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 @ 10:45 PM
Ignite Modification Date: 2025-12-25 @ 8:15 PM
NCT ID: NCT01285635
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01285635
Study Brief: A Study of AT-101 in Combination With Docetaxel in Squamous Cell Carcinoma Of The Head and Neck
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Docetaxel Then Metronomic AT-101 Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles. None None 6 13 12 13 View
Pulse AT-101 Then Metronomic AT-101 AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles. None None 7 11 11 11 View
Metronomic AT-101 Arm AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles. None None 6 11 9 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Aspiration None Respiratory, thoracic and mediastinal disorders None View
Fatigue None General disorders None View
Hematoma None Vascular disorders None View
Jejunal obstruction None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Periorbital infection None Infections and infestations None View
Pharyngeal fistula None Respiratory, thoracic and mediastinal disorders None View
Syncope None Nervous system disorders None View
Anorexia None Metabolism and nutrition disorders None View
Diarrhea None Gastrointestinal disorders None View
Hyponatremia None Metabolism and nutrition disorders None View
Hypoxia None Respiratory, thoracic and mediastinal disorders None View
Infections and infestations - Other None Infections and infestations None View
Pain None General disorders None View
Vomiting None Gastrointestinal disorders None View
Death NOS None General disorders None View
Stoma site infection None Infections and infestations None View
Febrile neutropenia None Blood and lymphatic system disorders None View
Lung infection None Respiratory, thoracic and mediastinal disorders None View
Laryngeal stenosis None Respiratory, thoracic and mediastinal disorders None View
Neoplasms benign, malignant and unspecified - Other None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Upper gastrointestinal hemorrhage None Gastrointestinal disorders None View
Dysphagia None Gastrointestinal disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Gastrointestinal disorders - Other None Gastrointestinal disorders None View
Hypotension None Cardiac disorders None View
Pharyngeal hemorrhage None Respiratory, thoracic and mediastinal disorders None View
Respiratory, thoracic and mediastinal disorders None Respiratory, thoracic and mediastinal disorders None View
Sepsis None Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Agitation None Psychiatric disorders None View
Alanine aminotransferase increased None Investigations None View
Alkaline phosphatase increased None Investigations None View
Alopecia None Skin and subcutaneous tissue disorders None View
Anemia None Blood and lymphatic system disorders None View
Anorexia None Metabolism and nutrition disorders None View
Arthritis None Musculoskeletal and connective tissue disorders None View
Aspartate aminotransferase increased None Investigations None View
Atrial flutter None Cardiac disorders None View
Back pain None Musculoskeletal and connective tissue disorders None View
Blurred vision None Eye disorders None View
Bruising None Injury, poisoning and procedural complications None View
Cholesterol high None Investigations None View
Confusion None Psychiatric disorders None View
Constipation None Gastrointestinal disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Creatinine increased None Investigations None View
Dehydration None Metabolism and nutrition disorders None View
Delirium None Psychiatric disorders None View
Depression None Psychiatric disorders None View
Diarrhea None Gastrointestinal disorders None View
Dizziness None Ear and labyrinth disorders None View
Dry skin None Skin and subcutaneous tissue disorders None View
Dysgeusia None Gastrointestinal disorders None View
Dyspepsia None Gastrointestinal disorders None View
Dysphagia None Gastrointestinal disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Edema limbs None General disorders None View
Epistaxis None Respiratory, thoracic and mediastinal disorders None View
Eye disorders - Other None Eye disorders None View
Fatigue None General disorders None View
Fever None General disorders None View
Flushing None Skin and subcutaneous tissue disorders None View
Generalized muscle weakness None Musculoskeletal and connective tissue disorders None View
Genital edema None General disorders None View
Headache None Nervous system disorders None View
Hematoma None Vascular disorders None View
Hemorrhoids None Gastrointestinal disorders None View
Hoarseness None Respiratory, thoracic and mediastinal disorders None View
Hyperglycemia None Metabolism and nutrition disorders None View
Hypernatremia None Metabolism and nutrition disorders None View
Hypoalbuminemia None Metabolism and nutrition disorders None View
Hypocalcemia None Metabolism and nutrition disorders None View
Hypokalemia None Metabolism and nutrition disorders None View
Hyponatremia None Metabolism and nutrition disorders None View
Hypophosphatemia None Metabolism and nutrition disorders None View
Hypotension None Cardiac disorders None View
Hypothyroidism None Endocrine disorders None View
Hypoxia None Respiratory, thoracic and mediastinal disorders None View
INR increased None Investigations None View
Infections and infestations - Other None Infections and infestations None View
Insomnia None Psychiatric disorders None View
