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:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT05489328
Description:
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
Frequency Threshold:
5
Time Frame:
Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
Study:
NCT05489328
Study Brief:
Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Candidate-1 | Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention. | 0 | None | 0 | 41 | 25 | 41 | View |
| Candidate-2 | Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention. | 0 | None | 0 | 42 | 27 | 42 | View |
| Candidate-3 | Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention. | 0 | None | 0 | 39 | 21 | 39 | View |
| Candidate-4 | Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention. | 0 | None | 0 | 44 | 28 | 44 | View |
| Candidate-5 | Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention. | 0 | None | 1 | 45 | 30 | 45 | View |
| Candidate-6 | Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention. | 0 | None | 0 | 46 | 30 | 46 | View |
| Candidate - Control | Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention. | 0 | None | 0 | 45 | 22 | 45 | View |
| PCV15 | Participants were administered a single intramuscular injection of pneumococcal 15-valent conjugate (PCV15) vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention. | 0 | None | 0 | 43 | 32 | 43 | View |
| 13vPnC | Participants were administered a single intramuscular injection of Prevnar 13 vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention. | 0 | None | 0 | 46 | 37 | 46 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fatigue (FATIGUE) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Injection site erythema (REDNESS) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Injection site pain (PAIN) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Injection site swelling (SWELLING) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Pyrexia (FEVER) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Arthralgia (JOINT PAIN) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Myalgia (MUSCLE PAIN) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Headache (HEADACHE) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |