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 @ 2:56 PM
Ignite Modification Date: 2025-12-25 @ 1:20 PM
NCT ID: NCT01616459
Description: Analysis of AEs and SAEs was performed on all subjects who received at least one primary vaccination dose or at least the booster vaccination. Analysis of solicited symptoms was performed on subjects who received at least one primary vaccination or at least the booster vaccination and for whom results were available.
Frequency Threshold: 5
Time Frame: Solicited symptoms: during the 4 days post-primary and post-booster vaccination. Unsolicited AEs: during 31 days post-primary and post-booster vaccination. SAEs: during the whole study period (from Day 0 to Month 11).
Study: NCT01616459
Study Brief: Immunogenicity and Safety of Two Formulations of GSK Biologicals' Pneumococcal Vaccine (2830929A and 2830930A) When Administered in Healthy Infants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
11Pn Group Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate). 0 None 29 240 234 240 View
12Pn Group Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate). 0 None 26 240 229 240 View
Synflorix Group Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate). 0 None 38 230 221 230 View
Prevnar13 Group Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ). 0 None 24 241 235 241 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypotonic-hyporesponsive episode NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Myoclonus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Bronchitis chronic NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Febrile convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Gastroenteritis rotavirus NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Head injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Bronchospasm NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Impetigo NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory syncytial virus bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Adenoiditis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Atelectasis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Bronchiectasis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Burning sensation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Dacryostenosis congenital NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Dermatitis allergic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Escherichia pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Exposure to toxic agent NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Foreign body NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Gastroenteritis adenovirus NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Hypotonia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Ingrowing nail NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Intervertebral discitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis media acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Paronychia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngotonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pyomyositis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory tract infection viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Retinoblastoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Thermal burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Varicella NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Inguinal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchopneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Escherichia urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Laryngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pertussis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia respiratory syncytial viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory syncytial virus bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tracheitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Concussion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Toxicity to various agents NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Milk allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bacterial pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Breast abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Redness SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Drowsiness SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Irritability/Fussiness SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Loss of appetite SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fever (rectal temperature ≥ 38°C) SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Redness SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Drowsiness SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Irritability/Fusiness SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Loss of appetite SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fever (rectal temperature ≥ 38°C) SYSTEMATIC_ASSESSMENT General disorders MedDRA View