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:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2025-12-25 @ 12:21 PM
NCT ID:
NCT05420961
Description:
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
Frequency Threshold:
5
Time Frame:
Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
Study:
NCT05420961
Study Brief:
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cohort 1: V116 | Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \[23-valent\], PNEUMOVAX™23) prior to the enrollment. | 0 | None | 2 | 230 | 107 | 230 | View |
| Cohort 1: PCV15 | Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment. | 0 | None | 4 | 117 | 66 | 117 | View |
| Cohort 2: V116 | Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment. | 0 | None | 2 | 174 | 85 | 174 | View |
| Cohort 2: PPSV23 | Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment. | 0 | None | 3 | 85 | 52 | 85 | View |
| Cohort 3: V116 | Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment. | 0 | None | 2 | 105 | 51 | 105 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Myocardial ischaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Aortoenteric fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Mallory-Weiss syndrome | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Small intestinal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Cholangitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.0 | View |
| Injection site cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |
| Anal fissure | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.0 | View |
| Ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Injection site swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |