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 @ 11:43 PM
Ignite Modification Date: 2025-12-25 @ 9:34 PM
NCT ID: NCT00248651
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00248651
Study Brief: Functional Dyspepsia Treatment Trial
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 escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks. None None 0 97 20 97 View
Amitriptyline Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding. None None 0 97 29 97 View
Escitalopram Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks. None None 0 98 28 98 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Change in appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intestinal fluid SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Liver function abnormality SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Nausea/Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Depression SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dream abnormalities SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tingling SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vasovagal syncope SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abrasion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Infection SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Decreased libido SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Enlarged thyroid SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hot/cold sensitivity SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Ovarian cysts SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Menstrual disorder SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Edema SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Weight gain SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain (other than back and pelvic) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pelvic pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Infectious SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Non-infectious SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Infection SYSTEMATIC_ASSESSMENT Eye disorders None View
Non-infection SYSTEMATIC_ASSESSMENT Eye disorders None View
Vision changes SYSTEMATIC_ASSESSMENT Eye disorders None View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Prostate infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Black Stools SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
C. Difficile Infection SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Drowsiness or Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Bruising SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Infectious SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Non-infectious SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View