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 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
NCT ID:
NCT04583618
Description:
Analysis was performed on SafAS.
Frequency Threshold:
5
Time Frame:
AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Study:
NCT04583618
Study Brief:
Study of a Pneumococcal Conjugate Vaccine in Adults Aged 50 to 84 Years.
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Group 1: SP0202-IIb | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-IIb formulation at Day 1. | 0 | None | 3 | 151 | 113 | 151 | View |
| Group 2: SP0202-VI | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1. | 1 | None | 7 | 151 | 122 | 151 | View |
| Group 3: SP0202-VII | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1. | 1 | None | 3 | 148 | 112 | 148 | View |
| Group 4: Prevnar 13 | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1. | 0 | None | 2 | 149 | 102 | 149 | View |
| Group 5: Pneumovax 23 | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1. | 0 | None | 2 | 150 | 93 | 150 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 24.1 | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 24.1 | View |
| Cardiac Arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 24.1 | View |
| Small Intestinal Obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 24.1 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
| Covid-19 Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
| Osteomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
| Pneumonia Aspiration | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
| Subdural Haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 24.1 | View |
| Oropharyngeal Squamous Cell Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | View |
| Plasma Cell Myeloma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | View |
| Prostate Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | View |
| Cerebral Haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 24.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 24.1 | View |
| Acute Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 24.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 24.1 | View |
| Injection Site Erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 24.1 | View |
| Injection Site Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 24.1 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 24.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 24.1 | View |
| Injection Site Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 24.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 24.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 24.1 | View |