Adverse Events Module

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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 @ 12:20 AM
Ignite Modification Date: 2025-12-25 @ 10:23 PM
NCT ID: NCT01706458
Description: None
Frequency Threshold: 0
Time Frame: Overall, patients were followed for a mean of 24 months.
Study: NCT01706458
Study Brief: Provenge With or Without pTVG-HP DNA Booster Vaccine in 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
Sipuleucel-T With DNA Vaccine Patients receive sipuleucel-T as patients in arm I and pTVG-HP plasmid DNA vaccine ID on weeks 6, 8, 10, and 12, and then at 6 and 9 months. sipuleucel-T: Given IV DNA Vaccine: Given ID 8 None 2 9 9 9 View
Sipuleucel-T Patients receive sipuleucel-T IV on weeks 0, 2, and 4. sipuleucel-T: Given IV 5 None 1 9 9 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications NCI CTCAE v3 View
Surgical and medical procedures - Other, specify SYSTEMATIC_ASSESSMENT Surgical and medical procedures NCI CTCAE v3 View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTCAE v3 View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI CTCAE v3 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications NCI CTCAE v3 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v3 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v3 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v3 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v3 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v3 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v3 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v3 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v3 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v3 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v3 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v3 View
Heahache SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3 View
Vasovagal reaction SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI CTCAE v3 View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI CTCAE v3 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders NCI CTCAE v3 View
Testicular pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders NCI CTCAE v3 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v3 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v3 View
Postnasal drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v3 View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v3 View
Skin and subcutaneous tissue disorders - Other, specify SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v3 View
Surgical and medical procedures - Other, specify SYSTEMATIC_ASSESSMENT Surgical and medical procedures NCI CTCAE v3 View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTCAE v3 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTCAE v3 View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTCAE v3 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v3 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3 View
Gastrointestinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3 View
Chills SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3 View
Pain SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v3 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v3 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications NCI CTCAE v3 View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications NCI CTCAE v3 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v3 View
Fever SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3 View
Localized edema SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3 View
Malaise SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3 View