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 @ 4:59 AM
Ignite Modification Date: 2025-12-26 @ 3:59 AM
NCT ID: NCT00618618
Description: None
Frequency Threshold: 5
Time Frame: From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
Study: NCT00618618
Study Brief: Phase 2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Deoxycholic Acid Injection 0.2 mL/0.7 cm Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. None None 0 24 24 24 View
Deoxycholic Acid Injection 0.2 mL/1.0 cm Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. None None 1 13 13 13 View
Deoxycholic Acid Injection 0.4 mL/1.0 cm Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. None None 0 20 20 20 View
Pooled Placebo Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. None None 0 14 14 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Bile Duct Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection Site Anaesthesia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection Site Induration SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection Site Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection Site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection Site Pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection Site Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection Site Nodule SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection Site Discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection Site Discolouration SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection Site Haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection Site Papule SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection Site Rash SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Pain In Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Muscle Spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Musculoskeletal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Joint Stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Faeces Pale SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Rosacea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Hair Growth Abnormal SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Vaginal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Sinus Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Productive Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Arthropod Bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Limb Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Chromaturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Premenstrual Syndrome SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Ear Pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 11.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Eye Swelling SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Gastrooesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Injection Site Bruising SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection Site Reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection Site Vesicles SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection Site Warmth SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Streptococcal Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Tooth Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Periorbital haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Blood Glucose Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Blood Pressure Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Lower Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Eye Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View