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 @ 10:00 PM
Ignite Modification Date: 2025-12-25 @ 7:37 PM
NCT ID: NCT03493932
Description: None
Frequency Threshold: 1
Time Frame: 1 year
Study: NCT03493932
Study Brief: Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Recurrent Glioblastoma Patients Nivolumab: OPDIVO is a human programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. BMS-986016: Anti-Lymphocyte Activation Gene-3 antibody undergoing clinical evaluation by Bristol-Myers Squibb 13 None 13 13 1 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
White blood cell decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Elevated WBC count SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
ALC low SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Abnormal thyroid function tests SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Cushingoid SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Alkalosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Investigations - Other specify SYSTEMATIC_ASSESSMENT Investigations None View
GGT increased SYSTEMATIC_ASSESSMENT Investigations None View
CK increased SYSTEMATIC_ASSESSMENT Investigations None View
elevated total bilirubin SYSTEMATIC_ASSESSMENT Investigations None View
elevated AST SYSTEMATIC_ASSESSMENT Investigations None View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fecal incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorectal infection SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blurred Vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Li Fraumeni Syndrome SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound dehisence of biopsy site SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
extremity weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Glioblastoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Urinary Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
urinary urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
benign prostate hypertrophy SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Skin and subcutaneous tissue disorders - Other, specify - limited skin erythema only, asymptomatic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Petechial rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Macular rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Papular erythematous rash on upper extremities SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Folliculitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pityrosporum folliculitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
balance instability SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebral edema SYSTEMATIC_ASSESSMENT Nervous system disorders None View
change with cognition "fuzzy cognition SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Communicating hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Difficulty reading SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Drowsiness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dysphasia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Edema, cerebral SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
intracranial edema SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Intracranial Hemorrhage (CT) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Left facial droop SYSTEMATIC_ASSESSMENT Nervous system disorders None View
left facial weakness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
left hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Left lower quadrantanopsia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Left superior quadrantanopsia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mental Fogginess- distraction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Photophobia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Positive pronator drift test SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pre-syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Facial muscle weakness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Short term memory difficulty SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View