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 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
NCT ID:
NCT00429793
Description:
None
Frequency Threshold:
5
Time Frame:
All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Study:
NCT00429793
Study Brief:
Temsirolimus in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal 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 (Temsirolimus) | Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. | None | None | 5 | 54 | 44 | 54 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Insomnia | None | General disorders | CTCAE (3.0) | View |
| Death No Ctcae Term - Disease Progression Nos | None | General disorders | CTCAE (3.0) | View |
| Ileus | 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 |
| Creatinine | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hyponatremia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Memory Impairment | None | Nervous system disorders | CTCAE (3.0) | View |
| Pain: Head/Headache | None | General disorders | CTCAE (3.0) | View |
| Pain: Abdominal Pain Nos | None | General disorders | CTCAE (3.0) | View |
| Pulmonary: Other | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Pulmonary Fibrosis | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Pneumonitis | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Dyspnea | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Obstruction, Gu - Bladder | None | Renal and urinary disorders | CTCAE (3.0) | View |
| Thrombosis/Thrombus/Embolism | None | Vascular disorders | CTCAE (3.0) | View |
| Fatigue | None | General disorders | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Tinnitus | None | Ear and labyrinth disorders | CTCAE (3.0) | 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 |
| Fibrinogen | None | Vascular disorders | CTCAE (3.0) | View |
| Ptt | None | Vascular disorders | CTCAE (3.0) | View |
| Fever | None | General disorders | CTCAE (3.0) | View |
| Weight Loss | 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 |
| Hair Loss/Alopecia (Scalp Or Body) | None | Skin and subcutaneous tissue 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 |
| Taste Alteration | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Mucositis (Functional/Sympt) - Oral Cavity | 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: Limb | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Ast | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Cholesterol,serum High | 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 |
| Bilirubin | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypermagnesemia | 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 |
| Hypertriglyceridemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypocalcemia | 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 |
| 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 - Other | None | General disorders | CTCAE (3.0) | View |
| Pain: Chest /Thorax Nos | None | General disorders | CTCAE (3.0) | View |
| Pain: Head/Headache | None | General 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 |
| Pain: Muscle | None | General disorders | CTCAE (3.0) | View |
| Nasal/Paranasal Reactions | None | Respiratory, thoracic and mediastinal 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 |
| Urinary Frequency | None | Renal and urinary disorders | CTCAE (3.0) | View |
| Heartburn | 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 |
| Dehydration | 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 |
| Dysphagia | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hot Flashes | None | Endocrine disorders | CTCAE (3.0) | View |