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 @ 4:41 PM
Ignite Modification Date:
2025-12-25 @ 2:29 PM
NCT ID:
NCT00085566
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00085566
Study Brief:
Everolimus and Gefitinib in Treating Patients With Progressive Glioblastoma Multiforme or Progressive Metastatic Prostate 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 |
|---|---|---|---|---|---|---|---|---|
| RAD 001 30 mg | 30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer | None | None | 0 | 3 | 2 | 3 | View |
| RAD 001 50 mg | 50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer | None | None | 1 | 3 | 3 | 3 | View |
| RAD 001 70 mg | 70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer | None | None | 18 | 57 | 48 | 57 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Confusion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-3.0 | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-3.0 | View |
| Hydrocephalus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-3.0 | View |
| Vision-blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTC-3.0 | View |
| ALT, SGPT | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-3.0 | View |
| Cardiac General, other | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTC-3.0 | View |
| Creatinine | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Death not associated w CTCAE term-Disease progression NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTC-3.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | General disorders | CTC-3.0 | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | View |
| Extremity-lower (gait/walking) | SYSTEMATIC_ASSESSMENT | General disorders | CTC-3.0 | View |
| Fatigue (asthenia, lethargy, malaise) | SYSTEMATIC_ASSESSMENT | General disorders | CTC-3.0 | View |
| Hemorrhage, Peritoneal cavity | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-3.0 | View |
| Incontinence, urinary | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTC-3.0 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTC-3.0 | View |
| Infection, other | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTC-3.0 | View |
| Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-3.0 | View |
| Mood alteration - Agitation | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-3.0 | View |
| Muscle weakness - Extremity-lower | SYSTEMATIC_ASSESSMENT | General disorders | CTC-3.0 | View |
| Neurology - Other | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-3.0 | View |
| Pain - Head/headache | SYSTEMATIC_ASSESSMENT | General disorders | CTC-3.0 | View |
| Pulmonary/upper respiratory - Other | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTC-3.0 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-3.0 | View |
| Thrombosis/embolism (vascular access-related) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | View |
| Thrombosis/thrombus/embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | View |
| Urinary retention (including neurogenic bladder) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTC-3.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-3.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-3.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Albumin, low (hypoalbuminemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| ALT, SGPT | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| AST, SGOT | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Calcium, low (hypocalcemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Cholesterol, high (hypercholestremia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Creatinine | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTC-3.0 | View |
| Edema: limb | SYSTEMATIC_ASSESSMENT | General disorders | CTC-3.0 | View |
| Fatigue (asthenia, lethargy, malaise) | SYSTEMATIC_ASSESSMENT | General disorders | CTC-3.0 | View |
| Glucose, high (hyperglycemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-3.0 | View |
| Prothrombin Time and International Normalized Ratio | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-3.0 | View |
| Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-3.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-3.0 | View |
| Mucositis (Clincal exam)- Oral cavity | SYSTEMATIC_ASSESSMENT | General disorders | CTC-3.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-3.0 | View |
| Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-3.0 | View |
| Phosphate, low (hypophosphatemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-3.0 | View |
| Partial Thromboplastin Time (PTT) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-3.0 | View |
| Rash: acne/acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTC-3.0 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-3.0 | View |
| Sodium, low (hyponatremia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Neuropathy: sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-3.0 | View |
| Pain - Bone | SYSTEMATIC_ASSESSMENT | General disorders | CTC-3.0 | View |
| Pruritus/itching | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTC-3.0 | View |
| Extremity-lower (gait/walking) | SYSTEMATIC_ASSESSMENT | General disorders | CTC-3.0 | View |