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: 2025-12-26 @ 4:04 PM
Ignite Modification Date: 2025-12-26 @ 4:04 PM
NCT ID: NCT01766206
Description: Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
Frequency Threshold: 0
Time Frame: Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Study: NCT01766206
Study Brief: Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects From 2 Months to 55 Years of Age in the Republic of South Korea
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MenACWY-CRM Group Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care. 0 None 8 3939 1379 3939 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site tenderness SYSTEMATIC_ASSESSMENT General disorders 21.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Eating disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Sleepiness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Diarrhea SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Nausea SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Myalgia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Arthralgia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Herpangina SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Viral pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Periodontitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Injection site warmth SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Injection site bruising SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gastritis erosive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Dermatitis allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Cold sweat SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Dyshidrotic eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Generalised erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Eating disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Nail injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Burning sensation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Conjunctivitis allergic SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Eye discharge SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Lymphadentitis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Renal cyst SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Tubulointerstitial nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Vitamin D deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Prostatic cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Impetigo SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Herpes dermatitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Otitis media acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Hand-foot-and-mouth disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Herpangina SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Viral pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pharyngitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pharyngotonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Tracheitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Bacterial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Croup infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Exanthema subitum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Gastrointestinal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Periodontitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Injection site rash SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Chronic gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gastritis erosive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Irritable bowel syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Dermatitis allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Dermatitis diaper SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Generalised erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Miliaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Seborrhoeic dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Eating disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Skin abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Conjunctivitis allergic SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Lymphadenitis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Renal cyst SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Tubulointerstitial nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 21.0 View
Vitamin D deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Prostatic cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Atopy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
sleepiness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View