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 @ 1:06 PM
Ignite Modification Date: 2025-12-25 @ 12:21 PM
NCT ID: NCT04211961
Description: None
Frequency Threshold: 0
Time Frame: From randomisation through to study completion, an average of about 4 weeks.
Study: NCT04211961
Study Brief: Scopolamine in Bipolar Depression
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Scopolamine Participants randomised to the treatment group will receive one 15-minute IV infusion of Scopolamine (dose 4μg/kg) at 4 visits. 1 None 3 26 25 26 View
Placebo Participants randomised to the placebo group will receive one 15-minute IV infusion of 100mL Saline at 4 visits. 0 None 1 24 14 24 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Emotional distress NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suspected suicide NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depressed mood NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Aphthous ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Respiratory disorder NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Abdominal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Blood glucose increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Colonoscopy NON_SYSTEMATIC_ASSESSMENT Investigations None View
Confusional state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness postural NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Endometriosis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Feeling abnormal NON_SYSTEMATIC_ASSESSMENT General disorders None View
Flushing NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Gingival abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Helminthic infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hot flush NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Joint swelling NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lower respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders None View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Panic reaction NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Restless legs syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sensation of foreign body NON_SYSTEMATIC_ASSESSMENT General disorders None View
Skin lesion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tension NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Tension headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Thirst NON_SYSTEMATIC_ASSESSMENT General disorders None View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Type 2 diabetes mellitus NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Vessel puncture site bruise NON_SYSTEMATIC_ASSESSMENT General disorders None View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vulvovaginal candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View