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 @ 6:59 PM
Ignite Modification Date:
2025-12-25 @ 4:32 PM
NCT ID:
NCT00049257
Description:
Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Frequency Threshold:
5
Time Frame:
Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately
Study:
NCT00049257
Study Brief:
Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Carboplatin, Paclitaxel | Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter. | None | None | 14 | 58 | 58 | None | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Deep Verin Thrombosis with Pulmonary Embolism | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v2.0 | View |
| Paresthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v2.0 | View |
| Subarachnoid Hemorrhage | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v2.0 | View |
| Angina | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v2.0 | View |
| Urinary retention with acute hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v2.0 | View |
| Death secondary to cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v2.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v2.0 | View |
| Anaphylaxix | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE v2.0 | View |
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v2.0 | View |
| Hyperglycemia and diabetic management | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v2.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v2.0 | View |
| back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v2.0 | View |
| Gall stones | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v2.0 | View |
| spinal injury; inability to walk or stand ultimately caused death | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v2.0 | View |
| Muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v2.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v2.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v2.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v2.0 | View |
| Edema, limb | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v2.0 | View |
| constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v2.0 | View |
| pain, extremity-lower | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v2.0 | View |
| Pain, Not otherwise specified | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v2.0 | View |
| mood alteration-depression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v2.0 | View |
| vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v2.0 | View |
| taste alteration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v2.0 | View |
| dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v2.0 | View |
| hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v2.0 | View |
| hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v2.0 | View |
| hemorrhage pulmonary- nose | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v2.0 | View |
| pain, head | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v2.0 | View |
| neuropathy-motor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v2.0 | View |
| dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v2.0 | View |
| fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v2.0 | View |
| infection-upper airway not otherwise specified | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v2.0 | View |
| rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v2.0 | View |
| pain, back | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v2.0 | View |
| pain, muscle | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v2.0 | View |
| pain, shoulder | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v2.0 | View |
| urinary frequency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v2.0 | View |
| cold symptoms | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v2.0 | View |
| cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v2.0 | View |
| infection- urinary tract not otherwise specified | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v2.0 | View |
| mood alteration- anxiety | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v2.0 | View |
| allergic rhinitis | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE v2.0 | View |
| congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v2.0 | View |
| pain, abdomen | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v2.0 | View |
| sweating | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v2.0 | View |
| allergic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE v2.0 | View |
| ALT, elevated | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v2.0 | View |
| dehydration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v2.0 | View |
| hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v2.0 | View |
| hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v2.0 | View |
| hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v2.0 | View |
| pain, chest- non-cardiac | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v2.0 | View |
| sore throat | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v2.0 | View |
| pruritis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v2.0 | View |
| weight loss | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v2.0 | View |
| alkaline phosphatase, elevated | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v2.0 | View |
| AST, elevated | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v2.0 | View |
| blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v2.0 | View |
| dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v2.0 | View |
| hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v2.0 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v2.0 | View |
| cachexia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v2.0 | View |
| pain-urination | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v2.0 | View |
| flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v2.0 | View |
| flu-like syndrome | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v2.0 | View |
| gastroenteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v2.0 | View |
| hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v2.0 | View |
| hyperphosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v2.0 | View |
| hypomagnesia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v2.0 | View |
| hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v2.0 | View |
| mucositis-oral cavity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v2.0 | View |
| Muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v2.0 | View |
| nail changes | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v2.0 | View |
| pain, bone | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v2.0 | View |
| pain, neck | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v2.0 | View |
| rigors/chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v2.0 | View |
| voice changes | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v2.0 | View |
| dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v2.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v2.0 | View |
| anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v2.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v2.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v2.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v2.0 | View |
| Neuropathy-sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v2.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v2.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v2.0 | View |