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 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
NCT ID:
NCT01641133
Description:
None
Frequency Threshold:
5
Time Frame:
Solicited local and general symptoms: during the 4-day post primary and booster vaccination period; Unsolicited AEs: during the 31-day post primary and booster vaccination period; SAEs: from first vaccination (Month 0) up to study end (11-14 months).
Study:
NCT01641133
Study Brief:
Primary Vaccination With Either Synflorix™ or Prevenar 13™ or Both Vaccines and Booster Vaccination With Synflorix™
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Prevnar 2 Group | Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age. | 0 | None | 1 | 98 | 86 | 98 | View |
| Synflorix Group | Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age. | 0 | None | 3 | 97 | 85 | 97 | View |
| Prevnar 1 Group | Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age. | 0 | None | 4 | 99 | 88 | 99 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.1 | View |
| Bronchiolitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.1 | View |
| Respiratory syncytial virus bronchiolitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | View |
| Pain (primary phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.1 | View |
| Redness (primary phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.1 | View |
| Swelling (primary phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.1 | View |
| Pain (booster phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.1 | View |
| Redness (booster phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.1 | View |
| Swelling (booster phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.1 | View |
| Drowsiness (primary phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.1 | View |
| Irritability (primary phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.1 | View |
| Loss of appetite (primary phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.1 | View |
| Fever (primary phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.1 | View |
| Drowsiness (booster phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.1 | View |
| Irritability (booster phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.1 | View |
| Loss of appetite (booster phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.1 | View |
| Fever (booster phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.1 | View |
| Nasopharyngitis (primary phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.1 | View |
| Bronchiolitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.1 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.1 | View |
| Nasopharyngitis (booster phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.1 | View |