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 @ 2:15 AM
Ignite Modification Date: 2025-12-26 @ 12:44 AM
NCT ID: NCT00728260
Description: None
Frequency Threshold: 5.0
Time Frame: Surveillance period for serious adverse events was from the day of vaccination up to 6 months post-vaccination from the inpatient database.
Study: NCT00728260
Study Brief: 36-Month Post-marketing Surveillance and Analysis of Menactra Vaccine in 2-10 Year Olds
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Menactra Vaccine Recipients Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination. Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31-180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses. Menactra vaccine was administered according to routine clinical practice. None None 16 1421 0 1421 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Congenital Anomaly of ureter NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 16.0 View
Sickle Cell Anemia NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 16.0 View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Febrile Illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Feeding problem NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View
Aspergillosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Pyogenic arthritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Respiratory infection, upper NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Trauma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Psychiatric NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.0 View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Small bowel obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Digestive congenital anomalies NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 16.0 View
Congenital atresia NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 16.0 View
Cerebral palsy NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 16.0 View
Cellulitis and abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Hereditary spherocytosis NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 16.0 View
Hydronephrosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16.0 View
Malignant neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16.0 View
Other non-traumatic joint disorders NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Other Events(If Any):