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 @ 12:05 AM
Ignite Modification Date: 2025-12-25 @ 10:04 PM
NCT ID: NCT03406858
Description: None
Frequency Threshold: 0
Time Frame: For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
Study: NCT03406858
Study Brief: Pembro and HER2Bi-Armed Activated T Cells in Treating Patients With Metastatic Castration Resistant 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
Treatment (Pembrolizumab, HER2Bi-armed Activated T Cells) Patients receive pembrolizumab IV over 30 minutes every 3 weeks. Treatment repeats every 3 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity. Beginning at least 1 week after pembrolizumab, patients receive HER2Bi-armed activated T cells IV over 5-15 minutes 2 times a week for 4 weeks in the absence of disease progression or unacceptable toxicity. HER2Bi-Armed Activated T Cells: Given IV Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV 9 None 7 14 14 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Immune system disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Generalized muscle weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Congenital, familial and genetic disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Allergic reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Allergic rhinitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cardiac disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cholesterol high NON_SYSTEMATIC_ASSESSMENT Investigations None View
Confusion NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
General disorders and administration site conditions - Other, specify NON_SYSTEMATIC_ASSESSMENT General disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hearing impaired NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Hoarseness NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hot flashes NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Memory impairment NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Musculoskeletal and connective tissue disorder - Other, specify NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pelvic pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Rash acneiform NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Renal and urinary disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory, thoracic and mediastinal disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Restlessness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sleep apnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sore throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Urinary frequency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vascular disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Edema limbs NON_SYSTEMATIC_ASSESSMENT General disorders None View
Infusion related reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Glucose intolerance NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Erectile dysfunction NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Urinary tract pain NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Generalized muscle weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View