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 @ 10:46 PM
Ignite Modification Date: 2025-12-25 @ 8:16 PM
NCT ID: NCT02721069
Description: None
Frequency Threshold: 5
Time Frame: 12 months
Study: NCT02721069
Study Brief: Repeat Dose Safety Study of NRL-1 in Epilepsy Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NRL-1 5mg Intranasal dose of NRL-1 will be administered at 5, 10, 15, and 20 mg based on age and weight. 0 None 2 9 6 9 View
NRL-1 10mg Intranasal dose of NRL-1 will be administered at 5, 10, 15, and 20 mg based on age and weight. 0 None 20 54 34 54 View
NRL-1 15mg Intranasal dose of NRL-1 will be administered at 5, 10, 15, and 20 mg based on age and weight. 0 None 15 46 24 46 View
NRL-1 20mg Intranasal dose of NRL-1 will be administered at 5, 10, 15, and 20 mg based on age and weight. 1 None 13 54 21 54 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Status Epilepticus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Seizure Cluster SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Disturbance in Attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Generalised tonic-clonic seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Lennox-Gastaut Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Muscle Spasticity SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Partial Seizures SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Petit Mal Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Postictal State SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Large Intestinal Ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Proctalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Hip Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Joint Dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Thermal Burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Wound Dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Wrist Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Sudden Unexplained Death in Epilepsy SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pneumonia Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Acute Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Restrictive Pulmonary Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Chronic Myeloid Leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Colorectal Adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Hallucination, Visual SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Major Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Feeding Disorder SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Scoliosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Uterine Haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Mitral Valve Prolapse SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Brain Lobectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Appendicitis Perforated SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Colonic Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngitis Streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Nasal Discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View