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 @ 4:59 AM
Ignite Modification Date: 2025-12-26 @ 3:59 AM
NCT ID: NCT02992418
Description: SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
Frequency Threshold: 5
Time Frame: AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination.
Study: NCT02992418
Study Brief: Study of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Adacel® in Healthy Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Month 1, and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (concomitantly with Tdap booster dose) and at Month 7. 0 None 8 338 248 338 View
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Day 0 and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (sequentially, one month after the Tdap booster dose) and at Month 7. 0 None 11 342 263 342 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Jaundice Cholestatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Atypical Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Dengue Fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Incisional Hernia SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Breast Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Cerebral Infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Abortion Complete SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 19.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Rash Generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Hypertensive Heart Disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Injection Site Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View