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: 2025-12-25 @ 5:02 AM
Ignite Modification Date: 2025-12-26 @ 4:03 AM
NCT ID: NCT02809118
Description: None
Frequency Threshold: 0
Time Frame: For each participant, adverse event data were collected from day 0 to day 91(±7).
Study: NCT02809118
Study Brief: Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo gel for intratympanic use Placebo: Placebo gel is administered with a single dose into the affected ear after topical anesthesia 0 None 1 18 8 18 View
AM-111 0.4 mg/ml AM-111 gel for intratympanic use (0.4 mg/ml AM-111) AM-111 0.4 mg/ml: AM-111 0.4 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia 0 None 1 19 11 19 View
AM-111 0.8 mg/ml AM-111 gel for intratympanic use (0.8 mg/ml AM-111) AM-111 0.8 mg/ml: AM-111 0.8 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia 0 None 0 19 10 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.0 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 19.0 View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 19.0 View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA Version 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA Version 19.0 View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA Version 19.0 View
Vertigo positional NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA Version 19.0 View
Ear discomfort NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA Version 19.0 View
Ear pruritus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA Version 19.0 View
Eustachian tube disfunction NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA Version 19.0 View
Otorrhoea NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA Version 19.0 View
Tympanic membrane perforation SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA Version 19.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 19.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 19.0 View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 19.0 View
Nystagmus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 19.0 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 19.0 View
Dyspesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 19.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 19.0 View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 19.0 View
Irritable bowel syndrome NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 19.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 19.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 19.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 19.0 View
Acute sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 19.0 View
Hepatitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 19.0 View
Hordeolum NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 19.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 19.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 19.0 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.0 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.0 View
Facial pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.0 View
Feeling hot NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.0 View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.0 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.0 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.0 View
Thirst NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.0 View
Fasciitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 19.0 View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 19.0 View
Muscoloskeletal stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 19.0 View
Temporomandibular joint syndrome NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 19.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 19.0 View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 19.0 View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 19.0 View
Dermatitis acneiform NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 19.0 View
Pruritus generalised NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 19.0 View
Conjunctival hyperaemia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 19.0 View
Eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 19.0 View
Ocular hyperaemia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 19.0 View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 19.0 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 19.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 19.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 19.0 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 19.0 View
Diabetes mellitus NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 19.0 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 19.0 View
Mastocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 19.0 View
Splenomegaly NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 19.0 View
Depressed mood NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 19.0 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 19.0 View
Emotional disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 19.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 19.0 View
Aortic dilation NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 19.0 View
Hot flush NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 19.0 View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 19.0 View
Colour blindness NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA Version 19.0 View
Meningioma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 19.0 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 19.0 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 19.0 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 19.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 19.0 View
Throat irritation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 19.0 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 19.0 View
Dyspesia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 19.0 View