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 @ 5:42 PM
Ignite Modification Date:
2025-12-25 @ 3:11 PM
NCT ID:
NCT01083368
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse event data was collected while participants were on study up to 3 1/2 years.
Study:
NCT01083368
Study Brief:
Temsirolimus and Bevacizumab in Hormone-Resistant Metastatic Prostate Cancer That Did Not Respond to Chemotherapy
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Dose Level 1 | Patients receive temsirolimus IV over 30-60 minutes once weekly and bevacizumab IV over 30-90 minutes once every two weeks . Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. temsirolimus: Given IV bevacizumab: Given IV polymorphism analysis: Correlative studies laboratory biomarker analysis: Correlative studies | 1 | None | 1 | 4 | 4 | 4 | View |
| Dose Level 2 | Patients receive temsirolimus IV over 30-60 minutes once weekly and bevacizumab IV over 30-90 minutes once every two weeks . Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. temsirolimus: Given IV bevacizumab: Given IV polymorphism analysis: Correlative studies | 7 | None | 7 | 20 | 20 | 20 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Confusion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Fatigue (asthenia, lethargy, malaise) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Hemoglobin | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Hemorrhage, pulmonary/upper respiratory - Nose | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) - Lung (pneumonia) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Muscle weakness, generalized or specific area (not due to neuropathy) - Pelvic | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Pain - Back | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Extremity-limb | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Pelvis | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Vision-blurred vision | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Weight loss | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Albumin, serum-low (hypoalbuminemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Alkaline phosphatase | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Allergic reaction/hypersensitivity (including drug fever) | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (3.0) | View |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (3.0) | View |
| ALT, SGPT (serum glutamic pyruvic transaminase) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Bicarbonate, serum-low | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Bruising (in absence of Grade 3 or 4 thrombocytopenia) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (3.0) | View |
| Calcium, serum-low (hypocalcemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Conduction abnormality/atrioventricular heart block - Asystole | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Constitutional Symptoms - Cold intolerance | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Constitutional Symptoms - Change of mental sttatus | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Creatinine | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dental: periodontal disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dermatology/Skin - hyperpigmentation-hands | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Dry mouth/salivary gland (xerostomia) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Dysphagia (difficulty swallowing) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dyspnea (shortness of breath) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Edema: limb | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Edema: trunk/genital | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Fatigue (asthenia, lethargy, malaise) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Febrile neutropenia (ANC <1.0 x 10e9/L, fever >=38.5 degrees C) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Fistula, GI - Oral cavity | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Fistula, GI - Stomach | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Gastrointestinal - early satiety | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| rectal fissure | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Heartburn/dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hemoglobin | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Hemorrhage, GI - Rectum | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hemorrhage, GI - Upper GI NOS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hemorrhage, GU - Bladder | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Hemorrhage, pulmonary/upper respiratory - Nose | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Hemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hot flashes/flushes | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (3.0) | View |
| Hyperpigmentation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Incontinence, anal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Incontinence, urinary | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Sinus | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Magnesium, serum-high (hypermagnesemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Mood alteration - Agitation | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Mood alteration - Anxiety | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Mood alteration - Depression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Mucositis/stomatitis (clinical exam) - Oral cavity | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Mucositis/stomatitis (functional/symptomatic) - Anus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Mucositis/stomatitis (functional/symptomatic) - Esophagus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Mucositis/stomatitis (functional/symptomatic) - Oral cavity | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Mucositis/stomatitis (functional/symptomatic) - Rectum | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Muscle weakness, generalized or specific area (not due to neuropathy) - Extraocular | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Muscle weakness, generalized or specific area (not due to neuropathy) - Ocular | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Neurology - decreased motivation | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Neuropathy: sensory | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Neutrophils/granulocytes (ANC/AGC) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Opportunistic infection associated with >=Grade 2 Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Pain - Abdomen NOS | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Anus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Pain - Back | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Bone | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Buttock | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Chest wall | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Chest/thorax NOS | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Extremity-limb | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Head/headache | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Joint | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Diffuse pain;back,shoulders,hips,legs,ribs | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - L and R thigh | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Pelvis | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Peritoneum | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Pleura | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Throat/pharynx/larynx | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Urethra | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Phosphate, serum-low (hypophosphatemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Platelets | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Potassium, serum-high (hyperkalemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Potassium, serum-low (hypokalemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Pruritus/itching | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Rash/desquamation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Rash: acne/acneiform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Sodium, serum-low (hyponatremia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Sweating (diaphoresis) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Taste alteration (dysgeusia) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Triglyceride, serum-high (hypertriglyceridemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Ulceration | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Urinary frequency/urgency | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Urinary retention (including neurogenic bladder) | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Watery eye (epiphora, tearing) | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| Weight loss | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Rigors/chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Sodium, serum-high (hypernatremia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Cholesterol, serum-high (hypercholesteremia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Glucose, serum-high (hyperglycemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Glucose, serum-low (hypoglycemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hair loss/alopecia (scalp or body) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| INR (International Normalized Ratio of prothrombin time) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Joint-function | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Leukocytes (total WBC) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Musculoskeletal/Soft Tissue -muscle aches in legs | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Nail changes | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Nasal cavity/paranasal sinus reactions | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Pain - Muscle | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Neck | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Oral cavity | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |