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: 2025-12-24 @ 9:11 PM
Ignite Modification Date: 2025-12-25 @ 7:01 PM
NCT ID: NCT00715104
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00715104
Study Brief: Sipuleucel-T as Neoadjuvant Treatment 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 Booster Subjects receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and then received an additional booster infusion 13 weeks after RP. None None 1 18 18 18 View
Sipuleucel-T Without Booster Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment. None None 4 16 14 16 View
Sipuleucel-T Without Randomization to Booster Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, and declined participation in the post-RP booster phase (received no further sipuleucel-T treatment). None None 1 8 8 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ARRHYTHMIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
RETINAL VEIN OCCLUSION SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
VISION BLURRED SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
INFUSION RELATED REACTION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
B-CELL LYMPHOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
CONFUSIONAL STATE SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
DISORIENTATION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
RESPIRATORY ARREST SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
LYMPHADENOPATHY SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
CARDIAC FLUTTER SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
PALPITATIONS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
CONJUNCTIVITIS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
EYE SWELLING SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
SCLERAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
VITREOUS DETACHMENT SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
VITREOUS HAEMORRHAGE SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
FOOD POISONING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
GASTROOESOPHAGEAL REFLUX DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
UMBILICAL HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA View
AXILLARY PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA View
CHILLS SYSTEMATIC_ASSESSMENT General disorders MedDRA View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA View
FEELING JITTERY SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INFLUENZA LIKE ILLNESS SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INFUSION SITE ERYTHEMA SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INFUSION SITE IRRITATION SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INFUSION SITE PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INJECTION SITE EXTRAVASATION SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INJECTION SITE PRURITUS SYSTEMATIC_ASSESSMENT General disorders MedDRA View
MALAISE SYSTEMATIC_ASSESSMENT General disorders MedDRA View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders MedDRA View
PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA View
THROMBOSIS IN DEVICE SYSTEMATIC_ASSESSMENT General disorders MedDRA View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
ORCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
SKIN INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
STAPHYLOCOCCAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
TOOTH INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
CITRATE TOXICITY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
EYE INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
GASTROENTERITIS RADIATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
JOINT INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
PERIORBITAL HAEMATOMA SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
TOOTH INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
ALANINE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
ASPARTATE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
BLOOD PRESSURE DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
HAEMATOCRIT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
HAEMOGLOBIN DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
WEIGHT INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
WHITE BLOOD CELL COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
DECREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPERKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPOGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
VITAMIN D DEFICIENCY SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
GROIN PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MUSCLE SPASMS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MUSCULAR WEAKNESS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MUSCULOSKELETAL PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
TENOSYNOVITIS STENOSANS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
HEPATIC NEOPLASM SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
LUNG NEOPLASM SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
MELANOCYTIC NAEVUS SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
SKIN PAPILLOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
DISTURBANCE IN ATTENTION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
HYPOAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
MIGRAINE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
PARAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
PARAESTHESIA ORAL SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
PERIPHERAL SENSORY NEUROPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
PRESYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
RADICULITIS LUMBOSACRAL SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
TREMOR SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
PERINEAL HAEMATOMA SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
ANXIETY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
LIBIDO DECREASED SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
CALCULUS BLADDER SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
DYSURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
NOCTURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
POLLAKIURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
URINARY INCONTINENCE SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
URINE ODOUR ABNORMAL SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
GYNAECOMASTIA SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
HAEMATOSPERMIA SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
PENILE PAIN SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
PERINEAL PAIN SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
TESTICULAR PAIN SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
DYSPHONIA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
DYSPNOEA EXERTIONAL SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
RESPIRATORY DISORDER SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
RHINORRHOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
SNORING SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
BLISTER SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
DERMATITIS CONTACT SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
HAIR GROWTH ABNORMAL SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
HYPERHIDROSIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
NIGHT SWEATS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
FLUSHING SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
HOT FLUSH SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
PHLEBITIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
HYPERLIPIDAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View