Adverse Events Module

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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 @ 1:44 AM
Ignite Modification Date: 2025-12-26 @ 12:02 AM
NCT ID: NCT03802994
Description: Adverse events were collected starting at day 7, 1 month, 6 months, 1 year, varying per participant depending on duration of enrollment. Adverse events were collected from every participant enrolled, including those that dropped out of the study after their initial immunization and blood draw..
Frequency Threshold: 0
Time Frame: Adverse events were collected over the duration of the duration of enrollment thus varying from participant to participant.
Study: NCT03802994
Study Brief: Pneumococcal Conjugate Vaccine in Aging Renal Transplant
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
1.Aging RT Renal transplant recipients between 65-75 years of age, on stable immunosuppression. who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23). Cause or renal failure was either DMII or HTN. Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) . 0 None 0 9 0 9 View
2.Young RT Renal transplant recipients between 35-45 years of age, on stable immunosuppression. who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23). Cause or renal failure was either DMII or HTN. Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) . 0 None 0 12 0 12 View
3.Healthy Elderly Healthy persons between the ages 65-75 who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23) Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) . 0 None 0 15 0 15 View
4.Elderly DMII or HTN and Normal Renal Function Persons between the ages 65-75 with DMII or hypertension but normal renal function who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23) Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) . 0 None 0 11 0 11 View
5.Healthy Young Healthy persons between the ages 35-45 who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) . 0 None 0 10 0 10 View
Serious Events(If Any):
Other Events(If Any):