD001 in the morning, at the same time each day. RAD001 may be taken with or without food. | 0 | None | 6 | 58 | 18 | 58 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Renal/Genitourinary | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Renal/Genitourinary | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| mucositis/stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| mucosititis/stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Dizzness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| mood alteration | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Mood Alteration | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Speech Impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (30) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| insomnia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Musculoskeletal/soft Tissue | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Leukocytes | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Increased ALT | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| hypertriglyceridemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypophosephatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypercholesteremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| ALT | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Neutrophils | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |