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 @ 12:13 AM
Ignite Modification Date: 2025-12-25 @ 10:15 PM
NCT ID: NCT00345358
Description: Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Frequency Threshold: 5
Time Frame: Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases.
Study: NCT00345358
Study Brief: Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Synflorix <6M Group This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate). None None 18 150 149 150 View
Synflorix 12-23M Group This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate). None None 2 150 144 150 View
Synflorix >=24M Group This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate). None None 0 150 135 150 View
Synflorix 7-11M Group This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate). None None 6 150 145 150 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bronchitis chronic - PRI NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Psychomotor retardation - PRI NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Abdominal pain upper - PRI NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pneumonia - PRI NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pyelonephritis acute - PRI NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis - PRI NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis rotavirus - PRI NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis media - PRI NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Exanthema subitum - PRI NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza - PRI NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory syncytial virus bronchiolitis - PRI NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory syncytial virus infection - PRI NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bacterial infection - BST NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis - BST NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Injection site haematoma SYSTEMATIC_ASSESSMENT General disorders None View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders None View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Swelling SYSTEMATIC_ASSESSMENT General disorders None View
Teething SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View