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 @ 12:03 PM
Ignite Modification Date: 2025-12-25 @ 11:58 AM
NCT ID: NCT01051661
Description: None
Frequency Threshold: 5
Time Frame: Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Study: NCT01051661
Study Brief: Safety and Efficacy of H1N1 Vaccines in Children Aged 6 Months to Less Than 10 Years of Age
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arepanrix 1D 6M-3Y Group Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. 1 None 29 612 439 612 View
GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months to 3 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. 0 None 33 613 446 613 View
GSK2340273A 3Y-10Y Group Subjects, male and female, aged 3 years to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm). 0 None 35 1436 891 1436 View
Arepanrix 2D 6M-3Y Group Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. 1 None 35 610 498 610 View
Arepanrix 2D 3Y-10Y Group Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm). 1 None 41 1438 1116 1438 View
Arepanrix 1D 3Y-10Y Group Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm). 0 None 37 1436 1047 1436 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Guillain-barre syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Extremity necrosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Subgaleal haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Idiopathic thrombocytopenic purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Cheilitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Intussusception SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Lymphadenitis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Faecaloma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Food poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Peritoneal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Rectal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Tongue disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Drowning SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.0 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Acute tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Amoebiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Carbuncle SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Conjunctivitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Dengue fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Gastritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Gastroenteritis rotavirus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Hand-foot-and-mouth disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Parasitic gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Periorbital cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pharyngotonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pneumonia parainfluenzae viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pneumonia viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pulmonary tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Craniocerebral injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Eye injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Facial bones fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Forearm fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Foreign body SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Osteosclerosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Synovitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Thyroid cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Extrapyramidal disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Febrile convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Glomerulonephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Vaginal laceration SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Asthmatic crisis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Bronchial hyperreactivity SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Nasal septum disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Tonsillar hypertrophy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Urticaria chronic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Sexual abuse SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 15.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Adenoiditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Ascariasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Ileus paralytic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Hepatitis a SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Hepatitis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Infectious mononucleosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Meningitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Meningitis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Tracheitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Typhoid fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Varicella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Mechanical ventilation complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Multiple injuries SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Toxicity to various agents SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Ulna fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Diarrohoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View