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 @ 12:09 AM
Ignite Modification Date: 2025-12-25 @ 10:09 PM
NCT ID: NCT00845858
Description: All AEs were followed in accordance with good medical practice until resolved or fully characterized. AEs that were ongoing at the end of the study were followed for at least 72 hours to determine the status of the event. All serious and related AEs that occurred within 30 days after the last dose of study drug were captured.
Frequency Threshold: 2
Time Frame: All adverse events (AEs) (from signing of Informed Consent Form until termination of study drug [28 days]), whether observed by the Investigator, reported by the subject, from laboratory findings, or other means, were captured.
Study: NCT00845858
Study Brief: Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Patients With Gastroparesis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Metoclopramide Nasal Spray 10 mg metoclopramide: 30 minutes before meals and at bedtime for 4 weeks None None 0 95 53 95 View
Metoclopramide Nasal Spray 14 mg metoclopramide: 30 minutes before meals and at bedtime for 4 weeks None None 2 95 57 95 View
Placebo Nasal Spray Placebo: 30 minutes before meals and at bedtime None None 3 95 53 95 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Non cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.1 View
Kidney infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Diabetic Ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Chronic Obstructive Pulmonary Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Condition aggravated SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Glycosylated Haemoglobin Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
Muscle Strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
Pollakiurua SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.1 View
Seasonal Allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 11.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Throat Irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Dry Throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Hyperglycemia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Hypoglycemia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Decreased Appetite SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Blood Glucose Increase SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Electrocardiogram Qt Prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Dysguesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Dyspesia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Gastrooesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Abdominal Pain Lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Eructation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Nasal Discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View