Adverse Events Module

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 @ 7:54 PM
Ignite Modification Date: 2025-12-25 @ 5:30 PM
NCT ID: NCT03224104
Description: Both serious adverse events (SAEs) and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed all registered patients. SAEs and all AEs were assessed in the registered patients who have started their allocated treatments.
Frequency Threshold: 0
Time Frame: Adverse Events (AEs) and All-Cause Mortality evaluated from TG02 treatment start to 30 days post-final dose or until chronic/stable. SAEs/serious suspected adverse reactions reported within 30 days followed until resolved/chronic/stable. All-Cause Mortality assessed until study end or loss to follow-up. Adverse Events (AEs) and All-Cause Mortality were evaluated up to 25 months from start of enrolment.
Study: NCT03224104
Study Brief: Multi-kinase Inhibitor TG02 (TG02) in Elderly Newly Diagnosed or Adult Relapsed Patients With Anaplastic Astrocytoma or Glioblastoma.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group A - TG02 + RT - 150 mg In Group A - TG02 + RT - 150 mg, we included patients who received TG02 at the initial 150 mg dose 7 None 4 9 9 9 View
Group B - TG02 + TMZ - 100 mg In Group B - TG02 + TMZ - 100 mg, we included patients who received TG02 at the initial 100 mg dose 3 None 0 3 3 3 View
Group B - TG02 + TMZ - 150 mg In Group B - TG02 + TMZ - 150 mg, we included patients who received TG02 at the initial 150 mg dose 3 None 3 6 6 6 View
Group C - TG02 In Group C - TG02 , we included patients who received TG02 at the initial 150 mg dose 42 None 13 50 46 50 View
Group A - TG02 + RT - 100 mg In Group A - TG02 + RT - 100 mg, we included patients who received TG02 at the initial 100 mg dose 3 None 2 3 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Colonic Perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Worsening Of General Condition SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Worsening Of General Condition Due To Clinical Progression SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Dystelectasis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Inhalation Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Brain Edema SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Edema Cerebral SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Neurological Worsening SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Other AE* SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Right Capsulolenticular Intraparenchymal Hematomas And Oedema SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Worsening Of Hemiparesis Left SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Skin Rash Toxidermia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Clinical Status Worsening SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Other AE SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Vascular Access Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (5.0) View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Tumor Hemorrhage SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (5.0) View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Convulsive Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Thromboembolic Event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (5.0) View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (5.0) View
Fecal Incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Gallstone Without Cholecystitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Gastroesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Pain Hypochondrial Left SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Asthenia SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Balance Disorder SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Clinical Status Worsening SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Flu Like Symptoms SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Gait Disturbance SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Ideomotor Deceleration SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Loss Of Appetite SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Malaise SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Other AE SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Reduced General Condition SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Transient Hemiparesis Left Side SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Worsening Of General Condition SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Worsening Of General Condition Due To Clinical Progr SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Allergic Reaction SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (5.0) View
Bronchial Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Covid-19 Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Dystelectasis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Herpes Simplex Reactivation SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Inhalation Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Soft Tissue Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Tooth Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (5.0) View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (5.0) View
Vascular Access Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (5.0) View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Blood Bilirubin Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Cardiac Troponin T Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Cd4 Lymphocytes Decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Cpk Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Decreased Lymphocyte Count SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Hypokalaemia SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Hyponatremia SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Increased Alt SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Increased Crp SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Lymphocyte Count Decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Neutropenia SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Platelet Count Decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Weight Gain SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Weight Loss SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hypoproteinemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Thigh Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Neoplasm Benign, Malignant And Unspecified SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (5.0) View
Tumor Hemorrhage SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (5.0) View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Brain Edema SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Cerebral Edema SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Cognitive Disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Convulsive Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Dysphasia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Edema Cerebral SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Frontal Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Hemiparesis Left SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Intracranial Hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Ischemia Cerebrovascular SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Left Hemiparisis 3/5 SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Left Lower Limb Deficit SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Memory Impairment SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Motor Degradation In The Left Hand SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Muscle Weakness Left Sided SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Muscle Weakness Left-Sided SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Worsening Of Hemiparesis Left SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Worsening Of Neurocognitive Deficits SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (5.0) View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (5.0) View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (5.0) View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (5.0) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (5.0) View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (5.0) View
Polyuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (5.0) View
Urinary Frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (5.0) View
Urinary Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (5.0) View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Common Cold SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Lung Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Respiratory Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Bedsore SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Thromboembolic Event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Vascular Access Compilation SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Pain Shoulder SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Hot Flashes SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Sinus Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (5.0) View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (5.0) View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (5.0) View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (5.0) View
Dry Eye SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (5.0) View
Hemianopsie Left SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (5.0) View
Periorbital Edema SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (5.0) View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Colonic Perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Pain In Both Feet SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
White Blood Cell Decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Muscle Weakness Right-Sided SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Neurological Worsening SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Other Nervous System Disorders- Hemiparesis Right SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Right Capsulolenticular Intraparenchymal Hematomas A SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Hirsutism SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Rash Maculo-Papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Skin And Subcutaneous Tissue Disorders, Other: Wound SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Skin Rash Toxidermia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View