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 @ 10:43 PM
Ignite Modification Date: 2025-12-25 @ 8:14 PM
NCT ID: NCT02963935
Description: Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Frequency Threshold: 5
Time Frame: From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days.
Study: NCT02963935
Study Brief: Effect and Safety of Liraglutide 3.0 mg as an Adjunct to Intensive Behaviour Therapy for Obesity in a Non-specialist Setting
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lira 3.0 mg Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. 0 None 6 142 124 142 View
Placebo Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. 0 None 2 140 101 140 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21 View
Ovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21 View
Papillary thyroid cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 21 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View