Laryngeal inflammation None Gastrointestinal disorders None View
Localized edema None General disorders None View
Lung infection None Respiratory, thoracic and mediastinal disorders None View
Lymph node pain None Vascular disorders None View
Lymphedema None Vascular disorders None View
Lymphocyte count decreased None Blood and lymphatic system disorders None View
Mucositis oral None Gastrointestinal disorders None View
Myalgia None Musculoskeletal and connective tissue disorders None View
Nail discoloration None Skin and subcutaneous tissue disorders None View
Nausea None Gastrointestinal disorders None View
Neck pain None Musculoskeletal and connective tissue disorders None View
Nervous system disorders - Other None Nervous system disorders None View
Neutrophil count decreased None Blood and lymphatic system disorders None View
Oral pain None Gastrointestinal disorders None View
Otitis externa None Ear and labyrinth disorders None View
Pain None General disorders None View
Pain in extremity None General disorders None View
Paresthesia None Nervous system disorders None View
Peripheral motor neuropathy None Nervous system disorders None View
Peripheral sensory neuropathy None Nervous system disorders None View
Pharyngitis None Infections and infestations None View
Platelet count decreased None Blood and lymphatic system disorders None View
Postnasal drip None Respiratory, thoracic and mediastinal disorders None View
Productive cough None Respiratory, thoracic and mediastinal disorders None View
Pruritus None Skin and subcutaneous tissue disorders None View
Rash acneiform None Skin and subcutaneous tissue disorders None View
Rash pustular None Skin and subcutaneous tissue disorders None View
Scleral disorder None Eye disorders None View
Skin and subcutaneous tissue disorders - Other None Skin and subcutaneous tissue disorders None View
Sore throat None Gastrointestinal disorders None View
Stroke None Nervous system disorders None View
Tinnitus None Ear and labyrinth disorders None View
Transient ischemic attacks None Nervous system disorders None View
Tremor None General disorders None View
Urinary frequency None Renal and urinary disorders None View
Vascular disorders - Other None Vascular disorders None View
Vomiting None Gastrointestinal disorders None View
Watering eyes None Eye disorders None View
Weight loss None General disorders None View
Wheezing None Respiratory, thoracic and mediastinal disorders None View
White blood cell decreased None Blood and lymphatic system disorders None View
Abdominal pain None Gastrointestinal disorders None View
Chills None General disorders None View
Edema face None General disorders None View
Facial pain None General disorders None View
Gingival pain None General disorders None View
Hypercalcemia None Metabolism and nutrition disorders None View
Hypertension None Cardiac disorders None View
Hyperthyroidism None Endocrine disorders None View
Hypomagnesemia None Metabolism and nutrition disorders None View
Infusion related reaction None Injury, poisoning and procedural complications None View
Injection site reaction None Injury, poisoning and procedural complications None View
Leukocytosis None Blood and lymphatic system disorders None View
Malaise None General disorders None View
Metabolism and nutrition disorders - Other None Metabolism and nutrition disorders None View
Pericardial effusion None Cardiac disorders None View
Pleural effusion None Respiratory, thoracic and mediastinal disorders None View
Rash maculo-papular None Skin and subcutaneous tissue disorders None View
Renal and urinary disorders - Other None Renal and urinary disorders None View
Sinus pain None General disorders None View
Sinus tachycardia None Cardiac disorders None View
Supraventricular tachycardia None Cardiac disorders None View
Thromboembolic event None Vascular disorders None View
Tracheal hemorrhage None Injury, poisoning and procedural complications None View
Tracheostomy site bleeding None Injury, poisoning and procedural complications None View
Trismus None Musculoskeletal and connective tissue disorders None View
Upper respiratory infection None Respiratory, thoracic and mediastinal disorders None View
Urinary incontinence None Renal and urinary disorders None View
Acute kidney injury None Renal and urinary disorders None View
Anxiety None Psychiatric disorders None View
Cognitive disturbance None Psychiatric disorders None View
Dry mouth None Gastrointestinal disorders None View
Ear pain None Ear and labyrinth disorders None View
Eye pain None Eye disorders None View
Eyelid function disorder None Eye disorders None View
Fall None Injury, poisoning and procedural complications None View
Flatulence None Gastrointestinal disorders None View
Flu like symptoms None Infections and infestations None View
Gastric fistula None Gastrointestinal disorders None View
Gastroesophageal reflux disease None Gastrointestinal disorders None View
Hot flashes None Endocrine disorders None View
Hyperhidrosis None Endocrine disorders None View
Hypoglycemia None Metabolism and nutrition disorders None View
Lethargy None General disorders None View
Mucosal infection None Infections and infestations None View
Non-cardiac chest pain None Musculoskeletal and connective tissue disorders None View
Otitis media None Ear and labyrinth disorders None View
Salivary gland infection None Infections and infestations None View
Skin infection None Infections and infestations None View
Surgical and medical procedures - Other None Injury, poisoning and procedural complications None View