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 @ 2:31 AM
Ignite Modification Date: 2025-12-26 @ 1:06 AM
NCT ID: NCT01959334
Description: None
Frequency Threshold: 0
Time Frame: The period of observation of adverse events extended from time of the first dose of study drug until the post-study completion (up to 10 weeks).
Study: NCT01959334
Study Brief: Evaluate the Immunogenicity of a Novel Glucagon Formulation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Glucagon IM Glucagon dose of 1 mg administered intramuscularly as 3 doses separated by at least 7 days. None None 0 26 21 26 View
Nasal Glucagon (NG) NG administered at 3 mg as 3 doses, separated by at least 7 days. None None 0 49 49 49 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Parosmia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Sinus headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Lacrimation increased NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Ocular hyperaemia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Eye pruritus NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Eye irritation NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Nasal discomfort NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Sneezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Throat irritation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Rhinalgia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Injection site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Feeling hot NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Injection site anaesthesia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Injection site reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Injection site discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Hot flush NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Musculoskeletal discomfort NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Iron deficiency anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Ear pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.1 View
Ear pruritus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.1 View
Eye Pain NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Ocular discomfort NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Abdominal Discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Abdominal Distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Abnormal faeces NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Salivary hypersecretion NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Administration site reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Chest discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Feeling cold NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Injection site hypoaesthesia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Injection site paraesthesia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Injection site warmth NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Hordeolum NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Administration related reaction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood glucose decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood sodium decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Neck Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Pain in jaw NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Head discomfort NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Pallor NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Paranasal sinus discomfort NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Nasal pruritus NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Nasal dryness NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Increased upper airway secretion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Hiccups NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Dry throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Tension headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Restless legs syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View