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 @ 11:53 PM
Ignite Modification Date: 2025-12-25 @ 9:48 PM
NCT ID: NCT03705351
Description: None
Frequency Threshold: 0
Time Frame: 15 weeks (8 weeks after completion of trimodal therapy)
Study: NCT03705351
Study Brief: Tumor Treating Fields With Chemoradiation in Newly Diagnosed GBM
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Safety lead-in Cohort Participants who finished the DLT period and were assessed by investigators 1 None 3 7 4 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thrombocytopenia - worsened SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Decreased lymphocytopenia SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia (decreased hemoglobin) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pain in lymph node, right cervical region SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Enlarged lymph node right cervical region SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Right Field Cut SYSTEMATIC_ASSESSMENT Eye disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mild constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea - worsened from baseline SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue in evenings SYSTEMATIC_ASSESSMENT General disorders None View
Generalized fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Impaired tandem gait SYSTEMATIC_ASSESSMENT General disorders None View
Allergic reaction due to OPTUNE - rash - diffuse SYSTEMATIC_ASSESSMENT Immune system disorders None View
Allergic reaction - rash, diffuse unknown origin SYSTEMATIC_ASSESSMENT Immune system disorders None View
Itching due to allergic reaction - diffuse, unknown origin SYSTEMATIC_ASSESSMENT Immune system disorders None View
Conjunctivitis in left eye SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bruising on abdomen, secondary to itching SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Scabs on knees from falls SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Increased ALT SYSTEMATIC_ASSESSMENT Investigations None View
Increased creatinine SYSTEMATIC_ASSESSMENT Investigations None View
Increased glucose SYSTEMATIC_ASSESSMENT Investigations None View
Decreased albumin SYSTEMATIC_ASSESSMENT Investigations None View
Decreased calcium SYSTEMATIC_ASSESSMENT Investigations None View
Decreased lymphocytes SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocytes, decreased SYSTEMATIC_ASSESSMENT Investigations None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Slight weight gain SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Weight loss SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Low Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Right Shoulder Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dull, throbbing headached - lower right side back of head SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysarthria NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysphasia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Facial Muscle Weakness (Left Side) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headaches - intermittent SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache - worsened from baseline SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Imbalance SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Left sided weakness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Memory Impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizures SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tingling - right side of face SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tingling in fingers - both hands SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Twitch on top of head - intermittent SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Worsening Imbalance SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vaginal bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Voice alteration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Blisters on scalp - diffuse SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Contact dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dryness on scalp - diffuse SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Edema - scalp - right side SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema, scalp SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema of temples SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema on scalp - front left side SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema scalp - circumferential under diodes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema scalp - diffuse SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Folliculitis - back of hand SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Folliculitis on lower back of head SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Itching on scalp - diffuse SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Itchy scalp - location not specified SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Moist dsequamation - right side of head SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Scalp blisters - diffuse SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Scalp peeling - left frontal lobe SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Two blisters on the back of head SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia - worsened SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Eye strain - right eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry skin on scalp - front left side SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dryness of skin on scalp - diffuse SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin Ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Three open sores on front left side of scalp SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View