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 @ 2:51 AM
Ignite Modification Date:
2025-12-26 @ 1:32 AM
NCT ID:
NCT04875533
Description:
Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.
Frequency Threshold:
5
Time Frame:
SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only.
Study:
NCT04875533
Study Brief:
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Pneumococcal Vaccine-Naïve Adults 60 Years of Age and Older in Japan, Korea, and Taiwan
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 20vPnC/Saline (Vaccination 1) | Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) | 0 | None | 3 | 711 | 448 | 711 | View |
| 13vPnC/PPSV23 (Vaccination 1) | Participants aged 60 years and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1). | 0 | None | 4 | 710 | 439 | 710 | View |
| 20vPnC/Saline (Vaccination 2) | Participants aged 60 years and above received a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1). | 0 | None | 4 | 695 | 78 | 695 | View |
| 13vPnC/PPSV23 (Vaccination 2) | Participants aged 60 years and above received a single dose of 0.5mL PPSV23 intramuscularly at Vaccination 2 (28 to 42 Days after Vaccination 1). | 0 | None | 3 | 699 | 333 | 699 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v25.1 | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v25.1 | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA v25.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Inguinal hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Pneumonia bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Viral rash | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Intervertebral disc protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Adenocarcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | View |
| Cerebral infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Ureterolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v25.1 | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v25.1 | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v25.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fatigue (FATIGUE) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Injection site erythema (REDNESS) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Injection site pain (PAIN) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Injection site swelling (SWELLING) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Arthralgia (JOINT PAIN) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Myalgia (MUSCLE PAIN) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Headache (HEADACHE) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |