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 @ 2:02 AM
Ignite Modification Date: 2025-12-26 @ 12:26 AM
NCT ID: NCT01439360
Description: None
Frequency Threshold: 5
Time Frame: Solicited local and general symptoms were assessed during the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2); unsolicited AEs were assessed during the 28-day (Days 0-27) post-vaccination period; SAEs were reported during the entire study period (approximately 6- 8 months per subject)
Study: NCT01439360
Study Brief: An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
D-QIV Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A). None None 217 6006 3427 6006 View
Control In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®). None None 201 6012 3501 6012 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypochromic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypoplastic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Immune thrombocytopenic purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphadenitis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Phimosis SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Aphthous ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intussusception SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acarodermatitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Amoebiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Amoebic dysentery SYSTEMATIC_ASSESSMENT Infections and infestations None View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ascariasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bacterial infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bacterial pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chest wall abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chikungunya virus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cholera SYSTEMATIC_ASSESSMENT Infections and infestations None View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Croup infectious SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dengue fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diarrhoea infectious SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dysentery SYSTEMATIC_ASSESSMENT Infections and infestations None View
Enterovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Escherichia pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Escherichia urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Exanthema subitum SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis norovirus SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis rotavirus SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis shigella SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hand-foot-and-mouth disease SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hepatitis a SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infectious mononucleosis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Mastoiditis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Meningitis viral SYSTEMATIC_ASSESSMENT Infections and infestations None View
Mycoplasma infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis media acute SYSTEMATIC_ASSESSMENT Infections and infestations None View
Parasitic gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Periorbital cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Peritonsillar abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngotonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia measles SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia mycoplasmal SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia respiratory syncytial viral SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia viral SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory syncytial virus bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rotavirus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Typhoid fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Varicella SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral rash SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Accidental exposure to product SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Accidental poisoning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Animal bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Burns second degree SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Chemical poisoning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Foreign body SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Foreign body aspiration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Near drowning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pelvic fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Blood electrolytes abnormal SYSTEMATIC_ASSESSMENT Investigations None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Polydipsia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Facial paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Febrile convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure anoxic SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Status epilepticus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cystitis haemorrhagic SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nephrotic syndrome SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Balanoposthitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Testicular pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Adenoidal hypertrophy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Apnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Asthmatic crisis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bronchial hyperreactivity SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bronchial obstruction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Drowning SYSTEMATIC_ASSESSMENT General disorders None View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Anaphylactic shock SYSTEMATIC_ASSESSMENT Immune system disorders None View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders None View
Atypical pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Swelling SYSTEMATIC_ASSESSMENT General disorders None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View