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 @ 11:42 PM
Ignite Modification Date: 2025-12-25 @ 9:34 PM
NCT ID: NCT00985751
Description: None
Frequency Threshold: 5
Time Frame: Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
Study: NCT00985751
Study Brief: Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
GSK 2189242A-LD Group Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). 0 None 5 51 47 51 View
GSK 2189242A-HD Group Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). 0 None 3 52 49 52 View
Synflorix/GSK 2189242A-LD Group Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). 0 None 5 52 49 52 View
Synflorix/GSK 2189242A-HD Group Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). 0 None 0 51 49 51 View
Synflorix Group Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate). 0 None 4 51 49 51 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Accidental exposure SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Foreign body SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Open wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Adenoidal hypertrophy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Febrile convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Ear haemorrhage SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 14.0 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Affective disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Type 1 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Gastroenteritis salmonella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Pharyngo-tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 14.0 View
Pain Primary SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Redness Primary SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Swelling Primary SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Pain Booster SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Redness Booster SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Swelling Booster SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Drowsiness Primary SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Irritability Primary SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Loss of appetite Primary SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Temperature/Rectally Primary SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Drowsiness Booster SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Irritability Booster SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Loss of appetite Booster SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Temperature/Rectally Booster SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Nasopharyngitis Primary SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Nasopharyngitis Booster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Rhinitis Primary SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Rhinitis Booster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Varicella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View