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 @ 5:49 PM
Ignite Modification Date: 2025-12-25 @ 3:15 PM
NCT ID: NCT01781468
Description: None
Frequency Threshold: 0
Time Frame: Up to 8 weeks
Study: NCT01781468
Study Brief: Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm I (150 mg Armodafinil) Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks. 0 None 12 109 55 109 View
Arm II (250 mg Armodafinil) Patients receive 250 mg Armodafinil orally every day in the morning for 8 weeks. 2 None 9 110 60 110 View
Arm III (Placebo) Patients receive placebo orally every day in the morning for 8 weeks. 1 None 8 109 42 109 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12 View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Neoplasms benign, mal, uncpec - Oth spec SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12 View
Aphonia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Edema cerebral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Hypersomnia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Movements involuntary SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Muscle weakness right-sided SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Gen disord and admin site conds-Oth spec SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
GGT increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Metabolism, nutrition disord - Oth spec SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Musculoskeletal, conn tissue - Oth spec SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Dysphasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Hypersomnia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Muscle weakness left-sided SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Personality change SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Voice alteration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Skin and subcut tissue disord - Oth spec SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View
Superficial thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View