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 @ 12:10 AM
Ignite Modification Date: 2025-12-25 @ 10:11 PM
NCT ID: NCT02737358
Description: Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Frequency Threshold: 0
Time Frame: 3 months (randomization to last post-treatment follow-up visit)
Study: NCT02737358
Study Brief: N-acetylcysteine for Tobacco Use Disorder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
N-Acetylcysteine (NAC) NAC will be given to half of the study participants. The dose of NAC will be 2400 mg per day (1200 mg taken twice per day as two 600 mg capsules) N-acetylcysteine (NAC): NAC or matched placebo will be given to study participants for 8 weeks. 0 None 0 59 33 59 View
Placebo Matched placebo will be given to half of the study participants. Placebo: Matched placebo (2 capsules taken in the morning and evening) will be taken by study participants for eight weeks. All participants will receive brief smoking cessation counseling and support. 0 None 0 55 32 55 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chromaturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Depressed Mood SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Folliculitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hip Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypertension (worsening) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Animal Bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cardiac Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back Pain (Worsening) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dermatitis Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza Like Illness SYSTEMATIC_ASSESSMENT Infections and infestations None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral Herpes SYSTEMATIC_ASSESSMENT Infections and infestations None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Intervertebral Disc Protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Malposition Teeth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mood Swings SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in Jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Peri-umbilical Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Post Operative Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Post Traumatic Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Shoulder Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin Abrasion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sore Throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sprained Knee SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Stomachache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tachycarida SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tooth Abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vivid Dreams SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View