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 @ 10:40 PM
Ignite Modification Date: 2025-12-25 @ 8:11 PM
NCT ID: NCT03548935
Description: All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomized treatment and no later than the date of last dose + 7 weeks.
Frequency Threshold: 5
Time Frame: week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of Semaglutide or placebo.
Study: NCT03548935
Study Brief: STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sema 2.4 mg Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity. 1 None 128 1306 1052 1306 View
Placebo Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity. 1 None 42 655 447 655 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Abdominoplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 22 View
Abortion spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 22 View
Actinic keratosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Acute stress disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22 View
Anal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22 View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Appendicitis perforated SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Arthritis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Arthropathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Atrial tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Bacterial colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22 View
Bone prosthesis insertion SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 22 View
Calculus urinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22 View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Cervix carcinoma stage 0 SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Cholecystectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 22 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22 View
Chronic sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Colitis ischaemic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Coronary artery stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Costochondritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Cranial nerve disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Cytomegalovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 22 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Dysfunctional uterine bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 22 View
Ectopic pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 22 View
Empyema SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 22 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Gastric bypass SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 22 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Gastroenteritis astroviral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Gastrointestinal stromal tumour SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Glioblastoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Gun shot wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22 View
Hairy cell leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Hepatitis E SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Hiatus hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Hidradenitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22 View
Hip surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 22 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 22 View
Hypertransaminasaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Idiopathic intracranial hypertension SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Intervertebral disc degeneration SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Intervertebral disc operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 22 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Intraductal proliferative breast lesion SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Invasive ductal breast carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Large intestine infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Ligament rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Meniere's disease SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 22 View
Meningitis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Meniscus injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Myalgia intercostal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Nasal polyps SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22 View
Nerve compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Neutropenic sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Oesophageal achalasia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Optic ischaemic neuropathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 22 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Ovarian adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Ovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 22 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Papillary thyroid cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Peroneal nerve palsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Pleurisy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Psychogenic seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Respiratory syncytial virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Splenic haemorrhage SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22 View
Thoracic vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Tonsillar hypertrophy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Toxoplasmosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Uterine haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 22 View
Vascular stent occlusion SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 22 View
Vertigo CNS origin SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Volvulus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Eructation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View