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 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
NCT ID:
NCT00225420
Description:
None
Frequency Threshold:
0
Time Frame:
5 years
Study:
NCT00225420
Study Brief:
Docetaxel, Androgen Ablation, and External-Beam Radiation Therapy in Patients With High-Risk Localized 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 |
|---|---|---|---|---|---|---|---|---|
| Single Arm | Single Arm docetaxel: Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments. leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel. radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments. | 0 | None | 0 | 18 | 18 | 18 | View |
Serious Events(If Any):
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 | Investigations | CTCAE (3.0) | View |
| Allergic reaction/hypersensitivity (including drug fever) | 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 |
| Apnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Arthritis (non-septic) | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue 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 |
| Bladder spasms | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Blood/Bone Marrow - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Calcium, serum-high (hypercalcemia) | 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 |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Constitutional Symptoms (Other, specify) | NON_SYSTEMATIC_ASSESSMENT | General 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 |
| Cytokine release syndrome/acute infusion reaction | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (3.0) | View |
| Dermatology/Skin - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Distension/bloating, abdominal | 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 |
| Dyspnea (shortness of breath) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Edema: head and neck | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Edema: limb | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Erectile dysfunction | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (3.0) | View |
| Fatigue (asthenia, lethargy, malaise) | NON_SYSTEMATIC_ASSESSMENT | General disorders | 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 |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Flu-like syndrome | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Gastrointestinal - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Glucose, serum-high (hyperglycemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition 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 - Abdomen NOS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal 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 |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Incontinence, anal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Infection - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Leukocytes (total WBC) | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Libido | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (3.0) | View |
| Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Magnesium, serum-high (hypermagnesemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Mood alteration - Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Mood alteration - Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Musculoskeletal/Soft Tissue - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Neuropathy: sensory | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Neutrophils/granulocytes (ANC/AGC) | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Pain - Abdomen NOS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Pain - Back | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Bladder | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Pain - Chest/thorax NOS | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Pain - Head/headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Pain - Joint | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Neck | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Penis | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (3.0) | View |
| Pain - Rectum | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Pain - Stomach | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Phosphate, serum-low (hypophosphatemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Platelets | NON_SYSTEMATIC_ASSESSMENT | Investigations | 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 |
| Proctitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Pulmonary/Upper Respiratory - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Rash: acne/acneiform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Renal/Genitourinary - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Skin breakdown/decubitus ulcer | 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 |
| Supraventricular and nodal arrhythmia - Sinus tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Taste alteration (dysgeusia) | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Triglyceride, serum-high (hypertriglyceridemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Ulcer, GI - Anus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal 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 |
| Vasovagal episode | NON_SYSTEMATIC_ASSESSMENT | Nervous system 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 |
| Weight gain | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Bilirubin (hyperbilirubinemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |