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 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
NCT ID:
NCT01011933
Description:
None
Frequency Threshold:
5
Time Frame:
Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Study:
NCT01011933
Study Brief:
Selumetinib in Treating Patients With Recurrent or Persistent Endometrial 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 |
|---|---|---|---|---|---|---|---|---|
| Treatment (Selumetinib) | Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies. | None | None | 32 | 50 | 38 | 50 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dysphagia | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Mucositis (Functional/Sympt) - Oral Cavity | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Obstruction, Gi - Small Bowel Nos | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dehydration | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Constipation | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hemorrhage, Gi - Rectum | None | Vascular disorders | CTCAE (3.0) | View |
| Liver Dysfunction | None | Hepatobiliary disorders | CTCAE (3.0) | View |
| Inf Unknown Anc: Skin (Cellulitis) | None | Infections and infestations | CTCAE (3.0) | View |
| Edema: Limb | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Dizziness | None | Nervous system disorders | CTCAE (3.0) | View |
| Neuropathy-Sensory | None | Nervous system disorders | CTCAE (3.0) | View |
| Ocular/Visual - Other | None | Eye disorders | CTCAE (3.0) | View |
| Pain: Chest /Thorax Nos | None | General disorders | CTCAE (3.0) | View |
| Pain: Abdominal Pain Nos | None | General disorders | CTCAE (3.0) | View |
| Dyspnea | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Obstruction, Gu - Ureter | None | Renal and urinary disorders | CTCAE (3.0) | View |
| Vaginitis | None | Reproductive system and breast disorders | CTCAE (3.0) | View |
| Thrombosis/Thrombus/Embolism | None | Vascular disorders | CTCAE (3.0) | View |
| Leukocytes | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Hemoglobin | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| S/N Arrhythmia: Atrial Fibrillation | None | Cardiac disorders | CTCAE (3.0) | View |
| Hypotension | None | Cardiac disorders | CTCAE (3.0) | View |
| Death No Ctcae Term - Disease Progression Nos | None | General disorders | CTCAE (3.0) | View |
| Death No Ctcae Term - Death Nos | None | General disorders | CTCAE (3.0) | View |
| Rash | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Hyponatremia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neutrophils | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Platelets | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Leukocytes | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Hemoglobin | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Hypotension | None | Cardiac disorders | CTCAE (3.0) | View |
| Ptt | None | Vascular disorders | CTCAE (3.0) | View |
| Weight Gain | None | General disorders | CTCAE (3.0) | View |
| Fever | None | General disorders | CTCAE (3.0) | View |
| Rigors/Chills | None | General disorders | CTCAE (3.0) | View |
| Fatigue | None | General disorders | CTCAE (3.0) | View |
| Insomnia | None | General disorders | CTCAE (3.0) | View |
| Acne | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Rash | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Dry Skin | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Pruritus | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Flatulence | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Heartburn | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Taste Alteration | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dry Mouth | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Mucositis (Clinical Exam) - Oral Cavity | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Vomiting | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Anorexia | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Constipation | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Nausea | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Diarrhea | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hemorrhage/Pulmonary - Nose | None | Vascular disorders | CTCAE (3.0) | View |
| Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos | None | Infections and infestations | CTCAE (3.0) | View |
| Edema: Trunk/Genital | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Edema: Limb | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Edema: Head And Neck | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Ast | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Creatinine | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypoalbuminemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Alt | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Alkaline Phosphatase | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypophosphatemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hyponatremia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypocalcemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hyperkalemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hyperglycemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypokalemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypoglycemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypomagnesemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Mood Alteration - Depression | None | Nervous system disorders | CTCAE (3.0) | View |
| Mood Alteration - Anxiety | None | Nervous system disorders | CTCAE (3.0) | View |
| Dizziness | None | Nervous system disorders | CTCAE (3.0) | View |
| Neuropathy-Sensory | None | Nervous system disorders | CTCAE (3.0) | View |
| Blurred Vision | None | Eye disorders | CTCAE (3.0) | View |
| Pain: Extremity-Limb | None | General disorders | CTCAE (3.0) | View |
| Pain: Back | None | General disorders | CTCAE (3.0) | View |
| Pain: Joint | None | General disorders | CTCAE (3.0) | View |
| Pain: Abdominal Pain Nos | None | General disorders | CTCAE (3.0) | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Dyspnea | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Thrombosis/Thrombus/Embolism | None | Vascular disorders | CTCAE (3.0) | View |