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 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
NCT ID:
NCT00502593
Description:
None
Frequency Threshold:
5
Time Frame:
Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Study:
NCT00502593
Study Brief:
Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) 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 |
|---|---|---|---|---|---|---|---|---|
| GSK1562902A -A Lot 1 3-5Y Group | Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21. | None | None | 0 | 51 | 42 | 51 | View |
| Fluarix-A 3-5Y Group | Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21. | None | None | 0 | 18 | 17 | 18 | View |
| GSK1562902A-A Lot 1 6-9Y Group | Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21. | None | None | 0 | 51 | 48 | 51 | View |
| Fluarix-A 6-9Y Group | Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21. | None | None | 0 | 18 | 14 | 18 | View |
| GSK1562902A-B Lot 2 3-5Y Group | Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21. | None | None | 1 | 51 | 42 | 51 | View |
| Fluarix-B 3-5Y Group | Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21. | None | None | 1 | 17 | 11 | 17 | View |
| GSK1562902A-B Lot 2 6-9Y Group | Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21. | None | None | 0 | 49 | 41 | 49 | View |
| Fluarix-B 6-9Y Group | Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21. | None | None | 0 | 17 | 13 | 17 | View |
| GSK1562902A-C Lot 3 3-5Y Group | Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21. | None | None | 2 | 49 | 43 | 49 | View |
| Fluarix-C 3-5Y Group | Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21. | None | None | 0 | 17 | 13 | 17 | View |
| GSK1562902A-C Lot 3 6-9Y Group | Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21. | None | None | 1 | 49 | 46 | 49 | View |
| Fluarix-C 6-9Y Group | Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21. | None | None | 0 | 18 | 17 | 18 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Autoimmune hepatitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Transaminases increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Type 1 diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Wound | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Traumatic brain injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Injection site reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Folliculitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Impetigo | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Myringitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Torticollis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Upper respiratory tract inflammation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Herpangina | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Laryngitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Scarlet fever | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Acute tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Thermal burn | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Tooth injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Otitis media acute | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Bronchitis chronic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Dermatitis contact | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Hepatic enzyme increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Transaminases increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Varicella | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Fibula fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Pityriasis rosea | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Tic | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Tooth abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pharyngolaryngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Ecchymosis | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Induration | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Redness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Swelling | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Drowsiness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fever (axillary temperature >=37.5°C) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Loss of appetite | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Shivering | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Sweating | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fever (axillary temperature >= 37.5°C) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Gastrointestinal symptoms | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Shivering | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Sweating | SYSTEMATIC_ASSESSMENT | General disorders | None | View |