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 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:11 AM
NCT ID:
NCT00307034
Description:
Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
Frequency Threshold:
5
Time Frame:
Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods.
Study:
NCT00307034
Study Brief:
Safety & Immunogenicity Study of 10-Valent Pneumococcal Conjugate Vaccine When Administered as a 2-Dose Schedule
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 I Group | Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh. | None | None | 5 | 175 | 173 | 175 | View |
| Synflorix II Group | Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh. | None | None | 7 | 176 | 175 | 176 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Asthma (Primary phase) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | View |
| Febrile convulsion (Booster phase) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.0 | View |
| Dyspepsia (Primary phase) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| Dermatitis allergic (Primary phase) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.0 | View |
| Respiratory syncytial virus infection (Primary phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Bronchopneumonia (Primary phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Gastroenteritis (Primary phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Gastroenteritis viral (Primary phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Lower respiratory tract infection (Primary phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Salmonellosis (Primary phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Tracheitis (Primary phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Urinary tract infection (Primary phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Viral infection (Primary phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Otitis media (Booster phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Pneumonia (Booster phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Urinary tract infection (Booster phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cough (Primary phase) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | View |
| Cough (Booster phase) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | View |
| Pain (Primary phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Redness (Primary phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Swelling (Primary phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Pain (Booster phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Redness (Booster phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Swelling (Booster phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Drowsiness (Primary phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Fever- rectal (Primary phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Irritability (Primary phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Loss of appetite (Primary phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Drowsiness (Booster phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Fever- rectal (Booster phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Irritability (Booster phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Loss of appetite (Booster phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Pyrexia (Primary phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Pyrexia (Booster phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| Nasopharyngitis (Primary phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Nasopharyngitis (Booster phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Otitis media (Booster phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |