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 @ 2:51 PM
Ignite Modification Date: 2025-12-25 @ 1:17 PM
NCT ID: NCT02192359
Description: None
Frequency Threshold: 5
Time Frame: Followed 30 days post treatment for all toxicities (min=33,max 142 days) up to 5 years for gene therapy toxicities
Study: NCT02192359
Study Brief: Carboxylesterase-Expressing Allogeneic Neural Stem Cells and Irinotecan Hydrochloride in Treating Patients With Recurrent High-Grade Gliomas
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dose Level 1: 5x10^7 (1 Dose) Carboxylesterase-expressing Allogeneic Neural Stem Cells: Given intracranially, 5x10\^7 (1 dose) Irinotecan: 180 mg/m2 4 None 0 4 4 4 View
Dose Level 2: 5x10^7 (2 Doses) Carboxylesterase-expressing Allogeneic Neural Stem Cells: Given intracranially, 5x10\^7 (2 doses) Irinotecan: 180 mg/m2 3 None 1 3 3 3 View
Dose Level 3: 1x10^8 (2 Doses) Carboxylesterase-expressing Allogeneic Neural Stem Cells: Given intracranially, 1x10\^8 (2 doses) Irinotecan: 180 mg/m2 4 None 2 4 4 4 View
Dose Level 4: 1.5x10^8 (2 Doses) Carboxylesterase-expressing Allogeneic Neural Stem Cells: Given intracranially, 1.5x10\^8 (2 doses) Irinotecan: 180 mg/m2 6 None 5 7 7 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myelodysplastic syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cerebrospinal fluid leakage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Intracranial hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Altered mental status SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Meningitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Brain abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
tachypnea SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Cushingoid SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders None View
limited peripheral vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
dry throat SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
thrush SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Edema face SYSTEMATIC_ASSESSMENT General disorders None View
Facial pain SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders None View
Irritability SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders None View
Localized edema SYSTEMATIC_ASSESSMENT General disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
balance impairment SYSTEMATIC_ASSESSMENT General disorders None View
generalized weakness SYSTEMATIC_ASSESSMENT General disorders None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Intraoperative head and neck injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Leakage from microdialysis catheters SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increase SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Weight loss SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations None View
Alkalosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Glucose intolerance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle weakness left-sided SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle weakness right-sided SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Joint range of motion decreased ce SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle weakness upper limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Right upper extremity twitching SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Aphonia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebrospinal fluid leakage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cognitive disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Concentration impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysphasia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypersomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Facial muscle weakness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
balance impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
facial twitching SYSTEMATIC_ASSESSMENT Nervous system disorders None View
pseudomeningocele SYSTEMATIC_ASSESSMENT Nervous system disorders None View
subgaleal fluid collection SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Emotional lability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
flat affect SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Postnasal drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bullous dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Scalp pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Periorbital edema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
abrasion on forehead SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
cutibacterium (propionibacterium) acnes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
erythema at site of incision SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View