Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 3:53 AM
Ignite Modification Date: 2025-12-26 @ 2:42 AM
NCT ID: NCT00779402
Description: None
Frequency Threshold: 5
Time Frame: AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Study: NCT00779402
Study Brief: PROvenge Treatment and Early Cancer Treatment
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 Provenge Provenge: Biologic: autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of PAP, linked to GM-CSF 20 None 31 116 114 116 View
Control Control Control: Autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen 9 None 19 59 57 59 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
DISSEMINATED INTRAVASCULAR COAGULATION NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
EOSINOPHILIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
ACUTE CORONARY SYNDROME NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
ANGINA PECTORIS NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
ARTERIOSCLEROSIS CORONARY ARTERY NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
ATRIAL FIBRILLATION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
ATRIOVENTRICULAR BLOCK COMPLETE NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
CARDIAC FAILURE CHRONIC NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
CORONARY ARTERY DISEASE NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
MYOCARDIAL INFARCTION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
MYOCARDIAL ISCHAEMIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
SINUS TACHYCARDIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
COLITIS ULCERATIVE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
SMALL INTESTINAL OBSTRUCTION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
UPPER GASTROINTESTINAL HAEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
INFUSION RELATED REACTION NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
CHOLECYSTITIS ACUTE NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
ARTHRITIS BACTERIAL NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
CLOSTRIDIUM DIFFICILE COLITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
LUNG ABSCESS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
PNEUMONIA NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
PSEUDOMONAL SEPSIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
STAPHYLOCOCCAL BACTERAEMIA NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
STAPHYLOCOCCAL SEPSIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
CERVICAL VERTEBRAL FRACTURE NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
LOWER LIMB FRACTURE NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
SKIN LACERATION NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
DEHYDRATION NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
ARTHRALGIA NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
BACK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
INTERVERTEBRAL DISC PROTRUSION NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
LUMBAR SPINAL STENOSIS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
OSTEOARTHRITIS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MUSCULOSKELETAL PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
ANAPLASTIC THYROID CANCER NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
BLADDER CANCER NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
CHRONIC MYELOMONOCYTIC LEUKAEMIA NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
METASTASES TO SPINE NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
METASTATIC NEOPLASM NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
NEUROENDOCRINE CARCINOMA OF THE SKIN NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
OESOPHAGEAL CARCINOMA NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
PANCREATIC CARCINOMA NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
RECTAL CANCER NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
CEREBRAL INFARCTION NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
CEREBROVASCULAR ACCIDENT NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
INTRACRANIAL ANEURYSM NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
SPINAL CORD COMPRESSION NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
SYNCOPE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
TRANSIENT ISCHAEMIC ATTACK NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
BLADDER OBSTRUCTION NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
RENAL ARTERY STENOSIS NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
URINARY RETENTION NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
CHEST PAIN NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
PULMONARY EMBOLISM NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
ANGIOEDEMA NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
PRURITUS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
DEEP VEIN THROMBOSIS NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
HYPERTENSIVE CRISIS NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
JUGULAR VEIN THROMBOSIS NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
SUBDURAL HAEMATOMA NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ANAEMIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
LYMPHADENOPATHY NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
DIARRHOEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
CONSTIPATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
GASTROOESOPHAGEAL REFLUX DISEASE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ABDOMINAL PAIN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
FATIGUE NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
CHILLS NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
PYREXIA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INFLUENZA LIKE ILLNESS NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
PAIN NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
ASTHENIA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
OEDEMA PERIPHERAL NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
UPPER RESPIRATORY TRACT INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
NASOPHARYNGITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
URINARY TRACT INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
SINUSITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
BRONCHITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
HERPES ZOSTER NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
CONTUSION NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
CITRATE TOXICITY NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
WEIGHT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
ALANINE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
HYPERCHOLESTEROLAEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
BACK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
ARTHRALGIA NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MYALGIA NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MUSCULOSKELETAL PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MUSCLE SPASMS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
NECK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
OSTEOARTHRITIS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
PAIN IN EXTREMITY NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MUSCULAR WEAKNESS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MUSCULOSKELETAL CHEST PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
TENDONITIS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
SPINAL OSTEOARTHRITIS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
BASAL CELL CARCINOMA NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
PARAESTHESIA ORAL NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
HEADACHE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
PARAESTHESIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
DIZZINESS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
HYPOAESTHESIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
TREMOR NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
DEPRESSION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
INSOMNIA NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
ANXIETY NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
SLEEP DISORDER NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
HAEMATURIA NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
DYSURIA NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
RENAL CYST NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
URINARY INCONTINENCE NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
LIBIDO DECREASED NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
GYNAECOMASTIA NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
COUGH NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
DYSPNOEA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
NASAL CONGESTION NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
DYSPNOEA EXERTIONAL NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
HYPERHIDROSIS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
RASH NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
NIGHT SWEATS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
HOT FLUSH NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
HYPERTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
HYPOTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
SINUS BRADYCARDIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
MALAISE NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
PROCEDURAL PAIN NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
WEIGHT INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
ASPARTATE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
BREAST TENDERNESS NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
ERECTILE DYSFUNCTION NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
NOCTURIA NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
AMNESIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
DYSPEPSIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
BONE PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
GROIN PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View