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 @ 1:16 PM
Ignite Modification Date: 2025-12-25 @ 12:24 PM
NCT ID: NCT00759395
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00759395
Study Brief: Study of Antidepressant Efficacy of a Selective, High Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder (AMDD)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AZD2327 AZD2327 3mg BID Tablet, Oral, Daily None None 1 13 13 13 View
Placebo Placebo BID, Tablet, Oral, Daily None None 0 9 9 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypotension None Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Flatulence None Gastrointestinal disorders None View
Thirst None General disorders None View
Pollakiuria None Renal and urinary disorders None View
Nausea None Gastrointestinal disorders None View
Abdominal Discomfort None Gastrointestinal disorders None View
Faeces discoloured None Gastrointestinal disorders None View
Dysgeusia None Nervous system disorders None View
Vomiting None Gastrointestinal disorders None View
Weight Increased None Investigations None View
Weight Decreased None Investigations None View
Muscle spasms None Musculoskeletal and connective tissue disorders None View
Libido Decreased None Psychiatric disorders None View
Genital Discomfort None Reproductive system and breast disorders None View
Libido Increased None Psychiatric disorders None View
Menstruation Irregular None Reproductive system and breast disorders None View
Dysuria None Renal and urinary disorders None View
Premenstrual syndrome None Reproductive system and breast disorders None View
Dizziness None Nervous system disorders None View
Headache None Nervous system disorders None View
Dental Care None Surgical and medical procedures None View
Dry Mouth None Gastrointestinal disorders None View
Gingival Disorder None Gastrointestinal disorders None View
Salivary Hypersecretion None Gastrointestinal disorders None View
Mouth Ulceration None Gastrointestinal disorders None View
Akathisia None Nervous system disorders None View
Dyskinesia None Nervous system disorders None View
Oedema None General disorders None View
Muscle Rigidity None Musculoskeletal and connective tissue disorders None View
Myalgia None Musculoskeletal and connective tissue disorders None View
Tic None Psychiatric disorders None View
Tremor None Nervous system disorders None View
Malignant Dysphagia None Gastrointestinal disorders None View
Influenza None Infections and infestations None View
Nasal Congestion None Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal Pain None Respiratory, thoracic and mediastinal disorders None View
Disturbance in attaention None Nervous system disorders None View
Confusional State None Psychiatric disorders None View
Depression None Psychiatric disorders None View
Initial Insomnia None Psychiatric disorders None View
Somnolence None Psychiatric disorders None View
Terminal Insomnia None Psychiatric disorders None View
Hallucinations None Psychiatric disorders None View
Poor quality sleep None Nervous system disorders None View
Irritability None General disorders None View
Memory Impairment None Nervous system disorders None View
Hypokinesia None Psychiatric disorders None View
Wheezing None Respiratory, thoracic and mediastinal disorders None View
Hypertension None Vascular disorders None View
Breast pain None Reproductive system and breast disorders None View
Ear Pain None Ear and labyrinth disorders None View
Tinnitus None Ear and labyrinth disorders None View
Vision blurred None Eye disorders None View
Eye Irritation None Eye disorders None View
Decreased Appetite None Metabolism and nutrition disorders None View
Increased Appetite None Metabolism and nutrition disorders None View
Constipation None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Psychomotor Hyperactivity None Psychiatric disorders None View
Dysarthria None Nervous system disorders None View
Suicidal Behavior None Psychiatric disorders None View
Suicidal Ideation None Psychiatric disorders None View
Fatigue None General disorders None View
Skin irritation None Skin and subcutaneous tissue disorders None View
Hyperhidrosis None Skin and subcutaneous tissue disorders None View
Injury None Injury, poisoning and procedural complications None View
Pyrexia None General disorders None View
Hypotension None Vascular disorders None View
Tachycardia None Cardiac disorders None View
Chest Pain None General disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Dyspnoea None Respiratory, thoracic and mediastinal disorders None View