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 @ 3:53 AM
Ignite Modification Date: 2025-12-26 @ 2:43 AM
NCT ID: NCT02243202
Description: Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
Frequency Threshold: 2
Time Frame: Up to 33 weeks
Study: NCT02243202
Study Brief: Effects of Co-administration of Canagliflozin 300 mg and Phentermine 15 mg With Placebo in the Treatment of Non-Diabetic Overweight and Obese Participants
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 Participants received placebo tablets orally for 26 weeks. None None 0 82 41 82 View
Phentermine 15 mg Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks. None None 0 85 37 85 View
Canagliflozin 300 mg Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks. None None 0 84 42 84 View
Canagliflozin 300 mg/Phentermine 15 mg Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks. None None 1 83 42 83 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA Version 18.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 18.0 View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 18.0 View
Abdominal Distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 18.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 18.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 18.0 View
Dry Mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 18.0 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 18.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 18.0 View
Rectal Haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 18.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 18.0 View
Acute Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 18.0 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 18.0 View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 18.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 18.0 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 18.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 18.0 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 18.0 View
Pharyngitis Streptococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 18.0 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 18.0 View
Tooth Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 18.0 View
Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 18.0 View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 18.0 View
Viral Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 18.0 View
Vulvovaginal Candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 18.0 View
Vulvovaginal Mycotic Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 18.0 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 18.0 View
Muscle Strain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 18.0 View
Blood Creatine Phosphokinase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 18.0 View
Decreased Appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 18.0 View
Polydipsia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 18.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 18.0 View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 18.0 View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 18.0 View
Pain in Extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 18.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 18.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 18.0 View
Tension Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 18.0 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 18.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 18.0 View
Sleep Disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 18.0 View
Sinus Congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 18.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 18.0 View